xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06001307</url>
    </required_header>
    <id_info>
      <org_study_id>2002002648</org_study_id>
      <secondary_id>1R34MH119968-01A1</secondary_id>
      <nct_id>NCT06001307</nct_id>
    </id_info>
    <brief_title>Supporting Trans Affirmation, Relationships, and Sex, Phase 3</brief_title>
    <acronym>STARS</acronym>
    <official_title>HIV Risk Reduction Intervention for Transwomen With Intimate Partner Victimization</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Brown University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Institute of Mental Health (NIMH)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
      <collaborator>
        <agency>The University of Akron</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Brown University</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of this clinical trial is to evaluate and test a newly developed gender-affirming&#xD;
        intervention that addresses the dual and interconnected risks of HIV and intimate partner&#xD;
        victimization (IPV) among transgender women (TW). The main questions it aims to answer are:&#xD;
        (1) will the study intervention reduce HIV risk within the context of IPV and related risk&#xD;
        factors (e.g., substance use and PTSD); (2) will STARS improve primary prevention behaviors,&#xD;
        such as condom use, pre-exposure prophylaxis (PrEP) use, and repeat HIV testing; and (3) what&#xD;
        are the mechanisms of change relevant to the theoretical foundations of the intervention,&#xD;
        including gender affirmation, empowerment, and self-efficacy. The findings from this study&#xD;
        will provide the necessary groundwork to examine the efficacy of this combined HIV-IPV&#xD;
        intervention in a future, large-scale clinical trial.&#xD;
  &#xD;
        There are several components to this research study:&#xD;
  &#xD;
          -  First, participants will be asked to complete a series of screening&#xD;
             interviews/questionnaires to determine eligibility, including completing a HIV test.&#xD;
  &#xD;
          -  If eligible, participants will then take part in a 2-3 hour baseline assessment&#xD;
             consisting of both interviewer administered questionnaires as well as self-administered&#xD;
             surveys.&#xD;
  &#xD;
          -  Participants will then be randomly assigned to one of two treatment conditions: (1) a&#xD;
             newly developed gender affirming intervention, known as Program STARS (Supporting Trans&#xD;
             Affirmation, relationships, and Sex) or (2) a time-matched, attention-controlled program&#xD;
             that offers free training in relaxation and stress reduction techniques (a.k.a., the&#xD;
             comparison group). Both interventions offer unique components and the researchers do not&#xD;
             yet know the impact the programs may have on participants' overall well-being.&#xD;
  &#xD;
          -  Participants randomized to Project STARS, will be invited to complete a semi-structured&#xD;
             exit interview (lasting 60-90 min.) after the completion of the program.&#xD;
  &#xD;
          -  This clinical trial has three follow-up assessments: (1) post-intervention (i.e., after&#xD;
             the peer-counseling programs are complete); (2) at 4-months follow-up; and (3) at&#xD;
             6-months follow-up. The follow-up assessments are structured the same way as the&#xD;
             baseline assessment and are estimated to take around 1-2 hours.&#xD;
  &#xD;
        The total study involvement for this clinical trial is estimated to take approximately 10 to&#xD;
        12 hours over the course of six months.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Transgender women (TW) are among the populations most heavily affected by HIV in the United&#xD;
        States (US), with nearly 1 in 5 TW living with HIV. The risk for HIV in TW often occurs in&#xD;
        the context of intimate partner relationships. Moreover, in the context of these&#xD;
        partnerships, TW are at elevated risk for intimate partner victimization (IPV). There is a&#xD;
        strong link between IPV and HIV risk. IPV risk is amplified in TW who have a history of IPV&#xD;
        or are in an abusive primary relationship. Thus, IPV and HIV as well as other sexually&#xD;
        transmitted infections (STIs) are interconnected public health problems facing TW. Despite&#xD;
        the dual and interconnected risks of HIV and IPV among TW, there are few empirically based&#xD;
        HIV prevention interventions that target TW and none that target HIV risks related to IPV in&#xD;
        this population.&#xD;
  &#xD;
        This overall research study is a 3-phase project (NIH R34MH119968). In Phase 1, researchers&#xD;
        conducted focus groups with TW and community-based service providers to identify specific&#xD;
        strategies for a brief health educational counseling intervention to support safety and HIV&#xD;
        risk reduction among TW who have experienced recent IPV and HIV risk. Phase 1 data collection&#xD;
        activities and preliminary analyses have been completed, and a full draft intervention&#xD;
        protocol was produced based on Phase 1 findings.&#xD;
  &#xD;
        Phase 2 of this study involved conducting an open pilot trail (OP) of the full draft&#xD;
        intervention protocol with 5 participants, using quantitative (i.e. surveys) and qualitative&#xD;
        (i.e. individual interviews) methods to gain experience delivering the protocol and obtaining&#xD;
        critical feedback on the intervention protocol, procedures and assessments. This knowledge&#xD;
        has informed finalizing the intervention and assessment protocols, which will be used in the&#xD;
        subsequent and final Phase 3 of the study.&#xD;
  &#xD;
        Phase 3 (the clinical trial registered here), involves conducting a pilot, two-arm Randomized&#xD;
        Control Trial (RCT) to evaluate the program's ability to increase knowledge of HIV and HIV&#xD;
        risk factors and reduce risk of intimate partner victimization among participants. The two&#xD;
        treatment conditions used in this clinical trial are: (1) a newly developed gender affirming&#xD;
        intervention, known as Program STARS (Supporting Trans Affirmation, relationships, and Sex) -&#xD;
        detailed below and (2) a time-matched, attention-controlled program that offers free training&#xD;
        in relaxation and stress reduction techniques (a.k.a., the comparison group).&#xD;
  &#xD;
        Participants will first complete a multi-step screening process to determine eligibility. If&#xD;
        eligible, enrolled participants will then complete a 2-3 hour baseline assessment that can be&#xD;
        conducted in-person or over Zoom. Assessments consist of interviewer administered safety&#xD;
        measures as well as self-report online questionnaires. After completing the baseline&#xD;
        assessment, participants will be randomly assigned to one of the two intervention arms.&#xD;
        Assessments will also be conducted post-intervention as well as at 4-months and 6-months&#xD;
        follow up. Participants who were randomized to the study intervention arm (i.e., the STARS&#xD;
        Program) will also be invited to complete a 60-90 minute semi-structured exit interview via&#xD;
        Zoom to provide qualitative feedback on the program.&#xD;
  &#xD;
        The overall purpose of this study is to develop a brief intervention that concurrently&#xD;
        targets HIV and IPV risk, as well as addresses inter-related risks of HIV and IPV (e.g.,&#xD;
        substance use and PTSD) for TW - referred to as Supporting Transwomen Affirmation,&#xD;
        Relationships and Sex (STARS). Program STARS will:&#xD;
  &#xD;
          -  Be based on the Gender Affirmation Framework, which emphasizes interpersonal processes&#xD;
             to positively affirm the identities and unique needs of TW.&#xD;
  &#xD;
          -  Integrate a trauma-informed empowerment approach.&#xD;
  &#xD;
          -  Include gender-affirming and empowering HIV prevention counseling that addresses HIV&#xD;
             risk within the context of IPV and related risk factors (e.g., substance use and PTSD),&#xD;
             and a range of HIV risk reduction options.&#xD;
  &#xD;
          -  Provide TW with behavioral skills and resources for addressing IPV and maximizing&#xD;
             personal safety.&#xD;
  &#xD;
        The aims of this treatment development research are to:&#xD;
  &#xD;
          1. Develop a behavioral intervention manual that addresses the specific and unique HIV&#xD;
             prevention needs of TW with IPV, and that uses a gender-affirmative, empowering, and&#xD;
             trauma-informed approach; and&#xD;
  &#xD;
          2. Evaluate the feasibility, acceptability, safety, and initial effects of STARS through&#xD;
             three phases of intervention development.&#xD;
  &#xD;
        Researchers are primarily interested in exploring the pattern of results for any evidence of&#xD;
        support for the intervention's influence on the primary and secondary outcomes, which are&#xD;
        listed below.&#xD;
  &#xD;
        Primary Outcomes:&#xD;
  &#xD;
          1. Composite Risk for HIV (CR-HIV) is a binary indicator of any HIV risk (e.g., yes=1 vs.&#xD;
             no=0), which is an algorithm based on whether the participant:&#xD;
  &#xD;
               -  report condomless anal sex with a HIV serodiscordant or status-unknown primary or&#xD;
                  other partner in the past 3 months;&#xD;
  &#xD;
               -  is using PrEP;&#xD;
  &#xD;
               -  is in a monogamous partnership with an HIV-uninfected partner or an ;&#xD;
  &#xD;
               -  is in a monogamous partnership with an HIV-infected partner who is virally&#xD;
                  suppressed.&#xD;
  &#xD;
               -  If participants are not certain about the latter two indicators, they are coded as&#xD;
                  having HIV risk according to this algorithm.&#xD;
  &#xD;
          2. IPV frequency will be assessed with:&#xD;
  &#xD;
               -  The Composite Abuse Scale revised short form (CASr-SF).and&#xD;
  &#xD;
               -  A trans-specific IPV Scale (T-IPV Scale; Peitzmeier et al, in press) that assesses&#xD;
                  IPV unique to TW (e.g., being forced not pursuing aspects of gender transition that&#xD;
                  you wanted).&#xD;
  &#xD;
          3. IPV safety will be assessed with the:&#xD;
  &#xD;
               -  Measure Of Victim Empowerment Related to Safety (MOVERS; Goodman et al., 2015),&#xD;
                  which is a 13-item scale that measures IPV survivors' safety-related psychosocial&#xD;
                  skills and efficacy and expectations of support, as well as the extent to which&#xD;
                  survivors feel that their efforts to achieve safety might create new difficulties.&#xD;
  &#xD;
        Secondary Outcomes:&#xD;
  &#xD;
          -  Biologically determined STI diagnoses, including HIV - The research staff will work with&#xD;
             participants to find gender-affirming health care clinics in their area that provide&#xD;
             free or low-cost STI and HIV testing. Participants will be encouraged to get tested for&#xD;
             STIs as part of the research study; however, STI testing is not a requirement for&#xD;
             participation. HIV self-test kits will be mailed to willing participants and the&#xD;
             research staff will walk participants through testing procedures as well as post-test&#xD;
             result counseling (as needed) over Zoom or in-person.&#xD;
  &#xD;
          -  Self-reported discrete behavioral risk indicators: CAS, multiple and concurrent&#xD;
             partnerships, partners' HIV status, monogamy and sexual agreements, substance use&#xD;
             including injection drug use, HIV testing behaviors (including self-testing) and&#xD;
             knowledge, intentions to use PrEP, PrEP uptake, use of any HIV prevention services, and&#xD;
             use of any additional IPV-related services/resources.&#xD;
  &#xD;
        Long-term aim: The findings from this R34 intervention development study will provide the&#xD;
        groundwork to examine the efficacy of STARS in a future, large-scale clinical trial, which&#xD;
        can be readily implemented in real-world settings.&#xD;
  &#xD;
        Dissemination&#xD;
  &#xD;
          -  Throughout the study, researchers will disseminate process reports and descriptive&#xD;
             summaries of the findings to colleagues at social service and medical/health agencies&#xD;
             with whom we established MOUs.&#xD;
  &#xD;
          -  As data are evaluated, researchers will prepare brief reports describing the major&#xD;
             findings from the study which we will share with our community partners, HIV prevention&#xD;
             and IPV scientists, and TW health and advocacy organizations through publications and&#xD;
             presentations at professional conferences.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 20, 2023</start_date>
    <completion_date type="Anticipated">May 2024</completion_date>
    <primary_completion_date type="Anticipated">April 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_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.</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
      <masking_description>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).</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Composite Risk for HIV (CR-HIV)</measure>
      <time_frame>4 months</time_frame>
      <description>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:&#xD;
  reports condomless anal sex with a HIV serodiscordant or status-unknown primary or other partner in the past 6 months;&#xD;
  is using PrEP;&#xD;
  is in a monogamous partnership with an HIV-uninfected partner or an ;&#xD;
  is in a monogamous partnership with an HIV-infected partner who is virally suppressed.&#xD;
  If participants are not certain about the latter two indicators, they are coded as having HIV risk according to this algorithm.&#xD;
  It will be captured at baseline, post-intervention, and at 4-months and 6-months follow up.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Intimate Partner Violence (IPV) Frequency: Composite Abuse Scale revised short form (CASr-SF)</measure>
      <time_frame>4 months</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Intimate Partner Violence (IPV) Frequency: Transgender-Specific Intimate Partner Violence (T-IPV) Scale</measure>
      <time_frame>4 months</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Intimate Partner Violence (IPV) Safety</measure>
      <time_frame>4 months</time_frame>
      <description>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 &quot;never true&quot; to &quot;always true&quot;). 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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Feasibility of online STARS as measured by recruitment rates</measure>
      <time_frame>2 months</time_frame>
      <description>One measure of feasibility will be participant recruitment rates.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Feasibility of online STARS as measured by retention rates.</measure>
      <time_frame>2 months</time_frame>
      <description>One measure of feasibility will be participant retention rates, as measured by engagement/completion of the interventions.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Acceptability of online STARS as measured by the Client Satisfaction Questionnaire</measure>
      <time_frame>2 months</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Acceptability of online STARS as measured by a session evaluation form</measure>
      <time_frame>2 months</time_frame>
      <description>One measure of acceptability will be via a session evaluation form that provides both qualitative and quantitative feedback on the study intervention.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Acceptability of online STARS as measured by semi-structured qualitative exit interview</measure>
      <time_frame>2 months</time_frame>
      <description>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.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Rates of STI/HIV testing and outcomes</measure>
      <time_frame>4 months</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Self-reported discrete behavioral risk indicators</measure>
      <time_frame>4 months</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>HIV</condition>
    <condition>Violence, Gender-Based</condition>
    <condition>Violence, Domestic</condition>
    <condition>Risk Reduction Behavior</condition>
    <arm_group>
      <arm_group_label>Program STARS (Supporting Trans Affirmation, relationships, and Sex)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>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.&#xD;
  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.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Relaxation and Stress Reduction</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>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.&#xD;
  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.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Program STARS (Supporting Trans Affirmation, relationships, and Sex)</intervention_name>
      <description>See description to the left.</description>
      <arm_group_label>Program STARS (Supporting Trans Affirmation, relationships, and Sex)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Relaxation and Stress Reduction</intervention_name>
      <description>See description to the left.</description>
      <arm_group_label>Relaxation and Stress Reduction</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  18+ years old;&#xD;
  &#xD;
            -  Assigned male at birth but identify as female, transgender, or transfeminine;&#xD;
  &#xD;
            -  Endorse at least one IPV incident during the previous 12 months based on the&#xD;
               trans-specific IPV Scale (T-IPV Scale; Peitzmeier et al, in press);&#xD;
  &#xD;
            -  Report at least one instance of condomless anal sex in the last 6 months.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Have been diagnosed with HIV or test positive for HIV.&#xD;
        </textblock>
      </criteria>
      <gender>Male</gender>
      <gender_based>Yes</gender_based>
      <gender_description>Assigned male at birth and identify as female, transgender, or transfeminine</gender_description>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Shufang Sun, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Brown University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Project STARS</last_name>
      <phone>401-863-2746</phone>
      <email>stars@brown.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>Brown University</name>
        <address>
          <city>Providence</city>
          <state>Rhode Island</state>
          <zip>02912</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Project STARS</last_name>
        <phone>401-863-2746</phone>
        <email>stars@brown.edu</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 4, 2023</study_first_submitted>
    <study_first_submitted_qc>August 14, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 21, 2023</last_update_submitted>
    <last_update_submitted_qc>August 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>LGBTQ</keyword>
    <keyword>HIV Prevention</keyword>
    <keyword>Transgender research</keyword>
    <keyword>Peer counseling</keyword>
    <keyword>Intimate Partner Violence (IPV)</keyword>
    <keyword>PrEP</keyword>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_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_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_time_frame>Data will become available sometime in during Summer 2024 and will be available for the duration of staff funding.</ipd_time_frame>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06001307
  org study id: 2002002648
  secondary id: 1R34MH119968-01A1
  nct id: NCT06001307
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  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.
  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.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention 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.
  primary purpose: Prevention
  masking: Single (Outcomes Assessor)
  masking description: 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).
  measure: Composite Risk for HIV (CR-HIV)
  time frame: 4 months
  description: 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.
  measure: Intimate Partner Violence (IPV) Frequency: Composite Abuse Scale revised short form (CASr-SF)
  time frame: 4 months
  description: 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.
  measure: Intimate Partner Violence (IPV) Frequency: Transgender-Specific Intimate Partner Violence (T-IPV) Scale
  time frame: 4 months
  description: 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.
  measure: Intimate Partner Violence (IPV) Safety
  time frame: 4 months
  description: 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.
  measure: Feasibility of online STARS as measured by recruitment rates
  time frame: 2 months
  description: One measure of feasibility will be participant recruitment rates.
  measure: Feasibility of online STARS as measured by retention rates.
  time frame: 2 months
  description: One measure of feasibility will be participant retention rates, as measured by engagement/completion of the interventions.
  measure: Acceptability of online STARS as measured by the Client Satisfaction Questionnaire
  time frame: 2 months
  description: 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.
  measure: Acceptability of online STARS as measured by a session evaluation form
  time frame: 2 months
  description: One measure of acceptability will be via a session evaluation form that provides both qualitative and quantitative feedback on the study intervention.
  measure: Acceptability of online STARS as measured by semi-structured qualitative exit interview
  time frame: 2 months
  description: 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.
  measure: Rates of STI/HIV testing and outcomes
  time frame: 4 months
  description: 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.
  measure: Self-reported discrete behavioral risk indicators
  time frame: 4 months
  description: 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.
  arm group label: Program STARS (Supporting Trans Affirmation, relationships, and Sex)
  arm group type: Experimental
  description: 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.
  arm group label: Relaxation and Stress Reduction
  arm group type: Active Comparator
  description: 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.
  intervention type: Behavioral
  intervention name: Program STARS (Supporting Trans Affirmation, relationships, and Sex)
  description: See description to the left.
  arm group label: Program STARS (Supporting Trans Affirmation, relationships, and Sex)
  intervention type: Behavioral
  intervention name: Relaxation and Stress Reduction
  description: See description to the left.
  arm group label: Relaxation and Stress Reduction
  criteria: 
  gender: Male
  gender based: Yes
  gender description: Assigned male at birth and identify as female, transgender, or transfeminine
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Shufang Sun, PhD
  role: Principal Investigator
  affiliation: Brown University
  last name: Project STARS
  phone: 401-863-2746
  email: stars@brown.edu
  facility: 
  status: Recruiting
  contact: 
  country: United States
  responsible party type: Sponsor
  sharing ipd: Yes
  ipd 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 info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd time frame: Data will become available sometime in during Summer 2024 and will be available for the duration of staff funding.