N/A
N=10
Development of a Community-based HCV Treatment Completion Intervention Among HCV Positive Homeless Adults
Hepatitis C Virus (HCV) Infection
Bottom Line
View on ClinicalTrials.gov: NCT04513899 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Mar 2024
Primary outcome: Primary: Number of Participants Completing HCV Treatment — 3; 6 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Community health worker (CHW)/ registered nurse (RN) [CHW/RN] (Behavioral); Clinic-based Standard of Care (cbSOC) Program (control group) (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, Irvine
- Primary completion
- Jul 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Completing HCV Treatment |
3; 6 | — |
| PRIMARY Number of Participants Attaining SVR12 (Sustained Viral Response at 12 Weeks After Treatment Completion) |
3; 4 | — |
| SECONDARY Drug Use |
5; 3.33; 2.7; 4.8 | — |
| SECONDARY Alcohol Use Disorders Identification Test-Concise (AUDIT-C) |
1.5; 2.8; 0.33; 3.6 | — |
| SECONDARY CAGE Substance Abuse Screening Scale |
0.667; 0.4; 0; 0.8 | — |
| SECONDARY Depression |
8; 8; 2; 7.6 | — |
| SECONDARY Mental Health |
65.3; 76; 45.3; 62.4 | — |
| SECONDARY Health Care Access |
3; 0; 3; 1 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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).
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT04513899). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.