Addition of Patient Navigator and Social Worker to Interdisciplinary Hepatitis C Team Increases Treatment Uptake: Results of the Prospective, Randomized, Controlled Care-C Trial.

Background: A substantial number of patients do not start hepatitis C virus (HCV) treatment (Tx), even after successful linkage to care. We aimed to investigate if the addition of a social worker/patient navigator (SW/PN) team can increase Tx-uptake using a standardized psychosocial evaluation (Psychosocial Readiness Evaluation and Preparation for Hepatitis C Treatment, PREP-C) and subsequent behavioral interventions. Description of model of care: This prospective, randomized, controlled trial was conducted in the University of Kentucky Hepatology outpatient clinic. Patients were randomized 1:1 at the first clinic visit to either a standard of care (SOC; HCV management by interdisciplinary team with provider, pharmacist, case manager), or intervention (SOC plus SW/PN-PREP-C). Primary endpoint was Tx-uptake within one year after initial visit. Analysis was performed using Chi-square, Kaplan-Meier time to event analysis, and multivariate logistic regression. Effectiveness: Baseline characteristics of 429 HCV RNA positive patients enrolled 8/2018 to 12/2019 were: Age 4112 years, BMI 286, 58% male, 93% Caucasian, 28% rural, 40% Appalachian, 16% cirrhosis, 76/10/12% Medicaid/Medicare/Commercial insurance, 64/10/25% Genotype 1/2/3, 97% treatment naïve, referral source community/internal 81/19%, HCV chronicity documentation needed for Tx-approval by insurance 37%, illicit drug use history excluding marijuana recent/remote/never/unspecified 23/60/9/8%, heavy alcohol use recent/remote/never/unspecified 11/18/53/16%. Tx-uptake was significantly higher with SW/PN-PREP-C intervention compared to SOC (59% vs. 48%, OR 1.6, p=0.02). The following additional variables were predictive: Remote illicit drug use (OR 1.98, p=0.001), GT2 (OR 4.16, p=0.001), need for chronicity documentation (OR 0.51, p=0.002), commercial insurance (OR 2.02, p=0.04). Top three reasons for not staring treatment in the intervention arm were loss to follow-up (33%), incarceration (24%), treatment not needed/deferred (21%). Conclusions and next steps: The addition of a social worker/patient navigator team performing a structured psychosocial assessment and interventions increases HCV Tx-uptake. However, further enhancement to this model is needed, since Tx-uptake rates still warrant improvement. Treatment Start Rate by Care Model

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