Coaching for HCV and HIV

NCT04314414 | Completed Results

• 3 other identifiers: H-397121UL1TR0014305P30AI042853
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

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)

Outcome Measures

Primary Outcomes (1)

• Acceptability of Intervention

  As part of an investigator developed survey a 5-point LIkert scale question will be asked on how acceptable the intervention/care was where 1 is not acceptable and 5 is very acceptable.

  6 months

Secondary Outcomes (6)

• Participant Linkage to HIV Care

  3 months and 6 months

• Participant Linkage to HCV Care

  6 months

• Participant Linkage to Care for Opioid Use

  3 months and 6 months

• Number of Participants Who Received Pre-exposure Prophylaxis (PrEP)

  6 months

• Number of Participants Who Received HCV Care

  6 months

Study Arms (1)

Intervention group

EXPERIMENTAL

Participants in the intervention group will receive a semi-scripted brief motivational interview from the peer recovery coach (PRC) in addition to the standard of care at Boston Medical Center (BMC) for HIV, HCV, and opioid use disorder.

Other: PRC brief motivational interview intervention; Other: Phone contact

Interventions

PRC brief motivational interview intervention OTHER

The intervention will involve the following elements: establishing rapport, asking permission to discuss drugs, discussing the pros and cons associated with drug use, uncovering the gaps between current and desired quality of life and determining readiness to change. The intervention will last approximately 20 minutes and take place at the time of the clinical visit while participants are waiting to be seen by a clinician or are awaiting laboratory testing.

Intervention group

Phone contact OTHER

The PRC will remain in at least weekly contact by phone with each participant.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Boston Medical Center: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator
• Boston University: collaborator

Study Sites (1)

Boston Medical Center - Low-Barrier-Access (LBA) walk-in clinic

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Hepatitis C; HIV Infections; Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Sabrina A Assoumou, MD MPH
• Organization: Boston Medical Center

sabrina.assoumou@bmc.org

(617) 414-5282

Study Officials

• Sabrina A Assoumou, MD MPH

  Boston Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2020
• First Posted: March 19, 2020
• Study Start: December 20, 2020
• Primary Completion: January 28, 2022
• Study Completion: January 28, 2022
• Last Updated: December 19, 2022
• Results First Posted: December 19, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)