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Clinical trialNCT04513899CompletedInterventional

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

SponsorUniversity of California, IrvineEnrollment10Hepatitis C Virus (HCV) Infection
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

7 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • Amity Foundation, Los Angeles

    Los Angeles, California, United States

  • Cardinal Manning Center, Los Angeles

    Los Angeles, California, United States

  • Downtown Women Center, Los Angeles

    Los Angeles, California, United States

  • Los Angeles Christian Health Centers (lachc)

    Los Angeles, California, United States

  • St. John'S Well Child and Family Center (sjwcfc), Prime Specialty Clinic

    Los Angeles, California, United States

  • Union Rescue Mission

    Los Angeles, California, United States

  • Weingart Center, Los Angeles

    Los Angeles, California, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
5 Oct 2020
Primary completion
20 Jul 2022
Completion
20 Jul 2022
Last update posted
1 Mar 2024
Registered enrollment
10
Registry id
NCT04513899

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 4 Nov 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.