Trans STAIR + PrEP Well for Trans and gender diverse people receiving PrEP
Official title: Trans STAIR: Implementing an Evidence Based Trauma Treatment With Community Led PrEP Navigation
Run by San Diego State University · NCT06724965 · Data updated 2026-11-12
This pilot tests whether adding Trans STAIR, a trauma-focused therapy adapted for TGD people, to the PrEP Well program helps improve PrEP adherence and mental health among HIV-negative transgender and nonbinary individuals.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 90 (estimated) |
| Sponsor | San Diego State University Academic / other |
| Locations | 1 site (Los Angeles, California) |
| Status | Recruiting |
| Started | July 17, 2026 |
| Main results expected | July 1, 2027 |
| Study ends | August 21, 2027 |
| Registry record updated | October 2, 2026 |
| Trial ID | NCT06724965 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are transgender or nonbinary adults (18+), HIV-negative, eligible for PrEP, with PTSD or depressive symptoms, proficient in English or Spanish, and able to participate in the PrEP Well setting.
✕Probably not a fit
Individuals without PrEP eligibility, without significant PTSD/depressive symptoms, or those not engaged with PrEP Well may derive limited or no benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional pilot adapts STAIR into Trans STAIR, a trauma-focused, trans-affirming treatment integrated with PrEP Well services at the Trans Wellness Center in Los Angeles. Phase 1 gathers input from community partners to tailor the intervention, tests acceptability and feasibility with 20 participants who have suboptimal PrEP adherence, and gathers feedback from participants and staff. Phase 2 will randomize 70 eligible participants to receive PrEP Well with Trans STAIR or PrEP Well alone to evaluate feasibility, acceptability, potential effectiveness, cost, and scalability. The study targets TGD individuals who are HIV-negative, eligible for PrEP, and experience PTSD or depressive symptoms, with outcomes including PrEP adherence and mental health measures. Lead and collaborating institutions include SDSU, LA LGBT Center, RAND, and NIMH, with sites at the LA LGBT Center.
Why it matters
Potential benefit: If successful, this approach could improve PrEP adherence and mental health among TGD individuals through integrated trauma-informed care and community-centered PrEP support.
How similar studies have gone: Previous implementation work on PrEP Well and trauma-informed approaches suggests feasibility; this trial tests a novel trans-affirming adaptation (Trans STAIR) in a hybrid effectiveness-implementation design.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * under 18 years old * cognitively impaired to the extent that it limits ability to consent * currently in a relationship or home where violence is occurring
Where it's running
-
Los Angeles LGBT Center
Los Angeles, California, United States Recruiting
Study contacts
- Principal investigator: Erik Storholm, PhD — San Diego State University
- Study coordinator: Erik D Storholm, PhD
- Email: estorholm@sdsu.edu
- Phone: 8056806480
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.