NCT06182280Active, not recruiting
Transmasculine One-on-One and Group Empowerment for Targeted HIV Reduction
Strategies to Prevent HIV Acquisition Among Transgender Men Who Have Sex With Men (TMSM)
Source: ClinicalTrials.gov · Last updated 16 Sept 2026
Brief summary (registry, in English)
Transgender masculine and gender diverse people who have sex with men (TMSM) have an increased risk of human immunodeficiency virus (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 pre-exposure prophylaxis (PrEP) engagement for HIV prevention. 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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 90 (actual)
- First submitted
- 13 Dec 2023
- Start date
- 1 Apr 2024
- Primary completion date
- 31 Oct 2026
- Lead sponsor
- Fenway Community Health
- Diseases
- HIV
- NCT number
- NCT06182280
What you commit to
- Study type: Interventional
- Participants enrolled: 90
- From 1 Apr 2024 to the primary completion date, 31 Oct 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Is living with HIV (HIV positive)
Age
- Less than age 18
Other
- Does not identify as a man, trans man, or another transmasculine identity
- Does not have access to a smartphone or computer
- Does not reside in one of the Ending the Epidemic geographic hotspots in the United States
- Will not or cannot provide written informed consent in English
- Does not meet the trans-adapted CDC guidelines for PrEP indications
Who the study is looking for
- Age 18 or over
- 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/frontal or anal sex with a partner assigned male at birth with a flesh penis
- Sharing needles or syringes for illicit drug use and/or hormones
- Self-reported anogenital sexually transmitted infection diagnosis
Age in the registry: 18 years to - · Sex: Male · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fenway Health Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.