Trial Outcomes & Findings for Pre-Exposure Prophylaxis in YMSM (NCT NCT01033942)
NCT ID: NCT01033942
Last Updated: 2017-04-17
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
68 participants
Primary outcome timeframe
24 weeks
Results posted on
2017-04-17
Participant Flow
This research was conducted at two clinical sites in Chicago. Accrual was open between August 2009 and May 2011.
Young males were approached for screening in the community. If eligible, a clinic-based screening was done to confirm eligibility. If confirmed, participants attended a behavioral intervention. Then a week 0 was scheduled for randomization. 68 participants were enrolled; 10 discontinued prior to randomization, for a total of 58 participants.
Participant milestones
| Measure |
FTC/TDF as PrEP
Blinded treatment with FTC (Emtricitabine) and Tenofovir (TDf) Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
Placebo Pill Control
Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
No Pill Control
Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
20
|
19
|
19
|
|
Overall Study
COMPLETED
|
18
|
15
|
18
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
1
|
Reasons for withdrawal
| Measure |
FTC/TDF as PrEP
Blinded treatment with FTC (Emtricitabine) and Tenofovir (TDf) Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
Placebo Pill Control
Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
No Pill Control
Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
|
Overall Study
Enrolled in Extension Study
|
0
|
3
|
0
|
Baseline Characteristics
Pre-Exposure Prophylaxis in YMSM
Baseline characteristics by cohort
| Measure |
FTC/TDF as PrEP
n=20 Participants
Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
Placebo Pill Control
n=19 Participants
Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
No Pill Control
n=19 Participants
Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
Total
n=58 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
19.8 years
STANDARD_DEVIATION 1.44 • n=99 Participants
|
20.26 years
STANDARD_DEVIATION 1.45 • n=107 Participants
|
19.84 years
STANDARD_DEVIATION 0.96 • n=206 Participants
|
19.97 years
STANDARD_DEVIATION 1.30 • n=7 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
58 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
23 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
35 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
31 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
8 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
22 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=99 Participants
|
19 participants
n=107 Participants
|
19 participants
n=206 Participants
|
58 participants
n=7 Participants
|
|
Education
Eighth Grade of Less
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
1 participants
n=7 Participants
|
|
Education
GED
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
2 participants
n=7 Participants
|
|
Education
Highschool Diploma
|
10 participants
n=99 Participants
|
3 participants
n=107 Participants
|
5 participants
n=206 Participants
|
18 participants
n=7 Participants
|
|
Education
Some College
|
8 participants
n=99 Participants
|
14 participants
n=107 Participants
|
8 participants
n=206 Participants
|
30 participants
n=7 Participants
|
|
Current Employment
Unemployed
|
12 participants
n=99 Participants
|
11 participants
n=107 Participants
|
9 participants
n=206 Participants
|
32 participants
n=7 Participants
|
|
Current Employment
Full Time
|
2 participants
n=99 Participants
|
2 participants
n=107 Participants
|
2 participants
n=206 Participants
|
6 participants
n=7 Participants
|
|
Current Employment
Part Time
|
6 participants
n=99 Participants
|
6 participants
n=107 Participants
|
8 participants
n=206 Participants
|
20 participants
n=7 Participants
|
|
Housing Experience (Responded YES)
Kicked out of House Due to Sexual Orientation
|
4 participants
n=99 Participants
|
2 participants
n=107 Participants
|
3 participants
n=206 Participants
|
9 participants
n=7 Participants
|
|
Housing Experience (Responded YES)
Spent at least 1 Night in Shelter S
|
5 participants
n=99 Participants
|
6 participants
n=107 Participants
|
8 participants
n=206 Participants
|
19 participants
n=7 Participants
|
|
Housing Experience (Responded YES)
Have Exchanged Sex for Money or Place to Stay
|
2 participants
n=99 Participants
|
3 participants
n=107 Participants
|
5 participants
n=206 Participants
|
10 participants
n=7 Participants
|
|
Unprotected Anal Sex with Man in Past 30 Days
Yes
|
9 participants
n=99 Participants
|
7 participants
n=107 Participants
|
8 participants
n=206 Participants
|
24 participants
n=7 Participants
|
|
Unprotected Anal Sex with Man in Past 30 Days
No
|
11 participants
n=99 Participants
|
12 participants
n=107 Participants
|
11 participants
n=206 Participants
|
34 participants
n=7 Participants
|
|
Unprotected Anal or Vaginal Sex with Woman
Yes
|
0 participants
n=99 Participants
|
2 participants
n=107 Participants
|
1 participants
n=206 Participants
|
3 participants
n=7 Participants
|
|
Unprotected Anal or Vaginal Sex with Woman
No
|
20 participants
n=99 Participants
|
17 participants
n=107 Participants
|
18 participants
n=206 Participants
|
55 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 24 weeksThis outcome measure looked at whether the actual number of study visits conducted by 24 weeks differed by treatment group over time.
Outcome measures
| Measure |
FTC/TDF as PrEP
n=20 Participants
Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
Placebo Pill Control
n=19 Participants
Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
No Pill Control
n=19 Participants
Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
|---|---|---|---|
|
Actual Number of Study Visits Completed by 24 Weeks
|
3.5927 Visits
Standard Error 0.7387
|
4.6263 Visits
Standard Error 0.9783
|
4.6374 Visits
Standard Error 0.9784
|
PRIMARY outcome
Timeframe: Week 24Population: Not all participants answered every question and therefore the number of responses in the outcome measure data table does not match the number of participants analyzed.
Outcome measures
| Measure |
FTC/TDF as PrEP
n=20 Participants
Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
Placebo Pill Control
n=19 Participants
Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
No Pill Control
Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
|---|---|---|---|
|
Acceptability of Size of Pill
Did not like it at all
|
3 Participants
|
3 Participants
|
—
|
|
Acceptability of Size of Pill
Did not like
|
3 Participants
|
3 Participants
|
—
|
|
Acceptability of Size of Pill
Liked
|
3 Participants
|
6 Participants
|
—
|
|
Acceptability of Size of Pill
Liked a lot
|
1 Participants
|
0 Participants
|
—
|
|
Acceptability of Size of Pill
Missing response
|
10 Participants
|
7 Participants
|
—
|
PRIMARY outcome
Timeframe: Week 24Population: Not all participants answered every question and therefore the number of responses in the outcome measure data table does not match the number of participants analyzed.
Outcome measures
| Measure |
FTC/TDF as PrEP
n=20 Participants
Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
Placebo Pill Control
n=19 Participants
Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
No Pill Control
Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
|---|---|---|---|
|
Acceptability of the Taste of the Pill
Did not like it at all
|
4 participants
|
3 participants
|
—
|
|
Acceptability of the Taste of the Pill
Did not like
|
1 participants
|
4 participants
|
—
|
|
Acceptability of the Taste of the Pill
Liked
|
4 participants
|
5 participants
|
—
|
|
Acceptability of the Taste of the Pill
Liked a lot
|
1 participants
|
0 participants
|
—
|
|
Acceptability of the Taste of the Pill
Missing response
|
10 participants
|
7 participants
|
—
|
PRIMARY outcome
Timeframe: Week 24Population: Not all participants answered every question and therefore the number of responses in the outcome measure data table does not match the number of participants analyzed.
Outcome measures
| Measure |
FTC/TDF as PrEP
n=20 Participants
Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
Placebo Pill Control
n=19 Participants
Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
No Pill Control
Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
|---|---|---|---|
|
Acceptability of the Color of the Pill
Did not like it at all
|
1 participants
|
1 participants
|
—
|
|
Acceptability of the Color of the Pill
Did not like
|
2 participants
|
3 participants
|
—
|
|
Acceptability of the Color of the Pill
Liked
|
4 participants
|
5 participants
|
—
|
|
Acceptability of the Color of the Pill
Liked a lot
|
3 participants
|
3 participants
|
—
|
|
Acceptability of the Color of the Pill
Missing response
|
10 participants
|
7 participants
|
—
|
PRIMARY outcome
Timeframe: Week 24Population: Not all participants answered every question and therefore the number of responses in the outcome measure data table does not match the number of participants analyzed.
Outcome measures
| Measure |
FTC/TDF as PrEP
n=20 Participants
Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
Placebo Pill Control
n=19 Participants
Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
No Pill Control
Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
|---|---|---|---|
|
Acceptability of Taking the Pill Everyday
Did not like it at all
|
3 participants
|
1 participants
|
—
|
|
Acceptability of Taking the Pill Everyday
Did not like
|
3 participants
|
7 participants
|
—
|
|
Acceptability of Taking the Pill Everyday
Liked
|
2 participants
|
4 participants
|
—
|
|
Acceptability of Taking the Pill Everyday
Liked a lot
|
2 participants
|
0 participants
|
—
|
|
Acceptability of Taking the Pill Everyday
Missing response
|
10 participants
|
7 participants
|
—
|
PRIMARY outcome
Timeframe: Week 24Population: Not all participants answered every question and therefore the number of responses in the outcome measure data table does not match the number of participants analyzed.
Outcome measures
| Measure |
FTC/TDF as PrEP
n=20 Participants
Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
Placebo Pill Control
n=19 Participants
Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
No Pill Control
n=19 Participants
Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
|---|---|---|---|
|
Acceptability of Taking Part in the Study
Did not like it at all
|
2 participants
|
0 participants
|
0 participants
|
|
Acceptability of Taking Part in the Study
Did not like
|
0 participants
|
1 participants
|
0 participants
|
|
Acceptability of Taking Part in the Study
Liked
|
0 participants
|
2 participants
|
1 participants
|
|
Acceptability of Taking Part in the Study
Liked a lot
|
8 participants
|
9 participants
|
12 participants
|
|
Acceptability of Taking Part in the Study
Missing response
|
10 participants
|
7 participants
|
6 participants
|
PRIMARY outcome
Timeframe: Week 24Population: Not all participants answered every question and therefore the number of responses in the outcome measure data table does not match the number of participants analyzed.
Outcome measures
| Measure |
FTC/TDF as PrEP
n=20 Participants
Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
Placebo Pill Control
n=19 Participants
Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
No Pill Control
n=19 Participants
Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
|---|---|---|---|
|
Acceptability of Participating in Group Sessions
Did not like it at all
|
0 participants
|
1 participants
|
0 participants
|
|
Acceptability of Participating in Group Sessions
Did not like
|
1 participants
|
2 participants
|
0 participants
|
|
Acceptability of Participating in Group Sessions
Liked
|
0 participants
|
2 participants
|
4 participants
|
|
Acceptability of Participating in Group Sessions
Liked a lot
|
9 participants
|
7 participants
|
9 participants
|
|
Acceptability of Participating in Group Sessions
Missing response
|
10 participants
|
7 participants
|
6 participants
|
PRIMARY outcome
Timeframe: Week 24Population: Not all participants answered every question and therefore the number of responses in the outcome measure data table does not match the number of participants analyzed.
Outcome measures
| Measure |
FTC/TDF as PrEP
n=20 Participants
Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
Placebo Pill Control
n=19 Participants
Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
No Pill Control
n=19 Participants
Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
|---|---|---|---|
|
Acceptability of Being Randomly Assigned to a Group
Did not like it at all
|
1 participants
|
4 participants
|
0 participants
|
|
Acceptability of Being Randomly Assigned to a Group
Did not like
|
3 participants
|
2 participants
|
2 participants
|
|
Acceptability of Being Randomly Assigned to a Group
Liked
|
4 participants
|
4 participants
|
5 participants
|
|
Acceptability of Being Randomly Assigned to a Group
Liked a lot
|
1 participants
|
2 participants
|
6 participants
|
|
Acceptability of Being Randomly Assigned to a Group
Missing response
|
11 participants
|
7 participants
|
6 participants
|
PRIMARY outcome
Timeframe: Week 24Population: Not all participants answered every question and therefore the number of responses in the outcome measure data table does not match the number of participants analyzed.
Outcome measures
| Measure |
FTC/TDF as PrEP
n=20 Participants
Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
Placebo Pill Control
n=19 Participants
Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
No Pill Control
n=19 Participants
Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
|---|---|---|---|
|
Acceptability of Having an HIV Test at Every Visit
Did not like
|
0 participants
|
1 participants
|
0 participants
|
|
Acceptability of Having an HIV Test at Every Visit
Liked
|
0 participants
|
3 participants
|
1 participants
|
|
Acceptability of Having an HIV Test at Every Visit
Liked a lot
|
10 participants
|
8 participants
|
12 participants
|
|
Acceptability of Having an HIV Test at Every Visit
Missing response
|
10 participants
|
7 participants
|
6 participants
|
PRIMARY outcome
Timeframe: Week 24Population: Not all participants answered every question and therefore the number of responses in the outcome measure data table does not match the number of participants analyzed.
Outcome measures
| Measure |
FTC/TDF as PrEP
n=20 Participants
Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
Placebo Pill Control
n=19 Participants
Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
No Pill Control
n=19 Participants
Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
|---|---|---|---|
|
Acceptability of Risk Reduction Counseling at Every Visit
Did not like it at all
|
0 participants
|
1 participants
|
0 participants
|
|
Acceptability of Risk Reduction Counseling at Every Visit
Liked
|
1 participants
|
5 participants
|
4 participants
|
|
Acceptability of Risk Reduction Counseling at Every Visit
Liked a lot
|
9 participants
|
6 participants
|
9 participants
|
|
Acceptability of Risk Reduction Counseling at Every Visit
Missing response
|
10 participants
|
7 participants
|
6 participants
|
PRIMARY outcome
Timeframe: Week 24Population: Not all participants answered every question and therefore the number of responses in the outcome measure data table does not match the number of participants analyzed.
Outcome measures
| Measure |
FTC/TDF as PrEP
n=20 Participants
Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
Placebo Pill Control
n=19 Participants
Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
No Pill Control
n=19 Participants
Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
|---|---|---|---|
|
Acceptability of Questions About Sexual Behavior at Every Visit
Did not like it at all
|
0 participants
|
1 participants
|
0 participants
|
|
Acceptability of Questions About Sexual Behavior at Every Visit
Did not like
|
0 participants
|
1 participants
|
0 participants
|
|
Acceptability of Questions About Sexual Behavior at Every Visit
Liked
|
1 participants
|
4 participants
|
4 participants
|
|
Acceptability of Questions About Sexual Behavior at Every Visit
Liked a lot
|
9 participants
|
6 participants
|
9 participants
|
|
Acceptability of Questions About Sexual Behavior at Every Visit
Missing response
|
10 participants
|
7 participants
|
6 participants
|
PRIMARY outcome
Timeframe: Week 24Population: Not all participants answered every question and therefore the number of responses in the outcome measure data table does not match the number of participants analyzed.
Outcome measures
| Measure |
FTC/TDF as PrEP
n=20 Participants
Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
Placebo Pill Control
n=19 Participants
Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
No Pill Control
n=19 Participants
Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
|---|---|---|---|
|
Acceptability of Being Contacted by the Research Team in Between Visits
Did not like
|
0 participants
|
2 participants
|
0 participants
|
|
Acceptability of Being Contacted by the Research Team in Between Visits
Liked
|
4 participants
|
5 participants
|
3 participants
|
|
Acceptability of Being Contacted by the Research Team in Between Visits
Liked a lot
|
6 participants
|
4 participants
|
10 participants
|
|
Acceptability of Being Contacted by the Research Team in Between Visits
Missing response
|
10 participants
|
8 participants
|
6 participants
|
PRIMARY outcome
Timeframe: Week 24Population: Not all participants answered every question and therefore the number of responses in the outcome measure data table does not match the number of participants analyzed.
Outcome measures
| Measure |
FTC/TDF as PrEP
n=20 Participants
Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
Placebo Pill Control
n=19 Participants
Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
No Pill Control
n=19 Participants
Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
|---|---|---|---|
|
Acceptability of Physical Examination by a Doctor
Did not like it at all
|
0 participants
|
3 participants
|
0 participants
|
|
Acceptability of Physical Examination by a Doctor
Did not like
|
1 participants
|
0 participants
|
0 participants
|
|
Acceptability of Physical Examination by a Doctor
Liked
|
2 participants
|
3 participants
|
3 participants
|
|
Acceptability of Physical Examination by a Doctor
Liked a lot
|
7 participants
|
6 participants
|
10 participants
|
|
Acceptability of Physical Examination by a Doctor
Missing response
|
10 participants
|
7 participants
|
6 participants
|
PRIMARY outcome
Timeframe: Week 24Population: Not all participants answered every question.
Outcome measures
| Measure |
FTC/TDF as PrEP
n=20 Participants
Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
Placebo Pill Control
n=19 Participants
Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
No Pill Control
n=19 Participants
Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
|---|---|---|---|
|
Acceptability of Health Clinic for Study Visits
Did not like
|
0 participants
|
2 participants
|
0 participants
|
|
Acceptability of Health Clinic for Study Visits
Liked
|
4 participants
|
4 participants
|
3 participants
|
|
Acceptability of Health Clinic for Study Visits
Liked a lot
|
6 participants
|
6 participants
|
10 participants
|
|
Acceptability of Health Clinic for Study Visits
Missing response
|
10 participants
|
7 participants
|
6 participants
|
PRIMARY outcome
Timeframe: 4 weeksMissed doses were calculated as the number of days between the date that subject came in for their current visit and the last date the subject was dispensed medication minus the total number of days the subject records having taken their medication in the last 31 days based on self-report calendar data. Since each subject is given a 30 day supply of medication at each visit, any days after 30 days are assumed to be missed medication days and are included in the total. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days.
Outcome measures
| Measure |
FTC/TDF as PrEP
n=20 Participants
Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
Placebo Pill Control
n=19 Participants
Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
No Pill Control
Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
|---|---|---|---|
|
Number of Missed Doses Based on Self-Report Calendar Data-Week 4
|
10 Missed Doses
Interval 0.0 to 32.0
|
10 Missed Doses
Interval 0.0 to 27.0
|
—
|
PRIMARY outcome
Timeframe: Week 8Missed doses were calculated as the number of days between the date that subject came in for their current visit and the last date the subject was dispensed medication minus the total number of days the subject records having taken their medication in the last 31 days based on self-report calendar data. Since each subject is given a 30 day supply of medication at each visit, any days after 30 days are assumed to be missed medication days and are included in the total. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days.
Outcome measures
| Measure |
FTC/TDF as PrEP
n=20 Participants
Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
Placebo Pill Control
n=19 Participants
Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
No Pill Control
Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
|---|---|---|---|
|
Number of Missed Doses Based on Self-Report Calendar Data-Week 8
|
14 Missed Doses
Interval 0.0 to 28.0
|
8 Missed Doses
Interval 0.0 to 29.0
|
—
|
PRIMARY outcome
Timeframe: Week 12Missed doses were calculated as the number of days between the date that subject came in for their current visit and the last date the subject was dispensed medication minus the total number of days the subject records having taken their medication in the last 31 days based on self-report calendar data. Since each subject is given a 30 day supply of medication at each visit, any days after 30 days are assumed to be missed medication days and are included in the total. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days.
Outcome measures
| Measure |
FTC/TDF as PrEP
n=20 Participants
Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
Placebo Pill Control
n=19 Participants
Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
No Pill Control
Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
|---|---|---|---|
|
Number of Missed Doses Based on Self-Report Calendar Data-Week 12
|
10 Missed Doses
Interval 0.0 to 29.0
|
6.5 Missed Doses
Interval 0.0 to 28.0
|
—
|
PRIMARY outcome
Timeframe: Week 16Missed doses were calculated as the number of days between the date that subject came in for their current visit and the last date the subject was dispensed medication minus the total number of days the subject records having taken their medication in the last 31 days based on self-report calendar data. Since each subject is given a 30 day supply of medication at each visit, any days after 30 days are assumed to be missed medication days and are included in the total. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days.
Outcome measures
| Measure |
FTC/TDF as PrEP
n=20 Participants
Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
Placebo Pill Control
n=19 Participants
Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
No Pill Control
Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
|---|---|---|---|
|
Number of Missed Doses Based on Self-Report Calendar Data-Week 16
|
5 Missed Doses
Interval 0.0 to 27.0
|
19 Missed Doses
Interval 0.0 to 28.0
|
—
|
PRIMARY outcome
Timeframe: Week 20Missed doses were calculated as the number of days between the date that subject came in for their current visit and the last date the subject was dispensed medication minus the total number of days the subject records having taken their medication in the last 31 days based on self-report calendar data. Since each subject is given a 30 day supply of medication at each visit, any days after 30 days are assumed to be missed medication days and are included in the total. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days.
Outcome measures
| Measure |
FTC/TDF as PrEP
n=20 Participants
Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
Placebo Pill Control
n=19 Participants
Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
No Pill Control
Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
|---|---|---|---|
|
Number of Missed Doses Based on Self-Report Calendar Data-Week 20
|
5 Missed Doses
Interval 0.0 to 35.0
|
10 Missed Doses
Interval 0.0 to 27.0
|
—
|
PRIMARY outcome
Timeframe: Week 24Missed doses were calculated as the number of days between the date that subject came in for their current visit and the last date the subject was dispensed medication minus the total number of days the subject records having taken their medication in the last 31 days based on self-report calendar data. Since each subject is given a 30 day supply of medication at each visit, any days after 30 days are assumed to be missed medication days and are included in the total. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days.
Outcome measures
| Measure |
FTC/TDF as PrEP
n=20 Participants
Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
Placebo Pill Control
n=19 Participants
Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
No Pill Control
Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
|---|---|---|---|
|
Number of Missed Doses Based on Self-Report Calendar Data-Week 24
|
17 Missed Doses
Interval 0.0 to 35.0
|
5.5 Missed Doses
Interval 0.0 to 11.0
|
—
|
PRIMARY outcome
Timeframe: 24 weeksThe outcome measure presents the least square means from the generalized linear model. The outcome here is a binary variable that determines whether the subject missed a dose or not. In a binomial model with logit link, the least squares means are predicted population margins of the logits.
Outcome measures
| Measure |
FTC/TDF as PrEP
n=20 Participants
Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
Placebo Pill Control
n=19 Participants
Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
No Pill Control
Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
|---|---|---|---|
|
Number of Missed Doses Over Time Based on Self-Report Calendar Data
|
0.4752 Doses
Standard Error 0.3965
|
0.4021 Doses
Standard Error 0.3596
|
—
|
PRIMARY outcome
Timeframe: Week 4Missed doses were calculated as the number of days between the actual and expected refill dates. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days.
Outcome measures
| Measure |
FTC/TDF as PrEP
n=20 Participants
Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
Placebo Pill Control
n=19 Participants
Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
No Pill Control
Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
|---|---|---|---|
|
Number of Missed Doses Based on Medication Refill Dates-Week 4
|
0 Missed doses
Interval 0.0 to 7.0
|
0 Missed doses
Interval 0.0 to 2.0
|
—
|
PRIMARY outcome
Timeframe: Week 8Missed doses were calculated as the number of days between the actual and expected refill dates. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days.
Outcome measures
| Measure |
FTC/TDF as PrEP
n=20 Participants
Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
Placebo Pill Control
n=19 Participants
Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
No Pill Control
Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
|---|---|---|---|
|
Number of Missed Doses Based on Medication Refill Dates-Week 8
|
0 Missed doses
Interval 0.0 to 1.0
|
0 Missed doses
Interval 0.0 to 3.0
|
—
|
PRIMARY outcome
Timeframe: Week 12Missed doses were calculated as the number of days between the actual and expected refill dates. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days.
Outcome measures
| Measure |
FTC/TDF as PrEP
n=20 Participants
Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
Placebo Pill Control
n=19 Participants
Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
No Pill Control
Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
|---|---|---|---|
|
Number of Missed Doses Based on Medication Refill Dates-Week 12
|
0 Missed doses
Interval 0.0 to 7.0
|
0 Missed doses
Interval 0.0 to 1.0
|
—
|
PRIMARY outcome
Timeframe: Week 16Missed doses were calculated as the number of days between the actual and expected refill dates. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days.
Outcome measures
| Measure |
FTC/TDF as PrEP
n=20 Participants
Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
Placebo Pill Control
n=19 Participants
Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
No Pill Control
Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
|---|---|---|---|
|
Number of Missed Doses Based on Medication Refill Dates-Week 16
|
0 Missed doses
Interval 0.0 to 8.0
|
0 Missed doses
Interval 0.0 to 5.0
|
—
|
PRIMARY outcome
Timeframe: Week 20Missed doses were calculated as the number of days between the actual and expected refill dates. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days.
Outcome measures
| Measure |
FTC/TDF as PrEP
n=20 Participants
Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
Placebo Pill Control
n=19 Participants
Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
No Pill Control
Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
|---|---|---|---|
|
Number of Missed Doses Based on Medication Refill Dates-Week 20
|
0 Missed doses
Interval 0.0 to 3.0
|
0 Missed doses
Interval 0.0 to 8.0
|
—
|
PRIMARY outcome
Timeframe: 20 WeeksMissed doses were calculated as the number of days between the actual and expected refill dates. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days.
Outcome measures
| Measure |
FTC/TDF as PrEP
n=20 Participants
Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
Placebo Pill Control
n=19 Participants
Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
No Pill Control
Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
|---|---|---|---|
|
Number of Missed Doses Based on Medication Refill Dates-Overall
|
0 Missed doses
Interval 0.0 to 8.0
|
0 Missed doses
Interval 0.0 to 8.0
|
—
|
PRIMARY outcome
Timeframe: BaselinePopulation: Only two subjects in the Placebo Pill Control arm were randomly selected for tenofovir plasma concentration testing at baseline. All subjects in the FTC/TDF as PrEP arm had tenofovir plasma concentration testing and no subjects in the No Pill arm had tenofovir plasma concentration testing at baseline.
Subjects reporting tenofovir is calculated as those subjects that had a tenofovir plasma concentration greater than zero (BLQ). Subjects with BLQ+ (\<10 ng/mL) were included in this count.
Outcome measures
| Measure |
FTC/TDF as PrEP
n=20 Participants
Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
Placebo Pill Control
n=2 Participants
Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
No Pill Control
Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
|---|---|---|---|
|
Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Baseline
|
0 percentage of participants
|
0 percentage of participants
|
—
|
PRIMARY outcome
Timeframe: Week 4Population: Only two subjects in the Placebo Pill Control arm were randomly selected for tenofovir plasma concentration testing at Week 4. 19 subjects in the FTC/TDF as PrEP arm had tenofovir plasma concentration testing and no subjects in the No Pill arm had tenofovir plasma concentration testing at Week 4.
Subjects reporting tenofovir is calculated as those subjects that had a tenofovir plasma concentration greater than zero (BLQ). Subjects with BLQ+ (\<10 ng/mL) were included in this count.
Outcome measures
| Measure |
FTC/TDF as PrEP
n=19 Participants
Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
Placebo Pill Control
n=2 Participants
Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
No Pill Control
Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
|---|---|---|---|
|
Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 4
|
63.2 percentage of participants
|
0 percentage of participants
|
—
|
PRIMARY outcome
Timeframe: Week 8Population: 18 subjects in the Placebo Pill Control arm were randomly selected for tenofovir plasma concentration testing at Week 8. 17 subjects in the FTC/TDF as PrEP arm had tenofovir plasma concentration testing and 17 subjects in the No Pill arm had tenofovir plasma concentration testing at Week 8.
Subjects reporting tenofovir is calculated as those subjects that had a tenofovir plasma concentration greater than zero (BLQ). Subjects with BLQ+ (\<10 ng/mL) were included in this count.
Outcome measures
| Measure |
FTC/TDF as PrEP
n=17 Participants
Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
Placebo Pill Control
n=18 Participants
Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
No Pill Control
n=17 Participants
Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
|---|---|---|---|
|
Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 8
|
47.1 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: Week 12Population: One subject in the Placebo Pill Control arm was randomly selected for tenofovir plasma concentration testing at Week 12. 15 subjects in the FTC/TDF as PrEP arm had tenofovir plasma concentration testing and 1 subject in the No Pill arm had tenofovir plasma concentration testing at Week 12.
Subjects reporting tenofovir is calculated as those subjects that had a tenofovir plasma concentration greater than zero (BLQ). Subjects with BLQ+ (\<10 ng/mL) were included in this count.
Outcome measures
| Measure |
FTC/TDF as PrEP
n=15 Participants
Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
Placebo Pill Control
n=1 Participants
Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
No Pill Control
n=1 Participants
Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
|---|---|---|---|
|
Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 12
|
60 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: Week 16Population: 13 subjects in the Placebo Pill Control arm were randomly selected for tenofovir plasma concentration testing at Week 16. 13 subjects in the FTC/TDF as PrEP arm had tenofovir plasma concentration testing and 14 subjects in the No Pill arm had tenofovir plasma concentration testing at Week 16.
Subjects reporting tenofovir is calculated as those subjects that had a tenofovir plasma concentration greater than zero (BLQ). Subjects with BLQ+ (\<10 ng/mL) were included in this count.
Outcome measures
| Measure |
FTC/TDF as PrEP
n=13 Participants
Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
Placebo Pill Control
n=13 Participants
Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
No Pill Control
n=14 Participants
Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
|---|---|---|---|
|
Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 16
|
53.8 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: Week 20Population: One subject in the Placebo Pill Control arm was randomly selected for tenofovir plasma concentration testing at Week 20. 12 subjects in the FTC/TDF as PrEP arm had tenofovir plasma concentration testing and no subjects in the No Pill arm had tenofovir plasma concentration testing at Week 20.
Subjects reporting tenofovir is calculated as those subjects that had a tenofovir plasma concentration greater than zero (BLQ). Subjects with BLQ+ (\<10 ng/mL) were included in this count.
Outcome measures
| Measure |
FTC/TDF as PrEP
n=12 Participants
Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
Placebo Pill Control
n=1 Participants
Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
No Pill Control
Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
|---|---|---|---|
|
Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 20
|
41.7 percentage of participants
|
0 percentage of participants
|
—
|
PRIMARY outcome
Timeframe: Week 24Population: No subjects in the Placebo Pill Control arm were randomly selected for tenofovir plasma concentration testing at Week 24. 10 subjects in the FTC/TDF as PrEP arm had tenofovir plasma concentration testing and no subjects in the No Pill arm had tenofovir plasma concentration testing at Week 24.
Subjects reporting tenofovir is calculated as those subjects that had a tenofovir plasma concentration greater than zero (BLQ). Subjects with BLQ+ (\<10 ng/mL) were included in this count.
Outcome measures
| Measure |
FTC/TDF as PrEP
n=10 Participants
Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
Placebo Pill Control
Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
No Pill Control
Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
|---|---|---|---|
|
Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 24
|
20 percentage of participants
|
—
|
—
|
PRIMARY outcome
Timeframe: 24 WeeksPopulation: Participants in the No Pill Control arm were not included in the analysis. Analysis measure type is the percentage of participants in each frequency category for missed dose reason.
Outcome measures
| Measure |
FTC/TDF as PrEP
n=20 Participants
Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
Placebo Pill Control
n=19 Participants
Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
No Pill Control
Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
|---|---|---|---|
|
Frequency of Missing Study Pills Because Participant Was Away From Home
Never
|
31.76 % of participants in each category
|
48.39 % of participants in each category
|
—
|
|
Frequency of Missing Study Pills Because Participant Was Away From Home
Rarely
|
34.12 % of participants in each category
|
20.43 % of participants in each category
|
—
|
|
Frequency of Missing Study Pills Because Participant Was Away From Home
Sometimes
|
16.47 % of participants in each category
|
26.88 % of participants in each category
|
—
|
|
Frequency of Missing Study Pills Because Participant Was Away From Home
Often
|
17.65 % of participants in each category
|
4.30 % of participants in each category
|
—
|
PRIMARY outcome
Timeframe: 24 WeeksPopulation: Participants in the No Pill Control arm were not included in the analysis. Analysis measure type is the percentage of participants in each frequency category for missed dose reason.
Outcome measures
| Measure |
FTC/TDF as PrEP
n=20 Participants
Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
Placebo Pill Control
n=19 Participants
Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
No Pill Control
Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
|---|---|---|---|
|
Frequency of Missing Study Pills Because Participant Was Too Busy With Other Things
Never
|
47.06 % of participants in each category
|
58.06 % of participants in each category
|
—
|
|
Frequency of Missing Study Pills Because Participant Was Too Busy With Other Things
Rarely
|
30.59 % of participants in each category
|
16.13 % of participants in each category
|
—
|
|
Frequency of Missing Study Pills Because Participant Was Too Busy With Other Things
Sometimes
|
15.29 % of participants in each category
|
21.51 % of participants in each category
|
—
|
|
Frequency of Missing Study Pills Because Participant Was Too Busy With Other Things
Often
|
7.06 % of participants in each category
|
4.30 % of participants in each category
|
—
|
PRIMARY outcome
Timeframe: 24 WeeksPopulation: Participants in the No Pill Control arm were not included in the analysis. Analysis measure type is the percentage of participants in each frequency category for missed dose reason.
Outcome measures
| Measure |
FTC/TDF as PrEP
n=20 Participants
Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
Placebo Pill Control
n=19 Participants
Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
No Pill Control
Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
|---|---|---|---|
|
Frequency of Missing Study Pills Because Participant Simply Forgot
Never
|
38.82 % of participants in each category
|
60.22 % of participants in each category
|
—
|
|
Frequency of Missing Study Pills Because Participant Simply Forgot
Rarely
|
40.00 % of participants in each category
|
16.13 % of participants in each category
|
—
|
|
Frequency of Missing Study Pills Because Participant Simply Forgot
Sometimes
|
9.41 % of participants in each category
|
15.05 % of participants in each category
|
—
|
|
Frequency of Missing Study Pills Because Participant Simply Forgot
Often
|
11.76 % of participants in each category
|
8.60 % of participants in each category
|
—
|
PRIMARY outcome
Timeframe: 24 weeksPopulation: Participants in the No Pill Control arm were not included in the analysis. Analysis measure type is the percentage of participants in each frequency category for missed dose reason.
Outcome measures
| Measure |
FTC/TDF as PrEP
n=20 Participants
Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
Placebo Pill Control
n=19 Participants
Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
No Pill Control
Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
|---|---|---|---|
|
Frequency of Missing Study Pills Because Participant Had Too Many Study Pills to Take
Never
|
92.94 % of participants in each category
|
95.70 % of participants in each category
|
—
|
|
Frequency of Missing Study Pills Because Participant Had Too Many Study Pills to Take
Rarely
|
7.06 % of participants in each category
|
2.15 % of participants in each category
|
—
|
|
Frequency of Missing Study Pills Because Participant Had Too Many Study Pills to Take
Sometimes
|
0.00 % of participants in each category
|
1.08 % of participants in each category
|
—
|
|
Frequency of Missing Study Pills Because Participant Had Too Many Study Pills to Take
Often
|
0.00 % of participants in each category
|
1.08 % of participants in each category
|
—
|
PRIMARY outcome
Timeframe: 24 weeksPopulation: Participants in the No Pill Control arm were not included in the analysis. Analysis measure type is the percentage of participants in each frequency category for missed dose reason.
Outcome measures
| Measure |
FTC/TDF as PrEP
n=20 Participants
Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
Placebo Pill Control
n=19 Participants
Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
No Pill Control
Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
|---|---|---|---|
|
Frequency of Missing Study Pills Because Participant Wanted to Avoid Side Effects
Never
|
82.35 % of participants in each category
|
91.40 % of participants in each category
|
—
|
|
Frequency of Missing Study Pills Because Participant Wanted to Avoid Side Effects
Rarely
|
9.41 % of participants in each category
|
3.23 % of participants in each category
|
—
|
|
Frequency of Missing Study Pills Because Participant Wanted to Avoid Side Effects
Sometimes
|
0.00 % of participants in each category
|
2.15 % of participants in each category
|
—
|
|
Frequency of Missing Study Pills Because Participant Wanted to Avoid Side Effects
Often
|
8.24 % of participants in each category
|
3.23 % of participants in each category
|
—
|
PRIMARY outcome
Timeframe: 24 weeksPopulation: Participants in the No Pill Control arm were not included in the analysis. Analysis measure type is the percentage of participants in each frequency category for missed dose reason.
Outcome measures
| Measure |
FTC/TDF as PrEP
n=20 Participants
Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
Placebo Pill Control
n=19 Participants
Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
No Pill Control
Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
|---|---|---|---|
|
Frequency of Missing Study Pills Because Participant Did Not Want Others to Notice Participant Was Taking Medications
Never
|
88.24 % of participants in each category
|
92.47 % of participants in each category
|
—
|
|
Frequency of Missing Study Pills Because Participant Did Not Want Others to Notice Participant Was Taking Medications
Rarely
|
5.88 % of participants in each category
|
4.30 % of participants in each category
|
—
|
|
Frequency of Missing Study Pills Because Participant Did Not Want Others to Notice Participant Was Taking Medications
Sometimes
|
2.35 % of participants in each category
|
0.00 % of participants in each category
|
—
|
|
Frequency of Missing Study Pills Because Participant Did Not Want Others to Notice Participant Was Taking Medications
Often
|
3.53 % of participants in each category
|
3.23 % of participants in each category
|
—
|
PRIMARY outcome
Timeframe: 24 weeksPopulation: Participants in the No Pill Control arm were not included in the analysis. Analysis measure type is the percentage of participants in each frequency category for missed dose reason.
Outcome measures
| Measure |
FTC/TDF as PrEP
n=20 Participants
Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
Placebo Pill Control
n=19 Participants
Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
No Pill Control
Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
|---|---|---|---|
|
Frequency of Missing Study Pills Because Participant Had a Change in Daily Routine
Never
|
62.35 % of participants in each category
|
70.97 % of participants in each category
|
—
|
|
Frequency of Missing Study Pills Because Participant Had a Change in Daily Routine
Rarely
|
25.53 % of participants in each category
|
15.05 % of participants in each category
|
—
|
|
Frequency of Missing Study Pills Because Participant Had a Change in Daily Routine
Sometimes
|
7.06 % of participants in each category
|
10.75 % of participants in each category
|
—
|
|
Frequency of Missing Study Pills Because Participant Had a Change in Daily Routine
Often
|
7.06 % of participants in each category
|
3.23 % of participants in each category
|
—
|
PRIMARY outcome
Timeframe: 24 weeksPopulation: Participants in the No Pill Control arm were not included in the analysis. Analysis measure type is the percentage of participants in each frequency category for missed dose reason.
Outcome measures
| Measure |
FTC/TDF as PrEP
n=20 Participants
Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
Placebo Pill Control
n=19 Participants
Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
No Pill Control
Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
|---|---|---|---|
|
Frequency of Missing Pills Because Participant Felt Like the Study Pill Was Toxic/Harmful
Never
|
87.06 % of participants in each category
|
95.70 % of participants in each category
|
—
|
|
Frequency of Missing Pills Because Participant Felt Like the Study Pill Was Toxic/Harmful
Rarely
|
5.88 % of participants in each category
|
2.15 % of participants in each category
|
—
|
|
Frequency of Missing Pills Because Participant Felt Like the Study Pill Was Toxic/Harmful
Sometimes
|
3.53 % of participants in each category
|
0.00 % of participants in each category
|
—
|
|
Frequency of Missing Pills Because Participant Felt Like the Study Pill Was Toxic/Harmful
Often
|
3.53 % of participants in each category
|
2.15 % of participants in each category
|
—
|
PRIMARY outcome
Timeframe: 24 weeksPopulation: Participants in the No Pill Control arm were not included in the analysis. Analysis measure type is the percentage of participants in each frequency category for missed dose reason.
Outcome measures
| Measure |
FTC/TDF as PrEP
n=20 Participants
Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
Placebo Pill Control
n=19 Participants
Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
No Pill Control
Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
|---|---|---|---|
|
Frequency of Missing Study Pills Because Participant Fell Asleep/Slept Through Dose Time
Never
|
68.24 % of participants in each category
|
86.02 % of participants in each category
|
—
|
|
Frequency of Missing Study Pills Because Participant Fell Asleep/Slept Through Dose Time
Rarely
|
24.71 % of participants in each category
|
6.45 % of participants in each category
|
—
|
|
Frequency of Missing Study Pills Because Participant Fell Asleep/Slept Through Dose Time
Sometimes
|
4.71 % of participants in each category
|
4.30 % of participants in each category
|
—
|
|
Frequency of Missing Study Pills Because Participant Fell Asleep/Slept Through Dose Time
Often
|
2.35 % of participants in each category
|
3.23 % of participants in each category
|
—
|
PRIMARY outcome
Timeframe: 24 weeksPopulation: Participants in the No Pill Control arm were not included in the analysis. Analysis measure type is the percentage of participants in each frequency category for missed dose reason.
Outcome measures
| Measure |
FTC/TDF as PrEP
n=20 Participants
Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
Placebo Pill Control
n=19 Participants
Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
No Pill Control
Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
|---|---|---|---|
|
Frequency of Missing Study Pills Because Participant Felt Sick or Ill
Never
|
81.18 % of participants in each category
|
89.25 % of participants in each category
|
—
|
|
Frequency of Missing Study Pills Because Participant Felt Sick or Ill
Rarely
|
11.76 % of participants in each category
|
5.38 % of participants in each category
|
—
|
|
Frequency of Missing Study Pills Because Participant Felt Sick or Ill
Sometimes
|
4.71 % of participants in each category
|
3.23 % of participants in each category
|
—
|
|
Frequency of Missing Study Pills Because Participant Felt Sick or Ill
Often
|
2.35 % of participants in each category
|
2.15 % of participants in each category
|
—
|
PRIMARY outcome
Timeframe: 24 weeksPopulation: Participants in the No Pill Control arm were not included in the analysis. Analysis measure type is the percentage of participants in each frequency category for missed dose reason.
Outcome measures
| Measure |
FTC/TDF as PrEP
n=20 Participants
Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
Placebo Pill Control
n=19 Participants
Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
No Pill Control
Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
|---|---|---|---|
|
Frequency of Missing Study Pills Because Participant Felt Depressed/Overwhelmed
Never
|
83.53 % of participants in each category
|
92.47 % of participants in each category
|
—
|
|
Frequency of Missing Study Pills Because Participant Felt Depressed/Overwhelmed
Rarely
|
12.94 % of participants in each category
|
2.15 % of participants in each category
|
—
|
|
Frequency of Missing Study Pills Because Participant Felt Depressed/Overwhelmed
Sometimes
|
0.00 % of participants in each category
|
3.23 % of participants in each category
|
—
|
|
Frequency of Missing Study Pills Because Participant Felt Depressed/Overwhelmed
Often
|
3.53 % of participants in each category
|
2.15 % of participants in each category
|
—
|
PRIMARY outcome
Timeframe: 24 weeksPopulation: Participants in the No Pill Control arm were not included in the analysis. Analysis measure type is the percentage of participants in each frequency category for missed dose reason.
Outcome measures
| Measure |
FTC/TDF as PrEP
n=20 Participants
Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
Placebo Pill Control
n=19 Participants
Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
No Pill Control
Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
|---|---|---|---|
|
Frequency of Missing Study Pills Because Participant Ran Out of Study Pills
Never
|
94.12 % of participants in each category
|
97.85 % of participants in each category
|
—
|
|
Frequency of Missing Study Pills Because Participant Ran Out of Study Pills
Rarely
|
4.71 % of participants in each category
|
1.08 % of participants in each category
|
—
|
|
Frequency of Missing Study Pills Because Participant Ran Out of Study Pills
Sometimes
|
0.00 % of participants in each category
|
1.08 % of participants in each category
|
—
|
|
Frequency of Missing Study Pills Because Participant Ran Out of Study Pills
Often
|
1.18 % of participants in each category
|
0.00 % of participants in each category
|
—
|
PRIMARY outcome
Timeframe: 24 weeksPopulation: Participants in the No Pill Control arm were not included in the analysis. Analysis measure type is the percentage of participants in each frequency category for missed dose reason.
Outcome measures
| Measure |
FTC/TDF as PrEP
n=20 Participants
Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
Placebo Pill Control
n=19 Participants
Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
No Pill Control
Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
|---|---|---|---|
|
Frequency of Missing Study Pills Because Participant Didn't Think it Was Needed Because he/She Was Not Engaged in Risky Sex
Never
|
90.59 % of participants in each category
|
96.77 % of participants in each category
|
—
|
|
Frequency of Missing Study Pills Because Participant Didn't Think it Was Needed Because he/She Was Not Engaged in Risky Sex
Rarely
|
4.71 % of participants in each category
|
0.00 % of participants in each category
|
—
|
|
Frequency of Missing Study Pills Because Participant Didn't Think it Was Needed Because he/She Was Not Engaged in Risky Sex
Sometimes
|
1.18 % of participants in each category
|
2.15 % of participants in each category
|
—
|
|
Frequency of Missing Study Pills Because Participant Didn't Think it Was Needed Because he/She Was Not Engaged in Risky Sex
Often
|
3.53 % of participants in each category
|
1.08 % of participants in each category
|
—
|
PRIMARY outcome
Timeframe: Week 4Population: Not all participants answered every question
Outcome measures
| Measure |
FTC/TDF as PrEP
n=20 Participants
Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
Placebo Pill Control
n=19 Participants
Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
No Pill Control
Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
|---|---|---|---|
|
Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 4
Placebo
|
9 participants
|
10 participants
|
—
|
|
Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 4
PrEP
|
4 participants
|
1 participants
|
—
|
|
Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 4
Don't Know
|
5 participants
|
6 participants
|
—
|
|
Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 4
Don't Understand Question
|
1 participants
|
1 participants
|
—
|
PRIMARY outcome
Timeframe: Week 8Population: Not all participants answered every question
Outcome measures
| Measure |
FTC/TDF as PrEP
n=20 Participants
Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
Placebo Pill Control
n=19 Participants
Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
No Pill Control
Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
|---|---|---|---|
|
Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 8
Placebo
|
8 participants
|
9 participants
|
—
|
|
Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 8
PrEP
|
5 participants
|
2 participants
|
—
|
|
Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 8
Don't Know
|
4 participants
|
7 participants
|
—
|
|
Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 8
Don't Understand Question
|
0 participants
|
0 participants
|
—
|
PRIMARY outcome
Timeframe: Week 12Population: Not all participants answered every question
Outcome measures
| Measure |
FTC/TDF as PrEP
n=20 Participants
Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
Placebo Pill Control
n=19 Participants
Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
No Pill Control
Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
|---|---|---|---|
|
Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 12
Placebo
|
6 participants
|
6 participants
|
—
|
|
Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 12
PrEP
|
3 participants
|
2 participants
|
—
|
|
Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 12
Don't Know
|
5 participants
|
8 participants
|
—
|
|
Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 12
Don't Understand Question
|
0 participants
|
0 participants
|
—
|
PRIMARY outcome
Timeframe: Week 16Population: Not all participants answered every question
Outcome measures
| Measure |
FTC/TDF as PrEP
n=20 Participants
Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
Placebo Pill Control
n=19 Participants
Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
No Pill Control
Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
|---|---|---|---|
|
Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 16
Don't Know
|
4 participants
|
9 participants
|
—
|
|
Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 16
Don't Understand Question
|
0 participants
|
0 participants
|
—
|
|
Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 16
Placebo
|
6 participants
|
5 participants
|
—
|
|
Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 16
PrEP
|
2 participants
|
1 participants
|
—
|
PRIMARY outcome
Timeframe: Week 20Population: Not all participants answered every question
Outcome measures
| Measure |
FTC/TDF as PrEP
n=20 Participants
Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
Placebo Pill Control
n=19 Participants
Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
No Pill Control
Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
|---|---|---|---|
|
Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 20
Placebo
|
4 participants
|
6 participants
|
—
|
|
Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 20
PrEP
|
3 participants
|
2 participants
|
—
|
|
Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 20
Don't Know
|
4 participants
|
6 participants
|
—
|
|
Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 20
Don't Understand Question
|
0 participants
|
0 participants
|
—
|
PRIMARY outcome
Timeframe: Week 24Population: Not all participants answered every question
Outcome measures
| Measure |
FTC/TDF as PrEP
n=20 Participants
Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
Placebo Pill Control
n=19 Participants
Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
No Pill Control
Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
|---|---|---|---|
|
Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 24
Placebo
|
2 participants
|
8 participants
|
—
|
|
Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 24
PrEP
|
3 participants
|
0 participants
|
—
|
|
Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 24
Don't Know
|
4 participants
|
4 participants
|
—
|
|
Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 24
Don't Understand Question
|
0 participants
|
0 participants
|
—
|
PRIMARY outcome
Timeframe: Week 4Population: Not all participants answered every question
Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "Because I am in this PrEP study, I am less concerned about becoming HIV positive".
Outcome measures
| Measure |
FTC/TDF as PrEP
n=20 Participants
Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
Placebo Pill Control
n=19 Participants
Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
No Pill Control
n=19 Participants
Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
|---|---|---|---|
|
Perceived Risk of Becoming HIV Positive at Week 4
Strongly Disagree
|
52.63 percentage of participants
|
38.89 percentage of participants
|
33.33 percentage of participants
|
|
Perceived Risk of Becoming HIV Positive at Week 4
Disagree
|
21.05 percentage of participants
|
33.33 percentage of participants
|
22.22 percentage of participants
|
|
Perceived Risk of Becoming HIV Positive at Week 4
Neutral
|
10.53 percentage of participants
|
11.11 percentage of participants
|
27.78 percentage of participants
|
|
Perceived Risk of Becoming HIV Positive at Week 4
Agree
|
15.79 percentage of participants
|
11.11 percentage of participants
|
0.00 percentage of participants
|
|
Perceived Risk of Becoming HIV Positive at Week 4
Strongly Agree
|
0.00 percentage of participants
|
5.56 percentage of participants
|
16.67 percentage of participants
|
PRIMARY outcome
Timeframe: Week 8Population: Not all participants answered every question
Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "Because I am in this PrEP study, I am less concerned about becoming HIV positive".
Outcome measures
| Measure |
FTC/TDF as PrEP
n=20 Participants
Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
Placebo Pill Control
n=19 Participants
Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
No Pill Control
n=19 Participants
Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
|---|---|---|---|
|
Perceived Risk of Becoming HIV Positive at Week 8
Strongly Disagree
|
29.41 percentage of participants
|
66.67 percentage of participants
|
58.82 percentage of participants
|
|
Perceived Risk of Becoming HIV Positive at Week 8
Disagree
|
17.65 percentage of participants
|
27.78 percentage of participants
|
11.76 percentage of participants
|
|
Perceived Risk of Becoming HIV Positive at Week 8
Neutral
|
23.53 percentage of participants
|
0.00 percentage of participants
|
11.76 percentage of participants
|
|
Perceived Risk of Becoming HIV Positive at Week 8
Agree
|
23.53 percentage of participants
|
5.56 percentage of participants
|
11.76 percentage of participants
|
|
Perceived Risk of Becoming HIV Positive at Week 8
Strongly Agree
|
5.88 percentage of participants
|
0.00 percentage of participants
|
5.88 percentage of participants
|
PRIMARY outcome
Timeframe: Week 12Population: Not all participants answered every question
Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "Because I am in this PrEP study, I am less concerned about becoming HIV positive".
Outcome measures
| Measure |
FTC/TDF as PrEP
n=20 Participants
Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
Placebo Pill Control
n=19 Participants
Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
No Pill Control
n=19 Participants
Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
|---|---|---|---|
|
Perceived Risk of Becoming HIV Positive at Week 12
Strongly Disagree
|
40.00 percentage of participants
|
75.00 percentage of participants
|
31.25 percentage of participants
|
|
Perceived Risk of Becoming HIV Positive at Week 12
Disagree
|
40.00 percentage of participants
|
6.25 percentage of participants
|
37.50 percentage of participants
|
|
Perceived Risk of Becoming HIV Positive at Week 12
Neutral
|
20.00 percentage of participants
|
6.25 percentage of participants
|
12.50 percentage of participants
|
|
Perceived Risk of Becoming HIV Positive at Week 12
Agree
|
0.00 percentage of participants
|
12.50 percentage of participants
|
6.25 percentage of participants
|
|
Perceived Risk of Becoming HIV Positive at Week 12
Strongly Agree
|
0.00 percentage of participants
|
0.00 percentage of participants
|
12.50 percentage of participants
|
PRIMARY outcome
Timeframe: Week 16Population: Not all participants answered every question
Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "Because I am in this PrEP study, I am less concerned about becoming HIV positive".
Outcome measures
| Measure |
FTC/TDF as PrEP
n=20 Participants
Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
Placebo Pill Control
n=19 Participants
Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
No Pill Control
n=19 Participants
Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
|---|---|---|---|
|
Perceived Risk of Becoming HIV Positive at Week 16
Strongly Disagree
|
58.33 percentage of partcipants
|
80.00 percentage of partcipants
|
42.86 percentage of partcipants
|
|
Perceived Risk of Becoming HIV Positive at Week 16
Disagree
|
16.67 percentage of partcipants
|
13.33 percentage of partcipants
|
21.43 percentage of partcipants
|
|
Perceived Risk of Becoming HIV Positive at Week 16
Neutral
|
8.33 percentage of partcipants
|
6.67 percentage of partcipants
|
21.43 percentage of partcipants
|
|
Perceived Risk of Becoming HIV Positive at Week 16
Agree
|
8.33 percentage of partcipants
|
0.00 percentage of partcipants
|
0.00 percentage of partcipants
|
|
Perceived Risk of Becoming HIV Positive at Week 16
Strongly Agree
|
8.33 percentage of partcipants
|
0.00 percentage of partcipants
|
14.29 percentage of partcipants
|
PRIMARY outcome
Timeframe: Week 20Population: Not all participants answered every question
Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "Because I am in this PrEP study, I am less concerned about becoming HIV positive".
Outcome measures
| Measure |
FTC/TDF as PrEP
n=20 Participants
Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
Placebo Pill Control
n=19 Participants
Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
No Pill Control
n=19 Participants
Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
|---|---|---|---|
|
Perceived Risk of Becoming HIV Positive at Week 20
Strongly Disagree
|
66.67 percentage of participants
|
78.57 percentage of participants
|
30.77 percentage of participants
|
|
Perceived Risk of Becoming HIV Positive at Week 20
Disagree
|
16.67 percentage of participants
|
21.43 percentage of participants
|
23.08 percentage of participants
|
|
Perceived Risk of Becoming HIV Positive at Week 20
Neutral
|
0.00 percentage of participants
|
0.00 percentage of participants
|
23.08 percentage of participants
|
|
Perceived Risk of Becoming HIV Positive at Week 20
Agree
|
16.67 percentage of participants
|
0.00 percentage of participants
|
7.69 percentage of participants
|
|
Perceived Risk of Becoming HIV Positive at Week 20
Strongly Agree
|
0.00 percentage of participants
|
0.00 percentage of participants
|
15.38 percentage of participants
|
PRIMARY outcome
Timeframe: Week 24Population: Not all participants answered every question
Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "Because I am in this PrEP study, I am less concerned about becoming HIV positive".
Outcome measures
| Measure |
FTC/TDF as PrEP
n=20 Participants
Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
Placebo Pill Control
n=19 Participants
Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
No Pill Control
n=19 Participants
Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
|---|---|---|---|
|
Perceived Risk of Becoming HIV Positive at Week 24
Strongly Disagree
|
60.00 percentage of participants
|
75.00 percentage of participants
|
38.46 percentage of participants
|
|
Perceived Risk of Becoming HIV Positive at Week 24
Disagree
|
20.00 percentage of participants
|
8.33 percentage of participants
|
23.08 percentage of participants
|
|
Perceived Risk of Becoming HIV Positive at Week 24
Neutral
|
0.00 percentage of participants
|
16.67 percentage of participants
|
15.38 percentage of participants
|
|
Perceived Risk of Becoming HIV Positive at Week 24
Agree
|
10.00 percentage of participants
|
0.00 percentage of participants
|
7.69 percentage of participants
|
|
Perceived Risk of Becoming HIV Positive at Week 24
Strongly Agree
|
10.00 percentage of participants
|
0.00 percentage of participants
|
15.38 percentage of participants
|
PRIMARY outcome
Timeframe: Week 4Population: Not all participants answered every question
Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "I am more willing to take a chance of getting infected now that I am in this PrEP study".
Outcome measures
| Measure |
FTC/TDF as PrEP
n=20 Participants
Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
Placebo Pill Control
n=19 Participants
Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
No Pill Control
n=19 Participants
Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
|---|---|---|---|
|
Perceived HIV Risk Reduction at Week 4: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study
Strongly Disagree
|
84.21 percentage of participants
|
83.33 percentage of participants
|
94.44 percentage of participants
|
|
Perceived HIV Risk Reduction at Week 4: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study
Disagree
|
5.26 percentage of participants
|
5.56 percentage of participants
|
0.00 percentage of participants
|
|
Perceived HIV Risk Reduction at Week 4: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study
Neutral
|
10.53 percentage of participants
|
0.00 percentage of participants
|
5.56 percentage of participants
|
|
Perceived HIV Risk Reduction at Week 4: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study
Agree
|
0.00 percentage of participants
|
5.56 percentage of participants
|
0.00 percentage of participants
|
|
Perceived HIV Risk Reduction at Week 4: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study
Strongly Agree
|
0.00 percentage of participants
|
5.56 percentage of participants
|
0.00 percentage of participants
|
PRIMARY outcome
Timeframe: Week 8Population: Not all participants answered every question
Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "I am more willing to take a chance of getting infected now that I am in this PrEP study".
Outcome measures
| Measure |
FTC/TDF as PrEP
n=20 Participants
Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
Placebo Pill Control
n=19 Participants
Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
No Pill Control
n=19 Participants
Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
|---|---|---|---|
|
Perceived HIV Risk Reduction at Week 8: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study
Strongly Disagree
|
68.75 percentage of participants
|
100.00 percentage of participants
|
64.71 percentage of participants
|
|
Perceived HIV Risk Reduction at Week 8: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study
Disagree
|
25.00 percentage of participants
|
0.00 percentage of participants
|
29.41 percentage of participants
|
|
Perceived HIV Risk Reduction at Week 8: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study
Neutral
|
6.25 percentage of participants
|
0.00 percentage of participants
|
5.88 percentage of participants
|
|
Perceived HIV Risk Reduction at Week 8: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study
Agree
|
0.00 percentage of participants
|
0.00 percentage of participants
|
0.00 percentage of participants
|
|
Perceived HIV Risk Reduction at Week 8: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study
Strongly Agree
|
0.00 percentage of participants
|
0.00 percentage of participants
|
0.00 percentage of participants
|
PRIMARY outcome
Timeframe: Week 12Population: Not all participants answered every question
Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "I am more willing to take a chance of getting infected now that I am in this PrEP study".
Outcome measures
| Measure |
FTC/TDF as PrEP
n=20 Participants
Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
Placebo Pill Control
n=19 Participants
Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
No Pill Control
n=19 Participants
Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
|---|---|---|---|
|
Perceived HIV Risk Reduction at Week 12: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study
Strongly Disagree
|
60.00 percentage of participants
|
93.75 percentage of participants
|
68.75 percentage of participants
|
|
Perceived HIV Risk Reduction at Week 12: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study
Disagree
|
33.33 percentage of participants
|
0.00 percentage of participants
|
18.75 percentage of participants
|
|
Perceived HIV Risk Reduction at Week 12: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study
Neutral
|
6.67 percentage of participants
|
6.25 percentage of participants
|
12.50 percentage of participants
|
|
Perceived HIV Risk Reduction at Week 12: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study
Agree
|
0.00 percentage of participants
|
0.00 percentage of participants
|
0.00 percentage of participants
|
|
Perceived HIV Risk Reduction at Week 12: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study
Strongly Agree
|
0.00 percentage of participants
|
0.00 percentage of participants
|
0.00 percentage of participants
|
PRIMARY outcome
Timeframe: Week 16Population: Not all participants answered every question
Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "I am more willing to take a chance of getting infected now that I am in this PrEP study".
Outcome measures
| Measure |
FTC/TDF as PrEP
n=20 Participants
Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
Placebo Pill Control
n=19 Participants
Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
No Pill Control
n=19 Participants
Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
|---|---|---|---|
|
Perceived HIV Risk Reduction at Week 16: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study
Strongly Disagree
|
66.67 percentage of participants
|
93.33 percentage of participants
|
71.43 percentage of participants
|
|
Perceived HIV Risk Reduction at Week 16: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study
Disagree
|
25.00 percentage of participants
|
6.67 percentage of participants
|
7.14 percentage of participants
|
|
Perceived HIV Risk Reduction at Week 16: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study
Neutral
|
0.00 percentage of participants
|
0.00 percentage of participants
|
7.14 percentage of participants
|
|
Perceived HIV Risk Reduction at Week 16: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study
Agree
|
8.33 percentage of participants
|
0.00 percentage of participants
|
7.14 percentage of participants
|
|
Perceived HIV Risk Reduction at Week 16: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study
Strongly Agree
|
0.00 percentage of participants
|
0.00 percentage of participants
|
7.14 percentage of participants
|
PRIMARY outcome
Timeframe: Week 20Population: Not all participants answered every question
Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "I am more willing to take a chance of getting infected now that I am in this PrEP study".
Outcome measures
| Measure |
FTC/TDF as PrEP
n=20 Participants
Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
Placebo Pill Control
n=19 Participants
Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
No Pill Control
n=19 Participants
Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
|---|---|---|---|
|
Perceived HIV Risk Reduction at Week 20: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study
Strongly Disagree
|
91.67 percentage of participants
|
92.86 percentage of participants
|
61.54 percentage of participants
|
|
Perceived HIV Risk Reduction at Week 20: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study
Disagree
|
8.33 percentage of participants
|
7.14 percentage of participants
|
30.77 percentage of participants
|
|
Perceived HIV Risk Reduction at Week 20: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study
Neutral
|
0.00 percentage of participants
|
0.00 percentage of participants
|
7.69 percentage of participants
|
|
Perceived HIV Risk Reduction at Week 20: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study
Agree
|
0.00 percentage of participants
|
0.00 percentage of participants
|
0.00 percentage of participants
|
|
Perceived HIV Risk Reduction at Week 20: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study
Strongly Agree
|
0.00 percentage of participants
|
0.00 percentage of participants
|
0.00 percentage of participants
|
PRIMARY outcome
Timeframe: Week 24Population: Not all participants answered every question
Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "I am more willing to take a chance of getting infected now that I am in this PrEP study."
Outcome measures
| Measure |
FTC/TDF as PrEP
n=20 Participants
Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
Placebo Pill Control
n=19 Participants
Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
No Pill Control
n=19 Participants
Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
|---|---|---|---|
|
Perceived HIV Risk Reduction at Week 24: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study
Strongly Disagree
|
80.00 percentage of participants
|
91.67 percentage of participants
|
53.85 percentage of participants
|
|
Perceived HIV Risk Reduction at Week 24: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study
Disagree
|
20.00 percentage of participants
|
0.00 percentage of participants
|
23.08 percentage of participants
|
|
Perceived HIV Risk Reduction at Week 24: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study
Neutral
|
0.00 percentage of participants
|
0.00 percentage of participants
|
23.08 percentage of participants
|
|
Perceived HIV Risk Reduction at Week 24: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study
Agree
|
0.00 percentage of participants
|
8.33 percentage of participants
|
0.00 percentage of participants
|
|
Perceived HIV Risk Reduction at Week 24: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study
Strongly Agree
|
0.00 percentage of participants
|
0.00 percentage of participants
|
0.00 percentage of participants
|
PRIMARY outcome
Timeframe: Week 4Population: Not all participants answered every question
Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "I am a lot less worried about 'slipping up' now that PrEP may be taken prior to unprotected sex."
Outcome measures
| Measure |
FTC/TDF as PrEP
n=20 Participants
Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
Placebo Pill Control
n=19 Participants
Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
No Pill Control
n=19 Participants
Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
|---|---|---|---|
|
Perceived HIV Risk Reduction at Week 4: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex
Strongly Disagree
|
66.67 percentage of participants
|
55.56 percentage of participants
|
55.56 percentage of participants
|
|
Perceived HIV Risk Reduction at Week 4: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex
Disagree
|
5.56 percentage of participants
|
27.78 percentage of participants
|
11.11 percentage of participants
|
|
Perceived HIV Risk Reduction at Week 4: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex
Neutral
|
11.11 percentage of participants
|
5.56 percentage of participants
|
16.67 percentage of participants
|
|
Perceived HIV Risk Reduction at Week 4: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex
Agree
|
11.11 percentage of participants
|
5.56 percentage of participants
|
16.67 percentage of participants
|
|
Perceived HIV Risk Reduction at Week 4: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex
Strongly Agree
|
5.56 percentage of participants
|
5.56 percentage of participants
|
0.00 percentage of participants
|
PRIMARY outcome
Timeframe: Week 8Population: Not all participants answered every question
Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "I am a lot less worried about 'slipping up' now that PrEP may be taken prior to unprotected sex."
Outcome measures
| Measure |
FTC/TDF as PrEP
n=20 Participants
Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
Placebo Pill Control
n=19 Participants
Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
No Pill Control
n=19 Participants
Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
|---|---|---|---|
|
Perceived HIV Risk Reduction at Week 8: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex
Strongly Disagree
|
47.06 percentage of participants
|
66.67 percentage of participants
|
35.29 percentage of participants
|
|
Perceived HIV Risk Reduction at Week 8: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex
Disagree
|
29.41 percentage of participants
|
5.56 percentage of participants
|
35.29 percentage of participants
|
|
Perceived HIV Risk Reduction at Week 8: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex
Neutral
|
17.65 percentage of participants
|
27.78 percentage of participants
|
11.76 percentage of participants
|
|
Perceived HIV Risk Reduction at Week 8: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex
Agree
|
5.88 percentage of participants
|
0.00 percentage of participants
|
17.65 percentage of participants
|
|
Perceived HIV Risk Reduction at Week 8: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex
Strongly Agree
|
0.00 percentage of participants
|
0.00 percentage of participants
|
0.00 percentage of participants
|
PRIMARY outcome
Timeframe: Week 12Population: Not all participants answered every question
Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "I am a lot less worried about 'slipping up' now that PrEP may be taken prior to unprotected sex."
Outcome measures
| Measure |
FTC/TDF as PrEP
n=20 Participants
Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
Placebo Pill Control
n=19 Participants
Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
No Pill Control
n=19 Participants
Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
|---|---|---|---|
|
Perceived HIV Risk Reduction at Week 12: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex
Strongly Disagree
|
64.29 percentage of participants
|
68.75 percentage of participants
|
43.75 percentage of participants
|
|
Perceived HIV Risk Reduction at Week 12: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex
Disagree
|
0.00 percentage of participants
|
12.50 percentage of participants
|
18.75 percentage of participants
|
|
Perceived HIV Risk Reduction at Week 12: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex
Neutral
|
21.43 percentage of participants
|
12.50 percentage of participants
|
18.75 percentage of participants
|
|
Perceived HIV Risk Reduction at Week 12: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex
Agree
|
14.29 percentage of participants
|
6.25 percentage of participants
|
18.75 percentage of participants
|
|
Perceived HIV Risk Reduction at Week 12: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex
Strongly Agree
|
0.00 percentage of participants
|
0.00 percentage of participants
|
0.00 percentage of participants
|
PRIMARY outcome
Timeframe: Week 16Population: Not all participants answered every question
Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "I am a lot less worried about 'slipping up' now that PrEP may be taken prior to unprotected sex."
Outcome measures
| Measure |
FTC/TDF as PrEP
n=20 Participants
Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
Placebo Pill Control
n=19 Participants
Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
No Pill Control
n=19 Participants
Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
|---|---|---|---|
|
Perceived HIV Risk Reduction at Week 16: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex
Strongly Disagree
|
53.85 percentage of participants
|
93.33 percentage of participants
|
42.86 percentage of participants
|
|
Perceived HIV Risk Reduction at Week 16: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex
Disagree
|
15.38 percentage of participants
|
0.00 percentage of participants
|
42.86 percentage of participants
|
|
Perceived HIV Risk Reduction at Week 16: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex
Neutral
|
23.08 percentage of participants
|
6.67 percentage of participants
|
7.14 percentage of participants
|
|
Perceived HIV Risk Reduction at Week 16: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex
Agree
|
7.69 percentage of participants
|
0.00 percentage of participants
|
0.00 percentage of participants
|
|
Perceived HIV Risk Reduction at Week 16: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex
Strongly Agree
|
0.00 percentage of participants
|
0.00 percentage of participants
|
7.14 percentage of participants
|
PRIMARY outcome
Timeframe: Week 20Population: Not all participants answered every question
Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "I am a lot less worried about 'slipping up' now that PrEP may be taken prior to unprotected sex."
Outcome measures
| Measure |
FTC/TDF as PrEP
n=20 Participants
Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
Placebo Pill Control
n=19 Participants
Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
No Pill Control
n=19 Participants
Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
|---|---|---|---|
|
Perceived HIV Risk Reduction at Week 20: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex
Strongly Disagree
|
75.00 percentage of participants
|
78.57 percentage of participants
|
38.46 percentage of participants
|
|
Perceived HIV Risk Reduction at Week 20: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex
Disagree
|
25.00 percentage of participants
|
7.14 percentage of participants
|
15.38 percentage of participants
|
|
Perceived HIV Risk Reduction at Week 20: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex
Neutral
|
0.00 percentage of participants
|
7.14 percentage of participants
|
15.38 percentage of participants
|
|
Perceived HIV Risk Reduction at Week 20: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex
Agree
|
0.00 percentage of participants
|
7.14 percentage of participants
|
23.08 percentage of participants
|
|
Perceived HIV Risk Reduction at Week 20: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex
Strongly Agree
|
0.00 percentage of participants
|
0.00 percentage of participants
|
7.69 percentage of participants
|
PRIMARY outcome
Timeframe: Week 24Population: Not all participants answered every question
Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "I am a lot less worried about 'slipping up' now that PrEP may be taken prior to unprotected sex."
Outcome measures
| Measure |
FTC/TDF as PrEP
n=20 Participants
Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
Placebo Pill Control
n=19 Participants
Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
No Pill Control
n=19 Participants
Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
|---|---|---|---|
|
Perceived HIV Risk Reduction at Week 24: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex
Strongly Disagree
|
50.00 percentage of participants
|
83.33 percentage of participants
|
46.15 percentage of participants
|
|
Perceived HIV Risk Reduction at Week 24: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex
Disagree
|
30.00 percentage of participants
|
16.67 percentage of participants
|
15.38 percentage of participants
|
|
Perceived HIV Risk Reduction at Week 24: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex
Neutral
|
10.00 percentage of participants
|
0.00 percentage of participants
|
23.08 percentage of participants
|
|
Perceived HIV Risk Reduction at Week 24: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex
Agree
|
0.00 percentage of participants
|
0.00 percentage of participants
|
15.38 percentage of participants
|
|
Perceived HIV Risk Reduction at Week 24: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex
Strongly Agree
|
10.00 percentage of participants
|
0.00 percentage of participants
|
0.00 percentage of participants
|
PRIMARY outcome
Timeframe: Week 4Population: Not all participants answered every question
Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "The availability of PrEP makes me less worried about having unprotected sex."
Outcome measures
| Measure |
FTC/TDF as PrEP
n=20 Participants
Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
Placebo Pill Control
n=19 Participants
Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
No Pill Control
n=19 Participants
Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
|---|---|---|---|
|
Perceived HIV Risk Reduction at Week 4: Less Worried About Having Unprotected Sex Due to the Availability of PrEP
Strongly Disagree
|
63.16 percentage of participants
|
66.67 percentage of participants
|
55.56 percentage of participants
|
|
Perceived HIV Risk Reduction at Week 4: Less Worried About Having Unprotected Sex Due to the Availability of PrEP
Disagree
|
5.26 percentage of participants
|
16.67 percentage of participants
|
27.78 percentage of participants
|
|
Perceived HIV Risk Reduction at Week 4: Less Worried About Having Unprotected Sex Due to the Availability of PrEP
Neutral
|
10.53 percentage of participants
|
5.56 percentage of participants
|
5.56 percentage of participants
|
|
Perceived HIV Risk Reduction at Week 4: Less Worried About Having Unprotected Sex Due to the Availability of PrEP
Agree
|
21.05 percentage of participants
|
11.11 percentage of participants
|
5.56 percentage of participants
|
|
Perceived HIV Risk Reduction at Week 4: Less Worried About Having Unprotected Sex Due to the Availability of PrEP
Strongly Agree
|
0.00 percentage of participants
|
0.00 percentage of participants
|
5.56 percentage of participants
|
PRIMARY outcome
Timeframe: Week 8Population: Not all participants answered every question
Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "The availability of PrEP makes me less worried about having unprotected sex."
Outcome measures
| Measure |
FTC/TDF as PrEP
n=20 Participants
Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
Placebo Pill Control
n=19 Participants
Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
No Pill Control
n=19 Participants
Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
|---|---|---|---|
|
Perceived HIV Risk Reduction at Week 8: Less Worried About Having Unprotected Sex Due to the Availability of PrEP
Strongly Disagree
|
58.82 percentage of participants
|
66.67 percentage of participants
|
35.29 percentage of participants
|
|
Perceived HIV Risk Reduction at Week 8: Less Worried About Having Unprotected Sex Due to the Availability of PrEP
Disagree
|
17.65 percentage of participants
|
11.11 percentage of participants
|
23.53 percentage of participants
|
|
Perceived HIV Risk Reduction at Week 8: Less Worried About Having Unprotected Sex Due to the Availability of PrEP
Neutral
|
17.65 percentage of participants
|
16.67 percentage of participants
|
11.76 percentage of participants
|
|
Perceived HIV Risk Reduction at Week 8: Less Worried About Having Unprotected Sex Due to the Availability of PrEP
Agree
|
0.00 percentage of participants
|
5.56 percentage of participants
|
29.41 percentage of participants
|
|
Perceived HIV Risk Reduction at Week 8: Less Worried About Having Unprotected Sex Due to the Availability of PrEP
Strongly Agree
|
5.88 percentage of participants
|
0.00 percentage of participants
|
0.00 percentage of participants
|
PRIMARY outcome
Timeframe: Week 12Population: Not all participants answered every question
Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "The availability of PrEP makes me less worried about having unprotected sex."
Outcome measures
| Measure |
FTC/TDF as PrEP
n=20 Participants
Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
Placebo Pill Control
n=19 Participants
Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
No Pill Control
n=19 Participants
Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
|---|---|---|---|
|
Perceived HIV Risk Reduction at Week 12: Less Worried About Having Unprotected Sex Due to the Availability of PrEP
Disagree
|
20.00 percentage of participants
|
6.25 percentage of participants
|
18.75 percentage of participants
|
|
Perceived HIV Risk Reduction at Week 12: Less Worried About Having Unprotected Sex Due to the Availability of PrEP
Neutral
|
6.67 percentage of participants
|
6.25 percentage of participants
|
25.00 percentage of participants
|
|
Perceived HIV Risk Reduction at Week 12: Less Worried About Having Unprotected Sex Due to the Availability of PrEP
Agree
|
0.00 percentage of participants
|
0.00 percentage of participants
|
12.50 percentage of participants
|
|
Perceived HIV Risk Reduction at Week 12: Less Worried About Having Unprotected Sex Due to the Availability of PrEP
Strongly Agree
|
0.00 percentage of participants
|
6.25 percentage of participants
|
0.00 percentage of participants
|
|
Perceived HIV Risk Reduction at Week 12: Less Worried About Having Unprotected Sex Due to the Availability of PrEP
Strongly Disagree
|
73.33 percentage of participants
|
81.25 percentage of participants
|
43.75 percentage of participants
|
PRIMARY outcome
Timeframe: Week 16Population: Not all participants answered every question
Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "The availability of PrEP makes me less worried about having unprotected sex."
Outcome measures
| Measure |
FTC/TDF as PrEP
n=20 Participants
Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
Placebo Pill Control
n=19 Participants
Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
No Pill Control
n=19 Participants
Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
|---|---|---|---|
|
Perceived HIV Risk Reduction at Week 16: Less Worried About Having Unprotected Sex Due to the Availability of PrEP
Neutral
|
8.33 percentage of participants
|
13.33 percentage of participants
|
28.57 percentage of participants
|
|
Perceived HIV Risk Reduction at Week 16: Less Worried About Having Unprotected Sex Due to the Availability of PrEP
Agree
|
0.00 percentage of participants
|
0.00 percentage of participants
|
0.00 percentage of participants
|
|
Perceived HIV Risk Reduction at Week 16: Less Worried About Having Unprotected Sex Due to the Availability of PrEP
Strongly Disagree
|
58.33 percentage of participants
|
80.00 percentage of participants
|
35.71 percentage of participants
|
|
Perceived HIV Risk Reduction at Week 16: Less Worried About Having Unprotected Sex Due to the Availability of PrEP
Disagree
|
33.33 percentage of participants
|
6.67 percentage of participants
|
21.43 percentage of participants
|
|
Perceived HIV Risk Reduction at Week 16: Less Worried About Having Unprotected Sex Due to the Availability of PrEP
Strongly Agree
|
0.00 percentage of participants
|
0.00 percentage of participants
|
14.29 percentage of participants
|
PRIMARY outcome
Timeframe: Week 20Population: Not all participants answered every question
Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "The availability of PrEP makes me less worried about having unprotected sex."
Outcome measures
| Measure |
FTC/TDF as PrEP
n=20 Participants
Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
Placebo Pill Control
n=19 Participants
Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
No Pill Control
n=19 Participants
Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
|---|---|---|---|
|
Perceived HIV Risk Reduction at Week 20: Less Worried About Having Unprotected Sex Due to the Availability of PrEP
Strongly Disagree
|
66.67 percentage of participants
|
78.57 percentage of participants
|
53.85 percentage of participants
|
|
Perceived HIV Risk Reduction at Week 20: Less Worried About Having Unprotected Sex Due to the Availability of PrEP
Disagree
|
25.00 percentage of participants
|
14.29 percentage of participants
|
23.08 percentage of participants
|
|
Perceived HIV Risk Reduction at Week 20: Less Worried About Having Unprotected Sex Due to the Availability of PrEP
Neutral
|
8.33 percentage of participants
|
7.14 percentage of participants
|
15.38 percentage of participants
|
|
Perceived HIV Risk Reduction at Week 20: Less Worried About Having Unprotected Sex Due to the Availability of PrEP
Agree
|
0.00 percentage of participants
|
0.00 percentage of participants
|
7.69 percentage of participants
|
|
Perceived HIV Risk Reduction at Week 20: Less Worried About Having Unprotected Sex Due to the Availability of PrEP
Strongly Agree
|
0.00 percentage of participants
|
0.00 percentage of participants
|
0.00 percentage of participants
|
PRIMARY outcome
Timeframe: Week 24Population: Not all participants answered every question
Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "The availability of PrEP makes me less worried about having unprotected sex."
Outcome measures
| Measure |
FTC/TDF as PrEP
n=20 Participants
Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
Placebo Pill Control
n=19 Participants
Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
No Pill Control
n=19 Participants
Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
|---|---|---|---|
|
Perceived HIV Risk Reduction at Week 24: Less Worried About Having Unprotected Sex Due to the Availability of PrEP
Strongly Disagree
|
50.00 percentage of participants
|
83.33 percentage of participants
|
53.85 percentage of participants
|
|
Perceived HIV Risk Reduction at Week 24: Less Worried About Having Unprotected Sex Due to the Availability of PrEP
Disagree
|
30.00 percentage of participants
|
8.33 percentage of participants
|
15.38 percentage of participants
|
|
Perceived HIV Risk Reduction at Week 24: Less Worried About Having Unprotected Sex Due to the Availability of PrEP
Neutral
|
10.00 percentage of participants
|
8.33 percentage of participants
|
15.38 percentage of participants
|
|
Perceived HIV Risk Reduction at Week 24: Less Worried About Having Unprotected Sex Due to the Availability of PrEP
Agree
|
10.00 percentage of participants
|
0.00 percentage of participants
|
15.38 percentage of participants
|
|
Perceived HIV Risk Reduction at Week 24: Less Worried About Having Unprotected Sex Due to the Availability of PrEP
Strongly Agree
|
0.00 percentage of participants
|
0.00 percentage of participants
|
0.00 percentage of participants
|
PRIMARY outcome
Timeframe: Week 4Population: Not all participants answered every question
Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "I am less concerned about having unprotected anal sex now that I am in this PrEP study."
Outcome measures
| Measure |
FTC/TDF as PrEP
n=20 Participants
Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
Placebo Pill Control
n=19 Participants
Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
No Pill Control
n=19 Participants
Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
|---|---|---|---|
|
Perceived HIV Risk Reduction at Week 4: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study
Strongly Disagree
|
57.89 percentage of participants
|
66.67 percentage of participants
|
50.00 percentage of participants
|
|
Perceived HIV Risk Reduction at Week 4: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study
Disagree
|
26.32 percentage of participants
|
22.22 percentage of participants
|
27.78 percentage of participants
|
|
Perceived HIV Risk Reduction at Week 4: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study
Neutral
|
15.79 percentage of participants
|
5.56 percentage of participants
|
16.67 percentage of participants
|
|
Perceived HIV Risk Reduction at Week 4: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study
Agree
|
0.00 percentage of participants
|
5.56 percentage of participants
|
0.00 percentage of participants
|
|
Perceived HIV Risk Reduction at Week 4: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study
Strongly Agree
|
0.00 percentage of participants
|
0.00 percentage of participants
|
5.56 percentage of participants
|
PRIMARY outcome
Timeframe: Week 8Population: Not all participants answered every question
Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "I am less concerned about having unprotected anal sex now that I am in this PrEP study."
Outcome measures
| Measure |
FTC/TDF as PrEP
n=20 Participants
Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
Placebo Pill Control
n=19 Participants
Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
No Pill Control
n=19 Participants
Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
|---|---|---|---|
|
Perceived HIV Risk Reduction at Week 8: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study
Strongly Disagree
|
47.06 percentage of participants
|
83.33 percentage of participants
|
35.29 percentage of participants
|
|
Perceived HIV Risk Reduction at Week 8: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study
Disagree
|
23.53 percentage of participants
|
11.11 percentage of participants
|
41.18 percentage of participants
|
|
Perceived HIV Risk Reduction at Week 8: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study
Neutral
|
23.53 percentage of participants
|
5.56 percentage of participants
|
23.53 percentage of participants
|
|
Perceived HIV Risk Reduction at Week 8: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study
Agree
|
0.00 percentage of participants
|
0.00 percentage of participants
|
0.00 percentage of participants
|
|
Perceived HIV Risk Reduction at Week 8: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study
Strongly Agree
|
5.88 percentage of participants
|
0.00 percentage of participants
|
0.00 percentage of participants
|
PRIMARY outcome
Timeframe: Week 12Population: Not all participants answered every question
Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "I am less concerned about having unprotected anal sex now that I am in this PrEP study."
Outcome measures
| Measure |
FTC/TDF as PrEP
n=20 Participants
Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
Placebo Pill Control
n=19 Participants
Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
No Pill Control
n=19 Participants
Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
|---|---|---|---|
|
Perceived HIV Risk Reduction at Week 12: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study
Strongly Disagree
|
57.14 percentage of participants
|
81.25 percentage of participants
|
50.00 percentage of participants
|
|
Perceived HIV Risk Reduction at Week 12: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study
Disagree
|
28.57 percentage of participants
|
12.50 percentage of participants
|
18.75 percentage of participants
|
|
Perceived HIV Risk Reduction at Week 12: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study
Neutral
|
7.14 percentage of participants
|
6.25 percentage of participants
|
25.00 percentage of participants
|
|
Perceived HIV Risk Reduction at Week 12: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study
Agree
|
7.14 percentage of participants
|
0.00 percentage of participants
|
6.25 percentage of participants
|
|
Perceived HIV Risk Reduction at Week 12: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study
Strongly Agree
|
0.00 percentage of participants
|
0.00 percentage of participants
|
0.00 percentage of participants
|
PRIMARY outcome
Timeframe: Week 16Population: Not all participants answered every question
Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "I am less concerned about having unprotected anal sex now that I am in this PrEP study."
Outcome measures
| Measure |
FTC/TDF as PrEP
n=20 Participants
Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
Placebo Pill Control
n=19 Participants
Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
No Pill Control
n=19 Participants
Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
|---|---|---|---|
|
Perceived HIV Risk Reduction at Week 16: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study
Strongly Disagree
|
75.00 percentage of participants
|
80.00 percentage of participants
|
42.86 percentage of participants
|
|
Perceived HIV Risk Reduction at Week 16: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study
Disagree
|
25.00 percentage of participants
|
6.67 percentage of participants
|
28.57 percentage of participants
|
|
Perceived HIV Risk Reduction at Week 16: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study
Neutral
|
0.00 percentage of participants
|
13.33 percentage of participants
|
14.29 percentage of participants
|
|
Perceived HIV Risk Reduction at Week 16: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study
Agree
|
0.00 percentage of participants
|
0.00 percentage of participants
|
7.14 percentage of participants
|
|
Perceived HIV Risk Reduction at Week 16: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study
Strongly Agree
|
0.00 percentage of participants
|
0.00 percentage of participants
|
7.14 percentage of participants
|
PRIMARY outcome
Timeframe: Week 20Population: Not all participants answered every question
Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "I am less concerned about having unprotected anal sex now that I am in this PrEP study."
Outcome measures
| Measure |
FTC/TDF as PrEP
n=20 Participants
Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
Placebo Pill Control
n=19 Participants
Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
No Pill Control
n=19 Participants
Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
|---|---|---|---|
|
Perceived HIV Risk Reduction at Week 20: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study
Strongly Disagree
|
75.00 percentage of participants
|
92.86 percentage of participants
|
61.54 percentage of participants
|
|
Perceived HIV Risk Reduction at Week 20: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study
Disagree
|
16.67 percentage of participants
|
7.14 percentage of participants
|
23.08 percentage of participants
|
|
Perceived HIV Risk Reduction at Week 20: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study
Neutral
|
0.00 percentage of participants
|
0.00 percentage of participants
|
7.69 percentage of participants
|
|
Perceived HIV Risk Reduction at Week 20: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study
Agree
|
8.33 percentage of participants
|
0.00 percentage of participants
|
7.69 percentage of participants
|
|
Perceived HIV Risk Reduction at Week 20: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study
Strongly Agree
|
0.00 percentage of participants
|
0.00 percentage of participants
|
0.00 percentage of participants
|
PRIMARY outcome
Timeframe: Week 24Population: Not all participants answered every question
Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "I am less concerned about having unprotected anal sex now that I am in this PrEP study."
Outcome measures
| Measure |
FTC/TDF as PrEP
n=20 Participants
Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
Placebo Pill Control
n=19 Participants
Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
No Pill Control
n=19 Participants
Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
|---|---|---|---|
|
Perceived HIV Risk Reduction at Week 24: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study
Strongly Disagree
|
60.00 percentage of participants
|
83.33 percentage of participants
|
46.15 percentage of participants
|
|
Perceived HIV Risk Reduction at Week 24: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study
Disagree
|
40.00 percentage of participants
|
16.67 percentage of participants
|
15.38 percentage of participants
|
|
Perceived HIV Risk Reduction at Week 24: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study
Neutral
|
0.00 percentage of participants
|
0.00 percentage of participants
|
23.08 percentage of participants
|
|
Perceived HIV Risk Reduction at Week 24: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study
Agree
|
0.00 percentage of participants
|
0.00 percentage of participants
|
7.69 percentage of participants
|
|
Perceived HIV Risk Reduction at Week 24: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study
Strongly Agree
|
0.00 percentage of participants
|
0.00 percentage of participants
|
7.69 percentage of participants
|
PRIMARY outcome
Timeframe: Week 4Population: Not all participants answered every question
Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "I have already risked getting infected with HIV through unsafe sex while I've been in this study."
Outcome measures
| Measure |
FTC/TDF as PrEP
n=20 Participants
Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
Placebo Pill Control
n=19 Participants
Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
No Pill Control
n=19 Participants
Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
|---|---|---|---|
|
Perceived HIV Risk Reduction at Week 4: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study
Strongly Disagree
|
63.16 percentage of participants
|
50.00 percentage of participants
|
44.44 percentage of participants
|
|
Perceived HIV Risk Reduction at Week 4: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study
Disagree
|
5.26 percentage of participants
|
16.67 percentage of participants
|
5.56 percentage of participants
|
|
Perceived HIV Risk Reduction at Week 4: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study
Neutral
|
10.53 percentage of participants
|
0.00 percentage of participants
|
22.22 percentage of participants
|
|
Perceived HIV Risk Reduction at Week 4: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study
Agree
|
21.05 percentage of participants
|
27.78 percentage of participants
|
22.22 percentage of participants
|
|
Perceived HIV Risk Reduction at Week 4: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study
Strongly Agree
|
0.00 percentage of participants
|
5.56 percentage of participants
|
5.56 percentage of participants
|
PRIMARY outcome
Timeframe: Week 8Population: Not all participants answered every question
Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "I have already risked getting infected with HIV through unsafe sex while I've been in this study."
Outcome measures
| Measure |
FTC/TDF as PrEP
n=20 Participants
Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
Placebo Pill Control
n=19 Participants
Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
No Pill Control
n=19 Participants
Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
|---|---|---|---|
|
Perceived HIV Risk Reduction at Week 8: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study
Strongly Disagree
|
52.94 percentage of participants
|
61.11 percentage of participants
|
23.53 percentage of participants
|
|
Perceived HIV Risk Reduction at Week 8: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study
Disagree
|
5.88 percentage of participants
|
11.11 percentage of participants
|
17.65 percentage of participants
|
|
Perceived HIV Risk Reduction at Week 8: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study
Neutral
|
17.65 percentage of participants
|
5.56 percentage of participants
|
23.53 percentage of participants
|
|
Perceived HIV Risk Reduction at Week 8: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study
Agree
|
5.88 percentage of participants
|
5.56 percentage of participants
|
17.65 percentage of participants
|
|
Perceived HIV Risk Reduction at Week 8: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study
Strongly Agree
|
17.65 percentage of participants
|
16.67 percentage of participants
|
17.65 percentage of participants
|
PRIMARY outcome
Timeframe: Week 12Population: Not all participants answered every question
Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "I have already risked getting infected with HIV through unsafe sex while I've been on this study."
Outcome measures
| Measure |
FTC/TDF as PrEP
n=20 Participants
Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
Placebo Pill Control
n=19 Participants
Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
No Pill Control
n=19 Participants
Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
|---|---|---|---|
|
Perceived HIV Risk Reduction at Week 12: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study
Strongly Disagree
|
46.67 percentage of participants
|
68.75 percentage of participants
|
25.00 percentage of participants
|
|
Perceived HIV Risk Reduction at Week 12: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study
Disagree
|
13.33 percentage of participants
|
6.25 percentage of participants
|
25.00 percentage of participants
|
|
Perceived HIV Risk Reduction at Week 12: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study
Neutral
|
13.33 percentage of participants
|
18.75 percentage of participants
|
18.75 percentage of participants
|
|
Perceived HIV Risk Reduction at Week 12: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study
Agree
|
13.33 percentage of participants
|
6.25 percentage of participants
|
18.75 percentage of participants
|
|
Perceived HIV Risk Reduction at Week 12: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study
Strongly Agree
|
13.33 percentage of participants
|
0.00 percentage of participants
|
12.50 percentage of participants
|
PRIMARY outcome
Timeframe: Week 16Population: Not all participants answered every question
Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "I have already risked getting infected with HIV through unsafe sex while I've been in this study."
Outcome measures
| Measure |
FTC/TDF as PrEP
n=20 Participants
Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
Placebo Pill Control
n=19 Participants
Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
No Pill Control
n=19 Participants
Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
|---|---|---|---|
|
Perceived HIV Risk Reduction at Week 16: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study
Strongly Disagree
|
46.15 percentage of participants
|
66.67 percentage of participants
|
42.86 percentage of participants
|
|
Perceived HIV Risk Reduction at Week 16: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study
Disagree
|
15.38 percentage of participants
|
6.67 percentage of participants
|
14.29 percentage of participants
|
|
Perceived HIV Risk Reduction at Week 16: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study
Neutral
|
15.38 percentage of participants
|
6.67 percentage of participants
|
7.14 percentage of participants
|
|
Perceived HIV Risk Reduction at Week 16: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study
Agree
|
7.69 percentage of participants
|
20.00 percentage of participants
|
21.43 percentage of participants
|
|
Perceived HIV Risk Reduction at Week 16: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study
Strongly Agree
|
15.38 percentage of participants
|
0.00 percentage of participants
|
14.29 percentage of participants
|
PRIMARY outcome
Timeframe: Week 20Population: Not all participants answered every question
Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "I have already risked getting infected with HIV through unsafe sex while I've been in this study."
Outcome measures
| Measure |
FTC/TDF as PrEP
n=20 Participants
Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
Placebo Pill Control
n=19 Participants
Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
No Pill Control
n=19 Participants
Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
|---|---|---|---|
|
Perceived HIV Risk Reduction at Week 20: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study
Strongly Disagree
|
75.00 percentage of participants
|
71.43 percentage of participants
|
61.54 percentage of participants
|
|
Perceived HIV Risk Reduction at Week 20: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study
Disagree
|
8.33 percentage of participants
|
21.43 percentage of participants
|
15.38 percentage of participants
|
|
Perceived HIV Risk Reduction at Week 20: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study
Neutral
|
8.33 percentage of participants
|
0.00 percentage of participants
|
7.69 percentage of participants
|
|
Perceived HIV Risk Reduction at Week 20: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study
Agree
|
0.00 percentage of participants
|
7.14 percentage of participants
|
7.69 percentage of participants
|
|
Perceived HIV Risk Reduction at Week 20: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study
Strongly Agree
|
8.33 percentage of participants
|
0.00 percentage of participants
|
7.69 percentage of participants
|
PRIMARY outcome
Timeframe: Week 24Population: Not all participants answered every question
Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "I have already risked getting infected with HIV through unsafe sex while I've been in this study."
Outcome measures
| Measure |
FTC/TDF as PrEP
n=20 Participants
Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
Placebo Pill Control
n=19 Participants
Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
No Pill Control
n=19 Participants
Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
|---|---|---|---|
|
Perceived HIV Risk Reduction at Week 24: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study
Strongly Disagree
|
50.00 percentage of participants
|
66.67 percentage of participants
|
30.77 percentage of participants
|
|
Perceived HIV Risk Reduction at Week 24: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study
Disagree
|
10.00 percentage of participants
|
16.67 percentage of participants
|
15.38 percentage of participants
|
|
Perceived HIV Risk Reduction at Week 24: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study
Neutral
|
10.00 percentage of participants
|
8.33 percentage of participants
|
15.38 percentage of participants
|
|
Perceived HIV Risk Reduction at Week 24: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study
Agree
|
10.00 percentage of participants
|
8.33 percentage of participants
|
30.77 percentage of participants
|
|
Perceived HIV Risk Reduction at Week 24: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study
Strongly Agree
|
20.00 percentage of participants
|
0.00 percentage of participants
|
7.69 percentage of participants
|
SECONDARY outcome
Timeframe: BaselineA high-risk sex act was defined as an answer of greater than 0 to any of the following questions: With your male HIV positive male partners during the past month: How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom? How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom?
Outcome measures
| Measure |
FTC/TDF as PrEP
n=20 Participants
Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
Placebo Pill Control
n=19 Participants
Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
No Pill Control
n=19 Participants
Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
|---|---|---|---|
|
Number of Participants Reporting No High-Risk Man With Man Sex Acts at Baseline
|
11 participants
|
11 participants
|
12 participants
|
SECONDARY outcome
Timeframe: Week 4Population: Not all participants answered every question
A high-risk sex act was defined as an answer of greater than 0 to any of the following questions: With your male HIV positive male partners during the past month: How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom? How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom?
Outcome measures
| Measure |
FTC/TDF as PrEP
n=20 Participants
Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
Placebo Pill Control
n=19 Participants
Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
No Pill Control
n=19 Participants
Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
|---|---|---|---|
|
Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 4
|
15 participants
|
14 participants
|
12 participants
|
SECONDARY outcome
Timeframe: Week 8Population: Not all participants answered every question
A high-risk sex act was defined as an answer of greater than 0 to any of the following questions: With your male HIV positive male partners during the past month: How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom? How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom?
Outcome measures
| Measure |
FTC/TDF as PrEP
n=20 Participants
Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
Placebo Pill Control
n=19 Participants
Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
No Pill Control
n=19 Participants
Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
|---|---|---|---|
|
Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 8
|
10 participants
|
12 participants
|
10 participants
|
SECONDARY outcome
Timeframe: Week 12Population: Not all participants answered every question.
A high-risk sex act was defined as an answer of greater than 0 to any of the following questions: With your male HIV positive male partners during the past month: How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom? How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom?
Outcome measures
| Measure |
FTC/TDF as PrEP
n=20 Participants
Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
Placebo Pill Control
n=19 Participants
Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
No Pill Control
n=19 Participants
Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
|---|---|---|---|
|
Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 12
|
13 participants
|
14 participants
|
12 participants
|
SECONDARY outcome
Timeframe: Week 16Population: Not all participants answered every question.
A high-risk sex act was defined as an answer of greater than 0 to any of the following questions: With your male HIV positive male partners during the past month: How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom? How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom?
Outcome measures
| Measure |
FTC/TDF as PrEP
n=20 Participants
Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
Placebo Pill Control
n=19 Participants
Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
No Pill Control
n=19 Participants
Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
|---|---|---|---|
|
Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 16
|
11 participants
|
13 participants
|
12 participants
|
SECONDARY outcome
Timeframe: Week 20Population: Not all participants answered every question
A high-risk sex act was defined as an answer of greater than 0 to any of the following questions: With your male HIV positive male partners during the past month: How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom? How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom?
Outcome measures
| Measure |
FTC/TDF as PrEP
n=20 Participants
Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
Placebo Pill Control
n=19 Participants
Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
No Pill Control
n=19 Participants
Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
|---|---|---|---|
|
Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 20
|
9 participants
|
11 participants
|
10 participants
|
SECONDARY outcome
Timeframe: Week 24Population: Not all participants answered every question
A high-risk sex act was defined as an answer of greater than 0 to any of the following questions: With your male HIV positive male partners during the past month: How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom? How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom?
Outcome measures
| Measure |
FTC/TDF as PrEP
n=20 Participants
Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
Placebo Pill Control
n=19 Participants
Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
No Pill Control
n=19 Participants
Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
|---|---|---|---|
|
Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 24
|
9 participants
|
7 participants
|
10 participants
|
Adverse Events
FTC/TDC
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
No Pill Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
FTC/TDC
n=20 participants at risk
Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
Placebo
n=19 participants at risk
Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
No Pill Control
n=19 participants at risk
Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
|
|---|---|---|---|
|
Investigations
Blood Bilirubin Increased
|
5.0%
1/20 • Number of events 1 • 24 weeks
|
0.00%
0/19 • 24 weeks
|
0.00%
0/19 • 24 weeks
|
|
Investigations
Protein Urine Present
|
5.0%
1/20 • Number of events 1 • 24 weeks
|
0.00%
0/19 • 24 weeks
|
0.00%
0/19 • 24 weeks
|
|
Investigations
Creatinine Renal Clearance Decreased
|
5.0%
1/20 • Number of events 2 • 24 weeks
|
0.00%
0/19 • 24 weeks
|
0.00%
0/19 • 24 weeks
|
|
Nervous system disorders
Migraine
|
5.0%
1/20 • Number of events 1 • 24 weeks
|
0.00%
0/19 • 24 weeks
|
0.00%
0/19 • 24 weeks
|
|
Psychiatric disorders
Suicidal Ideation
|
0.00%
0/20 • 24 weeks
|
5.3%
1/19 • Number of events 1 • 24 weeks
|
0.00%
0/19 • 24 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Adolescent Medicine Trials Network (ATN) for HIV/AIDS Interventions Publication Policy outlines procedures for the development and review of abstracts, publications and presentations. The Adolescent Medicine Leadership Group (AMLG) retains custody of and primary rights to the data. Use of data must be approved by the protocol team and AMLG.
- Publication restrictions are in place
Restriction type: OTHER