Clinical trial NCT06416020: Integrating MOUD in African American Community Settings (Better Together)
Official title: Integrating MOUD in African American Community Settings (Better Together)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Opioid Use Disorder
Keywords: MOUD
African American
OUD
Buprenorphine
Lead sponsor: Howard University
Sponsor class: OTHER
Collaborators: name: University of Illinois at Chicago
name: University of Miami
name: National Institute on Drug Abuse (NIDA)
name: The Emmes Company, LLC
First posted: 2024-05-16
Enrollment: 330
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A multisite hybrid Type 1 effectiveness-implementation randomized clinical trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Buprenorphine MOUD Treatment Retention
timeFrame: 0-168 days
Secondary outcomes:
measure: Self-reported adherence to MOUD with buprenorphine
timeFrame: 0-168 days
measure: Self-reported nonmedical opioid use
timeFrame: 0-168 days
measure: Self-reported nonmedical other drug use
timeFrame: 0-168 days
measure: Urine Toxicology
timeFrame: Months 1,2 3,4,5,6
measure: Health-related quality of life (HRQOL)
timeFrame: Months 1,2 3,4,5,6
measure: Patient Health Questionnaire Depression Scale
timeFrame: Months 1,2,3,4,5,6
Other outcomes:
Locations:
city: Washington
country: United States
facility: Howard University
state: District of Columbia
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Chicago
country: United States
facility: University of Illinois- Chicago
state: Illinois
Study officials:
affiliation: Howard University
name: Richard S Schottenfeld, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Miami
name: Viviana Horigian, MD, MHA
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Illinois Chicago
name: Niranjan Karnik, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Howard University
name: Denise M. Scott, PhD
role: STUDY_DIRECTOR
References: