Trauma Treatment + PrEP Navigation for Mental Health Symptoms

Overseen By Benji Jensen, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: San Diego State University

Must be taking: PrEP

Disqualifiers: Under 18, Cognitive impairment, Violence, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 33

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how well a specialized program can help transgender and gender-diverse people manage mental health symptoms linked to past trauma while navigating PrEP, a medication that helps prevent HIV. Participants will receive either PrEP navigation support alone or both PrEP support and a new group therapy program (Trans STAIR) tailored for their community. The goal is to determine if combining these treatments improves mental health and supports medication adherence better than PrEP support alone. The trial seeks transgender or nonbinary individuals who are HIV-negative and experiencing PTSD or depression symptoms. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research tailored to the community's needs.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the Trans STAIR program, part of the PrEP Well + Trans STAIR treatment in this trial, is generally easy for participants to handle. This program uses techniques to help with PTSD (post-traumatic stress disorder) and depression, which can make it difficult to adhere to medication plans. Previous studies have found that it can reduce these symptoms without causing serious side effects.

Regarding safety, reports indicate that participants are satisfied with the Trans STAIR approach and experience few negative effects. Another study on a similar method, called webSTAIR, also showed high satisfaction, indicating it is easy to use and safe.

The PrEP Well part of the program helps people take PrEP, a medication that prevents HIV. It includes support from peers and addresses important needs like healthcare and housing. Since PrEP is a well-researched and approved medication, the support strategies around it are considered safe.

Overall, existing evidence suggests that the treatments in this trial are safe and well-tolerated, focusing on helping people manage trauma and adhere to preventive HIV treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Trauma Treatment + PrEP Navigation for Mental Health Symptoms trial because it combines innovative strategies to address mental health in the transgender and gender-diverse (TGD) community. Unlike typical treatments that may focus solely on medication or therapy, this approach integrates PrEP Well, a program that combines PrEP navigation with support for social and structural needs, enhancing the overall wellbeing and healthcare access for TGD individuals. Additionally, the Trans STAIR component offers an adaptive, evidence-based cognitive-behavioral therapy specifically tailored for those who have experienced multiple traumas, aiming to improve emotional and interpersonal regulation. This dual approach not only targets mental health symptoms like PTSD and depression but also seeks to improve medication adherence, which is crucial for effective treatment outcomes.

What evidence suggests that this trial's treatments could be effective?

Research has shown that the Trans STAIR program, part of the PrEP Well + Trans STAIR treatment arm in this trial, effectively addresses PTSD and depression. Studies have found that participants experience significant improvements in their symptoms, particularly for PTSD. Individuals in similar programs report feeling better emotionally and gaining more confidence in themselves and others. This treatment employs cognitive-behavioral techniques, which are effective for mental health issues. Overall, evidence supports that PrEP Well + Trans STAIR can improve mental health symptoms. Meanwhile, the PrEP Well arm focuses on providing PrEP navigation and addressing social and structural needs, which may also enhance mental health outcomes. ^{2 4 6 7 8}

Who Is on the Research Team?

Erik Storholm, PhD

Principal Investigator

San Diego State University

Are You a Good Fit for This Trial?

This trial is for transgender/gender diverse individuals affected by HIV and violence. Participants should be interested in a program that combines peer-led PrEP navigation with support for social needs like housing and employment, provided at the Trans Wellness Center in LA.

Inclusion Criteria

Report not currently in a relationship or home where violence is occurring (participants will be referred to LGBT Center's STOP Violence Program)

Confirmed HIV-negative status

I identify as transgender or nonbinary.

Exclusion Criteria

Anyone who does not meet the above criteria

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1 Beta Test

Preliminary test of Trans STAIR with 20 PrEP Well participants to evaluate acceptability, appropriateness, and feasibility

90 days

Multiple visits for interviews and feedback

Phase 2 Pilot RCT

Pilot randomized controlled trial of PrEP Well + Trans STAIR vs. PrEP Well alone with 70 participants

90 days

3 sessions of PrEP Well, 8 sessions of Trans STAIR

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Follow-up visits at 30-day and 90-day intervals

What Are the Treatments Tested in This Trial?

Interventions

• PrEP Well
• Trans STAIR

Trial Overview The study tests 'Trans STAIR', a trauma treatment adapted for the TGD community, alongside 'PrEP Well', which helps with PrEP adherence. It's to see if combining these improves mental health, wound healing, and PrEP use compared to just 'PrEP Well'.

How Is the Trial Designed?

Group I: PrEP Well + Trans STAIR Experimental Treatment 2 Interventions

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.

Group II: PrEP Well Active Control 1 Intervention

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).

Who Is Running the Clinical Trial?

San Diego State University

Lead Sponsor

Trials

182

Recruited

119,000+

Los Angeles LGBT Center

Collaborator

Trials

8

Recruited

1,600+

RAND

Collaborator

Trials

145

Recruited

617,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

A pragmatic clinical trial involving 121 acutely injured trauma survivors showed that an IT-enhanced collaborative care intervention for PTSD resulted in modest symptom reductions, particularly significant at 3 and 6 months post-injury.

The intervention required a median of only 2.25 hours per patient, suggesting that this model could provide an efficient way to deliver PTSD treatment without extensive clinical resources.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Technology-Enhanced Stepped Collaborative Care Targeting Posttraumatic Stress Disorder and Comorbidity After Injury: A Randomized Controlled Trial. Zatzick, D., O'Connor, SS., Russo, J., et al.[2022]

Citations

1. withpower.com withpower.com/trial/trauma-treatment-prep-navigation-for-mental-health-symptoms-c2e97

Trauma Treatment + PrEP Navigation for Mental Health ... STAIR is based in cognitive-behavioral principles and delivered in a flexible manner, with demonstrated efficacy for the treatment of PTSD, depression and ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38442368/

Preliminary Investigation Into the Effectiveness of Group ... Results: Analyses revealed significant pre-to-post improvement in both PTSD and depression outcomes with a large effect size for PTSD (Hedges' ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2468749925000870

Examining the Efficacy of a Pilot Virtual Group Treatment ... Participants reported significant positive changes in severity of psychological symptoms, emotion regulation, beliefs about self and others, resilience, ...

4. mental.jmir.org mental.jmir.org/2024/1/e50977

Patient Satisfaction With a Coach-Guided, Technology-Based ... Previous work has demonstrated that webSTAIR is acceptable to participants and effective at reducing symptoms of posttraumatic stress disorder ...

5. researchprotocols.org researchprotocols.org/2025/1/e66115/

and Long-Term Effectiveness of Brief Intensive Trauma ... This is the first study to test the effectiveness of a 1-week BITT in adolescents with PTSD and comorbid symptoms and their caregivers.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06724965

Trans STAIR: Implementing an Evidence Based Trauma ... STAIR is based in cognitive-behavioral principles and delivered in a flexible manner, with demonstrated efficacy for the treatment of PTSD, depression and other ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8662839/

Redesign of a brief PTSD treatment in safety net integrated ... This study describes how an ongoing research study adapted to major changes to the implementation setting during the pandemic.

8. mdpi.com mdpi.com/2077-0383/13/10/2735

Utilization of Mental Health Provision, Epistemic Stance ... Participants with CPTSD had received mental health treatment significantly more often than participants with PTSD or depression (65.5% vs. 58.8% ...