NCT06724965Recruiting
Trans STAIR: Implementing an Evidence Based Trauma Treatment With Community Led PrEP Navigation
Source: ClinicalTrials.gov · Last updated 2 Oct 2026
Brief summary (registry, in English)
This pilot trial will leverage "PrEP Well," an ongoing multi-level implementation strategy for providing PrEP in transgender/gender diverse (TGD)-serving contexts by integrating peer-led PrEP navigation with programming that addresses other social and structural needs of the TGD community (e.g., housing, legal, employment, gender-affirmation, primary care). PrEP Well has been implemented at the Trans Wellness Center (TWC) in LA since 2021. TWC is a first-of-its-kind community-led, trans-affirming, TGD community center made up of 5 community-based TGD service organizations that serve the local racially and ethnically diverse TGD community. Together with our community and implementation partners this NIMH-funded R34 will adapt evidence-based Skills Training in Affect and Interpersonal Regulation (STAIR) into a trans-affirming, culturally appropriate trauma treatment for TGD persons affected by HIV and violence (Trans STAIR); evaluate the acceptability, appropriateness, and feasibility of the Trans STAIR intervention (Phase 1 beta test; Aim 1); and conduct a Type 1: Hybrid Effectiveness-Implementation pilot randomized controlled trail (Phase 2 pilot RCT; Aims 2 and 3) of PrEP Well + Trans STAIR vs. PrEP Well alone to provide preliminary support for a fully powered larger multisite R01 to test the efficacy of PrEP Well + Trans STAIR.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 90 (estimated)
- First submitted
- 6 Dec 2024
- Start date
- 17 Jul 2026
- Primary completion date
- 1 Jul 2027
- Lead sponsor
- San Diego State University
- Diseases
- HIV
- NCT number
- NCT06724965
What you commit to
- Study type: Interventional
- Planned participants: 90
- From 17 Jul 2026 to the primary completion date, 1 Jul 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Age
- under 18 years old
Other
- cognitively impaired to the extent that it limits ability to consent
- currently in a relationship or home where violence is occurring
Who the study is looking for
- identify as transgender or nonbinary (non-cisgender)
- be age 18 or older
- confirmed HIV-negative status
- eligible for PrEP based on CDC guidelines
- indication of clinically significant PTSD or depressive symptoms
- ability to speak and read in English and/or Spanish
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Los Angeles LGBT Center Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.