Pre-exposure Prophylaxis (PrEP) Adherence Intervention for Women with Substance Use Disorders

Официальное название

Development and Pilot Testing of an Addiction Clinic-Based PrEP Adherence Intervention for Women with Substance Use Disorders

Обзор

The goal of this clinical trial is to test an addiction-clinic based behavioral intervention for increasing PrEP uptake and adherence among women who engage in high-risk sexual behaviors and problematic substance use. The main question it aims to answer is: • If the integrated intervention increase PrEP uptake and adherence compared to standard treatment Participants will * receive provision of PrEP information through 4 counseling sessions * prevention navigation * receive nurse practitioner prescribed PrEP in an addiction treatment setting Researchers will compare intervention group with standard treatment to see if the integrated intervention help increase PrEP uptake and adherence

Вмешательства

• Поведенческое Addiction Clinic-Based PrEP Adherence Intervention for Women with Substance Use Disorders
  Provision of PrEP information through 4 counseling sessions, prevention navigation, and nurse practitioner prescribed PrEP in an addiction treatment setting.
• Другое Standard of care treatment
  Participants in substance use 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

• PrEP uptake [Срок оценки: 12 weeks post intervention]

Вторичные конечные точки (7)

• Daily PrEP adherence as assessed by the levels of tenofovir (TFV) urine concentrations [Срок оценки: 90 days post PrEP initiation]
• Daily PrEP adherence as assessed by the proportion of videos uploaded [Срок оценки: 12 weeks post PrEP initiation]
• Daily PrEP adherence as assessed by the proportion of self reported daily adherence [Срок оценки: 12 weeks post PrEP initiation]
• Enrollment rate as assessed by the number of participants that signed the consent form [Срок оценки: 12 weeks post intervention]
• Number of sessions attended by participants [Срок оценки: 12 weeks post enrollment]
• Study retention as assessed by the number of participants that completed the study [Срок оценки: 12 weeks post enrollment]
• Intervention acceptability as assessed by the Client satisfaction questionnaire [Срок оценки: 12 weeks post intervention]

Критерии участия

Критерии включения

• Black/African American and Hispanic/Latina cisgender women
• diagnosed with a Substance use disorder (SUD) per Diagnostic and Statistical Manual of Mental Illnesses (DSM)-5 criteria
• 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
• able to speak, read, and write in English; and
• own or have regular access to a smart phone.

Критерии исключения

• be concurrently participating in another SUD behavioral treatment program
• unable to provide informed consent for participation (e.g., 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
• be ineligible for PrEP based on Centers for Disease Control and Prevention (CDC)-defined criteria for PrEP based on substance use and sexual risk
• have medical contraindications for PrEP (e.g., known renal impairment which can be exacerbated by PrEP use).

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, Santa Maria D, Hill MJ, Suchting R, Evans KN, Gaul Z, Yammine L, de Dios C, Schmitz JM. Development and Pilot Testing of an Addiction Clinic-Based Pre-Exposure Prophylaxis Uptake and Adherence Intervention for Women with Substance Use Disorders: Protocol for a Pilot Randomized Trial. JMIR Res Protoc. 2025 May 23;14:e64961. doi: 10.2196/64961. PMID 40409752

Идентификаторы

NCT: NCT06158607 · HSC-MS-21-0451

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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