Coaching for HCV and HIV

NCT ID: NCT04314414

Last Updated: 2022-12-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-20

Study Completion Date

2022-01-28

Brief Summary

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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

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\*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.

Conditions

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Hepatitis C HIV Infections Opioid-use Disorder

Keywords

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Peer recovery coach (PRC) Pre-exposure prophylaxis (PrEP) HIV care HCV care Low-barrier-to-access (LBA)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

PRC brief motivational interview intervention

Intervention Type 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.

Phone contact

Intervention Type OTHER

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

Interventions

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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.

Intervention Type OTHER

Phone contact

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role collaborator

Boston University

OTHER

Sponsor Role collaborator

Boston Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sabrina A Assoumou, MD MPH

Role: PRINCIPAL_INVESTIGATOR

Boston Medical Center

Locations

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

Boston, Massachusetts, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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1UL1TR001430

Identifier Type: NIH

Identifier Source: secondary_id

View Link

5P30AI042853

Identifier Type: NIH

Identifier Source: secondary_id

View Link

H-39712

Identifier Type: -

Identifier Source: org_study_id