HIVNCT05424718
MyPEEPS Mobile for Young Transgender Men
A study testing MyPEEPS Mobile in people with HIV, run by Columbia University at 3 sites in United States.
Trial summary
The proposed MyPEEPS intervention for young transgender men is a novel and evidence-driven intervention using mobile technology to deliver HIV prevention information to high risk youth. The final product will be the basis for conducting a large-scale efficacy study in this population. Read more about this study
- Who is it for?
- Ages 15 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV
- What is being tested?
- MyPEEPS Mobile
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 3 sitesUnited States
- Study dates
- 16 Jun 2023to 21 Mar 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 25 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- To participate in any aspect of the study, participants must be:
- Between 15 and 25 years of age;
- Female sex assigned at birth;
- Identify as a transgender man or along the transmasculine spectrum (including a transmasculine non-binary gender; e.g., male, trans male, transmasculine gender non-binary);
- Understand and read English;
- Live within the US;
Show all 9Show fewer
- Own a smartphone;
- Self-report condomless receptive anal or vaginal penile sex with either a cisgender male or transgender woman (e.g., individual designated or assigned male at birth) in the past year; and
- Self-report HIV-negative or unknown status.
Who cannot join
- Youth are ineligible to participate in the trial if:
- HIV positive;
- Unable to provide informed consent due to severe mental or physical illness or substance intoxication at the time of enrollment;
- Concurrently enrolled in another HIV prevention study.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Ann & Robert H. Lurie Children's Hospital Chicago
Chicago, Illinois, 60640
Callen-Lorde Community Health Center
New York, New York, 10011
Columbia University
New York, New York, 10032
About this study
Official title: MyPEEPS (Male Youth Pursuing Empowerment, Education, and Prevention Around Sexuality) Mobile for Young Transgender Men
The proposed MyPEEPS intervention for young transgender men is a novel and evidence-driven intervention using mobile technology to deliver HIV prevention information to high risk youth. The final product will be the basis for conducting a large-scale efficacy study in this population.
Read the detailed description
Transgender youth in the United States have unique health needs but often face barriers to accessing and receiving health care services which contribute to disparate health outcomes including high vulnerability to HIV and other sexually transmitted infections. Emerging evidence has begun to document HIV-related sexual risk among young transgender men (YTM), as well as low uptake of pre-exposure prophylaxis among those with indications, suggesting high vulnerability to HIV infection. Despite the high prevalence and increased risk of HIV in YTM who have sex with cisgender men, only one prior HIV prevention intervention has been developed to address the specific sexual health needs of YTM, which indicates a critical gap in HIV prevention science. In response to this need, and building off preliminary work, the investigators propose to develop a mobile intervention for YTM building on MyPEEPS Mobile, which was originally developed for very young sexual minority men. Central to this intervention is the premise that it will be delivered to youth during a developmental period that precedes or coincides with sexual debut, an important time for intervention, prior to or concurrent with initiation of high-risk behaviors.
Given both the gap in HIV prevention science and the lack of current targeted interventions, and building upon our multidisciplinary team's extensive experience in HIV prevention, mobile health (mHealth), behavioral interventions, randomized controlled trials, and transgender health, the investigators propose the following specific aims: 1) Using qualitative methodology, expert feedback, and usability assessments, develop MyPEEPS Mobile for YTM, 2) Conduct a pilot randomized controlled trial to examine the feasibility, acceptability, and preliminary efficacy of the revised MyPEEPS Mobile App in a sample of 80 YTM (15-25 years) and refine the study methods for a future efficacy trial, and 3) Assess predisposing, enabling, and reinforcing factors for MyPEEPS Mobile among YTM through theoretically-guided in depth interviews. The proposed MyPEEPS intervention for YTM will be the first study to develop and pilot a scaled-up, mobile HIV prevention intervention designed by, and piloted for, a diverse group of YTM. The final product of this study will be the basis for an R01 application to conduct a large-scale efficacy study for this population.
- Conditions
- HIV
- Being tested
- MyPEEPS Mobile
- Keywords
- MyPEEPS, Mobile Intervention, Human Immunodeficiency Virus (HIV), Transgender Youth
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyPEEPS MobileBehavioural
Mobile technology to deliver HIV prevention information specifically developed for at-risk young men that have sex with men (YMSM).
| Study group | Role | What they receive |
|---|---|---|
| Immediate Intervention | Experimental | 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. Receives: Behavioral: MyPEEPS Mobile |
| Delayed Intervention | Experimental | 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. Receives: Behavioral: MyPEEPS Mobile |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Condomless Receptive Sex Acts
Change in self-reported number of condomless receptive anal or vaginal sex acts with sex partners assigned male at birth
Measured: Baseline, 3 and 6 months
Secondary outcomes (5)
Self-reported Nonoccupational HIV Postexposure Prophylaxis (nPEP) Use
Number of participants that self-reported nPEP use
Measured: 3 and 6 months
Self-reported Pre-exposure Prophylaxis (PrEP) Use
Number of participants that self-reported Pre-exposure Prophylaxis (PrEP) Use
Measured: 3 and 6 months
Self-reported HIV Testing
Number of participants that self-reported HIV testing
Measured: 3 and 6 months
Self-reported Sexually Transmitted Infections (STI) Testing
Number of participants that self-reported STI Testing
Measured: 3 and 6 months
Change in Partner PrEP Use and Adherence or Viral Suppression
Change in participant's self-report of their partner(s) PrEP use and adherence or viral suppression (if partner(s) is HIV+)
Measured: Baseline, 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start16 Jun 2023
- Primary completion21 Mar 2024
- Study completion21 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The intervention arm receives the intervention from baseline to 3 months and at the 3 month visit, access to the intervention is removed and the control/ delayed intervention arm then receives the intervention.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Ann & Robert H Lurie Children's Hospital of Chicago, Callen-Lorde Community Health Center
- Responsible party
- Principal investigator, Rebecca Schnall, RN, MPH, PhD, Columbia University
- Investigators
- Rebecca Schnall, PhD, MPH, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05424718
- Sponsor's protocol ID
- AAAT8624
- Other IDs
- R34MH128163
- Status last verified
- Feb 2025
- First submitted
- 15 Jun 2022
- Last updated
- 11 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: While individual participant data (IPD) will not be shared, the results of the study will be shared at conferences such as the American Public Health Association annual meeting and Infectious Disease week; provide organizations that are influential in HIV public health practice (e.g., International AIDS Society) with an executive summary, press releases, and/or published papers; publish results in peer-reviewed academic journals; provide a lay summary for participants and community partners.
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MyPEEPS (Male Youth Pursuing Empowerment, Education, and Prevention Around Sexuality) Mobile for Young Transgender Men
- ClinicalTrials.gov ID
- NCT05424718
- Acronym / sponsor ID
- AAAT8624
- Conditions
- HIV
- Keywords
- MyPEEPS, Mobile Intervention, Human Immunodeficiency Virus (HIV), Transgender Youth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Ann & Robert H Lurie Children's Hospital of Chicago, Callen-Lorde Community Health Center
- Study start
- 16 Jun 2023 (actual)
- Primary completion
- 21 Mar 2024 (actual)
- Study completion
- 21 Mar 2024 (actual)
- First posted
- 21 Jun 2022 (actual)
- Results
- Posted 11 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The proposed MyPEEPS intervention for young transgender men is a novel and evidence-driven intervention using mobile technology to deliver HIV prevention information to high risk youth. The final product will be the basis for conducting a large-scale efficacy study in this population.
Detailed description
Transgender youth in the United States have unique health needs but often face barriers to accessing and receiving health care services which contribute to disparate health outcomes including high vulnerability to HIV and other sexually transmitted infections. Emerging evidence has begun to document HIV-related sexual risk among young transgender men (YTM), as well as low uptake of pre-exposure prophylaxis among those with indications, suggesting high vulnerability to HIV infection. Despite the high prevalence and increased risk of HIV in YTM who have sex with cisgender men, only one prior HIV prevention intervention has been developed to address the specific sexual health needs of YTM, which indicates a critical gap in HIV prevention science. In response to this need, and building off preliminary work, the investigators propose to develop a mobile intervention for YTM building on MyPEEPS Mobile, which was originally developed for very young sexual minority men. Central to this intervention is the premise that it will be delivered to youth during a developmental period that precedes or coincides with sexual debut, an important time for intervention, prior to or concurrent with initiation of high-risk behaviors.
Given both the gap in HIV prevention science and the lack of current targeted interventions, and building upon our multidisciplinary team's extensive experience in HIV prevention, mobile health (mHealth), behavioral interventions, randomized controlled trials, and transgender health, the investigators propose the following specific aims: 1) Using qualitative methodology, expert feedback, and usability assessments, develop MyPEEPS Mobile for YTM, 2) Conduct a pilot randomized controlled trial to examine the feasibility, acceptability, and preliminary efficacy of the revised MyPEEPS Mobile App in a sample of 80 YTM (15-25 years) and refine the study methods for a future efficacy trial, and 3) Assess predisposing, enabling, and reinforcing factors for MyPEEPS Mobile among YTM through theoretically-guided in depth interviews. The proposed MyPEEPS intervention for YTM will be the first study to develop and pilot a scaled-up, mobile HIV prevention intervention designed by, and piloted for, a diverse group of YTM. The final product of this study will be the basis for an R01 application to conduct a large-scale efficacy study for this population.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The intervention arm receives the intervention from baseline to 3 months and at the 3 month visit, access to the intervention is removed and the control/ delayed intervention arm then receives the intervention.
| Arm | Type | Receives |
|---|---|---|
| Immediate Intervention | Experimental | Behavioral: MyPEEPS MobileStudy 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. |
| Delayed Intervention | Experimental | Behavioral: MyPEEPS MobileParticipants 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. |
Who may qualify
- Ages
- 15 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- Between 15 and 25 years of age;
- Female sex assigned at birth;
- Identify as a transgender man or along the transmasculine spectrum (including a transmasculine non-binary gender; e.g., male, trans male, transmasculine gender non-binary);
- Understand and read English;
- Live within the US;
Key exclusion criteria (4 listed)
- HIV positive;
- Unable to provide informed consent due to severe mental or physical illness or substance intoxication at the time of enrollment;
- Concurrently enrolled in another HIV prevention study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MyPEEPS MobileMobile technology to deliver HIV prevention information specifically developed for at-risk young men that have sex with men (YMSM). | Behavioural | Delayed Intervention, Immediate Intervention |
Primary outcome
Change in Condomless Receptive Sex Acts
Time frame: Baseline, 3 and 6 months
Change in self-reported number of condomless receptive anal or vaginal sex acts with sex partners assigned male at birth
5 secondary outcomes
Self-reported Nonoccupational HIV Postexposure Prophylaxis (nPEP) Use
Time frame: 3 and 6 months
Self-reported Pre-exposure Prophylaxis (PrEP) Use
Time frame: 3 and 6 months
Self-reported HIV Testing
Time frame: 3 and 6 months
Self-reported Sexually Transmitted Infections (STI) Testing
Time frame: 3 and 6 months
Change in Partner PrEP Use and Adherence or Viral Suppression
Time frame: Baseline, 3 and 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. While individual participant data (IPD) will not be shared, the results of the study will be shared at conferences such as the American Public Health Association annual meeting and Infectious Disease week; provide organizations that are influential in HIV public health practice (e.g., International AIDS Society) with an executive summary, press releases, and/or published papers; publish results in peer-reviewed academic journals; provide a lay summary for participants and community partners.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rebecca Schnall, PhD, MPH principal investigator
Columbia University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MyPEEPS Mobile in people with HIV, run by Columbia University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Condomless Receptive Sex Acts (time frame: Baseline, 3 and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2025.