Effect of Structural Interventions on Substance Use and HIV/HCV Risk Among Rural PWUD

The overarching goal of this demonstration project is to eliminate hepatitis C (HCV) transmission in Hazard, Kentucky, a rural Appalachian town. A three-pronged approach to elimination will be utilized, and includes: (1) increased testing and referrals to care for HCV-infected individuals. RNA-positive residents who are Medicaid-ineligible or uninsured will be offered treatment with direct-acting antivirals (DAAs) through the proposed project. Medicaid/insurance-eligible persons will be referred to a local physician or the University of Kentucky Hepatitis Clinic; (2) provision of medication-assisted treatment (MAT) for those who are opioid dependent; and (3) access to clean injection equipment via a to-be-established syringe services program (SSP). For this study, HCV elimination is defined as a 90% reduction in incidence and prevalence within 5 years after the launch of the program interventions, with regard to the National Academies of Sciences, Engineering and Medicine goals for the elimination of HCV incidence and mortality as public health threats by 2030. Based on a current model of HCV incidence and prevalence in eastern Kentucky, successful treatment of 750 HCV infected persons and successful scale up of MAT and SSP to meet international quality standards will result in this goal; 24% of treatment will occur in the first year of implementation. The health outcome targets include HCV RNA prevalence and incidence (including reinfection). Process measures include HCV treatment uptake, HCV treatment completion, sustained viral response (SVR), number of exchanges per PWID by SSP and number of PWID receiving MAT. Differences in these outcomes will be tested across treatment arms, which consist of assignment to either a case manager employing a Strengths-Based Case Management approach, and treatment as usual. All participants will be offered MAT, where appropriate, regardless of the treatment assignment. Reductions in incidence and prevalence rates will also be evaluated compared to a town with services profiles that are similar to Hazard. Results from this study will be used to further tailor interventions targeted to rural towns that are in the midst of an HCV epidemic due to opioid abuse. Budget for Preparation Phase In consulting with Dr. Asher at CDC, establishment of the SSP is essential to the HCV elimination plan and is a major task for this preparation phase. Therefore, the budget exceeds $100,000 (see below for specific costs, following aims), as it does include funds to start the SSP. To get a sense of the scope of work for this project, a draft of the aims that were developed in conjunction with CDC experts are as follows: 1. Establishment of a Community Advisory Board (CAB) consisting of local providers (primary care, nurse practitioner, pharmacist), public health practitioners, people who inject drugs (PWID), law enforcement/judicial, and key personnel from the research project. The CAB will work with the research team to establish community support for the project. Team members involved in this aim include Drs. Havens, and Hoven, NP Cissi Jones. Technical support will be provided by Dr. Asher and project support staff Rob Seaver and Susan Jent. 2. Conduct a community needs assessment to establish baseline incidence and prevalence rates, as well as the number needed to treat to eliminate HCV in the community. The research team will work with the state Hepatitis Coordinator to gather historical data to inform treatment need. These numbers will also be utilized in simulation models to determine the number of individuals that would need to be treated in order to achieve elimination, given varying levels of MAT uptake and SSP utilization. Team members involved in this aim include Drs. Havens, Hoven and Vickerman. 3. Establish a SSP that will allow for the safe acquisition and disposal of syringes and HCV/HIV testing in Hazard several days per week. The SSP will also provide HIV and HCV testing at a location independent of the local health department. Modeling will be used to estimate the scale that is necessary for the SSP to effectively reduce HCV transmission risk. Team members involved in this aim include the CAB, Drs. Havens, Vickerman, Hoven and Asher, and project support staff Rob Seaver and Susan Jent. 4. Develop proposals and meet with pharma companies in order to secure a DAA that will be used to treat HCV in the target community. Team members involved in this aim include Drs. Havens and Walsh as well as representatives from NIDA/NCI and/or CDC, as appropriate. 5. Establish treatment protocols for both the provision of hepatitis C treatment and MAT using a nurse-led provider model. Establishment of the treatment protocols during the preparation phase will allow the investigators to implement the trial in a timely manner, determine the number of NPs necessary to complete the study, and establish the skills and training that will be necessary for the nurse provider team. Team members involved in this aim include Drs. Havens, Rosenau, Walsh, and Lofwall, as well as local NP Cissi Jones. 6. Training of local providers for the provision of MAT using Project ECHO. The law in Kentucky allows for the delivery of MAT via nurse practitioners. Therefore, training on the delivery of MAT will be provided to local nurse practitioners and other interested physicians so that they may apply for their X-license. Ideally, NP’s will be identified and potentially hired for the project from these trainings. Team members involved in this aim include Drs. Lofwall (developer of the MAT NP training program in Kentucky) and Walsh, as well as support staff Rob Seaver and Susan Jent. 7. Establishment of data systems to measure SSP endpoints. See http://www.neo360.co/neo-solution.php. This software is integral for evaluating the SSP, which is a vitally important element in the HCV elimination plan. Team Members involved in this aim include Drs. Havens and Hoven, who will work to implement data collection with local public health personnel. Dr. Asher will provide technical support for this aim.