Trial Outcomes & Findings for A Pragmatic Clinical Trial of MyPEEPS Mobile to Improve HIV Prevention Behaviors in Diverse Adolescent MSM (NCT NCT03167606)
NCT ID: NCT03167606
Last Updated: 2023-02-23
Results Overview
The number of condomless anal sex acts (CASA) will be evaluated at all time points using the AIDS-Risk Behavior Assessment (ARBA) adapted for YMSM. At each timepoint, participants were asked to report the past 3 month number of insertive and receptive anal sex acts during which condoms were not used.
COMPLETED
NA
764 participants
Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group)
2023-02-23
Participant Flow
One participant was enrolled in error (ineligible age) and withdrawn from the study prior to randomization
Participant milestones
| Measure |
Immediate Intervention
Study participants randomized to the immediate intervention arm will have access to the MyPEEPS Mobile from the baseline visit to 3-month follow-up visit. They will continue with follow-up visits at 6 months and 9 months, but will no longer have access to the MyPEEPS Mobile past the 3-month follow-up visit.
MyPEEPS Mobile: Mobile technology to deliver HIV prevention information specifically developed for at-risk young men who have sex with men (YMSM).
|
Delayed Intervention
Study participants randomized to the delayed intervention arm will complete visits at baseline, 3 months, 6 months, 9 months, and 12 months. They will have access to the MyPEEPS Mobile from the 9-month follow-up visit until the 12-month follow-up visit.
MyPEEPS Mobile: Mobile technology to deliver HIV prevention information specifically developed for at-risk YMSM.
|
|---|---|---|
|
Overall Study
STARTED
|
382
|
381
|
|
Overall Study
COMPLETED
|
303
|
310
|
|
Overall Study
NOT COMPLETED
|
79
|
71
|
Reasons for withdrawal
| Measure |
Immediate Intervention
Study participants randomized to the immediate intervention arm will have access to the MyPEEPS Mobile from the baseline visit to 3-month follow-up visit. They will continue with follow-up visits at 6 months and 9 months, but will no longer have access to the MyPEEPS Mobile past the 3-month follow-up visit.
MyPEEPS Mobile: Mobile technology to deliver HIV prevention information specifically developed for at-risk young men who have sex with men (YMSM).
|
Delayed Intervention
Study participants randomized to the delayed intervention arm will complete visits at baseline, 3 months, 6 months, 9 months, and 12 months. They will have access to the MyPEEPS Mobile from the 9-month follow-up visit until the 12-month follow-up visit.
MyPEEPS Mobile: Mobile technology to deliver HIV prevention information specifically developed for at-risk YMSM.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
73
|
64
|
|
Overall Study
Withdrawal by Subject
|
6
|
5
|
|
Overall Study
Withdrawal by Investigator
|
0
|
2
|
Baseline Characteristics
A Pragmatic Clinical Trial of MyPEEPS Mobile to Improve HIV Prevention Behaviors in Diverse Adolescent MSM
Baseline characteristics by cohort
| Measure |
Immediate Intervention
n=379 Participants
Study participants randomized to the immediate intervention arm will have access to the MyPEEPS Mobile from the baseline visit to 3-month follow-up visit. They will continue with follow-up visits at 6 months and 9 months, but will no longer have access to the MyPEEPS Mobile past the 3-month follow-up visit.
MyPEEPS Mobile: Mobile technology to deliver HIV prevention information specifically developed for at-risk YMSM.
|
Delayed Intervention
n=381 Participants
Study participants randomized to the delayed intervention arm will complete visits at baseline, 3 months, 6 months, 9 months, and 12 months. They will have access to the MyPEEPS Mobile from the 9-month follow-up visit until the 12-month follow-up visit.
MyPEEPS Mobile: Mobile technology to deliver HIV prevention information specifically developed for at-risk YMSM.
|
Total
n=760 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
16.23 years
STANDARD_DEVIATION 1.4 • n=99 Participants
|
16.20 years
STANDARD_DEVIATION 1.4 • n=107 Participants
|
16.22 years
STANDARD_DEVIATION 1.4 • n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
379 Participants
n=99 Participants
|
381 Participants
n=107 Participants
|
760 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
169 Participants
n=99 Participants
|
142 Participants
n=107 Participants
|
311 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
210 Participants
n=99 Participants
|
239 Participants
n=107 Participants
|
449 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
20 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
43 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
36 Participants
n=99 Participants
|
36 Participants
n=107 Participants
|
72 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
6 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
75 Participants
n=99 Participants
|
83 Participants
n=107 Participants
|
158 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
132 Participants
n=99 Participants
|
152 Participants
n=107 Participants
|
284 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
55 Participants
n=99 Participants
|
39 Participants
n=107 Participants
|
94 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
55 Participants
n=99 Participants
|
43 Participants
n=107 Participants
|
98 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
379 Participants
n=99 Participants
|
381 Participants
n=107 Participants
|
760 Participants
n=206 Participants
|
|
Any Anal Sex Acts With Another Male
|
203 Participants
n=99 Participants
|
192 Participants
n=107 Participants
|
395 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group)Population: The analytic sample included 760 of the 764 participants enrolled because 1 participant was enrolled in error (ineligible age) and withdrawn from the study prior to randomization and 3 participants were excluded from the analytic sample due to missing or invalid data.
The number of condomless anal sex acts (CASA) will be evaluated at all time points using the AIDS-Risk Behavior Assessment (ARBA) adapted for YMSM. At each timepoint, participants were asked to report the past 3 month number of insertive and receptive anal sex acts during which condoms were not used.
Outcome measures
| Measure |
Immediate Intervention
n=379 Participants
Study participants randomized to the immediate intervention arm will have access to the MyPEEPS Mobile from the baseline visit to 3-month follow-up visit. They will continue with follow-up visits at 6 months and 9 months, but will no longer have access to the MyPEEPS Mobile past the 3-month follow-up visit.
MyPEEPS Mobile: Mobile technology to deliver HIV prevention information specifically developed for at-risk YMSM.
|
Delayed Intervention
n=381 Participants
Study participants randomized to the delayed intervention arm will complete visits at baseline, 3 months, 6 months, 9 months, and 12 months. They will have access to the MyPEEPS Mobile from the 9-month follow-up visit until the 12-month follow-up visit.
MyPEEPS Mobile: Mobile technology to deliver HIV prevention information specifically developed for at-risk YMSM.
|
|---|---|---|
|
Number of Condomless Anal Sex Acts
9-Month Follow-up
|
1.70 condomless anal sex acts
Standard Error 0.36
|
1.65 condomless anal sex acts
Standard Error 0.33
|
|
Number of Condomless Anal Sex Acts
Baseline
|
1.53 condomless anal sex acts
Standard Error 0.29
|
1.45 condomless anal sex acts
Standard Error 0.27
|
|
Number of Condomless Anal Sex Acts
3-Month Follow-up
|
1.04 condomless anal sex acts
Standard Error 0.26
|
1.63 condomless anal sex acts
Standard Error 0.38
|
|
Number of Condomless Anal Sex Acts
6-Month Follow-up
|
1.68 condomless anal sex acts
Standard Error 0.47
|
1.21 condomless anal sex acts
Standard Error 0.25
|
|
Number of Condomless Anal Sex Acts
12-Month Follow-up
|
—
|
1.47 condomless anal sex acts
Standard Error 0.36
|
PRIMARY outcome
Timeframe: Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group)Population: The analytic sample included 760 of the 764 participants enrolled because 1 participant was enrolled in error (ineligible age) and withdrawn from the study prior to randomization and 3 participants were excluded from the analytic sample due to missing or invalid data.
The number of anal sex partners will be evaluated at all time points using the AIDS-Risk Behavior Assessment (ARBA) adapted for YMSM. Participants are asked to report the number of insertive and receptive anal sex partners in their lifetime at the baseline timepoint and then asked to report the number of insertive and receptive anal sex partners in the past 3 months at each of the follow-up timepoints.
Outcome measures
| Measure |
Immediate Intervention
n=379 Participants
Study participants randomized to the immediate intervention arm will have access to the MyPEEPS Mobile from the baseline visit to 3-month follow-up visit. They will continue with follow-up visits at 6 months and 9 months, but will no longer have access to the MyPEEPS Mobile past the 3-month follow-up visit.
MyPEEPS Mobile: Mobile technology to deliver HIV prevention information specifically developed for at-risk YMSM.
|
Delayed Intervention
n=381 Participants
Study participants randomized to the delayed intervention arm will complete visits at baseline, 3 months, 6 months, 9 months, and 12 months. They will have access to the MyPEEPS Mobile from the 9-month follow-up visit until the 12-month follow-up visit.
MyPEEPS Mobile: Mobile technology to deliver HIV prevention information specifically developed for at-risk YMSM.
|
|---|---|---|
|
Number of Anal Sex Partners
Baseline
|
0.95 Anal sex partners
Standard Error 0.11
|
0.87 Anal sex partners
Standard Error 0.09
|
|
Number of Anal Sex Partners
3-Month Follow-up
|
0.86 Anal sex partners
Standard Error 0.13
|
0.71 Anal sex partners
Standard Error 0.09
|
|
Number of Anal Sex Partners
6-Month Follow-up
|
0.90 Anal sex partners
Standard Error 0.11
|
0.84 Anal sex partners
Standard Error 0.10
|
|
Number of Anal Sex Partners
9-Month Follow-up
|
1.00 Anal sex partners
Standard Error 0.13
|
0.77 Anal sex partners
Standard Error 0.08
|
|
Number of Anal Sex Partners
12-Month Follow-up
|
—
|
1.27 Anal sex partners
Standard Error 0.21
|
PRIMARY outcome
Timeframe: Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group)Population: The analytic sample included 760 of the 764 participants enrolled because 1 participant was enrolled in error (ineligible age) and withdrawn from the study prior to randomization and 3 participants were excluded from the analytic sample due to missing or invalid data.
The number of condomless anal sex (CAS) partners will be evaluated at all time points using the AIDS-Risk Behavior Assessment (ARBA) adapted for YMSM. Participants are asked to report the number of insertive and receptive anal sex partners with whom condoms were not used in their lifetime at the baseline timepoint and then asked to report the number of insertive and receptive anal sex partners with whom condoms were not used in the past 3 months at each of the follow-up timepoints.
Outcome measures
| Measure |
Immediate Intervention
n=379 Participants
Study participants randomized to the immediate intervention arm will have access to the MyPEEPS Mobile from the baseline visit to 3-month follow-up visit. They will continue with follow-up visits at 6 months and 9 months, but will no longer have access to the MyPEEPS Mobile past the 3-month follow-up visit.
MyPEEPS Mobile: Mobile technology to deliver HIV prevention information specifically developed for at-risk YMSM.
|
Delayed Intervention
n=381 Participants
Study participants randomized to the delayed intervention arm will complete visits at baseline, 3 months, 6 months, 9 months, and 12 months. They will have access to the MyPEEPS Mobile from the 9-month follow-up visit until the 12-month follow-up visit.
MyPEEPS Mobile: Mobile technology to deliver HIV prevention information specifically developed for at-risk YMSM.
|
|---|---|---|
|
Number of Condomless Anal Sex Partners
12-Month Follow-up
|
—
|
0.72 Condomless anal sex partners
Standard Error 0.17
|
|
Number of Condomless Anal Sex Partners
Baseline
|
0.53 Condomless anal sex partners
Standard Error 0.08
|
0.42 Condomless anal sex partners
Standard Error 0.05
|
|
Number of Condomless Anal Sex Partners
3-Month Follow-up
|
0.50 Condomless anal sex partners
Standard Error 0.08
|
0.38 Condomless anal sex partners
Standard Error 0.06
|
|
Number of Condomless Anal Sex Partners
6-Month Follow-up
|
0.43 Condomless anal sex partners
Standard Error 0.06
|
0.47 Condomless anal sex partners
Standard Error 0.06
|
|
Number of Condomless Anal Sex Partners
9-Month Follow-up
|
0.63 Condomless anal sex partners
Standard Error 0.11
|
0.40 Condomless anal sex partners
Standard Error 0.05
|
PRIMARY outcome
Timeframe: Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group)Population: The analytic sample included 760 of the 764 participants enrolled because 1 participant was enrolled in error (ineligible age) and withdrawn from the study prior to randomization and 3 participants were excluded from the analytic sample due to missing or invalid data.
The number of anal sex acts under the influence of drugs/alcohol will be evaluated at all time points using the AIDS-Risk Behavior Assessment (ARBA) adapted for YMSM. At each timepoint, participants were asked to report the past 3 month number of insertive and receptive anal sex acts during which they had been drinking alcohol or using drugs.
Outcome measures
| Measure |
Immediate Intervention
n=379 Participants
Study participants randomized to the immediate intervention arm will have access to the MyPEEPS Mobile from the baseline visit to 3-month follow-up visit. They will continue with follow-up visits at 6 months and 9 months, but will no longer have access to the MyPEEPS Mobile past the 3-month follow-up visit.
MyPEEPS Mobile: Mobile technology to deliver HIV prevention information specifically developed for at-risk YMSM.
|
Delayed Intervention
n=381 Participants
Study participants randomized to the delayed intervention arm will complete visits at baseline, 3 months, 6 months, 9 months, and 12 months. They will have access to the MyPEEPS Mobile from the 9-month follow-up visit until the 12-month follow-up visit.
MyPEEPS Mobile: Mobile technology to deliver HIV prevention information specifically developed for at-risk YMSM.
|
|---|---|---|
|
Number of Anal Sex Acts Under the Influence of Drugs/Alcohol
Baseline
|
0.33 Anal sex acts under the influence
Standard Error 0.09
|
0.45 Anal sex acts under the influence
Standard Error 0.11
|
|
Number of Anal Sex Acts Under the Influence of Drugs/Alcohol
3-Month Follow-up
|
0.35 Anal sex acts under the influence
Standard Error 0.16
|
0.42 Anal sex acts under the influence
Standard Error 0.14
|
|
Number of Anal Sex Acts Under the Influence of Drugs/Alcohol
6-Month Follow-up
|
0.35 Anal sex acts under the influence
Standard Error 0.18
|
0.43 Anal sex acts under the influence
Standard Error 0.09
|
|
Number of Anal Sex Acts Under the Influence of Drugs/Alcohol
9-Month Follow-up
|
0.41 Anal sex acts under the influence
Standard Error 0.11
|
0.54 Anal sex acts under the influence
Standard Error 0.12
|
|
Number of Anal Sex Acts Under the Influence of Drugs/Alcohol
12-Month Follow-up
|
—
|
0.53 Anal sex acts under the influence
Standard Error 0.16
|
PRIMARY outcome
Timeframe: Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group)Population: The analytic sample included 760 of the 764 participants enrolled because 1 participant was enrolled in error (ineligible age) and withdrawn from the study prior to randomization and 3 participants were excluded from the analytic sample due to missing or invalid data.
Participants were asked if they have ever used Pre-exposure Prophylaxis (PrEP) at baseline, if they have used PrEP in the prior 3 months at all timepoints, and if they are currently using PrEP at the time of study visit at all timepoints.
Outcome measures
| Measure |
Immediate Intervention
n=379 Participants
Study participants randomized to the immediate intervention arm will have access to the MyPEEPS Mobile from the baseline visit to 3-month follow-up visit. They will continue with follow-up visits at 6 months and 9 months, but will no longer have access to the MyPEEPS Mobile past the 3-month follow-up visit.
MyPEEPS Mobile: Mobile technology to deliver HIV prevention information specifically developed for at-risk YMSM.
|
Delayed Intervention
n=381 Participants
Study participants randomized to the delayed intervention arm will complete visits at baseline, 3 months, 6 months, 9 months, and 12 months. They will have access to the MyPEEPS Mobile from the 9-month follow-up visit until the 12-month follow-up visit.
MyPEEPS Mobile: Mobile technology to deliver HIV prevention information specifically developed for at-risk YMSM.
|
|---|---|---|
|
Number of Participants With Self-reported Pre-exposure Prophylaxis (PrEP) Use
Baseline
|
10 Participants
|
10 Participants
|
|
Number of Participants With Self-reported Pre-exposure Prophylaxis (PrEP) Use
3-Month Follow-up
|
14 Participants
|
14 Participants
|
|
Number of Participants With Self-reported Pre-exposure Prophylaxis (PrEP) Use
6-Month Follow-up
|
20 Participants
|
16 Participants
|
|
Number of Participants With Self-reported Pre-exposure Prophylaxis (PrEP) Use
9-Month Follow-up
|
13 Participants
|
14 Participants
|
|
Number of Participants With Self-reported Pre-exposure Prophylaxis (PrEP) Use
12-Month Follow-up
|
—
|
25 Participants
|
PRIMARY outcome
Timeframe: Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group)Population: The analytic sample included 760 of the 764 participants enrolled because 1 participant was enrolled in error (ineligible age) and withdrawn from the study prior to randomization and 3 participants were excluded from the analytic sample due to missing or invalid data.
Participants were asked if they've ever used Non-occupational Post-Exposure Prophylaxis (nPEP) at baseline and if they've used nPEP in the 3 months prior to each study visit timepoint.
Outcome measures
| Measure |
Immediate Intervention
n=379 Participants
Study participants randomized to the immediate intervention arm will have access to the MyPEEPS Mobile from the baseline visit to 3-month follow-up visit. They will continue with follow-up visits at 6 months and 9 months, but will no longer have access to the MyPEEPS Mobile past the 3-month follow-up visit.
MyPEEPS Mobile: Mobile technology to deliver HIV prevention information specifically developed for at-risk YMSM.
|
Delayed Intervention
n=381 Participants
Study participants randomized to the delayed intervention arm will complete visits at baseline, 3 months, 6 months, 9 months, and 12 months. They will have access to the MyPEEPS Mobile from the 9-month follow-up visit until the 12-month follow-up visit.
MyPEEPS Mobile: Mobile technology to deliver HIV prevention information specifically developed for at-risk YMSM.
|
|---|---|---|
|
Number of Participants With Self-reported Non-occupational Post-Exposure Prophylaxis (nPEP) Use
Baseline
|
4 Participants
|
6 Participants
|
|
Number of Participants With Self-reported Non-occupational Post-Exposure Prophylaxis (nPEP) Use
3-Month Follow-up
|
3 Participants
|
4 Participants
|
|
Number of Participants With Self-reported Non-occupational Post-Exposure Prophylaxis (nPEP) Use
6-Month Follow-up
|
5 Participants
|
8 Participants
|
|
Number of Participants With Self-reported Non-occupational Post-Exposure Prophylaxis (nPEP) Use
9-Month Follow-up
|
1 Participants
|
3 Participants
|
|
Number of Participants With Self-reported Non-occupational Post-Exposure Prophylaxis (nPEP) Use
12-Month Follow-up
|
—
|
3 Participants
|
PRIMARY outcome
Timeframe: Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group)Population: The analytic sample included 760 of the 764 participants enrolled because 1 participant was enrolled in error (ineligible age) and withdrawn from the study prior to randomization and 3 participants were excluded from the analytic sample due to missing or invalid data.
Participants were asked to report how many times they've ever been tested for HIV at baseline and at each follow-up timepoint they were asked how many times they've tested for HIV in the prior 3 months.
Outcome measures
| Measure |
Immediate Intervention
n=379 Participants
Study participants randomized to the immediate intervention arm will have access to the MyPEEPS Mobile from the baseline visit to 3-month follow-up visit. They will continue with follow-up visits at 6 months and 9 months, but will no longer have access to the MyPEEPS Mobile past the 3-month follow-up visit.
MyPEEPS Mobile: Mobile technology to deliver HIV prevention information specifically developed for at-risk YMSM.
|
Delayed Intervention
n=381 Participants
Study participants randomized to the delayed intervention arm will complete visits at baseline, 3 months, 6 months, 9 months, and 12 months. They will have access to the MyPEEPS Mobile from the 9-month follow-up visit until the 12-month follow-up visit.
MyPEEPS Mobile: Mobile technology to deliver HIV prevention information specifically developed for at-risk YMSM.
|
|---|---|---|
|
Number of Participants With Self-Reported HIV Testing
Baseline
|
63 Participants
|
55 Participants
|
|
Number of Participants With Self-Reported HIV Testing
3-Month Follow-up
|
90 Participants
|
79 Participants
|
|
Number of Participants With Self-Reported HIV Testing
6-Month Follow-up
|
84 Participants
|
69 Participants
|
|
Number of Participants With Self-Reported HIV Testing
9-Month Follow-up
|
93 Participants
|
69 Participants
|
|
Number of Participants With Self-Reported HIV Testing
12-Month Follow-up
|
—
|
71 Participants
|
PRIMARY outcome
Timeframe: Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group)Population: The analytic sample included 760 of the 764 participants enrolled because 1 participant was enrolled in error (ineligible age) and withdrawn from the study prior to randomization and 3 participants were excluded from the analytic sample due to missing or invalid data.
Participants were asked to report past 3-month testing for sexually transmitted infections (STIs) at each timepoint.
Outcome measures
| Measure |
Immediate Intervention
n=379 Participants
Study participants randomized to the immediate intervention arm will have access to the MyPEEPS Mobile from the baseline visit to 3-month follow-up visit. They will continue with follow-up visits at 6 months and 9 months, but will no longer have access to the MyPEEPS Mobile past the 3-month follow-up visit.
MyPEEPS Mobile: Mobile technology to deliver HIV prevention information specifically developed for at-risk YMSM.
|
Delayed Intervention
n=381 Participants
Study participants randomized to the delayed intervention arm will complete visits at baseline, 3 months, 6 months, 9 months, and 12 months. They will have access to the MyPEEPS Mobile from the 9-month follow-up visit until the 12-month follow-up visit.
MyPEEPS Mobile: Mobile technology to deliver HIV prevention information specifically developed for at-risk YMSM.
|
|---|---|---|
|
Number of Participants With Self-Reported Sexually Transmitted Infection (STI) Testing
Baseline
|
73 Participants
|
65 Participants
|
|
Number of Participants With Self-Reported Sexually Transmitted Infection (STI) Testing
3-Month Follow-up
|
63 Participants
|
49 Participants
|
|
Number of Participants With Self-Reported Sexually Transmitted Infection (STI) Testing
6-Month Follow-up
|
56 Participants
|
44 Participants
|
|
Number of Participants With Self-Reported Sexually Transmitted Infection (STI) Testing
9-Month Follow-up
|
59 Participants
|
44 Participants
|
|
Number of Participants With Self-Reported Sexually Transmitted Infection (STI) Testing
12-Month Follow-up
|
—
|
53 Participants
|
SECONDARY outcome
Timeframe: Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group)Population: The analytic sample included 760 of the 764 participants enrolled because 1 participant was enrolled in error (ineligible age) and withdrawn from the study prior to randomization and 3 participants were excluded from the analytic sample due to missing or invalid data.
Participants were presented with the statement "During the next 3 months, I am not planning to have anal sex" with response options ranging from 1=Very true to 4=Very untrue. The mean value was calculated per group and per timepoint.
Outcome measures
| Measure |
Immediate Intervention
n=379 Participants
Study participants randomized to the immediate intervention arm will have access to the MyPEEPS Mobile from the baseline visit to 3-month follow-up visit. They will continue with follow-up visits at 6 months and 9 months, but will no longer have access to the MyPEEPS Mobile past the 3-month follow-up visit.
MyPEEPS Mobile: Mobile technology to deliver HIV prevention information specifically developed for at-risk YMSM.
|
Delayed Intervention
n=381 Participants
Study participants randomized to the delayed intervention arm will complete visits at baseline, 3 months, 6 months, 9 months, and 12 months. They will have access to the MyPEEPS Mobile from the 9-month follow-up visit until the 12-month follow-up visit.
MyPEEPS Mobile: Mobile technology to deliver HIV prevention information specifically developed for at-risk YMSM.
|
|---|---|---|
|
Intent to Have Anal Sex
Baseline
|
2.35 score on a scale
Standard Error 0.06
|
2.40 score on a scale
Standard Error 0.05
|
|
Intent to Have Anal Sex
3-Month Follow-up
|
2.30 score on a scale
Standard Error 0.06
|
2.36 score on a scale
Standard Error 0.06
|
|
Intent to Have Anal Sex
6-Month Follow-up
|
2.33 score on a scale
Standard Error 0.06
|
2.35 score on a scale
Standard Error 0.06
|
|
Intent to Have Anal Sex
9-Month Follow-up
|
2.42 score on a scale
Standard Error 0.06
|
2.40 score on a scale
Standard Error 0.06
|
|
Intent to Have Anal Sex
12-Month Follow-up
|
—
|
2.42 score on a scale
Standard Error 0.06
|
SECONDARY outcome
Timeframe: Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group)Population: The analytic sample included 760 of the 764 participants enrolled because 1 participant was enrolled in error (ineligible age) and withdrawn from the study prior to randomization and 3 participants were excluded from the analytic sample due to missing or invalid data.
Participants responded to the statement "During the next 3 months, I plan to always use condoms during anal sex with all of my sex partners" with response options ranging from 1=Very true to 4=Very untrue. Mean values were calculated by group for each timepoint.
Outcome measures
| Measure |
Immediate Intervention
n=379 Participants
Study participants randomized to the immediate intervention arm will have access to the MyPEEPS Mobile from the baseline visit to 3-month follow-up visit. They will continue with follow-up visits at 6 months and 9 months, but will no longer have access to the MyPEEPS Mobile past the 3-month follow-up visit.
MyPEEPS Mobile: Mobile technology to deliver HIV prevention information specifically developed for at-risk YMSM.
|
Delayed Intervention
n=381 Participants
Study participants randomized to the delayed intervention arm will complete visits at baseline, 3 months, 6 months, 9 months, and 12 months. They will have access to the MyPEEPS Mobile from the 9-month follow-up visit until the 12-month follow-up visit.
MyPEEPS Mobile: Mobile technology to deliver HIV prevention information specifically developed for at-risk YMSM.
|
|---|---|---|
|
Intent to Always Use Condoms During Anal Sex With All Sex Partners
Baseline
|
3.38 units on a scale
Standard Error 0.04
|
3.41 units on a scale
Standard Error 0.04
|
|
Intent to Always Use Condoms During Anal Sex With All Sex Partners
3-Month Follow-up
|
3.45 units on a scale
Standard Error 0.05
|
3.44 units on a scale
Standard Error 0.04
|
|
Intent to Always Use Condoms During Anal Sex With All Sex Partners
6-Month Follow-up
|
3.34 units on a scale
Standard Error 0.05
|
3.37 units on a scale
Standard Error 0.05
|
|
Intent to Always Use Condoms During Anal Sex With All Sex Partners
9-Month Follow-up
|
3.42 units on a scale
Standard Error 0.05
|
3.38 units on a scale
Standard Error 0.04
|
|
Intent to Always Use Condoms During Anal Sex With All Sex Partners
12-Month Follow-up
|
—
|
3.35 units on a scale
Standard Error 0.05
|
SECONDARY outcome
Timeframe: Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group)Population: The analytic sample included 760 of the 764 participants enrolled because 1 participant was enrolled in error (ineligible age) and withdrawn from the study prior to randomization and 3 participants were excluded from the analytic sample due to missing or invalid data.
Participants responded to the statement "I plan to use PrEP as a strategy to reduce my risk for HIV infection during the next three months" with response values ranging from 1=Very true to 4=Very untrue. Mean values were calculated for each group at each timepoint.
Outcome measures
| Measure |
Immediate Intervention
n=379 Participants
Study participants randomized to the immediate intervention arm will have access to the MyPEEPS Mobile from the baseline visit to 3-month follow-up visit. They will continue with follow-up visits at 6 months and 9 months, but will no longer have access to the MyPEEPS Mobile past the 3-month follow-up visit.
MyPEEPS Mobile: Mobile technology to deliver HIV prevention information specifically developed for at-risk YMSM.
|
Delayed Intervention
n=381 Participants
Study participants randomized to the delayed intervention arm will complete visits at baseline, 3 months, 6 months, 9 months, and 12 months. They will have access to the MyPEEPS Mobile from the 9-month follow-up visit until the 12-month follow-up visit.
MyPEEPS Mobile: Mobile technology to deliver HIV prevention information specifically developed for at-risk YMSM.
|
|---|---|---|
|
Intent to Use PrEP as a Strategy to Reduce HIV Infection Risk
Baseline
|
2.67 units on a scale
Standard Error 0.06
|
2.65 units on a scale
Standard Error 0.05
|
|
Intent to Use PrEP as a Strategy to Reduce HIV Infection Risk
3-Month Follow-up
|
2.82 units on a scale
Standard Error 0.06
|
2.66 units on a scale
Standard Error 0.06
|
|
Intent to Use PrEP as a Strategy to Reduce HIV Infection Risk
6-Month Follow-up
|
2.79 units on a scale
Standard Error 0.06
|
2.66 units on a scale
Standard Error 0.06
|
|
Intent to Use PrEP as a Strategy to Reduce HIV Infection Risk
9-Month Follow-up
|
2.74 units on a scale
Standard Error 0.06
|
2.59 units on a scale
Standard Error 0.05
|
|
Intent to Use PrEP as a Strategy to Reduce HIV Infection Risk
12-Month Follow-up
|
—
|
2.83 units on a scale
Standard Error 0.06
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group)Population: The analytic sample included 760 of the 764 participants enrolled because 1 participant was enrolled in error (ineligible age) and withdrawn from the study prior to randomization and 3 participants were excluded from the analytic sample due to missing or invalid data.
Participants were asked to respond to 10 questions assessing self-efficacy in practicing condom use and safer sex communication with a partner. A sample item is "if I didn't want to have sex with my partner, I would be able to say no." Response options ranged from 1=Strongly agree to 4=Strongly disagree. Question scores ranged 1-4, values averaged and total scores ranged from 1 to 4, with lower values indicating higher self-efficacy
Outcome measures
| Measure |
Immediate Intervention
n=379 Participants
Study participants randomized to the immediate intervention arm will have access to the MyPEEPS Mobile from the baseline visit to 3-month follow-up visit. They will continue with follow-up visits at 6 months and 9 months, but will no longer have access to the MyPEEPS Mobile past the 3-month follow-up visit.
MyPEEPS Mobile: Mobile technology to deliver HIV prevention information specifically developed for at-risk YMSM.
|
Delayed Intervention
n=381 Participants
Study participants randomized to the delayed intervention arm will complete visits at baseline, 3 months, 6 months, 9 months, and 12 months. They will have access to the MyPEEPS Mobile from the 9-month follow-up visit until the 12-month follow-up visit.
MyPEEPS Mobile: Mobile technology to deliver HIV prevention information specifically developed for at-risk YMSM.
|
|---|---|---|
|
Self-efficacy for Safer Sex and Situational Temptation for Unsafe Sex
Baseline
|
1.51 units on a scale
Standard Error 0.02
|
1.52 units on a scale
Standard Error 0.02
|
|
Self-efficacy for Safer Sex and Situational Temptation for Unsafe Sex
3-Month Follow-up
|
1.44 units on a scale
Standard Error 0.02
|
1.54 units on a scale
Standard Error 0.02
|
|
Self-efficacy for Safer Sex and Situational Temptation for Unsafe Sex
6-Month Follow-up
|
1.50 units on a scale
Standard Error 0.02
|
1.52 units on a scale
Standard Error 0.02
|
|
Self-efficacy for Safer Sex and Situational Temptation for Unsafe Sex
9-Month Follow-up
|
1.47 units on a scale
Standard Error 0.02
|
1.55 units on a scale
Standard Error 0.02
|
|
Self-efficacy for Safer Sex and Situational Temptation for Unsafe Sex
12-Month Follow-up
|
—
|
1.44 units on a scale
Standard Error 0.02
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group)Population: The analytic sample included 760 of the 764 participants enrolled because 1 participant was enrolled in error (ineligible age) and withdrawn from the study prior to randomization and 3 participants were excluded from the analytic sample due to missing or invalid data.
The condom errors survey is a 12-item questionnaire was adapted to reflect a 6-week recall period. A sample question is "when you used condoms during the last six weeks, how often was the condom put on the wrong side up so that it had to be flipped over?" Response options ranged from 0=Never to 2=Always. Question scores ranged 0-2, values averaged and total scores ranged from 0 to 2, with lower values indicating fewer condom use errors.
Outcome measures
| Measure |
Immediate Intervention
n=379 Participants
Study participants randomized to the immediate intervention arm will have access to the MyPEEPS Mobile from the baseline visit to 3-month follow-up visit. They will continue with follow-up visits at 6 months and 9 months, but will no longer have access to the MyPEEPS Mobile past the 3-month follow-up visit.
MyPEEPS Mobile: Mobile technology to deliver HIV prevention information specifically developed for at-risk YMSM.
|
Delayed Intervention
n=381 Participants
Study participants randomized to the delayed intervention arm will complete visits at baseline, 3 months, 6 months, 9 months, and 12 months. They will have access to the MyPEEPS Mobile from the 9-month follow-up visit until the 12-month follow-up visit.
MyPEEPS Mobile: Mobile technology to deliver HIV prevention information specifically developed for at-risk YMSM.
|
|---|---|---|
|
Condom Use Errors
3-Month Follow-up
|
0.68 units on a scale
Standard Error 0.01
|
0.59 units on a scale
Standard Error 0.01
|
|
Condom Use Errors
Baseline
|
0.60 units on a scale
Standard Error 0.01
|
0.61 units on a scale
Standard Error 0.01
|
|
Condom Use Errors
6-Month Follow-up
|
0.67 units on a scale
Standard Error 0.01
|
0.58 units on a scale
Standard Error 0.01
|
|
Condom Use Errors
9-Month Follow-up
|
0.62 units on a scale
Standard Error 0.01
|
0.57 units on a scale
Standard Error 0.01
|
|
Condom Use Errors
12-Month Follow-up
|
—
|
0.64 units on a scale
Standard Error 0.02
|
Adverse Events
Immediate Intervention
Delayed Intervention
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Rebecca Schnall, RN, MPH, PhD, Professor of Disease Prevention and Health Promotion (in Nursing)
Columbia University
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place