Transmaculine One-on-One and Group Empowerment for Targeted HIV Reduction
Starting soon · Not applicable
Conditions studied: HIV Infections, Adherence, Medication
In brief
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.
Key facts
- Study ID
- NCT06182280
- Run by
- Fenway Community Health
- People needed
- 375
- Starts
- 2024-01-01
- Expected to finish
- 2027-06-01
- Last updated by the study team
- 2023-12-26
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 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/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
You may not qualify if…
- Less than age 18
- Not assigned female sex at birth
- Does not identify as a man, trans man, or another transmasculine identity
- Does not have access to a smartphone or computer
- Is living with HIV (HIV positive)
- 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
Where it is running
- Fenway Community Health — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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