Trial Outcomes & Findings for MyPEEPS Mobile for Young Transgender Men (NCT NCT05424718)
NCT ID: NCT05424718
Last Updated: 2025-03-11
Results Overview
Change in self-reported number of condomless receptive anal or vaginal sex acts with sex partners assigned male at birth
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
80 participants
Primary outcome timeframe
Baseline, 3 and 6 months
Results posted on
2025-03-11
Participant Flow
Participant milestones
| Measure |
Immediate Intervention
Study participants randomized to the intervention arm will have access to the MyPEEPS Mobile application for the first three months of the trial and then the intervention is removed at the 3 month follow-up visit.
MyPEEPS Mobile: Mobile technology to deliver HIV prevention information specifically developed for at-risk young men that have sex with men (YMSM).
|
Delayed Intervention
Participants randomized to the delayed intervention arm will not have access to MyPEEPS Mobile for the first 3 months of the study and will receive access to the MyPEEPS Mobile App at the 3 month follow-up visit.
MyPEEPS Mobile: Mobile technology to deliver HIV prevention information specifically developed for at-risk young men that have sex with men (YMSM).
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
40
|
|
Overall Study
COMPLETED
|
35
|
36
|
|
Overall Study
NOT COMPLETED
|
5
|
4
|
Reasons for withdrawal
| Measure |
Immediate Intervention
Study participants randomized to the intervention arm will have access to the MyPEEPS Mobile application for the first three months of the trial and then the intervention is removed at the 3 month follow-up visit.
MyPEEPS Mobile: Mobile technology to deliver HIV prevention information specifically developed for at-risk young men that have sex with men (YMSM).
|
Delayed Intervention
Participants randomized to the delayed intervention arm will not have access to MyPEEPS Mobile for the first 3 months of the study and will receive access to the MyPEEPS Mobile App at the 3 month follow-up visit.
MyPEEPS Mobile: Mobile technology to deliver HIV prevention information specifically developed for at-risk young men that have sex with men (YMSM).
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
5
|
4
|
Baseline Characteristics
MyPEEPS Mobile for Young Transgender Men
Baseline characteristics by cohort
| Measure |
Immediate Intervention
n=40 Participants
Study participants randomized to the intervention arm will have access to the MyPEEPS Mobile application for the first three months of the trial and then the intervention is removed at the 3 month follow-up visit.
MyPEEPS Mobile: Mobile technology to deliver HIV prevention information specifically developed for at-risk young men that have sex with men (YMSM).
|
Delayed Intervention
n=40 Participants
Participants randomized to the delayed intervention arm will not have access to MyPEEPS Mobile for the first 3 months of the study and will receive access to the MyPEEPS Mobile App at the 3 month follow-up visit.
MyPEEPS Mobile: Mobile technology to deliver HIV prevention information specifically developed for at-risk young men that have sex with men (YMSM).
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
21.9 years
STANDARD_DEVIATION 2.4 • n=5 Participants
|
22.2 years
STANDARD_DEVIATION 2.4 • n=7 Participants
|
22 years
STANDARD_DEVIATION 2.4 • n=5 Participants
|
|
Sex/Gender, Customized
Transgender Man
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Non-binary
|
9 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Other
|
17 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
40 participants
n=5 Participants
|
40 participants
n=7 Participants
|
80 participants
n=5 Participants
|
|
Self-Reported Nonoccupational Human Immunodeficiency Virus (HIV) Postexposure Prophylaxis (nPEP) Use
|
0 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Self-reported Pre-exposure Prophylaxis (PrEP) Use
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Self-reported HIV Testing
|
18 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Self-reported Sexually Transmitted Infection (STI) Testing
|
25 participants
n=5 Participants
|
20 participants
n=7 Participants
|
45 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 3 and 6 monthsChange in self-reported number of condomless receptive anal or vaginal sex acts with sex partners assigned male at birth
Outcome measures
| Measure |
Immediate Intervention
n=35 Participants
Study participants randomized to the intervention arm will have access to the MyPEEPS Mobile application for the first three months of the trial and then the intervention is removed at the 3 month follow-up visit.
MyPEEPS Mobile: Mobile technology to deliver HIV prevention information specifically developed for at-risk young men that have sex with men (YMSM).
|
Delayed Intervention
n=36 Participants
Participants randomized to the delayed intervention arm will not have access to MyPEEPS Mobile for the first 3 months of the study and will receive access to the MyPEEPS Mobile App at the 3 month follow-up visit.
MyPEEPS Mobile: Mobile technology to deliver HIV prevention information specifically developed for at-risk young men that have sex with men (YMSM).
|
|---|---|---|
|
Change in Condomless Receptive Sex Acts
Baseline and 3 Months
|
1.57 Condomless Receptive Sex Acts
Standard Deviation 5.55
|
3.19 Condomless Receptive Sex Acts
Standard Deviation 9.75
|
|
Change in Condomless Receptive Sex Acts
3 Months and 6 Months
|
1.43 Condomless Receptive Sex Acts
Standard Deviation 6.4
|
1.44 Condomless Receptive Sex Acts
Standard Deviation 17.7
|
SECONDARY outcome
Timeframe: 3 and 6 monthsNumber of participants that self-reported nPEP use
Outcome measures
| Measure |
Immediate Intervention
n=35 Participants
Study participants randomized to the intervention arm will have access to the MyPEEPS Mobile application for the first three months of the trial and then the intervention is removed at the 3 month follow-up visit.
MyPEEPS Mobile: Mobile technology to deliver HIV prevention information specifically developed for at-risk young men that have sex with men (YMSM).
|
Delayed Intervention
n=36 Participants
Participants randomized to the delayed intervention arm will not have access to MyPEEPS Mobile for the first 3 months of the study and will receive access to the MyPEEPS Mobile App at the 3 month follow-up visit.
MyPEEPS Mobile: Mobile technology to deliver HIV prevention information specifically developed for at-risk young men that have sex with men (YMSM).
|
|---|---|---|
|
Self-reported Nonoccupational HIV Postexposure Prophylaxis (nPEP) Use
3 months
|
1 Participants
|
2 Participants
|
|
Self-reported Nonoccupational HIV Postexposure Prophylaxis (nPEP) Use
6 months
|
1 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 3 and 6 monthsNumber of participants that self-reported Pre-exposure Prophylaxis (PrEP) Use
Outcome measures
| Measure |
Immediate Intervention
n=35 Participants
Study participants randomized to the intervention arm will have access to the MyPEEPS Mobile application for the first three months of the trial and then the intervention is removed at the 3 month follow-up visit.
MyPEEPS Mobile: Mobile technology to deliver HIV prevention information specifically developed for at-risk young men that have sex with men (YMSM).
|
Delayed Intervention
n=36 Participants
Participants randomized to the delayed intervention arm will not have access to MyPEEPS Mobile for the first 3 months of the study and will receive access to the MyPEEPS Mobile App at the 3 month follow-up visit.
MyPEEPS Mobile: Mobile technology to deliver HIV prevention information specifically developed for at-risk young men that have sex with men (YMSM).
|
|---|---|---|
|
Self-reported Pre-exposure Prophylaxis (PrEP) Use
6 Months
|
6 Participants
|
7 Participants
|
|
Self-reported Pre-exposure Prophylaxis (PrEP) Use
3 Months
|
6 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: 3 and 6 monthsNumber of participants that self-reported HIV testing
Outcome measures
| Measure |
Immediate Intervention
n=35 Participants
Study participants randomized to the intervention arm will have access to the MyPEEPS Mobile application for the first three months of the trial and then the intervention is removed at the 3 month follow-up visit.
MyPEEPS Mobile: Mobile technology to deliver HIV prevention information specifically developed for at-risk young men that have sex with men (YMSM).
|
Delayed Intervention
n=36 Participants
Participants randomized to the delayed intervention arm will not have access to MyPEEPS Mobile for the first 3 months of the study and will receive access to the MyPEEPS Mobile App at the 3 month follow-up visit.
MyPEEPS Mobile: Mobile technology to deliver HIV prevention information specifically developed for at-risk young men that have sex with men (YMSM).
|
|---|---|---|
|
Self-reported HIV Testing
3 Months
|
12 Participants
|
21 Participants
|
|
Self-reported HIV Testing
6 Months
|
15 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: 3 and 6 monthsNumber of participants that self-reported STI Testing
Outcome measures
| Measure |
Immediate Intervention
n=35 Participants
Study participants randomized to the intervention arm will have access to the MyPEEPS Mobile application for the first three months of the trial and then the intervention is removed at the 3 month follow-up visit.
MyPEEPS Mobile: Mobile technology to deliver HIV prevention information specifically developed for at-risk young men that have sex with men (YMSM).
|
Delayed Intervention
n=36 Participants
Participants randomized to the delayed intervention arm will not have access to MyPEEPS Mobile for the first 3 months of the study and will receive access to the MyPEEPS Mobile App at the 3 month follow-up visit.
MyPEEPS Mobile: Mobile technology to deliver HIV prevention information specifically developed for at-risk young men that have sex with men (YMSM).
|
|---|---|---|
|
Self-reported Sexually Transmitted Infections (STI) Testing
3 Months
|
19 Participants
|
23 Participants
|
|
Self-reported Sexually Transmitted Infections (STI) Testing
6 Months
|
19 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: Baseline, 3 and 6 monthsPopulation: Data was not analyzed as participant's self-report of partner(s) PrEP use and adherence/viral supression data were not collected (due to unintentional omision of partner related questions in the participant questionnaire).
Change in participant's self-report of their partner(s) PrEP use and adherence or viral suppression (if partner(s) is HIV+)
Outcome measures
Outcome data not reported
Adverse Events
Immediate Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Delayed Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Rebecca Schnall, PhD, MPH, RN-BC, FAAN, FACMI
Columbia University
Phone: 212-342-6886
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Any presentation, abstract, or manuscript will be made available for review by the study sponsor(s) prior to submission
- Publication restrictions are in place
Restriction type: OTHER