Transmaculine One-on-One and Group Empowerment for Targeted HIV Reduction

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Fenway Community Health
Study ID
NCT06182280
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • PrEP4T — BEHAVIORAL
    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.
  • LS4TM — BEHAVIORAL
    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.

Study Details

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 Dates

Start date
Jan 31, 2024
Status verified
Dec 2023
Primary completion
Jul 31, 2026
Completion
Jun 30, 2027

Study Design

Enrollment
375 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION

Arms

  • No Intervention: Condition A: Standard of Care (SOC)
    SOC will include linkage to the CDC's HIV Prevention Services Locator, a US directory of HIV testing and PrEP services. A Digital Library of HIV prevention, sexual health, and anti-stigma materials (written and video media) will be provided. This content is curated from CDC, Gate Trans Men \& HIV Project, UCSF Center for Excellence in Trans Health, and National LGBTQIA+ Health Education Center, among other sources.
  • Experimental: Condition B: Online one-on-one peer navigation (SOC + PrEP4T)
    PrEP4T is an individualized TMSM-specific intervention consisting of online one-on-one sessions between a peer and a participant. PrEP4T has 9 hours of content: 6 1.5-hour sessions conducted weekly for 6 weeks. Participants will also receive access to the SOC materials.
  • Experimental: Condition C: Online peer-delivered small group-based behavioral intervention (SOC + LS4TM)
    LS4TM is a theory-based peer-delivered small group-based behavioral intervention. The LS4TM manualized intervention is comprised of 9 hours of content: 6 2-hour small-group sessions with up to 12 participants per group delivered weekly for 6 weeks. Participants will also receive access to the SOC materials.
  • Experimental: Condition D: Peer-delivered and group-based intervention (SOC + PrEP4T + LS4TM)
    Both PrEP4T and LS4TM will be delivered to participants. Group D will receive 21 hours of content: 6 2-hour LS4TM sessions and 6 1.5-hour PrEP4T sessions. Group D participants may not receive both interventions simultaneously within 6 weeks.

Primary Outcome Measure

PrEP uptake [ Time Frame: 18 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Fenway Community HealthBostonMassachusetts02215
Sari Reisner, ScD
[email protected]
617-927-6400
Kevin Smith, PhD
[email protected]
617-927-6120
Sari Reisner, ScD (PRINCIPAL_INVESTIGATOR)
Ken Mayer, MD (SUB_INVESTIGATOR)

Find similar trials in Boston, MA

By condition
HIV
By specialty
Infectious disease
By research site
Fenway Community Health· Boston, MA

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