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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04314414
Other study ID # H-39712
Secondary ID 1UL1TR0014305P30
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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