N/A
N=37
Supporting Trans Affirmation, Relationships, and Sex, Phase 3
HIV · Violence, Gender-Based · Violence, Domestic · Risk Reduction Behavior
Bottom Line
View on ClinicalTrials.gov: NCT06001307 ↗Enrolled (actual)
37
Serious AEs
13.5%
Results posted
Nov 2025
Primary outcome: Primary: Composite Risk for HIV (CR-HIV) — 0; 1; 9; 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Program STARS (Supporting Trans Affirmation, relationships, and Sex) (Behavioral); Relaxation and Stress Reduction (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Brown University
- Primary completion
- May 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Composite Risk for HIV (CR-HIV) |
0; 1; 9; 1; 0; 1 | — |
| PRIMARY Intimate Partner Violence (IPV) Frequency: Composite Abuse Scale Revised Short Form (CASr-SF) |
2.37; 1.18; 1.06; 0.82; 0.22; 0.63 | — |
| PRIMARY Intimate Partner Violence (IPV) Frequency: Transgender-Specific Intimate Partner Violence (T-IPV) Scale |
0; 0; 0; 0; 0; 0.06 | — |
| PRIMARY Intimate Partner Violence (IPV) Safety: Measure Of Victim Empowerment Related to Safety (MOVERS) |
3.65; 3.46; 3.82; 3.61; 3.77; 3.73 | — |
| PRIMARY Feasibility of Online STARS as Measured by Recruitment Rates |
37 | — |
| PRIMARY Feasibility of Online STARS as Measured by Retention Rates. |
19; 17; 17; 11; 18; 16 | — |
| PRIMARY Acceptability of Online STARS as Measured by the Client Satisfaction Questionnaire |
3.29; 2.95 | — |
| SECONDARY Total Number of Receptive Condomless Anal Sex Acts With Any HIV Transmission Risk |
0; 0.5; 0; 1.45; 0; .25 | — |
Summary
The purpose of this clinical trial is to evaluate and test a newly developed gender-affirming intervention that addresses the dual and interconnected risks of HIV and intimate partner victimization (IPV) among transgender women (TW). The main questions it aims to answer are: (1) will the study intervention reduce HIV risk within the context of IPV and related risk factors (e.g., substance use and PTSD); (2) will STARS improve primary prevention behaviors, such as condom use, pre-exposure prophylaxis (PrEP) use, and repeat HIV testing; and (3) what are the mechanisms of change relevant to the theoretical foundations of the intervention, including gender affirmation, empowerment, and self-efficacy. The findings from this study will provide the necessary groundwork to examine the efficacy of this combined HIV-IPV intervention in a future, large-scale clinical trial.
There are several components to this research study:
* First, participants will be asked to complete a series of screening interviews/questionnaires to determine eligibility, including completing a HIV test.
* If eligible, participants will then take part in a 2-3 hour baseline assessment consisting of both interviewer administered questionnaires as well as self-administered surveys.
* Participants will then be randomly assigned to one of two treatment conditions: (1) a newly developed gender affirming intervention, known as Program STARS (Supporting Trans Affirmation, relationships, and Sex) or (2) a time-matched, attention-controlled program that offers free training in relaxation and stress reduction techniques (a.k.a., the comparison group). Both interventions offer unique components and the researchers do not yet know the impact the programs may have on participants' overall well-being.
* Participants randomized to Project STARS, will be invited to complete a semi-structured exit interview (lasting 60-90 min.) after the completion of the program.
* This clinical trial has three follow-up assessments: (1) post-intervention (i.e., after the peer-counseling programs are complete); (2) at 4-months follow-up; and (3) at 6-months follow-up. The follow-up assessments are structured the same way as the baseline assessment and are estimated to take around 1-2 hours.
The total study involvement for this clinical trial is estimated to take approximately 10 to 12 hours over the course of six months.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT06001307). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.