Join us at Health Research Day — June 6th at Canton Waterfront Park, Baltimore!   Learn More →
← Back to all trials
Recruiting NCT06724965

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

Conditions: PrEP Uptake Experiences, PrEP Adherence Experiences, Mental Health Symptoms

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 90
Sponsor: San Diego State University

Location: Los Angeles LGBT Center Los Angeles California

Summary

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.

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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06724965). StuddyBuddy aggregates publicly available trial information.