Supporting Trans Affirmation, Relationships, and Sex, Phase 3 (STARS)

HIV Risk Reduction Intervention for Transwomen With Intimate Partner Victimization

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.

Study Overview

• Status: Completed
• Conditions: HIV; Violence, Domestic; Risk Reduction Behavior; Violence, Gender-Based
• Intervention / Treatment: Behavioral: Program STARS (Supporting Trans Affirmation, relationships, and Sex); Behavioral: Relaxation and Stress Reduction

Detailed Description

Transgender women (TW) are among the populations most heavily affected by HIV in the United States (US), with nearly 1 in 5 TW living with HIV. The risk for HIV in TW often occurs in the context of intimate partner relationships. Moreover, in the context of these partnerships, TW are at elevated risk for intimate partner victimization (IPV). There is a strong link between IPV and HIV risk. IPV risk is amplified in TW who have a history of IPV or are in an abusive primary relationship. Thus, IPV and HIV as well as other sexually transmitted infections (STIs) are interconnected public health problems facing TW. Despite the dual and interconnected risks of HIV and IPV among TW, there are few empirically based HIV prevention interventions that target TW and none that target HIV risks related to IPV in this population.

This overall research study is a 3-phase project (NIH R34MH119968). In Phase 1, researchers conducted focus groups with TW and community-based service providers to identify specific strategies for a brief health educational counseling intervention to support safety and HIV risk reduction among TW who have experienced recent IPV and HIV risk. Phase 1 data collection activities and preliminary analyses have been completed, and a full draft intervention protocol was produced based on Phase 1 findings.

Phase 2 of this study involved conducting an open pilot trail (OP) of the full draft intervention protocol with 5 participants, using quantitative (i.e. surveys) and qualitative (i.e. individual interviews) methods to gain experience delivering the protocol and obtaining critical feedback on the intervention protocol, procedures and assessments. This knowledge has informed finalizing the intervention and assessment protocols, which will be used in the subsequent and final Phase 3 of the study.

Phase 3 (the clinical trial registered here), involves conducting a pilot, two-arm Randomized Control Trial (RCT) to evaluate the program's ability to increase knowledge of HIV and HIV risk factors and reduce risk of intimate partner victimization among participants. The two treatment conditions used in this clinical trial are: (1) a newly developed gender affirming intervention, known as Program STARS (Supporting Trans Affirmation, relationships, and Sex) - detailed below and (2) a time-matched, attention-controlled program that offers free training in relaxation and stress reduction techniques (a.k.a., the comparison group).

Participants will first complete a multi-step screening process to determine eligibility. If eligible, enrolled participants will then complete a 2-3 hour baseline assessment that can be conducted in-person or over Zoom. Assessments consist of interviewer administered safety measures as well as self-report online questionnaires. After completing the baseline assessment, participants will be randomly assigned to one of the two intervention arms. Assessments will also be conducted post-intervention as well as at 4-months and 6-months follow up. Participants who were randomized to the study intervention arm (i.e., the STARS Program) will also be invited to complete a 60-90 minute semi-structured exit interview via Zoom to provide qualitative feedback on the program.

The overall purpose of this study is to develop a brief intervention that concurrently targets HIV and IPV risk, as well as addresses inter-related risks of HIV and IPV (e.g., substance use and PTSD) for TW - referred to as Supporting Transwomen Affirmation, Relationships and Sex (STARS). Program STARS will:

• Be based on the Gender Affirmation Framework, which emphasizes interpersonal processes to positively affirm the identities and unique needs of TW.
• Integrate a trauma-informed empowerment approach.
• Include gender-affirming and empowering HIV prevention counseling that addresses HIV risk within the context of IPV and related risk factors (e.g., substance use and PTSD), and a range of HIV risk reduction options.
• Provide TW with behavioral skills and resources for addressing IPV and maximizing personal safety.

The aims of this treatment development research are to:

1. Develop a behavioral intervention manual that addresses the specific and unique HIV prevention needs of TW with IPV, and that uses a gender-affirmative, empowering, and trauma-informed approach; and
2. Evaluate the feasibility, acceptability, safety, and initial effects of STARS through three phases of intervention development.

Researchers are primarily interested in exploring the pattern of results for any evidence of support for the intervention's influence on the primary and secondary outcomes, which are listed below.

Primary Outcomes:

1. Composite Risk for HIV (CR-HIV) is a binary indicator of any HIV risk (e.g., yes=1 vs. no=0), which is an algorithm based on whether the participant:

   • report condomless anal sex with a HIV serodiscordant or status-unknown primary or other partner in the past 3 months;
   • is using PrEP;
   • is in a monogamous partnership with an HIV-uninfected partner or an ;
   • is in a monogamous partnership with an HIV-infected partner who is virally suppressed.
   • If participants are not certain about the latter two indicators, they are coded as having HIV risk according to this algorithm.

2. IPV frequency will be assessed with:

   • The Composite Abuse Scale revised short form (CASr-SF).and
   • A trans-specific IPV Scale (T-IPV Scale; Peitzmeier et al, in press) that assesses IPV unique to TW (e.g., being forced not pursuing aspects of gender transition that you wanted).

3. IPV safety will be assessed with the:

   • Measure Of Victim Empowerment Related to Safety (MOVERS; Goodman et al., 2015), which is a 13-item scale that measures IPV survivors' safety-related psychosocial skills and efficacy and expectations of support, as well as the extent to which survivors feel that their efforts to achieve safety might create new difficulties.

Secondary Outcomes:

• Biologically determined STI diagnoses, including HIV - The research staff will work with participants to find gender-affirming health care clinics in their area that provide free or low-cost STI and HIV testing. Participants will be encouraged to get tested for STIs as part of the research study; however, STI testing is not a requirement for participation. HIV self-test kits will be mailed to willing participants and the research staff will walk participants through testing procedures as well as post-test result counseling (as needed) over Zoom or in-person.
• Self-reported discrete behavioral risk indicators: CAS, multiple and concurrent partnerships, partners' HIV status, monogamy and sexual agreements, substance use including injection drug use, HIV testing behaviors (including self-testing) and knowledge, intentions to use PrEP, PrEP uptake, use of any HIV prevention services, and use of any additional IPV-related services/resources.

Long-term aim: The findings from this R34 intervention development study will provide the groundwork to examine the efficacy of STARS in a future, large-scale clinical trial, which can be readily implemented in real-world settings.

Dissemination

• Throughout the study, researchers will disseminate process reports and descriptive summaries of the findings to colleagues at social service and medical/health agencies with whom we established MOUs.
• As data are evaluated, researchers will prepare brief reports describing the major findings from the study which we will share with our community partners, HIV prevention and IPV scientists, and TW health and advocacy organizations through publications and presentations at professional conferences.

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02912
      • Brown University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 18+ 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: Program STARS (Supporting Trans Affirmation, relationships, and Sex); See description to the left.
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.	Behavioral: Relaxation and Stress Reduction; See description to the left.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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: 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); Is the participant using PrEP? (If yes, 0; If no, move onto question #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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Number of Receptive Condomless Anal Sex Acts With Any HIV Transmission Risk	The total number of receptive condomless anal sex acts with any HIV transmission risk was calculated by summing the number of receptive anal sex acts in which no prevention method (i.e., condom, PrEP) was used over the last 60 days.	Post-intervention, 4-months follow-up, 6-months follow-up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participants Reporting Instances of IPV		Post-intervention, 4-month follow-up, 6-month follow-up
Depressive Symptoms	Depressive symptoms were evaluated using the Center of Epidemiologic Studies Depression Scale-10 (CESD-10). The measure consists of 10 items that asked about feelings or behaviors related to depressive symptoms on a four-point Likert scale (0-3). Items 5 and 8 were first reverse coded, and all points were summed to create a total score ranging from 0 to 30, with higher scores representing greater degrees of depressed mood.	Post-intervention, 4-month follow-up, 6-month follow-up
PTSD Symptoms: PTSD Checklist for DSM-5 (PCL-5)	PTSD symptoms were evaluated using the PTSD Checklist for DSM-5, a 20-item measure that assesses symptom frequency in the past month on a five-point Likert scale (0 = "Not at all" to 4 = "Extremely"). The total score is calculated by summing the responses for all 20 items, resulting in a score between 0 and 80. A higher total score indicates more severe PTSD symptoms.	Post-intervention, 4-month follow-up, and 6-month follow-up

Collaborators and Investigators

• Sponsor: Brown University
• Collaborators: National Institute of Mental Health (NIMH); The University of Akron
• Investigators: Principal Investigator: Shufang Sun, PhD, Brown University

Publications and helpful links

General Publications

• 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. doi: 10.1037/cou0000832. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2023
• Primary Completion (Actual): May 30, 2024
• Study Completion (Actual): May 30, 2024

Study Registration Dates

• First Submitted: August 4, 2023
• First Submitted That Met QC Criteria: August 14, 2023
• First Posted (Actual): August 21, 2023

Study Record Updates

• Last Update Posted (Actual): November 19, 2025
• Last Update Submitted That Met QC Criteria: November 5, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: PrEP; HIV Prevention; Intimate Partner Violence (IPV); LGBTQ; Transgender research; Peer counseling
• Additional Relevant MeSH Terms: Behavior; Risk Reduction Behavior; Psychotherapy; Behavioral Disciplines and Activities; Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena; Psychotherapeutic Processes; Sex; Association
• Other Study ID Numbers: 2002002648; 1R34MH119968-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Following data collection, cleaning, and analysis, we plan to publish deidentified quantitative data at an open science data repository (e.g., Open Science Framework). De-identified qualitative data will be available upon request to the study PI.
• IPD Sharing Time Frame: Data will become available sometime in during Summer 2024 and will be available for the duration of staff funding.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No