HIV Risk Reduction Intervention for Transwomen With Intimate Partner Victimization
Phase: NA
Conditions: HIV, Violence, Gender-Based, Violence, Domestic, Risk Reduction Behavior
Sponsor: Brown University

 
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STUDY PROTOCOL DRAFT: 2/10/2023 
 
 
 
 
 
 
Formative and Pilot Intervention Research for Prevention and Treatment of HIV/AIDS (R34 Clinical 
Trial Option): 
 
 
 
 
 HIV Risk Reduction Intervention for Transwomen with Intimate Partner 
Victimization 
 
 
 
Investigators: 
 
Shufang Sun (local PI), Don Operario (former PI / Co-I), Dawn Johnson, Caron Zlotnik 
 
 
 
 
Sponsor: 
 
National Institute of Health 
 
 
 

 
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1. Background  
 
• 
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.  
• 
IPV is a pervasive public health problem for transgender people. Results of the 2015 US 
Transgender Survey (USTS) indicated that over half (54%) of TW experience lifetime IPV, and 
comparative research shows elevated IPV rates among transgender people compared with their 
cisgender counterparts.  
• 
IPV is associated with increased HIV risk due to greater likelihood of condomless sex, sex with 
high-risk partners (e.g., who are HIV-positive or who inject drugs), and compromised condom 
negotiation skills, as well as high rates of posttraumatic stress disorder (PTSD) and substance use 
disorder (SUD) which are also associated with HIV risk behaviors. 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.  
• 
To address syndemics of HIV and IPV, multicomponent interventions that target relevant risk 
factors and that consider population-specific vulnerabilities are needed.   
 
2. Study Objective 
 
The purpose of this treatment development research 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). 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. 
 
3. Study Aims 
 
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  
 
(2) Evaluate the feasibility, acceptability, safety, and initial effects of STARS through three 
phases of intervention development.  
 
We are primarily interested in exploring the pattern of results for any evidence of support for the 
intervention’s influence on our primary and secondary outcomes.  
 
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. 
 

 
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4. Description of Study Design, Materials and Methods  
 
4.1 Study Design  
 
Phase 1, Initial Development: Employ qualitative methods to strengthen our understanding of the 
dynamics between HIV risk and IPV among TW, and use those findings to develop a STARS manual, 
interventionist training protocol, and fidelity scales. 
 
Phase 2, Open Trial: Conduct an open pilot of the STARS protocol and use cognitive interviewing 
techniques to refine the STARS manual, interventionist training protocol, and fidelity scales, based on 
participant feedback.  
 
Phase 3, Pilot RCT: Conduct a pilot test of the STARS protocol using a two-arm trial comparing 
effects of the STARS intervention vs Relaxation Training (a validated time and attention matched 
control) over 6-months of follow up with respect to our primary and secondary outcomes.  
 
4.2 Study Procedures  
 
Phase 1 (Year 1 & 2, April 2021 – June 2022) 
 
General Overview  
• 
Formative phase  
• 
Development of STARS 
• 
Focus group and informant interviews 
• 
Feedback on STARS  
• 
Fidelity 
• 
Interventions training and fidelity  
 
Participants/eligibility 
• 
Individuals will be eligible if they are:  
(1) 18+ years old;  
(2) Assigned male at birth but identify as female, transgender, or transfeminine;  
(3) Endorse at least one IPV incident during the previous 12 months based on the Conflict Tactic 
Scales-Revised (CTS-2; Straus, 2017) or the trans-specific IPV Scale (T-IPV Scale; Peitzmeier et 
al, in press);  
(4) Report at least one instance of condomless anal sex in the last 3 months.  
• 
Individuals will be considered ineligible if they: 
(1)  Have been diagnosed with HIV or test positive for HIV.   
• 
Individuals expressing interest in the research will undergo brief screening by telephone and then 
complete a more detailed in-person eligibility assessment prior to enrollment.  
• 
All participants will provide informed consent prior to initiating the study protocol. 
 
Recruitment & Retention 
• 
All research activities will take place in Providence, Rhode Island metropolitan area  
• 
Participant reimbursement: 
o Focus group participants will receive $30 reimbursement and a brochure with a list of 
TW-sensitive HIV testing sites and other social/health services upon completing the 
study. 
o Key informants will receive $30 upon completing the study. 

 
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• 
Multifaceted recruitment approach: online advertisements in social media for TW audiences, 
placing fliers in targeted venues, and conducting in-person outreach to agencies, clinics, bars and 
community events.  
• 
Retention strategies: close communication and collaboration with CBOs that serve local TW and 
hiring an outreach specialist from within the local trans community.  
 
Procedures 
• 
Develop/design a preliminary manual for STARS and control (relaxation training; RT).  
• 
Conduct focus groups and individual interviews (if applicable) with TW with HIV risk and IPV 
(n = 18) to understand ways of increasing acceptability and efficacy of STARS and acceptability 
of RT for this population. 
• 
Designate specific benchmarks to determine if additional focus groups are needed to further 
develop STARS. 
• 
Solicit feedback on STARS from participants, and community experts/key informants that 
provide services for TW. 
• 
Solicit feedback from participants regarding barriers to attending sessions and brainstorm 
methods to address barriers and maximize attendance.  
• 
Assess the acceptability and feasibility of booster sessions, including their number, length, 
timing, and setting (i.e., phone-calls vs. in person).  
• 
Make changes to STARS based on feedback 
• 
Develop STARS and RT interventionist training protocol and fidelity scales.  
 
Analysis  
• 
Focus groups and interviews (if applicable) will be audio-recorded, transcribed and coded using 
qualitative analysis.  
• 
A descriptive summary will be developed to represent key content of the focus group. 
 
Phase 2 (Year 2, June – February 2023)  
 
General Overview  
• 
Refinement phase: gain experience with the screening, assessment and intervention to inform 
subsequent refinement of protocol and procedures 
• 
Cognitive interviewing and open pilot (nonrandomized)  
 
Participants/eligibility 
• 
Individuals will be eligible if they are:  
(1) 18+ years old;  
(2) Assigned male at birth but identify as female, transgender, or transfeminine;  
(3) Endorse at least one IPV incident during the previous 12 months based on the Conflict Tactic 
Scales-Revised (CTS-2; Straus, 2017) or the trans-specific IPV Scale (T-IPV Scale; Peitzmeier et 
al, in press);  
(4) Report at least one instance of condomless anal sex in the last 3 months.  
• 
Individuals will be considered ineligible if they: 
(1)  Have been diagnosed with HIV or test positive for HIV.   
• 
Individuals expressing interest in the research will undergo brief screening online or by telephone 
and then complete a more detailed in-person eligibility assessment prior to enrollment.  
• 
All participants will provide informed consent prior to initiating the study protocol. 
 
Recruitment & Retention  
• 
All research activities will take place online via Zoom and/or in Providence, Rhode Island 
metropolitan area  

 
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• 
Participant reimbursement: Participants will receive $75 for their first assessment and $50 for 
their second and third assessments as reimbursement ($175 total), as well as a brochure with a list 
of TW-sensitive HIV testing sites and other social/health services. All transportation required for 
the study will also be covered using study funds.   
• 
Multifaceted recruitment approach: online advertisements in social media for TW audiences, 
placing fliers in targeted venues, and conducting in-person outreach to agencies, clinics, bars and 
community events.  
• 
Retention strategies: close communication and collaboration with CBOs that serve local TW and 
hiring an outreach specialist from within the local trans community.  
 
Procedures  
• 
Pilot STARS among TW (n=5-8) with elevated HIV 
risk and IPV.  
• 
Elicit feedback via exit interviews (structured 
informant interview and evaluation surveys) to 
finalize STARS protocol and research procedures.  
• 
Refine and finalize STARS manual, interventionist 
training protocol, and fidelity scales using participant 
feedback and acceptability and feasibility metrics. 
 
Analysis  
• 
Detailed notes of IDI exit interviews will be analyzed 
(consider recording) to review feedback and make 
final adjustments 
• 
At the end of phase 2, compute descriptive data on all 
target outcomes in Table 1 and discuss how actual 
outcomes compare to target outcomes. 
• 
Discrepancies will result in: 1) investigation of the 
reason for failure to meet this outcome, and 2) 
discussion among the research team.  
 
 
Phase 3 (Years 1-4, October 2021 – July 2024) 
 
General Overview  
• 
Pilot RCT phase: two-arm, randomized, controlled design with up to 50 TW. 
• 
Participants will be followed for up to 6-months post enrollment with assessments taking place at 
T1: Baseline; T2: Post-intervention; T3: 4-months follow up; and T4: 6-months follow up. 
• 
Refer to Figure 1 below for the study flow 
• 
The control group will be given an attention and time-matched control condition focused on 
relaxation and stress reduction.  
• 
Both the STARS intervention and the control protocol consist 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. 
• 
Both interventions are designed to be delivered by peer counselors. Requirements for peer 
counselors include identifying as trans women or trans feminine and having leadership roles in the 
trans community. 
 
 
 
 

 
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Figure 1.  STARS - Phase 3: Randomized Controlled Trial (RCT) Study Flow Chart 
 
 
 
Participants/eligibility 
• 
Individuals will be eligible if they are:  
(1) 18+ years old;  
(2) Assigned male at birth but identify as female, transgender, or transfeminine;  

 
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(3) Endorse at least one IPV incident during the previous 12 months based on the Conflict Tactic 
Scales-Revised (CTS-2; Straus, 2017) or the trans-specific IPV Scale (T-IPV Scale; Peitzmeier et 
al, in press);  
(4) Report at least one instance of condomless anal sex in the last 6-months.  
• 
Individuals will be considered ineligible if they: 
(1)  Have been diagnosed with HIV or test positive for HIV.   
• 
Individuals expressing interest in the research will undergo brief screening online or by telephone 
and then complete a more detailed in-person eligibility assessment prior to enrollment.  
• 
All participants will provide informed consent prior to initiating the study protocol. 
 
Recruitment  
• 
All research activities will take place online via Zoom and/or in Providence, Rhode Island 
metropolitan area  
• 
Multifaceted recruitment approach: online advertisements in social media for TW audiences, 
placing fliers in targeted venues, and conducting in-person outreach to agencies, clinics, bars and 
community events.  
• 
Retention strategies: close communication and collaboration with CBOs that serve local TW and 
hiring an outreach specialist from within the local trans community.  
 
Compensation 
• 
Participant reimbursement: Participants will have an opportunity to earn up to $250 in total – they 
will receive $50 for completing the T1: baseline assessment; $50 for the T2: post-intervention 
assessment, $25 for the exit interview; $50 for the T3: 4-month follow up; $50 for the T4: 6-
month assessment; and a $25 bonus if they complete all four assessments (T1-T4). 
• 
Participants will be given the option to receive their compensation in the form of an Amazon gift 
card or on a VISA clincard. 
 
Procedures  
• 
Conduct a randomized pilot trial of STARS in 50 TW with elevated HIV risk and IPV to 
demonstrate the (a) feasibility, (b) acceptability, and (c) safety of the intervention. 
• 
Examine preliminary evidence that relative to an attention and time matched control, STARS will 
result in improvements in our:  
o Primary outcomes; 
o Secondary outcomes; and 
o Mechanisms of change consistent with the theoretical foundations of the intervention, 
including greater perceived gender affirmation, and increases in empowerment and self-
efficacy.  
• 
Test, diagnose and (if positive) treat baseline STIs (and HIV) prior to initiating the STARS 
program. 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 

 
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get tested for STIs as part of the research study; however, STI testing is not a requirement for 
participation. 
• 
Complete a baseline behavioral and psychosocial baseline survey assessments administered via 
ACASI. Refer to the Phase 3 RCT Measures document for the complete list of standardized 
measures administered at baseline and at follow up. 
• 
Upon completion of the baseline assessment, participants will be randomized to either the 
Intervention (STARS) condition or to a time-attention matched control (see details below). 
o STARS Intervention (the final version of STARS was developed though an iterative 
process and refined/finalized by findings from Phases 1 and 2) 
§ 
Participants randomized to STARS will participate in a brief intervention 
immediately following the baseline (BL) assessment consisting 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.  
§ 
Participants will develop personalized risk reduction plan (RRP), which will 
include participants identifying “next steps” for reducing their HIV and IPV 
related risks.  
§ 
Booster sessions will include a review of the RRP, identification and 
reinforcement of accomplishments, as well as identification of and problem 
solving around any social barriers to the RRP.  
§ 
The RRP will be revised based on identified accomplishments and social barriers 
at each booster session. 
o Control Intervention  
§ 
Participants randomized to the time-attention matched control condition will 
participate in a relaxation and stress reduction intervention that also 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. 
§ 
Content will serve to keep the RA blind to participant condition and will include 
a series of guided relaxations (e.g., breathing meditation, visual imagery). 
§ 
During booster sessions, the interventionist will review participants’ success with 
their relaxation plan and identify further strategies to integrate relaxation into 
daily lives. 
 
Analysis  
• 
At 2-time points during phase 3, compute descriptive data on all target outcomes in Table 1 and 
discuss how actual outcomes compare to target outcomes. 
Discrepancies will result in: 1) investigation of the reason for failure to meet this outcome, and 2) 
discussion among the research team.  
 
 
 

 
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4.3 Measures (Phases 2 & 3) -- For the complete list of standardized measures administered at 
baseline and at follow up time points, refer to the Phase 3 RCT Measures document. 
 
Acceptability:  
• 
8-item Client Satisfaction Questionnaire-Revised (CSQ-8-R) (Attkisson & Zwick, 1982) will be 
used to assess satisfaction with the intervention.  
• 
An End of Intervention Questionnaire (EIQ) will be developed that will assess the perceived 
helpfulness of intervention components.  
• 
These scales will be administered to both conditions after the initial 90-min intervention (PI), as 
well as after each booster session.  
• 
Exit interviews will be conducted with participants randomized to the STARS intervention. 
 
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 

 
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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. 
 
Exploratory Tertiary Outcome/Potential Mediators: Refer to the Phase 3 RCT Measures 
document for the complete list of standardized measures administered at baseline and at 
follow up time points. 
 
5. Dissemination  
 
• 
Throughout the study, we 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, we 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.