Coaching for HCV and HIV

November 18, 2022 updated by: Boston Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston Medical Center - Low-Barrier-Access (LBA) walk-in clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptability of Intervention
Time Frame: 6 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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participant Linkage to HIV Care
Time Frame: 3 months and 6 months
Participants will be interviewed and asked investigator developed questions about linkage to HIV care
3 months and 6 months
Participant Linkage to HCV Care
Time Frame: 6 months
Participants will be interviewed and asked investigator developed questions about linkage to HCV care
6 months
Participant Linkage to Care for Opioid Use
Time Frame: 3 months and 6 months
Participants will be interviewed and asked investigator developed questions about their linkage to care for opioid use
3 months and 6 months
Number of Participants Who Received Pre-exposure Prophylaxis (PrEP)
Time Frame: 6 months
Whether participants received PrEp treatment will be abstracted from their electronic medical records (EMR) system.
6 months
Number of Participants Who Received HCV Care
Time Frame: 6 months
Whether participants received HCV care will be abstracted from their electronic medical records (EMR) system.
6 months
Number of Participants Who Received Opioid Use Treatment
Time Frame: 6 months
Whether participants received opioid use treatment will be abstracted from their electronic medical records (EMR) system.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Medical Center

Collaborators

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

Investigators

  • Principal Investigator: Sabrina A Assoumou, MD MPH, Boston Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 20, 2020

Primary Completion (Actual)

January 28, 2022

Study Completion (Actual)

January 28, 2022

Study Registration Dates

First Submitted

March 13, 2020

First Submitted That Met QC Criteria

March 17, 2020

First Posted (Actual)

March 19, 2020

Study Record Updates

Last Update Posted (Actual)

December 19, 2022

Last Update Submitted That Met QC Criteria

November 18, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-39712
  • 1UL1TR001430 (U.S. NIH Grant/Contract)
  • 5P30AI042853 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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