Clinical trial NCT06724965: Trans STAIR: Implementing an Evidence Based Trauma Treatment with Community Led PrEP Navigation
Official title: Trans STAIR: Implementing an Evidence Based Trauma Treatment with Community Led PrEP Navigation for Transgender and Nonbinary Persons Affected by Violence
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: PrEP Uptake Experiences
PrEP Adherence Experiences
Mental Health Symptoms
Keywords: PrEP
HIV prevention
Trauma
Mental Health
PrEP adherence
PrEP uptake
STAIR
Skills Training in Affect and Interpersonal Regulation
Trauma Treatment
Lead sponsor: San Diego State University
Sponsor class: OTHER
Collaborators: name: Los Angeles LGBT Center
name: RAND
First posted: 2024-12-09
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed description: In Phase 1, together with community and implementation partners, the investigators will adapt evidence-based STAIR into a trans-affirming, culturally appropriate trauma treatment for TGD persons affected by HIV and violence (Trans STAIR), making suggested changes and reaching consensus at each step among the team. The investigators will then evaluate the acceptability, appropriateness, and feasibility of the Trans STAIR intervention by running a preliminary test of Trans STAIR with 20 PrEP Well participants with demonstrated suboptimal PrEP adherence. The investigators will then conduct and analyze interviews with participants and staff to obtain feedback and work with our community and implementation partners to make suggested changes until the investigators reach consensus again among the team. The investigators will then conduct interviews with key leaders, administrators, and TWC staff to assess the perceived barriers to integration of Trans STAIR into the PrEP Well implementation strategy. The investigators will then select implementation strategies that will address the identified barriers. In Phase 2, the investigators will conduct a Type 1, hybrid effectiveness-implementation pilot RCT of 70 participants randomized to receive PrEP Well + Trans STAIR vs. PrEP Well alone. The overarching goals of the pilot RCT are twofold: 1) establish the feasibility, acceptability, adoptability; preliminary effects; and cost and sustainability, and potential scalability of the PrEP Well + Trans STAIR implementation intervention; and 2) estimate the non-response rates after second-stage randomization. The aims follow the phases of the EPIS (Exploration Preparation Implementation Sustainment) framework integrated with the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) framework to assess outcomes. The investigators will systematically collect important data on factors relevant to implementation during the pilot RCT, including cost data (e.g., program budgets, interview questions leadership staff) on the resources necessary to successfully deliver the PrEP Well + Trans STAIR interventions. Consistent with a Hybrid Type I design, the investigators will leverage mixed methods data from the pilot RCT in key informant interviews with 30 participants and 10 key stakeholders/staff to document the perceptions of providers regarding implementation of PrEP Well + Trans STAIR in real-world clinical settings will set the stage for a planned multisite fully powered hybrid RCT.

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

Primary outcomes:
measure: PrEP Uptake
timeFrame: Collected at 30-day and at 90-day visits.
measure: PrEP Adherence
timeFrame: Collected at 90-day follow up visit
Secondary outcomes:
measure: Depressive symptoms (PHQ-9)
timeFrame: Baseline, 30-day, and 90-day visits
measure: Anxiety symptoms (GAD-7)
timeFrame: Baseline, 30-day, and 90-day visits
measure: PTSD symptoms (PC-PTSD-5)
timeFrame: Baseline, 30-day, and 90-day visits
measure: DSM-5 Self-Rated Level 1 Cross-Cutting Symptom Measure--Adult
timeFrame: Baseline, 30-day, and 90-day visits
measure: Inventory of Interpersonal Problems (IIP-32)
timeFrame: Baseline, 30-day, and 90-day visits
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Los Angeles LGBT Center
state: California
Study officials:
affiliation: San Diego State University
name: Erik Storholm, PhD
role: PRINCIPAL_INVESTIGATOR
References: