NOTRE: Optimizing Long-Acting Pre-Exposure Prophylaxis and Medications for Opioid Use Disorder Interventions in Carceral Settings

Официальное название

Optimizing Long-Acting Pre-Exposure Prophylaxis and Medications for Opioid Use Disorder Interventions in Carceral Settings

Обзор

The investigators plan to conduct an R61/33 hybrid type 2 implementation-effectiveness trial that includes 1) a one-year exploratory R61 phase that will enable the development of the intervention protocol needed for the R33 trial phase including concrete R61 phase milestones; 2) a four-year R33 phase that will include a concurrent implementation evaluation and a randomized control trial.

Подробное описание

Study aims are: Aim 1 (R61): Develop the intervention protocol for delivery of LAI PrEP + XR-B. We will conduct interviews with stakeholders (staff at partner and other carceral and community sites, n=18:) and currently or recently incarcerated individuals (n=18). Interviews will focus on how to optimize intervention components for the R33 phase. Aim 2 (R33): Evaluate implementation facilitation as a strategy to support co-located LAI PrEP + XR-B in carceral and re-entry settings. Guided by the Consolidated Framework for Implementation Research (CFIR), implementation outcomes from Proctor et al.,including acceptability, appropriateness, adoption, feasibility, and sustainability will be assessed using surveys, interviews, and administrative records. Aim 3 (R33): Compare the effectiveness of co-located LAI PrEP + XR-B to oral PrEP + SL-B. Patient preference trial for 450 adults who are clinically indicated for both PrEP and MOUD and soon-to-be-released from a carceral setting to either LAI Prep + X-RB (n=150) or oral PrEP + SL-B (n=150) treatment initiated in jail or prison. A baseline assessment will be conducted prior to release followed by monthly follow-up for 7 months and a final long-term follow-up visit at 12-months.

Вмешательства

• Препарат Cabotegravir Injection
  Long-acting injection (LAI) Prep + X-RB treatment initiated in jail or prison.
• Препарат Cabotegravir Pill
  Oral PrEP + SL-B treatment initiated in jail or prison.
• Препарат Buprenorphine injection
  Long-acting injection (LAI) Prep + X-RB treatment initiated in jail or prison.
• Препарат Buprenorphine Pill
  Oral PrEP + SL-B treatment initiated in jail or prison.

Первичные конечные точки

• PrEP adherence, time to dropout [Срок оценки: up to 12 months]
• Buprenorphine adherence, time to dropout [Срок оценки: up to 12 months]

Вторичные конечные точки (5)

• Substance use as measured by number of participants with positive Urine Drug Test (UDT) [Срок оценки: up to 12 months]
• Number of participants with a fatal or non-fatal overdose [Срок оценки: up to 12 months]
• Number of participants engaging in HIV risk behaviors [Срок оценки: up to 12 months]
• Number of participants with past criminal system engagement [Срок оценки: Baseline]
• Number of participants with HIV acquisition [Срок оценки: up to 12 months]

Критерии участия

Критерии включения

• Adults (age 18) at a participating carceral site;
• Eligible for release within 120 days (sentenced and/or pretrial). Individuals who might be sentenced to federal prison will be excluded;
• History of OUD (meeting DSM-5 criteria of moderate or severe opioid use disorder at the time of incarceration; individuals not meeting the opioid-disorder criterion will be eligible if they were treated in an opioid agonist treatment program during the year before incarceration or met OUD criteria in the year prior to incarceration);
• HIV negative (as confirmed by a HIV rapid test);
• Clinically indicated for PrEP based on CDC guidelines during incarceration and/or the year prior to incarceration;
• Willing to enroll in buprenorphine treatment and PrEP and be randomized to either study arm; and
• Report that, during community re-entry they will reside in the geographic locations of the study.

Критерии исключения

• Liver function test levels greater than four times normal (if we are unable to obtain labs, a determination by our site partner physicians will be made to allow inclusion);
• Active medical illness that may make participation hazardous (e.g., unstable diabetes, heart disease; renal impairment, Hepatitis B);
• Conditions or medications that may predispose to QTc prolongation (personal or family history of long QT syndrome, hypokalemia, medications that prolong QTc interval, e.g., macrolide antibiotics, azole antifungal compounds, anti-arrhythmics, antipsychotics and antidepressants);
• Untreated psychiatric disorder that may make participation hazardous (e.g., untreated psychosis, treated psychiatric disorders will be allowed);
• Known allergic reaction to PrEP or buprenorphine; and
• Suicidal ideation.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• Duke University Medical System — Durham

Идентификаторы

NCT: NCT06854029 · Pro00117590 · R61DA060583

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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