Recruiting

PrEP Well & Trans STAIR

Sponsor:

San Diego State University

Code:

NCT06724965

Conditions

PrEP Uptake Experiences

PrEP Adherence Experiences

Mental Health Symptoms

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Trans STAIR

PrEP Well

Study Details

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

Study ID

NCT06724965

Start date

Jul 17, 2026

Status verified date

Sep, 2026

Completion date

Aug 21, 2027

Anticipated

Primary completion date

Jul 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: PrEP Well + Trans STAIR

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.

active comparator: PrEP Well

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).

Interventions

Trans STAIR

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

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)

Primary outcome measure

  • PrEP Uptake [ Time Frame: Collected at 30-day and at 90-day visits. ]
  • PrEP Adherence [ Time Frame: Collected at 90-day follow up visit ]

Central Contacts and Locations

Central contacts

Erik D Storholm, PhD

8056806480estorholm@sdsu.edu

Benji Jensen, MS

bjensen2@sdsu.edu

Locations

Los Angeles LGBT Center

Recruiting

Los Angeles, California, United States, 90028

Contacts

Risa Flynn

323-993-7500rflynn@lalgbtcenter.org

More Information

Sponsor

San Diego State University

Last update posted

Oct 2, 2026

Last verified

Sep, 2026

Keywords

  • PrEP
  • HIV prevention
  • Trauma
  • Mental Health
  • PrEP adherence
  • PrEP uptake
  • STAIR
  • Skills Training in Affect and Interpersonal Regulation
  • Trauma Treatment

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-03. This information was provided to ClinicalTrials.gov by San Diego State University on 2026-10-02. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.