Strategies to Prevent HIV Acquisition Among Transgender Men Who Have Sex With Men (TMSM)
Fenway Community Health
Summary
Transgender masculine and gender diverse people who have sex with men (TMSM) have an increased risk of HIV and face unique barriers engaging in prevention services. Digitally delivered support interventions addressing HIV prevention barriers delivered by peers in one-on-one or small-group settings may be effective at increasing PrEP engagement. This study examines the independent and combined effects of individual and group-based peer-support interventions on PrEP outcomes. Participants will be randomly assigned to receive: (i) standard-of-care HIV prevention information, (ii) a one-on-one healthy lifestyle intervention tailored for transgender masculine people, (iii) a peer-group based healthy lifestyle intervention for transgender masculine people, or (iv) both the one-on-one and group-based interventions delivered together. The hypotheses are that the individual group-based interventions will result in higher PrEP uptake and persistence than the standard of care and that the combined interventions will be more effective than receiving one individual intervention.
Description
This study will comprise a digitally delivered, open-label randomized 2x2 factorial trial (1:1:1:1 randomization) of peer-delivered HIV prevention strategies. The 2x2 factorial design has two actors: individualized, one-on-one peer navigation (PrEP4T vs none) (Condition B) and group-based behavioral intervention (LS4TM vs none) (Condition C). The trial will compare the efficacy of the interventions to increase PrEP uptake. Participants in Conditions B and C will receive 6 weeks of their assigned intervention in addition to SOC. Participants in Condition D will be assigned to receive both inte…
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- Yes
Inclusion Criteria: * Age 18 or over * Assigned female sex at birth * Identifies as a man, trans man, or another transmasculine identity * Has had sex with a partner assigned male sex at birth with a flesh penis in the last 3 months * Has access to a smartphone or computer with internet access * Is HIV-uninfected * Resides in one of the Ending the Epidemic targeted geographic hotspots in the United States * Willing and able to provide informed consent in English * Meets CDC guidelines for PrEP indications in the last 3 months (adapted for TMSM) including: * Condomless receptive vaginal/fronta…
Interventions
- BehavioralPrEP4T
PrEP4T is an individualized TMSM-specific intervention adapted from The Fenway Model. PrEP4T consists of online one-on-one sessions between a peer and a participant using a strengths-based case management manualized curriculum. Peer navigators (PNs) share transmasculine community membership with participants and are trained to provide linkages. They use an individualized approach to navigate barriers, apply an assets-based frame to promote resiliencies, and pragmatically leverage these to improve biomedical HIV prevention outcomes. PNs utilize techniques from established behavior change models (e.g., Motivational Interviewing; Transtheoretical Model) in PrEP decision-making.
- BehavioralLS4TM
LS4TM is a theory-based peer-delivered small group-based behavioral intervention to reduce HIV risk and address mental health-related effects of stigma for TMSM. Groups will be led by trained peer navigator staff and comprise no more than 10 participants per cohort.
Location
- Fenway Community HealthBoston, Massachusetts