Adaptation and testing of a primary care HCV group medical treatment intervention



 DESCRIPTION (provided by applicant): Brianna Norton, DO, MPH is an infectious diseases trained physician-investigator who cares for patients in a community-based Federally Qualified Health Center (FQHC) and conducts research to improve health outcomes among HCV- and HIV/HCV-infected injection drug users (IDUs). Though IDUs comprise the overwhelming majority of all HCV+ and HIV/HCV+ persons in the U.S, our current health care delivery system has failed to engage such patients in HCV care, and without imminent action, HCV-related deaths will triple over the next decade. New HCV medications have cure rates as high as 100% and few side effects, but gaps along the HCV cascade of care prevent IDUs from ever initiating treatment. Innovative health care delivery interventions, based in primary care settings that IDUs are already accessing, are urgently needed to improve uptake of life-saving HCV medications. Group medical visits can harness beneficial peer dynamics to provide support and motivation for positive health behaviors, and improve knowledge and self-efficacy skills through group education and training. The overall goal of this career development application is to test a primary care clinic-based HCV Group Evaluation and Treatment UPtake (HCV GET-UP) intervention for HCV+ and HIV/HCV+ IDUs. The proposal's specific aims are: 1) to conduct a feasibility and acceptability study of HCV GET-UP; 2) to test, in a pilot RCT, the efficacy of the HCV GET-UP intervention for improving HCV treatment uptake among HCV+ and HIV/HCV+ IDUs; and 3) to conduct quantitative and qualitative analyses in order to determine potential moderators and mediators of the HCV GET-UP intervention on HCV treatment uptake. To achieve Aim 1, we will conduct a feasibility and acceptability study of two HCV GET-UP groups (total of 16 participants). Based on these findings, we will refine the intervention and create an HCV GET-UP intervention manual. We anticipate that group medical visits will include HCV clinical assessments, education, peer and provider support, and self-management skill development. To test the efficacy of HCV GET-UP (Aim 2), we will enroll 96 HCV+ and HIV/HCV+ IDUs and randomize them 1:1 to HCV GET-UP vs. onsite treatment alone. The primary outcome will be initiation of HCV treatment; secondary outcomes will include HCV evaluation, treatment completion, and cure. Finally, using a sequential explanatory design, we will determine potential moderators and mediators of the HCV GET-UP intervention on HCV treatment uptake. These findings will help to improve the intervention design for a future R01, as well as enhance our understanding of current barriers and facilitators to HCV treatment uptake for IDUs. Dr. Norton will receive mentorship from a multidisciplinary team of experts. Dr. Norton's training goal is to develop skills in: 1) development and testing of behavioral interventions; 2) design and conduct of randomized controlled trials, 3) statistical analysis of complex data; and 4) qualitative methods. Completion of the proposed project will provide the foundation for Dr. Norton's career as an independent investigator dedicated to improving health outcomes for HCV and HIV/HCV+ IDUs.