Trial Outcomes & Findings for An Open Label Demonstration Project and Phase II Safety Study of Pre-Exposure Prophylaxis Use Among 15 to 17 Year Old Young Men Who Have Sex With Men (YMSM) (NCT NCT01769456)
NCT ID: NCT01769456
Last Updated: 2018-01-17
Results Overview
This represents one of the indicators associated with the objective: Additional safety data regarding FTC/TDF (Truvada®) use among HIV-uninfected YMSM. Participants were assessed for any serum creatinine event of Grade 1 or higher over the course of the study (Week 0 through Week 48).
COMPLETED
PHASE2
78 participants
48 weeks
2018-01-17
Participant Flow
This research was conducted at 6 clinical sites. Accrual was open between 7/16/2013 and 9/30/2014.
Participant milestones
| Measure |
PCC Behavioral Intervention Group
PCC is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. The PCC intervention was conducted as a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. After completion of the PCC intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
|
|---|---|
|
Overall Study
STARTED
|
78
|
|
Overall Study
COMPLETED
|
41
|
|
Overall Study
NOT COMPLETED
|
37
|
Reasons for withdrawal
| Measure |
PCC Behavioral Intervention Group
PCC is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. The PCC intervention was conducted as a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. After completion of the PCC intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
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|---|---|
|
Overall Study
Lost to Follow-up
|
19
|
|
Overall Study
Withdrawal by Subject
|
3
|
|
Overall Study
Did not receive PCC intervention
|
6
|
|
Overall Study
Moved out of the area
|
3
|
|
Overall Study
No wk 0 visit w/in 30 days of screening
|
5
|
|
Overall Study
Parental request to youth to withdraw
|
1
|
Baseline Characteristics
Subjects with DXA data at baseline.
Baseline characteristics by cohort
| Measure |
PCC Behavioral Intervention Group
n=78 Participants
PCC is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. The PCC intervention was conducted as a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. After completion of the PCC intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
|
|---|---|
|
Age, Continuous
|
16.52 years
STANDARD_DEVIATION 0.66 • n=78 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=78 Participants
|
|
Sex: Female, Male
Male
|
78 Participants
n=78 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
35 Participants
n=78 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
42 Participants
n=78 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=78 Participants
|
|
Race/Ethnicity, Customized
Black/African-American · Black/African-American
|
33 Participants
n=78 Participants
|
|
Race/Ethnicity, Customized
Black/African-American · Non-Black/African-American
|
45 Participants
n=78 Participants
|
|
Race/Ethnicity, Customized
Race/ethnicity · Asian/Pacific Islander
|
2 Participants
n=78 Participants
|
|
Race/Ethnicity, Customized
Race/ethnicity · Black/African American
|
23 Participants
n=78 Participants
|
|
Race/Ethnicity, Customized
Race/ethnicity · White
|
11 Participants
n=78 Participants
|
|
Race/Ethnicity, Customized
Race/ethnicity · White/Hispanic
|
16 Participants
n=78 Participants
|
|
Race/Ethnicity, Customized
Race/ethnicity · Other/Mixed Race
|
26 Participants
n=78 Participants
|
|
Region of Enrollment
United States
|
78 Participants
n=78 Participants
|
|
Lumbar spine bone mineral density (BMD)
|
1.03 g/cm2
STANDARD_DEVIATION 0.15 • n=75 Participants • Subjects with DXA data at baseline.
|
|
Femoral neck bone mineral density (BMD)
|
0.99 g/cm2
STANDARD_DEVIATION 0.16 • n=75 Participants • Subjects with DXA data at baseline.
|
|
Total body bone mineral density (BMD)
|
1.15 g/cm2
STANDARD_DEVIATION 0.11 • n=75 Participants • Subjects with DXA data at baseline.
|
|
Total hip bone mineral density (BMD)
|
1.06 g/cm2
STANDARD_DEVIATION 0.15 • n=75 Participants • Subjects with DXA data at baseline.
|
|
Number of participants reporting unprotected sex with a male partner in the past month
|
52 Participants
n=60 Participants • Participants who provided a response to this question on the ACASI survey.
|
|
Number of male sexual partners in the last month
|
1.95 male sexual partners
STANDARD_DEVIATION 2.15 • n=73 Participants • Participants who provided a response to this question on the ACASI survey.
|
PRIMARY outcome
Timeframe: 48 weeksThis represents one of the indicators associated with the objective: Additional safety data regarding FTC/TDF (Truvada®) use among HIV-uninfected YMSM. Participants were assessed for any serum creatinine event of Grade 1 or higher over the course of the study (Week 0 through Week 48).
Outcome measures
| Measure |
PCC Behavioral Intervention Group
n=78 Participants
PCC Behavioral Intervention Group combined with open label FTC/TDF (Truvada®) as PrEP
PCC: Personalized Cognitive Counseling (PCC) is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. PCC is a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting.
Emtricitabine/tenofovir (FTC/TDF (Truvada®)): All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP
|
|---|---|
|
Number of Participants With Serum Creatinine Event of Grade 1 or Higher Over the Course of the Study
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 48Population: Subjects with dual energy x-ray absorptiometry (DXA) data at both baseline and Week 48.
The percent change in lumbar spine BMD from baseline measurement to Week 48 is calculated as: Percent change= \[(Value at Week 48 - Value at Baseline)/(Value at Baseline)\] x 100 This represents one of the indicators associated with the objective: Additional safety data regarding FTC/TDF (Truvada®) use among HIV-uninfected YMSM.
Outcome measures
| Measure |
PCC Behavioral Intervention Group
n=43 Participants
PCC Behavioral Intervention Group combined with open label FTC/TDF (Truvada®) as PrEP
PCC: Personalized Cognitive Counseling (PCC) is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. PCC is a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting.
Emtricitabine/tenofovir (FTC/TDF (Truvada®)): All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP
|
|---|---|
|
Lumbar Spine Bone Mineral Density: Percent Change From Baseline to Week 48
|
2.59 percent change
Standard Deviation 3.22
|
PRIMARY outcome
Timeframe: Baseline, Week 48Population: Subjects with DXA data at both baseline and Week 48.
The percent change in femoral neck BMD from baseline measurement to Week 48 is calculated as: Percent change= \[(Value at Week 48 - Value at Baseline)/(Value at Baseline)\] x 100 This represents one of the indicators associated with the objective: Additional safety data regarding FTC/TDF (Truvada®) use among HIV-uninfected YMSM.
Outcome measures
| Measure |
PCC Behavioral Intervention Group
n=43 Participants
PCC Behavioral Intervention Group combined with open label FTC/TDF (Truvada®) as PrEP
PCC: Personalized Cognitive Counseling (PCC) is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. PCC is a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting.
Emtricitabine/tenofovir (FTC/TDF (Truvada®)): All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP
|
|---|---|
|
Femoral Neck Bone Mineral Density: Percent Change From Baseline to Week 48
|
1.16 percent change
Standard Deviation 3.66
|
PRIMARY outcome
Timeframe: Baseline, Week 48Population: Subjects with DXA data at both baseline and Week 48.
The percent change in total body BMD from baseline measurement to Week 48 is calculated as: Percent change= \[(Value at Week 48 - Value at Baseline)/(Value at Baseline)\] x 100 This represents one of the indicators associated with the objective: Additional safety data regarding FTC/TDF (Truvada®) use among HIV-uninfected YMSM.
Outcome measures
| Measure |
PCC Behavioral Intervention Group
n=43 Participants
PCC Behavioral Intervention Group combined with open label FTC/TDF (Truvada®) as PrEP
PCC: Personalized Cognitive Counseling (PCC) is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. PCC is a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting.
Emtricitabine/tenofovir (FTC/TDF (Truvada®)): All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP
|
|---|---|
|
Total Body Bone Mineral Density: Percent Change From Baseline to Week 48
|
1.29 percent change
Standard Deviation 2.28
|
PRIMARY outcome
Timeframe: Baseline, Week 48Population: Subjects with DXA data at both baseline and Week 48.
The percent change in total hip BMD from baseline measurement to Week 48 is calculated as: Percent change= \[(Value at Week 48 - Value at Baseline)/(Value at Baseline)\] x 100 This represents one of the indicators associated with the objective: Additional safety data regarding FTC/TDF (Truvada®) use among HIV-uninfected YMSM.
Outcome measures
| Measure |
PCC Behavioral Intervention Group
n=43 Participants
PCC Behavioral Intervention Group combined with open label FTC/TDF (Truvada®) as PrEP
PCC: Personalized Cognitive Counseling (PCC) is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. PCC is a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting.
Emtricitabine/tenofovir (FTC/TDF (Truvada®)): All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP
|
|---|---|
|
Total Hip Bone Mineral Density: Percent Change From Baseline to Week 48
|
1.27 percent change
Standard Deviation 3.71
|
PRIMARY outcome
Timeframe: 48 weeksPopulation: Enrolled subjects with DXA results for baseline and Week 48
The proportion of subjects with DXA data through Week 48 who experienced varying degrees of decrease in absolute BMD in at least one region (spine, hip, or whole body). This represents one of the indicators associated with the objective: Additional safety data regarding FTC/TDF (Truvada®) use among HIV-uninfected YMSM.
Outcome measures
| Measure |
PCC Behavioral Intervention Group
n=43 Participants
PCC Behavioral Intervention Group combined with open label FTC/TDF (Truvada®) as PrEP
PCC: Personalized Cognitive Counseling (PCC) is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. PCC is a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting.
Emtricitabine/tenofovir (FTC/TDF (Truvada®)): All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP
|
|---|---|
|
Number of Participants With Decrease in Bone Mineral Density
Decrease in absolute BMD >=1% baseline to Wk48
|
16 Participants
|
|
Number of Participants With Decrease in Bone Mineral Density
Decrease in absolute BMD >=5% baseline to Wk48
|
2 Participants
|
|
Number of Participants With Decrease in Bone Mineral Density
Decrease in absolute BMD >10% baseline to Wk48
|
0 Participants
|
PRIMARY outcome
Timeframe: Week 48Population: Participants providing data for this question at Week 48.
Behavioral disinhibition/risk compensation was assessed based on a number of questions, including the following related to unprotected sex from the participant ACASI: "Of these males \[male partners\], how many did you have unprotected oral or anal sex with since the last time you took this survey?" An event is defined as an answer of greater than 0. This represents one of the indicators associated with the objective: Additional safety data regarding FTC/TDF (Truvada®) use among HIV-uninfected YMSM.
Outcome measures
| Measure |
PCC Behavioral Intervention Group
n=31 Participants
PCC Behavioral Intervention Group combined with open label FTC/TDF (Truvada®) as PrEP
PCC: Personalized Cognitive Counseling (PCC) is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. PCC is a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting.
Emtricitabine/tenofovir (FTC/TDF (Truvada®)): All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP
|
|---|---|
|
Behavioral Disinhibition/Risk Compensation: Number of Participants Reporting Unprotected Sex
|
25 Participants
|
PRIMARY outcome
Timeframe: Week 48Population: Participants providing data for this question at Week 48.
Behavioral disinhibition/risk compensation was assessed based on a number of questions, including the following related to related to number of male sexual partners from the participant ACASI: "Since the last time you took this survey, how many male partners have you had sexual contact with (oral or anal)?" This represents one of the indicators associated with the objective: Additional safety data regarding FTC/TDF (Truvada®) use among HIV-uninfected YMSM.
Outcome measures
| Measure |
PCC Behavioral Intervention Group
n=46 Participants
PCC Behavioral Intervention Group combined with open label FTC/TDF (Truvada®) as PrEP
PCC: Personalized Cognitive Counseling (PCC) is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. PCC is a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting.
Emtricitabine/tenofovir (FTC/TDF (Truvada®)): All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP
|
|---|---|
|
Behavioral Disinhibition/Risk Compensation: Number of Male Sexual Partners
|
1.64 male sexual partners
Standard Deviation 1.88
|
PRIMARY outcome
Timeframe: Week 12Population: Enrolled subjects with Week 12 data (individual row totals vary based on number of subjects providing responses for each question)
This represents one of the indicators associated with the objective: Acceptability when YMSM are provided open label FTC/TDF (Truvada®) and information regarding the safety and efficacy of PrEP from prior studies. Acceptability of PrEP as measured by the acceptability assessment that includes questions on usability of PrEP, user-friendliness of the medication regimen, including an assessment of side effects and delivery format, and acceptability of behavioral intervention sessions.
Outcome measures
| Measure |
PCC Behavioral Intervention Group
n=62 Participants
PCC Behavioral Intervention Group combined with open label FTC/TDF (Truvada®) as PrEP
PCC: Personalized Cognitive Counseling (PCC) is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. PCC is a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting.
Emtricitabine/tenofovir (FTC/TDF (Truvada®)): All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP
|
|---|---|
|
Acceptability of PrEP Regimen and Study Visits
Size of the pill · Did not like it at all
|
3 Participants
|
|
Acceptability of PrEP Regimen and Study Visits
Size of the pill · Did not like
|
14 Participants
|
|
Acceptability of PrEP Regimen and Study Visits
Size of the pill · Liked
|
36 Participants
|
|
Acceptability of PrEP Regimen and Study Visits
Size of the pill · Liked a lot
|
6 Participants
|
|
Acceptability of PrEP Regimen and Study Visits
Taste of the pill · Did not like it at all
|
8 Participants
|
|
Acceptability of PrEP Regimen and Study Visits
Taste of the pill · Did not like
|
27 Participants
|
|
Acceptability of PrEP Regimen and Study Visits
Taste of the pill · Liked
|
22 Participants
|
|
Acceptability of PrEP Regimen and Study Visits
Taste of the pill · Liked a lot
|
3 Participants
|
|
Acceptability of PrEP Regimen and Study Visits
Color of the pill · Did not like it at all
|
2 Participants
|
|
Acceptability of PrEP Regimen and Study Visits
Color of the pill · Did not like
|
8 Participants
|
|
Acceptability of PrEP Regimen and Study Visits
Color of the pill · Liked
|
42 Participants
|
|
Acceptability of PrEP Regimen and Study Visits
Color of the pill · Liked a lot
|
9 Participants
|
|
Acceptability of PrEP Regimen and Study Visits
Taking the pill every day · Did not like it at all
|
1 Participants
|
|
Acceptability of PrEP Regimen and Study Visits
Taking the pill every day · Did not like
|
17 Participants
|
|
Acceptability of PrEP Regimen and Study Visits
Taking the pill every day · Liked
|
34 Participants
|
|
Acceptability of PrEP Regimen and Study Visits
Taking the pill every day · Liked a lot
|
7 Participants
|
|
Acceptability of PrEP Regimen and Study Visits
Taking part in the study · Did not like it at all
|
1 Participants
|
|
Acceptability of PrEP Regimen and Study Visits
Taking part in the study · Did not like
|
0 Participants
|
|
Acceptability of PrEP Regimen and Study Visits
Taking part in the study · Liked
|
26 Participants
|
|
Acceptability of PrEP Regimen and Study Visits
Taking part in the study · Liked a lot
|
35 Participants
|
|
Acceptability of PrEP Regimen and Study Visits
HIV test at every visit · Did not like it at all
|
1 Participants
|
|
Acceptability of PrEP Regimen and Study Visits
HIV test at every visit · Did not like
|
4 Participants
|
|
Acceptability of PrEP Regimen and Study Visits
HIV test at every visit · Liked
|
25 Participants
|
|
Acceptability of PrEP Regimen and Study Visits
HIV test at every visit · Liked a lot
|
32 Participants
|
|
Acceptability of PrEP Regimen and Study Visits
Risk Reduction Counseling at every visit · Did not like it at all
|
2 Participants
|
|
Acceptability of PrEP Regimen and Study Visits
Risk Reduction Counseling at every visit · Did not like
|
3 Participants
|
|
Acceptability of PrEP Regimen and Study Visits
Risk Reduction Counseling at every visit · Liked
|
26 Participants
|
|
Acceptability of PrEP Regimen and Study Visits
Risk Reduction Counseling at every visit · Liked a lot
|
30 Participants
|
|
Acceptability of PrEP Regimen and Study Visits
Questions about sexual behavior at every visit · Did not like it at all
|
2 Participants
|
|
Acceptability of PrEP Regimen and Study Visits
Questions about sexual behavior at every visit · Did not like
|
10 Participants
|
|
Acceptability of PrEP Regimen and Study Visits
Questions about sexual behavior at every visit · Liked
|
36 Participants
|
|
Acceptability of PrEP Regimen and Study Visits
Questions about sexual behavior at every visit · Liked a lot
|
14 Participants
|
|
Acceptability of PrEP Regimen and Study Visits
Physician exam by a doctor · Did not like it at all
|
1 Participants
|
|
Acceptability of PrEP Regimen and Study Visits
Physician exam by a doctor · Did not like
|
9 Participants
|
|
Acceptability of PrEP Regimen and Study Visits
Physician exam by a doctor · Liked
|
35 Participants
|
|
Acceptability of PrEP Regimen and Study Visits
Physician exam by a doctor · Liked a lot
|
15 Participants
|
|
Acceptability of PrEP Regimen and Study Visits
Health clinic for study visits · Did not like it at all
|
1 Participants
|
|
Acceptability of PrEP Regimen and Study Visits
Health clinic for study visits · Did not like
|
3 Participants
|
|
Acceptability of PrEP Regimen and Study Visits
Health clinic for study visits · Liked
|
41 Participants
|
|
Acceptability of PrEP Regimen and Study Visits
Health clinic for study visits · Liked a lot
|
17 Participants
|
PRIMARY outcome
Timeframe: Week 4, Week 12, Week 24, Week 36, Week 48Population: Number analyzed in each row varies based on the number of enrolled subjects with DBS data available for each week.
This outcome addresses the objective: Rates of adherence and measured levels of drug exposure when YMSM are provided open label FTC/TDF (Truvada®) and information regarding the safety and efficacy of PrEP from prior studies. Medication adherence is estimated by factors including levels of drug exposure as measured by DBS red blood cell (RBC) samples. The TFV dosing level was translated into number of dosing days per week for week 8 onwards using lab estimates as follows: '\<2 days' is defined as \<350 (fmol/punch), '2 days' as 350 to 700 (fmol/punch), '4 days' as \>700 to 1250 (fmol/punch), and 'Daily' as \>1250 (fmol/punch). The TFV dosing level was translated into number of dosing days for week 4 using lab estimates as follows: '\<2 days' is defined as \<275 (fmol/punch), '2 days' as 275 to 525 (fmol/punch), '4 days' as \>525 to 950 (fmol/punch),and 'Daily' as \>950 (fmol/punch)
Outcome measures
| Measure |
PCC Behavioral Intervention Group
n=78 Participants
PCC Behavioral Intervention Group combined with open label FTC/TDF (Truvada®) as PrEP
PCC: Personalized Cognitive Counseling (PCC) is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. PCC is a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting.
Emtricitabine/tenofovir (FTC/TDF (Truvada®)): All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP
|
|---|---|
|
Estimation of Medication Adherence by Dried Blood Spot (DBS) Results
DBS RBC TFV-DP (fmol/punch), Week 4 · Below level of quantification
|
3 Participants
|
|
Estimation of Medication Adherence by Dried Blood Spot (DBS) Results
DBS RBC TFV-DP (fmol/punch), Week 4 · <2 days
|
12 Participants
|
|
Estimation of Medication Adherence by Dried Blood Spot (DBS) Results
DBS RBC TFV-DP (fmol/punch), Week 4 · 2 days
|
11 Participants
|
|
Estimation of Medication Adherence by Dried Blood Spot (DBS) Results
DBS RBC TFV-DP (fmol/punch), Week 4 · 4 days
|
24 Participants
|
|
Estimation of Medication Adherence by Dried Blood Spot (DBS) Results
DBS RBC TFV-DP (fmol/punch), Week 4 · Daily
|
15 Participants
|
|
Estimation of Medication Adherence by Dried Blood Spot (DBS) Results
DBS RBC TFV-DP (fmol/punch), Week 8 · Below level of quantification
|
3 Participants
|
|
Estimation of Medication Adherence by Dried Blood Spot (DBS) Results
DBS RBC TFV-DP (fmol/punch), Week 8 · <2 days
|
13 Participants
|
|
Estimation of Medication Adherence by Dried Blood Spot (DBS) Results
DBS RBC TFV-DP (fmol/punch), Week 8 · 2 days
|
14 Participants
|
|
Estimation of Medication Adherence by Dried Blood Spot (DBS) Results
DBS RBC TFV-DP (fmol/punch), Week 8 · 4 days
|
21 Participants
|
|
Estimation of Medication Adherence by Dried Blood Spot (DBS) Results
DBS RBC TFV-DP (fmol/punch), Week 8 · Daily
|
12 Participants
|
|
Estimation of Medication Adherence by Dried Blood Spot (DBS) Results
DBS RBC TFV-DP (fmol/punch), Week 12 · Below level of quantification
|
3 Participants
|
|
Estimation of Medication Adherence by Dried Blood Spot (DBS) Results
DBS RBC TFV-DP (fmol/punch), Week 12 · <2 days
|
17 Participants
|
|
Estimation of Medication Adherence by Dried Blood Spot (DBS) Results
DBS RBC TFV-DP (fmol/punch), Week 12 · 2 days
|
7 Participants
|
|
Estimation of Medication Adherence by Dried Blood Spot (DBS) Results
DBS RBC TFV-DP (fmol/punch), Week 12 · 4 days
|
22 Participants
|
|
Estimation of Medication Adherence by Dried Blood Spot (DBS) Results
DBS RBC TFV-DP (fmol/punch), Week 12 · Daily
|
11 Participants
|
|
Estimation of Medication Adherence by Dried Blood Spot (DBS) Results
DBS RBC TFV-DP (fmol/punch), Week 24 · Below level of quantification
|
15 Participants
|
|
Estimation of Medication Adherence by Dried Blood Spot (DBS) Results
DBS RBC TFV-DP (fmol/punch), Week 24 · <2 days
|
18 Participants
|
|
Estimation of Medication Adherence by Dried Blood Spot (DBS) Results
DBS RBC TFV-DP (fmol/punch), Week 24 · 2 days
|
5 Participants
|
|
Estimation of Medication Adherence by Dried Blood Spot (DBS) Results
DBS RBC TFV-DP (fmol/punch), Week 24 · 4 days
|
12 Participants
|
|
Estimation of Medication Adherence by Dried Blood Spot (DBS) Results
DBS RBC TFV-DP (fmol/punch), Week 24 · Daily
|
5 Participants
|
|
Estimation of Medication Adherence by Dried Blood Spot (DBS) Results
DBS RBC TFV-DP (fmol/punch), Week 36 · Below level of quantification
|
17 Participants
|
|
Estimation of Medication Adherence by Dried Blood Spot (DBS) Results
DBS RBC TFV-DP (fmol/punch), Week 36 · <2 days
|
11 Participants
|
|
Estimation of Medication Adherence by Dried Blood Spot (DBS) Results
DBS RBC TFV-DP (fmol/punch), Week 36 · 2 days
|
6 Participants
|
|
Estimation of Medication Adherence by Dried Blood Spot (DBS) Results
DBS RBC TFV-DP (fmol/punch), Week 36 · 4 days
|
7 Participants
|
|
Estimation of Medication Adherence by Dried Blood Spot (DBS) Results
DBS RBC TFV-DP (fmol/punch), Week 36 · Daily
|
3 Participants
|
|
Estimation of Medication Adherence by Dried Blood Spot (DBS) Results
DBS RBC TFV-DP (fmol/punch), Week 48 · Below level of quantification
|
19 Participants
|
|
Estimation of Medication Adherence by Dried Blood Spot (DBS) Results
DBS RBC TFV-DP (fmol/punch), Week 48 · <2 days
|
8 Participants
|
|
Estimation of Medication Adherence by Dried Blood Spot (DBS) Results
DBS RBC TFV-DP (fmol/punch), Week 48 · 2 days
|
2 Participants
|
|
Estimation of Medication Adherence by Dried Blood Spot (DBS) Results
DBS RBC TFV-DP (fmol/punch), Week 48 · 4 days
|
7 Participants
|
|
Estimation of Medication Adherence by Dried Blood Spot (DBS) Results
DBS RBC TFV-DP (fmol/punch), Week 48 · Daily
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4 Participants
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SECONDARY outcome
Timeframe: 48 weeksPopulation: Data not collected; only one type of risk reduction intervention was ultimately implemented.
Study subjects were given a brief Session Evaluation Form at the end of the behavioral intervention session consisting of ten items on a 4-point response scale aimed at eliciting information about the subject's experience with the session (i.e., was session interesting, was it relevant to their life, and did they learn from the session)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline through Week 48Population: The analysis population for those discontinued is the population (N=22) of those who initially signed up to receive reminders.
This represents one of the indicators associated with the objective: Acceptability and feasibility of text message reminders.
Outcome measures
| Measure |
PCC Behavioral Intervention Group
n=78 Participants
PCC Behavioral Intervention Group combined with open label FTC/TDF (Truvada®) as PrEP
PCC: Personalized Cognitive Counseling (PCC) is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. PCC is a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting.
Emtricitabine/tenofovir (FTC/TDF (Truvada®)): All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP
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|---|---|
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Number of Participants Using Text Messaging Reminders
Signed up for text message reminders
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22 Participants
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Number of Participants Using Text Messaging Reminders
Discontinued reminders while on study agent
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2 Participants
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Number of Participants Using Text Messaging Reminders
Discontinued reminders while still on study
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1 Participants
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SECONDARY outcome
Timeframe: 48 weeksPopulation: Enrolled subjects with a Week 48 visit; individual rows may have varying Ns due to the number of subjects providing data for each question.
This represents one of the indicators associated with the objective: Acceptability and feasibility of text message reminders, as measured by subject rating of the reasons for missing medications on a 4-point Likert scale. Subjects were asked to rate various measures as "Never," "Rarely," "Sometimes," or "Often" the reason for missing taking study pills. Data shown for Week 48. Question: In the past month, how often have you missed taking your study pills because you:
Outcome measures
| Measure |
PCC Behavioral Intervention Group
n=46 Participants
PCC Behavioral Intervention Group combined with open label FTC/TDF (Truvada®) as PrEP
PCC: Personalized Cognitive Counseling (PCC) is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. PCC is a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting.
Emtricitabine/tenofovir (FTC/TDF (Truvada®)): All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP
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|---|---|
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Rating of the Reasons for Missing Medications on a 4-point Likert Scale.
Were away from home · Never
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15 Participants
|
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Rating of the Reasons for Missing Medications on a 4-point Likert Scale.
Were away from home · Rarely
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8 Participants
|
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Rating of the Reasons for Missing Medications on a 4-point Likert Scale.
Were away from home · Sometimes
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12 Participants
|
|
Rating of the Reasons for Missing Medications on a 4-point Likert Scale.
Were away from home · Often
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5 Participants
|
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Rating of the Reasons for Missing Medications on a 4-point Likert Scale.
Were too busy with other things · Never
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15 Participants
|
|
Rating of the Reasons for Missing Medications on a 4-point Likert Scale.
Were too busy with other things · Rarely
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10 Participants
|
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Rating of the Reasons for Missing Medications on a 4-point Likert Scale.
Were too busy with other things · Sometimes
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7 Participants
|
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Rating of the Reasons for Missing Medications on a 4-point Likert Scale.
Were too busy with other things · Often
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8 Participants
|
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Rating of the Reasons for Missing Medications on a 4-point Likert Scale.
Simply forgot · Never
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21 Participants
|
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Rating of the Reasons for Missing Medications on a 4-point Likert Scale.
Simply forgot · Rarely
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4 Participants
|
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Rating of the Reasons for Missing Medications on a 4-point Likert Scale.
Simply forgot · Sometimes
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7 Participants
|
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Rating of the Reasons for Missing Medications on a 4-point Likert Scale.
Simply forgot · Often
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8 Participants
|
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Rating of the Reasons for Missing Medications on a 4-point Likert Scale.
Had too many study pills to take · Never
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36 Participants
|
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Rating of the Reasons for Missing Medications on a 4-point Likert Scale.
Had too many study pills to take · Rarely
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4 Participants
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Rating of the Reasons for Missing Medications on a 4-point Likert Scale.
Had too many study pills to take · Sometimes
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0 Participants
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Rating of the Reasons for Missing Medications on a 4-point Likert Scale.
Had too many study pills to take · Often
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0 Participants
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Rating of the Reasons for Missing Medications on a 4-point Likert Scale.
Wanted to avoid side effects · Never
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37 Participants
|
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Rating of the Reasons for Missing Medications on a 4-point Likert Scale.
Wanted to avoid side effects · Rarely
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2 Participants
|
|
Rating of the Reasons for Missing Medications on a 4-point Likert Scale.
Wanted to avoid side effects · Sometimes
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1 Participants
|
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Rating of the Reasons for Missing Medications on a 4-point Likert Scale.
Wanted to avoid side effects · Often
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0 Participants
|
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Rating of the Reasons for Missing Medications on a 4-point Likert Scale.
Did not want others to notice you taking meds · Never
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36 Participants
|
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Rating of the Reasons for Missing Medications on a 4-point Likert Scale.
Did not want others to notice you taking meds · Rarely
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3 Participants
|
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Rating of the Reasons for Missing Medications on a 4-point Likert Scale.
Did not want others to notice you taking meds · Sometimes
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0 Participants
|
|
Rating of the Reasons for Missing Medications on a 4-point Likert Scale.
Did not want others to notice you taking meds · Often
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1 Participants
|
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Rating of the Reasons for Missing Medications on a 4-point Likert Scale.
Had a change in daily routine · Never
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27 Participants
|
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Rating of the Reasons for Missing Medications on a 4-point Likert Scale.
Had a change in daily routine · Rarely
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4 Participants
|
|
Rating of the Reasons for Missing Medications on a 4-point Likert Scale.
Had a change in daily routine · Sometimes
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5 Participants
|
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Rating of the Reasons for Missing Medications on a 4-point Likert Scale.
Had a change in daily routine · Often
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4 Participants
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SECONDARY outcome
Timeframe: 48 weeksPopulation: Data were not collected.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 48 weeksPopulation: Quantitative data were not collected for this outcome.
Brief phone interviews and review of written institutional review board (IRB) correspondence will be conducted for all sites whether the study is approved at that site or not. If approved, the steps needed for approval and how barriers were addressed will be examined. If the study was rejected, the reasons for disapproval, the IRB's interpretation of the risk of PrEP, and other barriers will be examined. In addition, data from a survey specific to each site's IRB's responses of minor YMSM inclusion in PrEP studies will be evaluated. NOTE: Data collected to address this outcome were primarily qualitative in nature, and as such are not presented here. For more information on this outcome, refer to: Gilbert AL, Knopf AS, Fortenberry JD, Hosek SG, Kapogiannis BG, Zimet GD. Adolescent Self-Consent for Biomedical Human Immunodeficiency Virus Prevention Research. J Adolesc Health. 2015 Jul;57(1):113-9.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 48 weeksPopulation: Data were not collected.
Behavioral disinhibition/risk compensation endpoints will be compared.
Outcome measures
Outcome data not reported
Adverse Events
PCC Behavioral Intervention Group
Serious adverse events
| Measure |
PCC Behavioral Intervention Group
n=78 participants at risk
PCC Behavioral Intervention Group combined with open label FTC/TDF (Truvada®) as PrEP
PCC: Personalized Cognitive Counseling (PCC) is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. PCC is a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting.
Emtricitabine/tenofovir (FTC/TDF (Truvada®)): All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP
|
|---|---|
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Psychiatric disorders
Suicidal Ideation
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1.3%
1/78 • Number of events 1 • Adverse event data was collected over the duration of the study, from the start of enrollment on 7/16/2013 until the completion of subject follow-up on 8/18/2016 (approximately 3 years).
Per protocol, only grade 3 and higher clinical adverse events and lab toxicities are systematically recorded on the Adverse Event Evaluation Form and reported here.
|
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Psychiatric disorders
Depression
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1.3%
1/78 • Number of events 1 • Adverse event data was collected over the duration of the study, from the start of enrollment on 7/16/2013 until the completion of subject follow-up on 8/18/2016 (approximately 3 years).
Per protocol, only grade 3 and higher clinical adverse events and lab toxicities are systematically recorded on the Adverse Event Evaluation Form and reported here.
|
|
Infections and infestations
Appendicitis
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1.3%
1/78 • Number of events 1 • Adverse event data was collected over the duration of the study, from the start of enrollment on 7/16/2013 until the completion of subject follow-up on 8/18/2016 (approximately 3 years).
Per protocol, only grade 3 and higher clinical adverse events and lab toxicities are systematically recorded on the Adverse Event Evaluation Form and reported here.
|
|
Nervous system disorders
Convulsion
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1.3%
1/78 • Number of events 1 • Adverse event data was collected over the duration of the study, from the start of enrollment on 7/16/2013 until the completion of subject follow-up on 8/18/2016 (approximately 3 years).
Per protocol, only grade 3 and higher clinical adverse events and lab toxicities are systematically recorded on the Adverse Event Evaluation Form and reported here.
|
|
Infections and infestations
Cellulitis
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1.3%
1/78 • Number of events 1 • Adverse event data was collected over the duration of the study, from the start of enrollment on 7/16/2013 until the completion of subject follow-up on 8/18/2016 (approximately 3 years).
Per protocol, only grade 3 and higher clinical adverse events and lab toxicities are systematically recorded on the Adverse Event Evaluation Form and reported here.
|
Other adverse events
| Measure |
PCC Behavioral Intervention Group
n=78 participants at risk
PCC Behavioral Intervention Group combined with open label FTC/TDF (Truvada®) as PrEP
PCC: Personalized Cognitive Counseling (PCC) is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. PCC is a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting.
Emtricitabine/tenofovir (FTC/TDF (Truvada®)): All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP
|
|---|---|
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Investigations
Weight Decreased
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1.3%
1/78 • Number of events 1 • Adverse event data was collected over the duration of the study, from the start of enrollment on 7/16/2013 until the completion of subject follow-up on 8/18/2016 (approximately 3 years).
Per protocol, only grade 3 and higher clinical adverse events and lab toxicities are systematically recorded on the Adverse Event Evaluation Form and reported here.
|
|
Metabolism and nutrition disorders
Abnormal loss of weight
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2.6%
2/78 • Number of events 4 • Adverse event data was collected over the duration of the study, from the start of enrollment on 7/16/2013 until the completion of subject follow-up on 8/18/2016 (approximately 3 years).
Per protocol, only grade 3 and higher clinical adverse events and lab toxicities are systematically recorded on the Adverse Event Evaluation Form and reported here.
|
|
Metabolism and nutrition disorders
Hypokalaemia
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1.3%
1/78 • Number of events 1 • Adverse event data was collected over the duration of the study, from the start of enrollment on 7/16/2013 until the completion of subject follow-up on 8/18/2016 (approximately 3 years).
Per protocol, only grade 3 and higher clinical adverse events and lab toxicities are systematically recorded on the Adverse Event Evaluation Form and reported here.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
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1.3%
1/78 • Number of events 1 • Adverse event data was collected over the duration of the study, from the start of enrollment on 7/16/2013 until the completion of subject follow-up on 8/18/2016 (approximately 3 years).
Per protocol, only grade 3 and higher clinical adverse events and lab toxicities are systematically recorded on the Adverse Event Evaluation Form and reported here.
|
|
Psychiatric disorders
Suicidal Ideation
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1.3%
1/78 • Number of events 1 • Adverse event data was collected over the duration of the study, from the start of enrollment on 7/16/2013 until the completion of subject follow-up on 8/18/2016 (approximately 3 years).
Per protocol, only grade 3 and higher clinical adverse events and lab toxicities are systematically recorded on the Adverse Event Evaluation Form and reported here.
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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