Brief Summary

This randomized controlled trial (RCT) will test the efficacy of a Community Health Worker/Registered Nurse (CHW-RN) HCV intervention for homeless individuals, many who are also drug users. The intervention will be designed during Phase I of the proposal using an iterative process between a Community Advisory Board (CAB) and focus groups. The CHW/RN intervention will occur over a 2 or 3 month (8-12 weeks) period depending on the Direct-Acting Antiviral (DAA) prescribed. Homeless adults assigned to the CHW/RN HCV treatment group will receive culturally-sensitive education, case management, and daily DOT delivery of DAA by an RN-guided CHW. The CHW will run a brief (20 min) weekly 1:1 education and 20 min case management session over the 8 or 12 weeks and will deliver all components of the program (which will be developed and refined during Phase I). The CHW-RN HCV intervention will be compared to a clinic-based standard of care group (cbSOC). Primary outcomes are the completion of the Direct-Acting Agent (DAA) treatment (month 2 or 3) and SVR12 Cure (month 5 or 6). Secondary outcomes are improved mental health status, decrease in substance use, and improved access to health care, and shelter stability at month 5 or 6.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for not_applicable

Timeline

Completed

Started Oct 2020

Typical duration for not_applicable

Geographic Reach

1 country

7 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

1.8 years study duration

First Submitted

Initial submission to the registry

August 5, 2020

Completed

9 days until next milestone

First Posted

Study publicly available on registry

August 14, 2020

Completed

2 months until next milestone

Study Start

First participant enrolled

October 5, 2020

Completed

1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2022

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2022

Completed

1.6 years until next milestone

Results Posted

Study results publicly available

March 1, 2024

Completed

Last Updated

March 1, 2024

Status Verified

February 1, 2024

Enrollment Period

1.8 years

First QC Date

August 5, 2020

Results QC Date

June 30, 2023

Last Update Submit

February 27, 2024

Conditions

Hepatitis C Virus (HCV) Infection

Outcome Measures

Primary Outcomes (2)

Number of Participants Completing HCV Treatment
The number of participants completing HCV treatment (7 days per week x 2- or 3 month treatment of DAA) was measured by pill count to measure adherence in both groups. For the RN/CHW group, directly observed therapy was utilized where the CHW or RN delivered the medication daily and documented each time s/he observed the participant swallow a pill. For the cbSOC Program (control group), the clinic-based MD/NP conducted a pill count monthly, based on the medications left in the pill bottle each month the participant is scheduled to pick up the next supply
2-3 months depending on which DAA drug was provided. Some required 2 months and others, 3 months.
Number of Participants Attaining SVR12 (Sustained Viral Response at 12 Weeks After Treatment Completion)
The number of participants who attained SVR12 Cure (HCV RNA \< 25 IU/ml, detectable or undetectable) as tested at 5 or 6-month follow-up (12 weeks after treatment completion)
5 or 6 months

Secondary Outcomes (6)

Drug Use
2 or 3- and 5 or 6-month follow-up
Alcohol Use Disorders Identification Test-Concise (AUDIT-C)
Assessment at 2 or 3- and 5 or 6-month follow-up
CAGE Substance Abuse Screening Scale
2 or 3- and 5 or 6-month follow-up
Depression
2 or 3- and 5 or 6-month follow-up
Mental Health
2 or 3- and 5 or 6-month follow-up
+1 more secondary outcomes

Study Arms (2)

Community Health Worker/Registered Nurse (CHW/RN)

EXPERIMENTAL

Nurse-led Community Health Worker (CHW/RN) program delivered DOT for HCV treatment.

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

Clinic-based Standard of Care (cbSOC)

ACTIVE COMPARATOR

Standard of care for HCV treatment delivered by a clinic-based MD or clinic-based NP at the clinic site

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

Interventions

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

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.

Community Health Worker/Registered Nurse (CHW/RN)

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

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.

Clinic-based Standard of Care (cbSOC)

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

currently homeless. A homeless person is defined as anyone who spent the previous night in a public or private shelter, a place not meant for sleeping (van, car, public facility, abandoned building) or in outdoor areas.
age 18 or older;
willing and able to provide informed consent;
able to complete the screener;
willing to have blood tests to be screened for HCV and tested HCV antibody positive;
APRI ≤ 0.7, no signs of advanced cirrhosis (jaundice, ascites, encephalopathy) and willing to undergo the abdominal US as the standard of care (at the clinic).
history of substance use (past 5 years).

You may not qualify if:

current ongoing treatment for HCV;
current HBV infection;
HIV infection and not receiving medications for HIV treatment;
not speaking English or Spanish; and
testing pregnant; and
judged to be cognitively impaired

Contact the study team to confirm eligibility.

Sponsors & Collaborators

University of California, Irvinelead
University of California, Los Angelescollaborator
National Institute on Minority Health and Health Disparities (NIMHD)collaborator

Study Sites (7)

Amity Foundation, Los Angeles

Los Angeles, California, 90007, United States

Location

Cardinal Manning Center, Los Angeles