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=99 Participants
|
22.2 years
STANDARD_DEVIATION 2.4 • n=107 Participants
|
22 years
STANDARD_DEVIATION 2.4 • n=206 Participants
|
|
Sex/Gender, Customized
Transgender Man
|
14 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
|
Sex/Gender, Customized
Non-binary
|
9 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Sex/Gender, Customized
Other
|
17 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
40 participants
n=99 Participants
|
40 participants
n=107 Participants
|
80 participants
n=206 Participants
|
|
Self-Reported Nonoccupational Human Immunodeficiency Virus (HIV) Postexposure Prophylaxis (nPEP) Use
|
0 participants
n=99 Participants
|
3 participants
n=107 Participants
|
3 participants
n=206 Participants
|
|
Self-reported Pre-exposure Prophylaxis (PrEP) Use
|
6 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Self-reported HIV Testing
|
18 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
34 Participants
n=206 Participants
|
|
Self-reported Sexually Transmitted Infection (STI) Testing
|
25 participants
n=99 Participants
|
20 participants
n=107 Participants
|
45 participants
n=206 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
3 Months
|
6 Participants
|
7 Participants
|
|
Self-reported Pre-exposure Prophylaxis (PrEP) Use
6 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