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Coaching for HCV and HIV

Primary Purpose

Hepatitis C, HIV Infections, Opioid-use Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PRC brief motivational interview intervention
Phone contact
Sponsored by
Boston Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Hepatitis C focused on measuring Peer recovery coach (PRC), Pre-exposure prophylaxis (PrEP), HIV care, HCV care, Low-barrier-to-access (LBA)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Exclusion Criteria:

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention group

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
March 13, 2020
Last Updated
November 18, 2022
Sponsor
Boston Medical Center
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID), BU Clinical and Translational Science Institute (CTSI)
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1. Study Identification

Unique Protocol Identification Number
NCT04314414
Brief Title
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

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
December 20, 2020 (Actual)
Primary Completion Date
January 28, 2022 (Actual)
Study Completion Date
January 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Medical Center
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID), BU Clinical and Translational Science Institute (CTSI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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)

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
PRC brief motivational interview intervention
Intervention Description
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 Type
Other
Intervention Name(s)
Phone contact
Intervention Description
The PRC will remain in at least weekly contact by phone with each participant.
Primary Outcome Measure Information:
Title
Acceptability of Intervention
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Participant Linkage to HIV Care
Description
Participants will be interviewed and asked investigator developed questions about linkage to HIV care
Time Frame
3 months and 6 months
Title
Participant Linkage to HCV Care
Description
Participants will be interviewed and asked investigator developed questions about linkage to HCV care
Time Frame
6 months
Title
Participant Linkage to Care for Opioid Use
Description
Participants will be interviewed and asked investigator developed questions about their linkage to care for opioid use
Time Frame
3 months and 6 months
Title
Number of Participants Who Received Pre-exposure Prophylaxis (PrEP)
Description
Whether participants received PrEp treatment will be abstracted from their electronic medical records (EMR) system.
Time Frame
6 months
Title
Number of Participants Who Received HCV Care
Description
Whether participants received HCV care will be abstracted from their electronic medical records (EMR) system.
Time Frame
6 months
Title
Number of Participants Who Received Opioid Use Treatment
Description
Whether participants received opioid use treatment will be abstracted from their electronic medical records (EMR) system.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sabrina A Assoumou, MD MPH
Organizational Affiliation
Boston Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston Medical Center - Low-Barrier-Access (LBA) walk-in clinic
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Coaching for HCV and HIV

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