Supporting Trans Affirmation, Relationships, and Sex, Phase 3

Summary

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.

Conditions

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

Interventions

BEHAVIORAL

Program STARS (Supporting Trans Affirmation, relationships, and Sex)

See description to the left.

BEHAVIORAL

Relaxation and Stress Reduction

See description to the left.

Sponsors & Collaborators

• National Institute of Mental Health (NIMH)

  collaborator NIH

• The University of Akron

  collaborator OTHER

• Brown University

  lead OTHER

Principal Investigators

• Shufang Sun, PhD · Brown University

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

MALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-06-20

Primary Completion

2024-05-30

Completion

2024-05-30

Countries

• United States

Study Locations