Pre-exposure Prophylaxis (PrEP) Uptake and Adherence Intervention for Women with Trauma-related Conditions

Official title

Development and Pilot Testing of a Mental Health Clinic-Based PrEP Uptake and Adherence Intervention for Women in Treatment for Trauma-Related Conditions

Overview

The investigators have previously developed an integrated bio-behavioral intervention to promote PrEP uptake and adherence in cisgender women who are undergoing treatment for trauma-related mental health conditions and who are at a higher risk for HIV. The intervention is delivered within the mental health treatment setting and integrates knowledge, behavioral skills, and motivation to engage in and adhere to PrEP care. The purpose of this study is to assess the preliminary efficacy, feasibility, and acceptability of this intervention. The hypothesis is that, compared to standard treatment, the intervention will be feasible, acceptable, and associated with greater PrEP uptake and adherence.

Interventions

• Behavioral Integrated Intervention to Promote PrEP Uptake
  Provision of PrEP information through 3 counseling sessions, prevention navigation, and nurse practitioner-prescribed PrEP in an addiction treatment setting.
• Other Standard Treatment Condition
  Participants in trauma treatment will be given information and referral to a community partner who will evaluate them to determine if they could benefit from PrEP for HIV prevention

Primary outcome measures

• Number of participants who uptake PrEP [Time frame: 12 weeks post intervention]

Secondary outcome measures (11)

• Number of Participants who adhere to PrEP [Time frame: 12 weeks post PrEP initiation]
• PrEP adherence as assessed by proportion of videos uploaded [Time frame: from the time of PrEP initiation to 12 weeks post PrEP initiation]
• PrEP adherence as assessed by proportion of self-reported daily adherence [Time frame: from the time of PrEP initiation to 12 weeks post PrEP initiation]
• Intervention feasibility as assessed by number of participants enrolled [Time frame: at the time of enrollment]
• Intervention feasibility as assessed by number of sessions attended by participants [Time frame: 15 weeks post enrollment]
• Intervention feasibility as assessed by study retention [Time frame: 15 weeks post enrollment]
• Intervention acceptability as assessed by score on a satisfaction questionnaire [Time frame: 15 weeks post enrollment]
• Change in PrEP Anticipated Stigma as assessed by the PrEP Anticipated Stigma Scale [Time frame: baseline, 15 weeks post enrollment]
• Change in perceived HIV risk as assessed by Perceived Risk of HIV Scale [Time frame: baseline, 15 weeks post enrollment]
• Change in PrEP knowledge as assessed by PrEP Knowledge Questionnaire [Time frame: baseline, 15 weeks post enrollment]
• Change in PrEP attitudes as assessed by PrEP Attitudes Measure [Time frame: baseline, 15 weeks post enrollment]

Eligibility criteria

Inclusion criteria

• Currently undergoing mental health treatment;
• Have a history of trauma;
• HIV negative;
• Sexually active with an opposite sex partner within the past 6 months;
• Not using PrEP for HIV prevention at the time of screening;
• Eligible for PrEP based on having at least one Centers for Disease Control and Prevention (CDC)-defined criteria for PrEP;
• Fluent in English;
• Own or have regular access to a smart phone.

Exclusion criteria

• HIV positive;
• Concurrently participating in another HIV prevention program;
• Have severe cognitive impairment that would interfere with their ability to consent, understand study procedures and/or effectively participate in therapy;
• Have psychological distress that would prohibit them from participating in the study;
• Be unable or unwilling to meet study requirements.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Prevention

Study locations

United States · 1 center

• Louis A. Faillace, MD, Department of Psychiatry and Behavioral Sciences, University of Tex — Houston

Publications

• Heads AM, An K, Hill MJ, Gameon JA, de Dios C, Suchting R, Acierno R. Development and feasibility testing of a PrEP uptake and adherence intervention for women with trauma-related mental health conditions: Protocol for a randomized controlled trial. Contemp Clin Trials Commun. 2026 May 9;51:101645. doi: 10.1016/j.conctc.2026.101645. eCollection 2026 Jun. PMID 42200033

Identifiers

NCT: NCT06558825 · HSC-MS-21-0544 · 1R34DA055496-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗