Supporting Trans Affirmation, Relationships, and Sex, Phase 3

Part of paid clinical trials in Providence, Rhode Island.

Sponsor
Brown University
Study ID
NCT06001307
Status
Completed

Conditions

  • HIV
  • Risk Reduction Behavior
  • Violence, Domestic
  • Violence, Gender-Based

Eligibility Criteria

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

Interventions

  • Program STARS (Supporting Trans Affirmation, relationships, and Sex) — BEHAVIORAL
    See description to the left.
  • Relaxation and Stress Reduction — BEHAVIORAL
    See description to the left.

Study Details

The purpose of this clinical trial is to evaluate and test a newly developed gender-affirming intervention that addresses the dual and interconnected risks of HIV and intimate partner victimization (IPV) among transgender women (TW). The main questions it aims to answer are: (1) will the study intervention reduce HIV risk within the context of IPV and related risk factors (e.g., substance use and PTSD); (2) will STARS improve primary prevention behaviors, such as condom use, pre-exposure prophylaxis (PrEP) use, and repeat HIV testing; and (3) what are the mechanisms of change relevant to the theoretical foundations of the intervention, including gender affirmation, empowerment, and self-efficacy. The findings from this study will provide the necessary groundwork to examine the efficacy of this combined HIV-IPV intervention in a future, large-scale clinical trial. There are several components to this research study: * First, participants will be asked to complete a series of screening interviews/questionnaires to determine eligibility, including completing a HIV test. * If eligible, participants will then take part in a 2-3 hour baseline assessment consisting of both interviewer administered questionnaires as well as self-administered surveys. * Participants will then be randomly assigned to one of two treatment conditions: (1) a newly developed gender affirming intervention, known as Program STARS (Supporting Trans Affirmation, relationships, and Sex) or (2) a time-matched, attention-controlled program that offers free training in relaxation and stress reduction techniques (a.k.a., the comparison group). Both interventions offer unique components and the researchers do not yet know the impact the programs may have on participants' overall well-being. * Participants randomized to Project STARS, will be invited to complete a semi-structured exit interview (lasting 60-90 min.) after the completion of the program. * This clinical trial has three follow-up assessments: (1) post-intervention (i.e., after the peer-counseling programs are complete); (2) at 4-months follow-up; and (3) at 6-months follow-up. The follow-up assessments are structured the same way as the baseline assessment and are estimated to take around 1-2 hours. The total study involvement for this clinical trial is estimated to take approximately 10 to 12 hours over the course of six months.

Key Dates

Start date
Jun 20, 2023
Status verified
Nov 2025
Primary completion
May 30, 2024
Completion
May 30, 2024

Study Design

Enrollment
37 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Program STARS (Supporting Trans Affirmation, relationships, and Sex)
    STARS is an HIV prevention intervention for trans women/femmes with recent intimate partner violence (IPV). Delivered by peer counselors, STARS consists of two one-hour sessions held one week apart and two brief 20-30 minute booster sessions held two- and four-weeks after the 2nd hour long session. Requirements for peer counselors include identifying as trans women or trans feminine and having leadership roles in the trans community. STARS is an empowerment-based intervention that integrates trauma-informed and gender affirmation approaches. The first session emphasizes education and discussion around HIV and IPV, as well as the interaction between IPV and HIV risk. The second session focuses on identifying partners where HIV/IPV risk exists and developing an empowerment plan to address those risks. Participants create an empowerment plan in session 2 and this plan is reviewed and updated in the booster sessions.
  • Active Comparator: Relaxation and Stress Reduction
    The Relaxation and Stress Reduction Program is structured to mirror STARS (time matched, attention-controlled). Delivered by peer counselors, the Relaxation and Stress Reduction Program consists of two one-hour sessions held one week apart and two brief 20-30 minute booster sessions held two- and four-weeks after the 2nd hour long session. Requirements for peer counselors include identifying as trans women or trans feminine and having leadership roles in the trans community. The relaxation and stress reduction protocol is an attention and time-matched control condition. The intervention focuses on providing both education and opportunities to practice various relaxation strategies. In addition, education is provided on healthy eating as an additional tool for reducing stress. Booster sessions focus on providing participants with additional practice of relaxation strategies.

Primary Outcome Measure

Composite Risk for HIV (CR-HIV) [ Time Frame: Post-intervention, 4-month follow-up, and 6-month follow-up ]

Locations (1)

FacilityCityStateZIPSite coordinators
Brown UniversityProvidenceRhode Island02912-

Find similar trials in Providence, RI

By condition
HIV
By specialty
Infectious disease
By research site
Brown University· Providence, RI

Related Studies