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| ID | Type | Description | Link |
|---|---|---|---|
| R34MH128163 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
| Ann & Robert H Lurie Children's Hospital of Chicago | OTHER |
| Callen-Lorde Community Health Center | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MyPEEPS Mobile | Behavioral | Mobile technology to deliver HIV prevention information specifically developed for at-risk young men that have sex with men (YMSM). |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline, 3 and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Self-reported Nonoccupational HIV Postexposure Prophylaxis (nPEP) Use | Number of participants that self-reported nPEP use | 3 and 6 months |
| Self-reported Pre-exposure Prophylaxis (PrEP) Use | Number of participants that self-reported Pre-exposure Prophylaxis (PrEP) Use |
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Inclusion Criteria:
To participate in any aspect of the study, participants must be:
Exclusion Criteria:
Youth are ineligible to participate in the trial if:
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);
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| Name | Affiliation | Role |
|---|---|---|
| Rebecca Schnall, PhD, MPH | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ann & Robert H. Lurie Children's Hospital Chicago | Chicago | Illinois | 60640 | United States | ||
| Callen-Lorde Community Health Center |
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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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| FG001 | 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Mean | Standard Deviation | Condomless Receptive Sex Acts | Baseline, 3 and 6 months |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rebecca Schnall, PhD, MPH, RN-BC, FAAN, FACMI | Columbia University | 212-342-6886 | rb897@columbia.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 9, 2023 | Feb 19, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 24, 2023 | Feb 19, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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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.
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| 3 and 6 months |
| Self-reported HIV Testing | Number of participants that self-reported HIV testing | 3 and 6 months |
| Self-reported Sexually Transmitted Infections (STI) Testing | Number of participants that self-reported STI Testing | 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+) | Baseline, 3 and 6 months |
| New York |
| New York |
| 10011 |
| United States |
| Columbia University | New York | New York | 10032 | United States |
| BG001 | 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). |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Self-Reported Nonoccupational Human Immunodeficiency Virus (HIV) Postexposure Prophylaxis (nPEP) Use | The number of participants that self-reported Nonoccupational HIV Postexposure Prophylaxis (nPEP) use. | Number | participants |
|
| Self-reported Pre-exposure Prophylaxis (PrEP) Use | Number of participants that self-reported Pre-exposure Prophylaxis (PrEP) Use | Count of Participants | Participants |
|
| Self-reported HIV Testing | Number of participants that self-reported HIV testing | Count of Participants | Participants |
|
| Self-reported Sexually Transmitted Infection (STI) Testing | Number of participants that self-reported STI testing | Number | participants |
|
|
|
| Secondary | Self-reported Nonoccupational HIV Postexposure Prophylaxis (nPEP) Use | Number of participants that self-reported nPEP use | Posted | Count of Participants | Participants | 3 and 6 months |
|
|
|
| Secondary | Self-reported Pre-exposure Prophylaxis (PrEP) Use | Number of participants that self-reported Pre-exposure Prophylaxis (PrEP) Use | Posted | Count of Participants | Participants | 3 and 6 months |
|
|
|
| Secondary | Self-reported HIV Testing | Number of participants that self-reported HIV testing | Posted | Count of Participants | Participants | 3 and 6 months |
|
|
|
| Secondary | Self-reported Sexually Transmitted Infections (STI) Testing | Number of participants that self-reported STI Testing | Posted | Count of Participants | Participants | 3 and 6 months |
|
|
|
| Secondary | 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+) | 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). | Posted | Baseline, 3 and 6 months |
|
|
| 0 |
| 40 |
| 0 |
| 40 |
| 0 |
| 40 |
| EG001 | 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). | 0 | 40 | 0 | 40 | 0 | 40 |
Any presentation, abstract, or manuscript will be made available for review by the study sponsor(s) prior to submission
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |