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

Официальное название

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

Обзор

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.

Вмешательства

• Поведенческое 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.
• Другое 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

Первичные конечные точки

• Number of participants who uptake PrEP [Срок оценки: 12 weeks post intervention]

Вторичные конечные точки (11)

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

США · 1 центр

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

Публикации

• 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

Идентификаторы

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

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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