Coaching for HCV and HIV

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04314414
• Other study ID #: H-39712
• Secondary ID: 1UL1TR0014305P30
• Status: Completed
• Phase: N/A
• Start date: December 20, 2020
• Est. completion date: January 28, 2022

Study information

• Verified date: November 2022
• Source: Boston Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: January 28, 2022
• Est. primary completion date: January 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis C
• HIV Infections
• Opioid-Related Disorders
• Opioid-use Disorder

Intervention

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

Locations

Country	Name	City	State
United States	Boston Medical Center - Low-Barrier-Access (LBA) walk-in clinic	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Boston Medical Center	BU Clinical and Translational Science Institute (CTSI), National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

Outcome

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