HIV
Conditions
Keywords
MyPEEPS, Mobile Intervention, Human Immunodeficiency Virus (HIV), Transgender Youth
Brief 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.
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.
Interventions
BEHAVIORALMyPEEPS Mobile
Mobile technology to deliver HIV prevention information specifically developed for at-risk young men that have sex with men (YMSM).
Sponsors
National Institute of Mental Health (NIMH)
Ann & Robert H Lurie Children's Hospital of Chicago
Callen-Lorde Community Health Center
Columbia University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Intervention 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.
Eligibility
Sex/Gender
FEMALE
Age
15 Years to 25 Years
Healthy volunteers
Yes
Inclusion criteria
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; * 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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Condomless Receptive Sex Acts | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-reported Nonoccupational HIV Postexposure Prophylaxis (nPEP) Use | 3 and 6 months | Number of participants that self-reported nPEP use |
| Self-reported Pre-exposure Prophylaxis (PrEP) Use | 3 and 6 months | Number of participants that self-reported Pre-exposure Prophylaxis (PrEP) Use |
| Self-reported HIV Testing | 3 and 6 months | Number of participants that self-reported HIV testing |
| Self-reported Sexually Transmitted Infections (STI) Testing | 3 and 6 months | Number of participants that self-reported STI Testing |
| Change in Partner PrEP Use and Adherence or Viral Suppression | Baseline, 3 and 6 months | Change in participant's self-report of their partner(s) PrEP use and adherence or viral suppression (if partner(s) is HIV+) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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). | 40 |
| 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). | 40 |
| Total | 80 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 5 | 4 |
Baseline characteristics
| Characteristic | Immediate Intervention | Total | Delayed Intervention |
|---|---|---|---|
| Age, Continuous | 21.9 years STANDARD_DEVIATION 2.4 | 22 years STANDARD_DEVIATION 2.4 | 22.2 years STANDARD_DEVIATION 2.4 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 9 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants | 24 Participants | 13 Participants |
| Race (NIH/OMB) More than one race | 4 Participants | 10 Participants | 6 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 5 Participants | 3 Participants |
| Race (NIH/OMB) White | 17 Participants | 29 Participants | 12 Participants |
| Region of Enrollment United States | 40 participants | 80 participants | 40 participants |
| Self-reported HIV Testing | 18 Participants | 34 Participants | 16 Participants |
| Self-Reported Nonoccupational Human Immunodeficiency Virus (HIV) Postexposure Prophylaxis (nPEP) Use | 0 participants | 3 participants | 3 participants |
| Self-reported Pre-exposure Prophylaxis (PrEP) Use | 6 Participants | 13 Participants | 7 Participants |
| Self-reported Sexually Transmitted Infection (STI) Testing | 25 participants | 45 participants | 20 participants |
| Sex/Gender, Customized Non-binary | 9 Participants | 12 Participants | 3 Participants |
| Sex/Gender, Customized Other | 17 Participants | 40 Participants | 23 Participants |
| Sex/Gender, Customized Transgender Man | 14 Participants | 28 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 40 | 0 / 40 |
| other Total, other adverse events | 0 / 40 | 0 / 40 |
| serious Total, serious adverse events | 0 / 40 | 0 / 40 |
Outcome results
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
Time frame: Baseline, 3 and 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Immediate Intervention | Change in Condomless Receptive Sex Acts | Baseline and 3 Months | 1.57 Condomless Receptive Sex Acts | Standard Deviation 5.55 |
| Immediate Intervention | Change in Condomless Receptive Sex Acts | 3 Months and 6 Months | 1.43 Condomless Receptive Sex Acts | Standard Deviation 6.4 |
| Delayed Intervention | Change in Condomless Receptive Sex Acts | Baseline and 3 Months | 3.19 Condomless Receptive Sex Acts | Standard Deviation 9.75 |
| Delayed Intervention | Change in Condomless Receptive Sex Acts | 3 Months and 6 Months | 1.44 Condomless Receptive Sex Acts | Standard Deviation 17.7 |
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+)
Time frame: Baseline, 3 and 6 months
Population: 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).
Secondary
Self-reported HIV Testing
Number of participants that self-reported HIV testing
Time frame: 3 and 6 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Immediate Intervention | Self-reported HIV Testing | 3 Months | 12 Participants |
| Immediate Intervention | Self-reported HIV Testing | 6 Months | 15 Participants |
| Delayed Intervention | Self-reported HIV Testing | 3 Months | 21 Participants |
| Delayed Intervention | Self-reported HIV Testing | 6 Months | 17 Participants |
Secondary
Self-reported Nonoccupational HIV Postexposure Prophylaxis (nPEP) Use
Number of participants that self-reported nPEP use
Time frame: 3 and 6 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Immediate Intervention | Self-reported Nonoccupational HIV Postexposure Prophylaxis (nPEP) Use | 3 months | 1 Participants |
| Immediate Intervention | Self-reported Nonoccupational HIV Postexposure Prophylaxis (nPEP) Use | 6 months | 1 Participants |
| Delayed Intervention | Self-reported Nonoccupational HIV Postexposure Prophylaxis (nPEP) Use | 3 months | 2 Participants |
| Delayed Intervention | Self-reported Nonoccupational HIV Postexposure Prophylaxis (nPEP) Use | 6 months | 4 Participants |
Secondary
Self-reported Pre-exposure Prophylaxis (PrEP) Use
Number of participants that self-reported Pre-exposure Prophylaxis (PrEP) Use
Time frame: 3 and 6 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Immediate Intervention | Self-reported Pre-exposure Prophylaxis (PrEP) Use | 6 Months | 6 Participants |
| Immediate Intervention | Self-reported Pre-exposure Prophylaxis (PrEP) Use | 3 Months | 6 Participants |
| Delayed Intervention | Self-reported Pre-exposure Prophylaxis (PrEP) Use | 6 Months | 7 Participants |
| Delayed Intervention | Self-reported Pre-exposure Prophylaxis (PrEP) Use | 3 Months | 7 Participants |
Secondary
Self-reported Sexually Transmitted Infections (STI) Testing
Number of participants that self-reported STI Testing
Time frame: 3 and 6 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Immediate Intervention | Self-reported Sexually Transmitted Infections (STI) Testing | 3 Months | 19 Participants |
| Immediate Intervention | Self-reported Sexually Transmitted Infections (STI) Testing | 6 Months | 19 Participants |
| Delayed Intervention | Self-reported Sexually Transmitted Infections (STI) Testing | 3 Months | 23 Participants |
| Delayed Intervention | Self-reported Sexually Transmitted Infections (STI) Testing | 6 Months | 20 Participants |