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NCT06001307 · ClinicalTrials.gov registry record · NA
Supporting Trans Affirmation, Relationships, and Sex, Phase 3
A NA study, sponsored by Brown University.
- Completed
- Registry status
- NA
- Development phase
- 37
- Enrollment target
NCT06001307: Completed NA study, sponsored by Brown University.
NCT06001307 is a NA study that has completed, run by Brown University. The registered enrollment target is 37 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06001307, a NA study, has completed, sponsored by Brown University.
- COMPLETED
- Registry status
- NA
- Development phase
- 37 participants
- Enrollment target
Study 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:
Primary Outcome
Composite Risk for HIV (CR-HIV) calculates a binary indicator (0=No, 1=Yes) of a participant's risk for HIV acquisition using an algorithm based on the following questions: 1. Do they report condomless anal sex with a HIV serodiscordant or status-unknown primary or other partner in the past 6 months? (If yes, move on to question #2; If no, 0) 2. Is the participant using PrEP? (If yes, 0; If no, move onto question #3) 3. Is the participant in a monogamous partnership with an HIV-uninfected partn
Interventions
- BEHAVIORAL Program STARS (Supporting Trans Affirmation, relationships, and Sex)
- BEHAVIORAL Relaxation and Stress Reduction
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2023-06-20 |
| Est. Completion | 2024-05-30 |
| Phase | NA |
What the finished NCT06001307 record still lists
NCT06001307 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 37 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which Program STARS (Supporting Trans Affirmation, relationships, and Sex) is the first listed.
NCT06001307 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06001307 about?
NCT06001307 is a clinical study titled "Supporting Trans Affirmation, Relationships, and Sex, Phase 3". 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 inter...
What is the current status of trial NCT06001307?
This trial is currently completed. It is a NA study. The enrollment target is 37 participants. The study started on 2023-06-20. Estimated completion is 2024-05-30.
What interventions are being tested in trial NCT06001307?
The interventions under investigation include: Program STARS (Supporting Trans Affirmation, relationships, and Sex) (BEHAVIORAL), Relaxation and Stress Reduction (BEHAVIORAL).
Who is sponsoring clinical trial NCT06001307?
This trial is sponsored by Brown University, which has 231 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06001307's enrollment target sits among peer trials
37 1540th of 2000 higher than 460 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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