A Mobile Health Intervention to Monitor and Provide Support along the Continuum of Hepatitis C Care for People with Opioid Use Disorder: Protocol for a Randomized Trial (Preprint)

BACKGROUND People who inject opioids are at a disproportionate risk for contracting hepatitis C virus (HCV). However, use of HCV prevention and treatment services remains suboptimal among people with substance use disorders due to various health system, societal, and individual barriers. Incorporating HCV-specific resources into addiction treatment services, such as mobile-health applications, may reduce the transmission of HCV and improve screening and treatment rates among people with opioid use disorder. OBJECTIVE The goals of this manuscript are to (1) describe the development of the HCV-specific functionality of a mobile-health innovation called A-CHESS and its implementation and evaluation through a randomized control trial and (2) discuss early implementation issues encountered while monitoring and supporting participants’ movement across the continuum of HCV care. METHODS Opioid users from two addiction treatment centers in Massachusetts were randomly assigned to receive either medication assisted treatment (MAT) alone (control arm) or MAT + A-CHESS (experimental arm), and are followed for 24 months. Data on patient’s HCV risk behaviors and stage of care were collected upon enrollment by telephone interview and used to assign a baseline stage of HCV care. Individual’s stage of care are updated through subsequent weekly surveys delivered electronically through the A-CHESS application. Private messages were sent to individuals’ tailored to their stage of HCV care. Additional HCV prevention and treatment resources were incorporated into A-CHESS including multimedia health education content, access to online resources, and location-specific testing facilities and clinical care. RESULTS Between April 2016 and April 2018, 416 individuals were enrolled and completed the baseline interview; 207 were randomly assigned to the control arm and 209 were assigned to the intervention arm. The sample was 86% non-Hispanic white and 55% male with a mean age of 37 years. The majority of the sample (72%) was receiving methadone at the time of enrollment and heroin was the most commonly used opioid. At baseline, 202 individuals (49%) reported ever testing HCV-antibody positive. Of those, 180 (89%) reported receiving HCV-RNA confirmatory testing, of which 139 (77%) tested HCV-RNA positive. Of those who reported testing HCV-RNA positive, 44 (32%) had ever been prescribed HCV treatment and 32 (23%) had been cured. Of the remaining 214 individuals who had never tested anti-HCV positive, 31% (n=129) reported testing HCV-antibody negative within the past year and 20% (n=85) reported not being tested within the past year. CONCLUSIONS The A-CHESS mobile-health system allows for the implementation of a bundle of services and the collection of longitudinal data related to drug use and HCV care among people with opioid use disorders. This study will provide preliminary evidence to determine whether HCV-specific services embedded into the A-CHESS program can increase the frequency of HCV testing, linkage to care, and treatment for people engaged in addiction treatment. CLINICALTRIAL NCT02712034