Clinical trial NCT04314414: Coaching for HCV and HIV
Official title: Peer Recovery Coaching to Facilitate Comprehensive HCV, HIV and Opioid Use Disorder Treatment: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatitis C
HIV Infections
Opioid-use Disorder
Keywords: Peer recovery coach (PRC)
Pre-exposure prophylaxis (PrEP)
HIV care
HCV care
Low-barrier-to-access (LBA)
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
name: Boston University
First posted: 2020-03-19
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The objective of this study is to determine the feasibility and acceptability of a peer recovery coach (PRC) intervention to improve linkage to hepatitis C (HCV) and/or human immunodeficiency virus (HIV) care, treatment initiation, and evaluation for HIV pre-exposure prophylaxis (PrEP) (when applicable) among individuals with a history of opioid use disorder accessing a substance use low-barrier-to-access (LBA) walk-in clinic.

In-depth interviews will be administered to participants at baseline, three- and six-months for study participants (40 total participants). The investigator will also follow-up with the per recovery coach and administer surveys to assess the feasibility of a peer recovery coaching intervention in improving HCV/HIV related linkage to care and management. Patient medical records and peer recovery coach monthly reports will be accessed and reviewed to determine fidelity to research protocols.

Detailed description: \*NOTE\* Due to the COVID-19 pandemic, surveys were conducted via telephone and not all participants could be contacted. Therefore, the number of results from participants at three months and six months vary. The data gathered are from participants that were reachable and completed the surveys.

Eligibility criteria: Inclusion Criteria:

* Individuals with opioid use disorder, non-reactive HIV antibody test and reactive HCV antibody testing at the BMC LBA walk-in clinic
* Able to speak English
* Individuals providing contact information of two family members or friends
* Individuals signing a medical records release form

Exclusion Criteria:

* Individuals already linked to substance use care
* Individuals co-infected with HIV and HCV and engaged in care

Primary outcomes:
measure: Acceptability of Intervention
timeFrame: 6 months
Secondary outcomes:
measure: Participant Linkage to HIV Care
timeFrame: 3 months and 6 months
measure: Participant Linkage to HCV Care
timeFrame: 6 months
measure: Participant Linkage to Care for Opioid Use
timeFrame: 3 months and 6 months
measure: Number of Participants Who Received Pre-exposure Prophylaxis (PrEP)
timeFrame: 6 months
measure: Number of Participants Who Received HCV Care
timeFrame: 6 months
measure: Number of Participants Who Received Opioid Use Treatment
timeFrame: 6 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center - Low-Barrier-Access (LBA) walk-in clinic
state: Massachusetts
Study officials:
affiliation: Boston Medical Center
name: Sabrina A Assoumou, MD MPH
role: PRINCIPAL_INVESTIGATOR
References: