Integrating MOUD in Nonmedical Community Settings (Better Together)

Обзор

A multisite effectiveness-implementation study will be conducted in four sites to evaluate interventions to improve engagement and retention in MOUD with buprenorphine treatment persons with Opioid Use Disorder (OUD) in urban neighborhoods with high overdose rates. The investigators hypothesize that treatment with the Better Together Integrated Collaborative Community MOUD care model (BT-MOUD) will result in better retention in treatment than standard-of-care MOUD with buprenorphine provided in the hub buprenorphine clinic only (HC-MOUD Only) through 24 weeks following randomization. BT-MOUD provides MOUD with buprenorphine in nonmedical community-based settings via telemedicine from a hub buprenorphine clinic combined with Recovery Guiding, a manual guided coaching developed for this approach, provided onsite in the community organization.

Подробное описание

This multi-site hybrid Type 1 effectiveness-implementation study conducted in Washington, District of Columbia (DC), Chicago, Miami-Dade County and Baltimore will evaluate: 1) the effectiveness of providing MOUD with buprenorphine onsite (via telemedicine from a hub buprenorphine clinic) combined with Recovery Guiding in nonmedical community-based settings (the Better Together Integrated Collaborative Community MOUD care model - BT-MOUD) compared to standard-of-care MOUD with buprenorphine provided in the hub buprenorphine clinic only (HC-MOUD Only) and 2) BT-MOUD implementation barriers and facilitators. In the BT-MOUD intervention, community sites serve as "spokes" for telemedicine provision of MOUD by buprenorphine providers based in a "hub" buprenorphine clinic. A trained and supervised Recovery Guide with roots or connections with the community provides manual-guided Recovery Guiding on-site in the community site. Recovery Guiding includes psychoeducation (about OUD and effective buprenorphine MOUD) and behavioral counseling to promote engagement in MOUD with buprenorphine, retention in care, medication adherence, and behavioral change supportive of recovery. In HC-MOUD Only, participants will receive MOUD with buprenorphine and other available services in the hub buprenorphine clinic only. A Peer Outreach Specialist (POS) will assist with outreach and recruitment of all participants across conditions and with maintaining high rates of follow-up in research assessments. This study will test the hypothesis that BT-MOUD is more effective than HC-MOUD Only in retaining persons with OUD in MOUD with buprenorphine through six months post-randomization.

Вмешательства

• Поведенческое HC-MOUD Only
  MOUD with buprenorphine provided in a hub buprenorphine clinic
• Поведенческое BT-MOUD with Buprenorphine
  MOUD with buprenorphine provided by a hub buprenorphine provider either in the hub clinic or via telemedicine at a community hub; Recovery Guiding provided to participants

Первичные конечные точки

• Buprenorphine MOUD Treatment Retention [Срок оценки: 0-168 days]

Вторичные конечные точки (7)

• Self-reported adherence to MOUD with buprenorphine [Срок оценки: 0-168 days]
• Self-reported nonmedical opioid use [Срок оценки: 0-168 days]
• Self-reported nonmedical other drug use [Срок оценки: 0-168 days]
• Urine Toxicology [Срок оценки: Months 1,2 3,4,5,6]
• Health-related quality of life (HRQOL) [Срок оценки: Months 1,2 3,4,5,6]
• Patient Health Questionnaire Depression Scale [Срок оценки: Months 1,2,3,4,5,6]
• Pharmacy Dispensed Buprenorphine [Срок оценки: Months 1, 2, 3, 4, 5, 6]

Критерии участия

Критерии включения

• Be 16 years of age or older
• Has been newly prescribed MOUD with buprenorphine by a hub clinic provider no more than 10 days before the day of randomization or on the day of randomization \[Note that the "start" of a "current, new treatment episode" of MOUD with buprenorphine is defined as the date MOUD with buprenorphine was prescribed by a hub clinic provider.\]
• Is willing and able to provide written informed consent
• Is willing and able to provide reliable locator information to facilitate contacting the participant for research follow-up assessments
• Speaks English well enough to be able to comprehend the study procedures and complete the assessments

Критерии исключения

• In the 30 days prior to receiving the prescription for MOUD with buprenorphine from the hub clinic provider, has either taken prescribed MOUD as an outpatient for more than 10 consecutive days OR received injectable MOUD that covers more than 10 consecutive days \[Note that receipt of MOUD in a hospital, residential treatment, or carceral setting would not trigger exclusion.\]
• Plans to move out of the area or anticipate not being able to remain in the study for 6 months
• Is currently in jail, prison, or other overnight facility as required by a court of law or have pending legal action that could prevent participation in study activities
• Has been previously enrolled in CTN-0144 or CTN-0088 or is currently enrolled in another clinical trial for treatment of OUD

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

• Howard University — Washington D.C.
• University of Miami — Miami
• University of Illinois- Chicago — Chicago
• University of Maryland — Baltimore

Идентификаторы

NCT: NCT06416020 · NIDA CTN Protocol 0144 · UG1DA013720

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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