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

Not Yet RecruitingNA

Sponsor: San Diego State University

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

Interventions: Trans STAIR, PrEP Well

Countries: United States

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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

Locations (1)

Los Angeles, California, United States