Development of a Community-based HCV Treatment Completion Intervention Among HCV Positive Homeless Adults

NACompletedINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

October 5, 2020

Primary Completion Date

July 20, 2022

Study Completion Date

July 20, 2022

Conditions
Hepatitis C Virus (HCV) Infection
Interventions
BEHAVIORAL

Community health worker (CHW)/ registered nurse (RN) [CHW/RN]

A team of 2-3 CHWs and a research RN will deliver all components of the program including daily DOT delivery of Direct Acting Antiviral (DAA) and assess HCV side effects all under the guidance of their RN. Recruitment will be continuous: each CHW may be assigned up to 7-8 participants every 2-3 months until the target sample size (n=54 for the intervention group) is achieved. After the first dose of the DAA, the CHW will run a brief weekly 1:1 education and case management session over the 8 or 12 weeks (total 20 minutes). The CHW/RN team will assist the participant in picking up the monthly medication and storing the medication in a secure, locked cabinet at the research office. The CHW will rigorously track participants who have missed a dose, and will also be involved in facilitating medical, mental health, substance use, social service, legal appointments for participants, housing referrals, and accompany the participants to the appointments.

BEHAVIORAL

Clinic-based Standard of Care (cbSOC) Program (control group)

This program will be delivered by a clinic-based MD or clinic-based NP at the clinic site. Evaluation Staff (ES) will be hired and trained to do the interviewing/survey administration and follow-ups at the clinic-based site. The clinic NP will conduct, per usual care at the study clinics, the education and monitoring of these participants who will interact with the clinic-based-MD and/or NP monthly over the 8 or 12-week program. Usual care will include: 1) HCV pre-treatment education; 2) two month supply of DAA; 3) monitoring adverse events; and 4) responding to questions on HCV. Referral to drug/alcohol and housing programs will be provided over the standard of care. The cbSOC participants will not receive the community delivery of the DAA, or case management, or accompaniment to needed services. The cbSOC Program will receive the medication on a monthly basis from the clinic MD or NP.

Trial Locations (7)

90007

Amity Foundation, Los Angeles, Los Angeles

90013

Cardinal Manning Center, Los Angeles, Los Angeles

Downtown Women Center, Los Angeles, Los Angeles

Los Angeles Christian Health Centers (LACHC), Los Angeles

Union Rescue Mission, Los Angeles

Weingart Center, Los Angeles, Los Angeles

90037

St. John's Well Child and Family Center (SJWCFC), PRIME Specialty Clinic, Los Angeles

All Listed Sponsors
collaborator

University of California, Los Angeles

OTHER

collaborator

National Institute on Minority Health and Health Disparities (NIMHD)

NIH

lead

University of California, Irvine

OTHER

NCT04513899 - Development of a Community-based HCV Treatment Completion Intervention Among HCV Positive Homeless Adults | Biotech Hunter | Biotech Hunter