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

NCT06724965 | Not Yet Recruiting

• 2 other identifiers: HS-2024-0209R34MH138228
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• PrEP Uptake

  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.

  Collected at 30-day and at 90-day visits.

• PrEP Adherence

  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.

  Collected at 90-day follow up visit

Secondary Outcomes (5)

• Depressive symptoms (PHQ-9)

  Baseline, 30-day, and 90-day visits

• Anxiety symptoms (GAD-7)

  Baseline, 30-day, and 90-day visits

• PTSD symptoms (PC-PTSD-5)

  Baseline, 30-day, and 90-day visits

• DSM-5 Self-Rated Level 1 Cross-Cutting Symptom Measure--Adult

  Baseline, 30-day, and 90-day visits

• Inventory of Interpersonal Problems (IIP-32)

  Baseline, 30-day, and 90-day visits

Study Arms (2)

PrEP Well + Trans STAIR

EXPERIMENTAL

Participants assigned to this condition will be enrolled in 3 sessions of PrEP Well + 8 sessions of Trans STAIR over 90 days. PrEP Well is a multi-level implementation strategy for providing PrEP in 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). Trans STAIR (Experimental Treatment) Skills Training in Affect and Interpersonal Regulation (STAIR) adapted for TGD is 8-session, group delivery of transdiagnostic evidenced-based treatment for individuals who have experienced multiple traumas. STAIR is based in cognitive-behavioral principles and delivered in a flexible manner, with demonstrated efficacy for the treatment of PTSD, depression and other mental health symptoms known to be associated with poor medication adherence.

Behavioral: Trans STAIR; Behavioral: PrEP Well

PrEP Well

ACTIVE COMPARATOR

Participants assigned to this condition will be enrolled in 3 sessions of PrEP Well over 90 days, PrEP Well is a multi-level implementation strategy for providing PrEP in 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).

Behavioral: PrEP Well

Interventions

Trans STAIR BEHAVIORAL

Skills Training in Affect and Interpersonal Regulation (STAIR) is a transdiagnostic evidenced-based mental health treatment for individuals who have experienced multiple traumas. STAIR is based in cognitive-behavioral principles and delivered in a flexible manner over 8 group sessions, with demonstrated efficacy for the treatment of PTSD and other mental health symptoms. This trial will adapt and pilot test the STAIR intervention to be culturally appropriate and acceptable for TGD persons, adding content related to TGD health and wellness, coping with minority stress, responding to stigma and microaggressions, social support, and community connectedness, self-compassion, celebrating trans joy, trans advocacy, sexual health and PrEP use.

PrEP Well + Trans STAIR

PrEP Well BEHAVIORAL

This pilot trial will leverage "PrEP Well," a multi-level implementation strategy for providing PrEP in 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; PrEP Well + Trans STAIR

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: transgender male, transgender female, nonbinary identity.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• San Diego State University: lead
• Los Angeles LGBT Center: collaborator
• RAND: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Los Angeles LGBT Center

Los Angeles, California, 90028, United States

Location

MeSH Terms

Conditions

Wounds and Injuries; Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Study Officials

• Erik Storholm, PhD

  San Diego State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Erik D Storholm, PhD

CONTACT

8056806480; estorholm@sdsu.edu

Benji Jensen, MS

CONTACT

bjensen2@sdsu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2024
• First Posted: December 9, 2024
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 1, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: All quantitative data will be deposited to NDA 12 months after the award begins (or following the start of the pilot trial) and every six months following the usual NDA data submission dates. The research community will have access to data when the award ends. As required by the NDA, studies will also be created that contain the data used for every publication. Data associated with each publication will be made available at the time of publication. NDA studies have digital object identifiers (DOI) to aid in findability. We will include that DOI in relevant publications. NDA will make decisions about how long to preserve the data but no data have been removed or archived to date.
• Access Criteria: IPD will be available to researchers, healthcare professionals, and the general public, depending on the specific policies of the sponsoring organization or regulatory requirements.

Locations

US (1)