Supporting Trans Affirmation, Relationships, and Sex, Phase 3

NCT06001307 | Completed Results DMC

• 2 other identifiers: 20020026481R34MH119968-01A1
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

LGBTQ; HIV Prevention; Transgender research; Peer counseling; Intimate Partner Violence (IPV); PrEP

Outcome Measures

Primary Outcomes (7)

• Composite Risk for HIV (CR-HIV)

  Composite Risk for HIV (CR-HIV) calculates a binary indicator (0=No, 1=Yes) of a participant's risk for HIV acquisition using an algorithm based on the following questions: 1. Do they report condomless anal sex with a HIV serodiscordant or status-unknown primary or other partner in the past 6 months? (If yes, move on to question #2; If no, 0) 2. Is the participant using PrEP? (If yes, 0; If no, move onto question #3) 3. Is the participant in a monogamous partnership with an HIV-uninfected partner or an HIV-infected partner who is virally suppressed? (If yes, 0; If no, 1) \*If participants are not certain about their partner's HIV status or viral suppression status in the last question, they are coded as having HIV risk according to this algorithm. The total number of participants at risk for HIV acquisition for each arm is reported.

  Post-intervention, 4-month follow-up, and 6-month follow-up

• Intimate Partner Violence (IPV) Frequency: Composite Abuse Scale Revised Short Form (CASr-SF)

  Intimate Partner Violence (IPV) Frequency was measured using the Composite Abuse Scale Revised-Short Form (CASr-SF), a 15-item scale. For each item, participants answer if the type of abuse occurred and how often from, "Not in the past 2 months (0)" to "Daily/ almost daily (5)." Total score was calculated by summing all items, which could range from 0 to 75 with higher scores indicate higher frequency and severity of IPV.

  Post-intervention, 4-month follow-up, and 6-month follow-up

• Intimate Partner Violence (IPV) Frequency: Transgender-Specific Intimate Partner Violence (T-IPV) Scale

  IPV frequency is assessed using the trans-specific IPV scale (T-IPV), a 4-item scale that screens for IPV among transgender individuals. Participants reponsded to statements covering the presence of controlling behaviors and psychological abuse tactics (No=0; Yes=1). Scores range from 0 to 4, with higher scores indicating higher frequency of recent T-IPV.

  Post-intervention, 4-month follow-up, and 6-month follow-up

• Intimate Partner Violence (IPV) Safety: Measure Of Victim Empowerment Related to Safety (MOVERS)

  MOVERS is a 13-item scale designed to assess empowerment related to safety among IPV survivors. Participants rate each item on a five-point Likert scale (1 = Never true to 5 = Always true). For each participant, the mean score across all 13 items was calculated (score range: 1-5). The scale includes 3 subscales: Internal Tools, Expectations of Support, and Trade-Offs. Scores for each subscale were computed as the mean score of the items corresponding to that subscale (score range: 1-5 for all subscales). For both the composite scale and subscales, higher scores indicate greater empowerment.

  Post-intervention, 4-month follow-up, and 6-month follow-up

• Feasibility of Online STARS as Measured by Recruitment Rates

  One measure of feasibility will be participant recruitment rates.

  During recruitment period of study, up to 4 months

• Feasibility of Online STARS as Measured by Retention Rates.

  One measure of feasibility will be participant retention rates, as measured by engagement/completion of the interventions.

  Post-intervention, 4-month follow-up, and 6-month follow-up

• Acceptability of Online STARS as Measured by the Client Satisfaction Questionnaire

  One measure of acceptability will be via acceptability ratings using the validated 8-item Client Satisfaction Questionnaire (CSQ-8). Participants rated each item on a four-point Likert scale. For each participant, the mean score across all 8 items was calculated (score range: 1-4), with higher values indicating higher satisfaction.

  Post-intervention

Secondary Outcomes (1)

• Total Number of Receptive Condomless Anal Sex Acts With Any HIV Transmission Risk

  Post-intervention, 4-months follow-up, 6-months follow-up

Other Outcomes (3)

• Participants Reporting Instances of IPV

  Post-intervention, 4-month follow-up, 6-month follow-up

• Depressive Symptoms

  Post-intervention, 4-month follow-up, 6-month follow-up

• PTSD Symptoms: PTSD Checklist for DSM-5 (PCL-5)

  Post-intervention, 4-month follow-up, and 6-month follow-up

Study Arms (2)

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

EXPERIMENTAL

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.

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

Relaxation and Stress Reduction

ACTIVE COMPARATOR

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.

Behavioral: Relaxation and Stress Reduction

Interventions

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

See description to the left.

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

Relaxation and Stress Reduction BEHAVIORAL

See description to the left.

Relaxation and Stress Reduction

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Assigned male at birth and identify as female, transgender, or transfeminine
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• + years old;
• Assigned male at birth but identify as female, transgender, or transfeminine;
• Endorse at least one IPV incident during the previous 12 months based on the trans-specific IPV Scale (T-IPV Scale; Peitzmeier et al, in press);
• Report at least one instance of condomless anal sex in the last 6 months.

You may not qualify if:

• Have been diagnosed with HIV or test positive for HIV.

Sponsors & Collaborators

• Brown University: lead
• National Institute of Mental Health (NIMH): collaborator
• The University of Akron: collaborator

Study Sites (1)

Brown University

Providence, Rhode Island, 02912, United States

Location

Related Publications (1)

• Guy AA, Chen CA, McCarthy-Belash N, Kang TK, Kolbasov LA, Gregory R, Scott T, Garcia J, Banson J, Zlotnick C, Operario D, Johnson DM, Sun S. Mixed methods trial of a peer intervention for HIV and partner victimization in transgender women. J Couns Psychol. 2025 Nov 6:10.1037/cou0000832. doi: 10.1037/cou0000832. Online ahead of print.

  PMID: 41196739 DERIVED

MeSH Terms

Conditions

Risk Reduction Behavior

Interventions

Association; Sex

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Psychotherapeutic Processes; Psychotherapy; Behavioral Disciplines and Activities; Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Results Point of Contact

• Title: Arryn Guy
• Organization: Illinois Institute of Technology

aguy1@iit.edu

312-567-6467

Study Officials

• Shufang Sun, PhD

  Brown University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: All research staff conducting participant assessments will remain blinded to group assignment. Randomization procedures will be conducted by a high level researcher (co-investigator responsible for clinical supervision).
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The methodological approach includes a 2-arm trial of Project STARS vs. a time matched, attention-controlled comparison group, with up to n=20 per arm (total Phase 3 sample size = up to 40 participants enrolled and randomized). The study is intended to evaluate the impacts of STARS on the specified outcomes.

Study Record Dates

• First Submitted: August 4, 2023
• First Posted: August 21, 2023
• Study Start: June 20, 2023
• Primary Completion: May 30, 2024
• Study Completion: May 30, 2024
• Last Updated: November 19, 2025
• Results First Posted: November 5, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will become available sometime in during Summer 2024 and will be available for the duration of staff funding.

Locations

US (1)