The Collaborative Care PrTNER Study

Официальное название

The Collaborative Care PrTNER (Prevention, Treatment, Navigation, Engagement, Resource) Project

Обзор

A randomized controlled trial to assess the ability of a Collaborative Care Prevention, Treatment, Navigation, Engagement, Resource (PrTNER) intervention to increase initiation of preexposure prophylaxis (PrEP) (for those at-risk for HIV) and decrease viral load (for those living with HIV) among young aged 15 to 29 through engagement in SU treatment.

Подробное описание

The Collaborative Care (CC) PrTNER is a multi-component intervention developed by members of the research team specifically for young men aged 15 to 29 who are at-risk for or living with HIV. This model moves beyond the individual to consider the broader context in which, substance use (SU), and HIV risk are (re)produced.

Enhanced models that integrate SU treatment into HIV and PrEP primary care services (using a collaborative care approach that incorporates feedback from a psychiatrist and support from a peer coach) are needed to address the nuance of substance use in this population. We, therefore, are proposing to conduct a randomized trial to evaluate an integrated collaborative care model (CC PrTNER).

Вмешательства

• Поведенческое CC PrTNER
  Participants randomized to CC PrTNER will be assigned a peer coach. They will conduct interviewer-administered behavioral surveys. The surveys provide an in-depth assessment of SU, HIV prevention and care, engagement, and adherence. Behavioral surveys are administered monthly. The coach will discuss with the participant the areas that are flagged by the psychiatrist; provide psychoeducation around areas identified, and work with the participant to identify their health goals and how changes in S

Первичные конечные точки

• PrEP uptake at 12 months [Срок оценки: 12 months]
• HIV virologic suppression at 12 months [Срок оценки: 12 months]
• Number of days of past-28-day non-tobacco drug/alcohol use [Срок оценки: 12 months]

Вторичные конечные точки (5)

• PrEP persistence [Срок оценки: 12 months]
• Sustained viral suppression [Срок оценки: 12 months]
• Uptake of HIV Antiretroviral therapy (ART) treatment [Срок оценки: 12 months]
• Mean number of negative urine drug screens (UDS) [Срок оценки: 12 months]
• Substance-related problems [Срок оценки: 12 months]

Критерии участия

Критерии включения

Aim 1:

• 15-24 years old;
• Cisgender male;
• History of condomless sex;
• Moderate-to-high risk SU behaviors based upon a Car, Relax, Alone, Forget, Friends, Trouble (CRAFFT) score ≥2,
• Living in Philadelphia, PA or Baltimore, MD, and surrounding areas;
• Able to read and write in English

Aim 2:

• 15-29 years old;
• Cisgender male;
• Living with a diagnosis of HIV;
• CRAFFT score ≥2,
• Living in Philadelphia, PA or Baltimore, MD, and surrounding areas;
• Able to read and write in English

Aim 3

• All randomized study participants will be included in Aim 3.

Критерии исключения

Aim 2:

• Participants will be excluded if they are:
• Assigned female sex at birth
• Identify as transgender
• Outside the age criteria (<15 or >29 years old)
• Cognitively unable to complete study requirements
• Living outside of the two geographic areas
• Do not screen positive for SU
• No prior substance use history
• No prior condomless sex;
• Unable to read or write in English,
• Plan to move in the next 12 months.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Другое

Центры проведения

США · 2 центра

• Johns Hopkins Center for Adolescent and Young Adult Health — Baltimore
• Children's Hospital of Philadelphia — Philadelphia

Идентификаторы

NCT: NCT06585631 · 23-021859 · R01DA059022

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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