Integrating MOUD in African American Community Settings (Better Together)

Not Applicable

Not yet recruiting

• Conditions: Opioid Use Disorder
• Interventions: Behavioral: BT-MOUD with Buprenorphine; Behavioral: HC-MOUD Only

• Registration Number: NCT06416020
• Lead Sponsor: Howard University

Brief Summary

A multisite effectiveness-implementation study will be conducted in three sites to evaluate interventions to improve engagement and retention in MOUD with buprenorphine treatment of Black persons with OUD. 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.

Detailed Description

This multi-site hybrid Type 1 effectiveness-implementation study conducted in Washington, District of Columbia (DC), Chicago, and Miami-Dade County 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 Black persons with OUD in MOUD with buprenorphine through six months post-randomization.

Study Timeline

• Study First Submitted: 2024-04-19
• Study First Submitted QC: 2024-05-14
• Study First Posted: 2024-05-16
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-04
• Last Update Posted: 2025-03-07
• Study Start: 2025-05-19
• Primary Completion: 2028-03
• Study Completion: 2028-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 330

Inclusion Criteria

1. Be 16 years of age or older, as documented by self-report and verified by staff at the hub buprenorphine clinic.
2. Self-identify race as Black (or African American, African, or Afro-Caribbean) (self report)
3. Meets the Diagnostic Statistical Manual (DSM) -5 diagnostic criteria for current moderate or severe OUD, based on clinical evaluation by a hub clinic buprenorphine provider and documented in the hub clinic medical record.
4. Be seeking, interested in receiving, and suitable for MOUD with buprenorphine, based on clinical evaluation by a hub clinic buprenorphine provider and documented in the hub clinic medical record.
5. Have not received MOUD in the 30 days prior to enrolling in MOUD in the hub buprenorphine clinic (based on Prescription Drug Monitoring Program [PDMP] and self-report)
6. Willing and able to provide informed consent, and when applicable, signed assent (consent process)
7. Speak English well enough to be able to comprehend the study procedures and complete the assessments.

Exclusion Criteria

1. Have significant cognitive or developmental impairment to the extent that they are unable to provide informed consent/assent.
2. Have a psychiatric, cognitive, or medical condition which would make participation inappropriate or contraindicated, as assessed by the hub buprenorphine clinic provider.
3. Plan to move out of the area or do not anticipate being able to remain in the study for 6 months.
4. Are unable or unwilling to provide reliable locator information.
5. Are 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.
6. They have previously enrolled in Clinical Trials Network (CTN) Protocol-0144 or are currently enrolled in another clinical trial for treatment of OUD.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Recovery Guiding / Better Together Medications for Opioid Use Disorder (BT-MOUD) procedures	BT-MOUD with Buprenorphine	Better Together Medications for Opioid Use Disorder (BT-MOUD) includes HC-MOUD plus access to telemedicine provision of MOUD with buprenorphine at a nonmedical community organization spoke, plus manual-guided Recovery Guiding provided onsite at the spoke, and plus any other services available at the community organization spoke. Recovery Guiding is a manualized, highly structured, stepwise intervention that uses educational and behavioral tools to provide pragmatic guidance for patients beginning buprenorphine treatment and to address the key recovery misconceptions and dysfunctional behaviors that frequently interfere with recovery efforts of patients initiating medication for opioid use disorder (MOUD) treatment.
Hub Clinic MOUD with buprenorphine only (HC-MOUD Only)	HC-MOUD Only	Participants will receive MOUD with buprenorphine prescribed by providers based at participating hub clinics. MOUD treatment with buprenorphine will follow standard guidelines for induction and maintenance using a sublingual buprenorphine formulation. Hub clinic buprenorphine providers and participants may shift to long acting injection buprenorphine formulations after initial induction with sublingual buprenorphine. If telemedicine prescribing of MOUD with buprenorphine is part of the usual standard of care at the clinic, participants assigned to HC-MOUD Only may be prescribed buprenorphine via telemedicine, following the clinic's usual guidelines. Participants may not receive telemedicine services at the community spokes or Recovery Guiding, which are available only to participants assigned to BTMOUD. All study participants, however, may have access to any services that are routinely provided as part of the MOUD with buprenorphine treatment-as-usual care in the hub clinic.

Primary Outcome Measures

Name	Time	Method
Buprenorphine MOUD Treatment Retention	0-168 days	Duration of continuous participation in the hub clinic provided buprenorphine treatment

Secondary Outcome Measures

Name	Time	Method
Health-related quality of life (HRQOL)	Months 1,2 3,4,5,6	Assess quality of life using the Health-related Quality of Life Health Related Quality of Life -4: Scores range from 1-5 for Q1, assessing overall health-related quality of life, and from 0-30 for Q2, Q3, and Q4 assessing physical health (Q2), mental health (Q3), and interference from health or mental health problems (Q4); higher scores indicate worse outcomes.
Self-reported nonmedical other drug use	0-168 days	Number of days self-reported other drug use
Urine Toxicology	Months 1,2 3,4,5,6	Number of opioid-negative urine toxicology tests, ranging from 0 to 6.
Patient Health Questionnaire Depression Scale	Months 1,2,3,4,5,6	Assess depressive symptoms using Patient Health Questionnaire Depression Scale-8 (PHQ-8). Scores range from 0 to 24. Higher scores are indicators of greater depression severity.
Self-reported adherence to MOUD with buprenorphine	0-168 days	Number of days self-reported adherence to MOUD with buprenorphine assessed using timeline follow back (TLFB) Adherence to buprenorphine during the 168-day study period
Self-reported nonmedical opioid use	0-168 days	Number of days self-reported days of nonmedical opioid use, stimulant use, benzodiazepine use during the 168 study period

Trial Locations

Locations (3)

Howard University; 🇺🇸 Washington, District of Columbia, United States

University of Miami; 🇺🇸 Miami, Florida, United States

University of Illinois- Chicago; 🇺🇸 Chicago, Illinois, United States