A Mobile Health Intervention to Improve Hepatitis C Outcomes Among People With Opioid Use Disorder: Protocol for a Randomized Controlled Trial
Authors: Hochstatter Karli R , Gustafson Sr David H , Landucci Gina , Pe-Romashko Klaren , Maus Adam , Shah Dhavan V , Taylor Quinton A , Gill Emma K , Miller Rebecca , Krechel Sarah , Westergaard Ryan P 
Published: June 2019

Background
People who inject drugs 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. Mobile health applications offer promising strategies to support people in recovery from substance use disorders. We sought to determine whether the Addiction-Comprehensive Health Enhancement Support System (A-CHESS), an existing mobile health application for opioid use disorder, could be adapted to improve HCV screening and treatment.

Objective
The goals of this paper are to describe: (1) the components and functionality of an HCV intervention incorporated into the existing A-CHESS system; and (2) how data are collected and will be used to evaluate HCV testing, linkage to care, and treatment.

Methods
People with recent opioid use were enrolled in a randomized controlled trial to test whether A-CHESS reduced relapse. We developed and implemented HCV intervention content within the A-CHESS platform to simultaneously evaluate whether A-CHESS improved secondary outcomes related to HCV care. All A-CHESS users received the HCV intervention content, which includes educational information, private messages tailored to an individual’s stage of HCV care, and a public discussion forum. Data on patients’ HCV risk behaviors and stage of care were collected through quarterly telephone interviews and weekly surveys delivered through A-CHESS. The proportion of people with opioid use disorder who are HCV untested, HCV-negative, HCV antibody-positive, or HCV RNA–positive, as well as linked to care, treated and cured at baseline is described here. The 24-month follow-up is ongoing and will be completed in April 2020. Survey data will then be used to assess whether individuals who received the HCV-enhanced A-CHESS intervention were more likely to reduce risky injection behaviors, receive HCV testing, link to medical care, initiate treatment, and be cured of HCV compared to the control group.

Results
Between April 2016 and April 2018, 416 individuals were enrolled and completed the baseline interview. Of these individuals, 207 were then randomly assigned to the control arm and 209 were assigned to the intervention arm. At baseline, 202 individuals (49%) self-reported ever testing HCV antibody-positive. Of those, 179 (89%) reported receiving HCV RNA confirmatory testing, 134 (66%) tested HCV RNA–positive, 125 (62%) were linked to medical care and 27 (13%) were treated and cured of HCV. Of the remaining 214 individuals who had never tested HCV antibody–positive, 129 (31%) had tested HCV antibody–negative within the past year and 85 (20%) had not been tested within the past year.

Conclusions
The A-CHESS mobile health system allows for the implementation of a bundle of services as well as 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 improve HCV outcomes for people engaged in addiction treatment.

Trial Registration
ClinicalTrials.gov NCT02712034; https://clinicaltrials.gov/ct2/show/NCT02712034

International Registered Report Identifier (IRRID)
DERR1-10.2196/12620