Shared Decision Making to Treat Or Prevent (STOP) HIV in Criminal Legal Involved Populations (R33)

Официальное название

STOP (Shared Decision Making to Treat Or Prevent) HIV in Criminal Legal Involved Populations

Обзор

This study seeks to compare the effectiveness of two Patient Navigation models of care to evaluate the proportion who initiate PrEP/ART and substance use/substance use disorder (SU/SUD) treatment. A standardized Patient Navigation (PN) arm will be compared with a shared decision-making model in the form of Patient Choice (PC) through the offer of a menu of existing community-based health service delivery options. This design will offer providers, correctional and public health authorities, payers and policy makers' timely and relevant data to assess the effectiveness of Patient Navigation and Patient Choice models of care as potentially useful re-entry and relapse prevention treatment options.

Подробное описание

This study will be done in two phases. Aim 1, the R61 portion of the project will be a Pilot Study, and Aim 2, the R33 portion of the project will be a Randomized Controlled Trail informed by the pilot.

The focus of this registration is Aim 2, the randomized controlled trial. The Aim 1 (R61) portion is registered with NCT06439329. In Aim 2 (R33), investigators will evaluate standard PN compared to PN+PC on participant outcomes, implementation outcomes and costs associated with implementing the study.

Вмешательства

• Поведенческое Standard PN
  Standard of care
• Поведенческое Patient Choice
  Participants can select from a menu of options including brick and mortar services, Mobile Health Unit (MHU) or telehealth services.

Первичные конечные точки

• Percentage of participants who initiate or re-initiate PrEP [Срок оценки: 6 months]
• Percentage of participants who initiate or re-initiate ART [Срок оценки: 6 months]

Вторичные конечные точки (12)

• Percentage of participants that adhere to PrEP [Срок оценки: 6 and 12 months]
• Percentage of participants retaining on PrEP [Срок оценки: 6 and 12 months]
• HIV incidence [Срок оценки: 6 and 12 months]
• Percentage of participants that adhere to ART [Срок оценки: 6 and 12 months]
• ART retention [Срок оценки: 6 and 12 months]
• Substance use treatment [Срок оценки: 6 and 12 months]
• HIV viral suppression [Срок оценки: 6 months]
• Retention in HIV PrEP/ART [Срок оценки: 6 months]
• Number of Participants Who Had Any Needle Sharing Activity to Assess HIV Risk Behavior [Срок оценки: 6 and 12 months]
• Number of Participants Who Had Sex Without a Condom to assess HIV Risk Behavior [Срок оценки: 6 and 12 months]
• Days of using opioids [Срок оценки: 6 and 12 months]
• Number of participants with with overdose events [Срок оценки: 6 and 12 months]

Критерии участия

Критерии включения

• able to provide written informed consent in English or Spanish;
• living in the community of Western, CT, Dallas and Tarrant Counties in TX and Madison County, KY (potential for Fayette county as well);
• Those with current justice involvement (with in the past 12 months) (e.g., prison, jail, community supervision);
• willing to have HIV testing to determine negative or positive status;
• persons with HIV who report not currently taking ART in past 6 months OR persons who test negative for HIV who report not taking PrEP that have a PrEP indication in past 12 months, including (i) condomless sexual intercourse; and/or (ii) sharing IDU equipment with HIV positive or unknown status partner; and/or (iii) bacterial STI and;
• Having a history of opioid and/or stimulant use in the last 12 months within the community.

Критерии исключения

• severe medical or psychiatric disability making participation unsafe;
• unable to provide consent.
• persons self-reporting pregnancy

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

Открытое

Основная цель

Лечение

Центры проведения

США · 4 центра

• Yale School of Medicine — New Haven
• College of Medicine at the University of Kentucky — Lexington
• University of Texas Southwestern Medical Center (UTSW) — Dallas
• Texas Christian University's (TCU) School of Medicine — Fort Worth

Идентификаторы

NCT: NCT07223398 · 2000037052_a · 4R33DA060625-02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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