Status:
NOT_YET_RECRUITING
Transmaculine One-on-One and Group Empowerment for Targeted HIV Reduction
Lead Sponsor:
Fenway Community Health
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
HIV Infections
Adherence, Medication
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief 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 interve...
Detailed 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: ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
375 Patients enrolled
Trial Details
Trial ID
NCT06182280
Start Date
January 1 2024
End Date
June 1 2027
Last Update
December 26 2023
Active Locations (1)
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1
Fenway Community Health
Boston, Massachusetts, United States, 02215