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Completed

NCT Number: NCT04314414

Coaching for HCV and HIV

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Boston, Massachusetts, 02118, United States

About this study

*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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Phone contact

Other

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. Participant Linkage to HCV Care

    Time frame: 6 months

    Participants will be interviewed and asked investigator developed questions about linkage to HCV care

  3. 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

  4. 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.

  5. 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. 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.

Sponsors and collaborators

Lead sponsor

Boston Medical Center

Other

Collaborators

  • Boston University
  • National Institute of Allergy and Infectious Diseases (NIAID)

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Mar 19, 2020
Registry last updated
Dec 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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