Coaching for HCV and HIV

Sponsor

Boston Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT04314414

Collaborator

National Institute of Allergy and Infectious Diseases (NIAID) (NIH), BU Clinical and Translational Science Institute (CTSI) (Other)

Enrollment

Location

Arm

13.3

Actual Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis C HIV Infections Opioid-use Disorder	Other: PRC brief motivational interview intervention Other: Phone contact	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

31 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

Peer Recovery Coaching to Facilitate Comprehensive HCV, HIV and Opioid Use Disorder Treatment: A Pilot Study

Actual Study Start Date :

Dec 20, 2020

Actual Primary Completion Date :

Jan 28, 2022

Actual Study Completion Date :

Jan 28, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention group 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 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. Other: Phone contact The PRC will remain in at least weekly contact by phone with each participant.

Arm

Intervention/Treatment

Experimental: Intervention group

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

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.

Other: Phone contact

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

Outcome Measures

Primary Outcome Measures

Acceptability of intervention [12 months]
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.

Secondary Outcome Measures

Participant linkage to HIV care [baseline, 3 months, 6 months]
Participants will be interviewed and asked investigator developed questions about linkage to HIV care
Participant linkage to HCV care [baseline, 3 months, 6 months]
Participants will be interviewed and asked investigator developed questions about linkage to HCV care
Participant linkage to care for opioid use [baseline, 3 months, 6 months]
Participants will be interviewed and asked investigator developed questions about linkage to care for opioid use
Number of participants who received pre-exposure prophylaxis (PrEP) [12 months]
Whether participants received PrEp treatment will be abstracted from their electronic medical records (EMR) system.
Number of participants who received HCV care [12 months]
Whether participants received HCV care will be abstracted from their electronic medical records (EMR) system.
Number of participants who received opioid use treatment [12 months]
Whether participants received opioid use treatment will be abstracted from their electronic medical records (EMR) system.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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