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RECRUITING Not applicable ClinicalTrials.gov

Trans STAIR: Implementing an Evidence Based Trauma Treatment With Community Led PrEP Navigation

Sponsor: San Diego State University • ClinicalTrials.gov ID: NCT06724965

Registry updated: 2026-10-02
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Description

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.

Interventions

  • Trans STAIR (Behavioral)
    Skills Training in Affect and Interpersonal Regulation (STAIR) is a transdiagnostic evidenced-based mental health treatment for individuals who have experienced multiple traumas. STAIR is based in cognitive-behavioral principles and delivered in a flexible manner over 8 group sessions, with demonstrated efficacy for the treatment of PTSD and other mental health symptoms. This trial will adapt and pilot test the STAIR intervention to be culturally appropriate and acceptable for TGD persons, adding content related to TGD health and wellness, coping with minority stress, responding to stigma and microaggressions, social support, and community connectedness, self-compassion, celebrating trans joy, trans advocacy, sexual health and PrEP use.
  • PrEP Well (Behavioral)
    This pilot trial will leverage "PrEP Well," a multi-level implementation strategy for providing PrEP in 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)

Eligibility 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

Conditions

PrEP Uptake Experiences PrEP Adherence Experiences Mental Health Symptoms

Locations

  • Los Angeles LGBT Center — Los Angeles, California, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record