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

Not Applicable

Not yet recruiting

• Conditions: PrEP Uptake Experiences; PrEP Adherence Experiences; Mental Health Symptoms

• Registration Number: NCT06724965
• Lead Sponsor: San Diego State University

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.

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-06
• Study First Submitted QC: 2024-12-06
• Last Update Submitted: 2024-12-08
• Study First Posted: 2024-12-09
• Last Update Posted: 2024-12-12
• Study Start: 2025-03-01
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
PrEP Uptake	Collected at 30-day and at 90-day visits.	PrEP uptake measured via SureQuick test, a rapid point-of-care diagnostic assay used to detect the presence of tenofovir diphosphate (TFV-DP) in urine.
PrEP Adherence	Collected at 90-day follow up visit	PrEP Adherence will be assessed via Dried Blood Spot (DBS) test, a laboratory method used for the quantitative assessment of long-term levels of Tenofovir Diphosphate (TFV-DP) in the blood, helping to monitor and confirm adherence PrEP medications such as Descovy® or Truvada®. DBS levels consistent with 4 or more average doses/week were considered adherent.

Secondary Outcome Measures

Name	Time	Method
Depressive symptoms (PHQ-9)	Baseline, 30-day, and 90-day visits	The PHQ-9 (Patient Health Questionnaire-9) is a self-administered screening tool designed to assess the presence and severity of depressive symptoms in individuals. It consists of nine questions that align with the diagnostic criteria for major depressive disorder, asking respondents about their feelings and behaviors over the previous two weeks. Each question is scored on a scale from 0 (not at all) to 3 (nearly every day), resulting in a total score that can range from 0 to 27. Higher scores indicate greater severity of depression, making the PHQ-9 a valuable measure for both clinical assessments and research studies aimed at evaluating treatment outcomes and mental health interventions.
Anxiety symptoms (GAD-7)	Baseline, 30-day, and 90-day visits	The GAD-7 (Generalized Anxiety Disorder-7) is a widely recognized self-report questionnaire used to assess the severity of generalized anxiety disorder and other anxiety-related conditions. Comprising seven questions, the GAD-7 prompts respondents to evaluate how often they have experienced specific anxiety symptoms over the past two weeks, using a scale from 0 (not at all) to 3 (nearly every day). The total score ranges from 0 to 21, with higher scores indicating more severe anxiety symptoms. This measure is frequently employed in both clinical and research settings to help identify individuals experiencing significant anxiety and to monitor changes in symptoms over time, facilitating effective treatment and intervention strategies.
PTSD symptoms (PC-PTSD-5)	Baseline, 30-day, and 90-day visits	The PC-PTSD-5 (Primary Care Post-Traumatic Stress Disorder Screen for DSM-5) is a brief, validated screening tool designed to identify individuals at risk for post-traumatic stress disorder (PTSD) based on the diagnostic criteria specified in the DSM-5. It consists of five questions that focus on the presence of key PTSD symptoms, including intrusive thoughts, avoidance behaviors, negative changes in mood and cognition, and hyperarousal, experienced in the context of a traumatic event. Respondents answer each question with one of two options: "Yes" or "No," allowing for a quick assessment of PTSD risk. The PC-PTSD-5 is particularly useful in primary care and other clinical settings for early detection and referral for further evaluation and treatment of PTSD while being user-friendly for both patients and healthcare providers.
DSM-5 Self-Rated Level 1 Cross-Cutting Symptom Measure--Adult	Baseline, 30-day, and 90-day visits	The DSM-5 Cross-Cutting Symptoms Measurement is a comprehensive assessment tool designed to evaluate a range of mental health symptoms that may be present across various psychiatric disorders. This assessment includes 23 symptom domains, such as anxiety, depression, psychosis, and somatic symptoms, allowing clinicians to identify and assess the severity of symptoms that might not fit neatly into specific diagnostic categories. Each item on the measure is rated on a 5-point scale (0=none or not at all; 1=slight or rare, less than a day or two; 2=mild or several days; 3=moderate or more than half the days; and 4=severe or nearBy capturing cross-cutting symptoms, this tool promotes a more holistic understanding of an individual's mental health and can facilitate better treatment planning and intervention strategies. It is particularly useful in clinical settings where comorbidity is common, as it aids in identifying overlapping symptoms that may impact overall functioning and well-being.
Inventory of Interpersonal Problems (IIP-32)	Baseline, 30-day, and 90-day visits	The Inventory of Interpersonal Problems (IIP) is a 32-item psychological assessment tool designed to evaluate interpersonal difficulties and their impact on an individual's relationships and social functioning. The IIP consists of a series of items that assess different dimensions of interpersonal problems, such as assertiveness, reliance on others, and ability to communicate effectively. Respondents indicate the degree to which they experience difficulties in various social situations, helping to identify patterns of interpersonal behavior that may contribute to distress or dysfunction. Scores range from 0-128 with higher scores corresponding with greater interpersonal levels of dysfunction. This inventory is useful in both clinical and research settings, providing insights that can guide therapeutic interventions and enhance understanding of the relational challenges individuals face, ultimately fostering improved interpersonal dynamics and personal growth.

Trial Locations

Locations (1)

Los Angeles LGBT Center; 🇺🇸 Los Angeles, California, United States