About this trial
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
Qualifiers
identify as transgender or nonbinary (non-cisgender)
be age 18 or older
confirmed HIV-negative status
eligible for PrEP based on CDC guidelines
Disqualifiers
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
Trial design
Treatments tested in this trial
- Trans STAIR
- PrEP Well
Treatment groups
Sponsors and collaborators
San Diego State University
Lead sponsor
Los Angeles LGBT Center
Collaborator
RAND
Collaborator
National Institute of Mental Health (NIMH)
Collaborator