Ignite Creation Date:
2024-05-19 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06416020
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-16
First Post:
2024-04-19
Brief Title:
Integrating MOUD in African American Community Settings Better Together
Sponsor:
Howard University
Organization:
Howard University
Study Overview
Official Title:
Integrating MOUD in African American Community Settings Better Together
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UG1DA013720 | NIH | None | httpsreporternihgovquickSearchUG1DA013720 |