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

90 Participants
are divided into 2 treatment groups

Locations

1
Los Angeles LGBT Center90028, Los AngelesCalifornia, United States

Sponsors and collaborators

San Diego State University

Lead sponsor

Los Angeles LGBT Center

Collaborator

RAND

Collaborator

National Institute of Mental Health (NIMH)

Collaborator