Hepatitis C clinical trials at UC Irvine
1 in progress, 0 open to eligible people
Development of a Community-based HCV Treatment Completion Intervention Among HCV Positive Homeless Adults
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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 month (8 weeks) period. Homeless adults assigned to the CHW/RN HCV treatment group will receive culturally-sensitive education, case management, and daily DOT delivery of Mavyret™ (pibrentasvir/glecaprevir) 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 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) and SVR12 Cure (month 5). Secondary outcomes are improved mental health status, decrease in substance use, and improved access to health care, and shelter stability at month 5.
Los Angeles, California and other locations