Supporting Trans Affirmation, Relationships, and Sex, Phase 3

Study Overview
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Brief Summary
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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.

Detailed Description
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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: 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 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: 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. 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). 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.

Official Title
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HIV Risk Reduction Intervention for Transwomen With Intimate Partner Victimization

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

Intervention / Treatment
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* Behavioral: Program STARS (Supporting Trans Affirmation, relationships, and Sex)
* Behavioral: Relaxation and Stress Reduction


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Program STARS (Supporting Trans Affirmation, relationships, and Sex)<br>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)<br>* See description to the left.<br>|
| Active Comparator: Relaxation and Stress Reduction<br>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<br>* See description to the left.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite Risk for HIV (CR-HIV) | 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: reports condomless anal sex with a HIV serodiscordant or status-unknown primary or other partner in the past 6 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. It will be captured at baseline, post-intervention, and at 4-months and 6-months follow up. | 4 months | 
| Intimate Partner Violence (IPV) Frequency: Composite Abuse Scale revised short form (CASr-SF) | IPV frequency will be assessed using two standardized scales. The first scale used is the Composite Abuse Scale revised short form (CASr-SF). Total scores for the CASR-SF, range from 0 to 75, and are calculated by computing the mean of past 12-month frequency of abuse experience responses and multiplying by 15, where there are responses for at least 11 of 15 items ( 70%). Higher scores indicate higher frequency and severity of IPV. It will be administered at baseline, post-intervention, and at 4-months and 6-months follow up. | 4 months | 
| Intimate Partner Violence (IPV) Frequency: Transgender-Specific Intimate Partner Violence (T-IPV) Scale | IPV frequency will be assessed using two standardized scales. The second scale used is a trans-specific IPV scale (T-IPV) developed by Peitzmeier et al. The T-IPV Scale is an 8-item scale that screens for IPV among transgender individuals. Items cover controlling behaviors and psychological abuse tactics. Scores range from 0 to 8, with higher scores indicating higher frequency of recent T-IPV. | 4 months | 
| Intimate Partner Violence (IPV) Safety | IPV safety will be assessed with the Measure Of Victim Empowerment Related to Safety (MOVERS Scale; Goodman et al., 2015), which is a 13-item scale that measures IPV survivors empowerment within the domain of safety. MOVERS is composed of three sub-scales that assess distinct domains of safety related empowerment: (a) Internal Tools, (b) Expectation of Support, and (c) Trade-off. Participants respond to each item using a five-point Likert scale (from never true to always true). Scores on each sub-scale are summed and averaged to produce sub-scale scores. Higher scores indicate higher perceived safety and empowerment. It will be administered at baseline, post-intervention, and at 4-months and 6-months follow up. | 4 months | 
| Feasibility of online STARS as measured by recruitment rates | One measure of feasibility will be participant recruitment rates. | 2 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. | 2 months | 
| 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). Scores for the CSQ-8 range from 8 to 32, with higher values indicating higher satisfaction. | 2 months | 
| Acceptability of online STARS as measured by a session evaluation form | One measure of acceptability will be via a session evaluation form that provides both qualitative and quantitative feedback on the study intervention. | 2 months | 
| Acceptability of online STARS as measured by semi-structured qualitative exit interview | One measure of acceptability will be via a semi-structured qualitative exit interview conducted with one-on-one with study participants via a videoconferencing platform (i.e., Zoom). Interviews will be transcribed and coded for analysis. | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rates of STI/HIV testing and outcomes | 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. Rates of testing and the subsequent outcomes of those tests are a secondary outcome of this study. | 4 months | 
| Self-reported discrete behavioral risk indicators | 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. | 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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LGBTQ, HIV Prevention, Transgender research, Peer counseling, Intimate Partner Violence (IPV), PrEP