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

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 6 months later Dec 2026 → Jul 1, 2027
See other at-risk trials from San Diego State University

Record History

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  1. Primary completion pushed from Dec 2026 to Jul 1, 2027 Show 6 more changesShow less
    • Recruitment opened
    • Study completion pushed from Dec 2026 to Aug 21, 2027
    • Start date changed from estimate of Sep 2026 to Jul 17, 2026
    • Eligibility criteria expanded, about 9 words
    • Secondary endpoints: details revised at 5 of 5 entries
    • Site details revised
  2. Start date: Feb 2026 to Sep 2026v4
  3. Start date: Mar 1, 2025 to Feb 2026
    • Collaborators: 2 to 3
    v3
  4. Eligibility criteria shortened, about 74 words
    • Secondary endpoints revised (5)
    • Study description expanded, about 4 words
    v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06724965
Lead Sponsor San Diego State University
Collaborators: Los Angeles LGBT Center, RAND, National Institute of Mental Health (NIMH)
Conditions
(from sponsor)		 PrEP Uptake Experiences, PrEP Adherence Experiences, Mental Health Symptoms
Related terms Psychological Well-Being, Wounds and Injuries
Enrollment 90 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov