Intervention to Improve HCV Treatment Uptake and Adherence in HIV/HCV Coinfection

In response to PAR-12-279 "Pilot Intervention and Services Research Grants (R34)," this application proposes to develop and to test the feasibility, acceptability, and preliminary efficacy of a nurse-delivered intervention addressing patient-level barriers (Information, Motivation, and Behavioral Skills) to hepatitis C virus (HCV) treatment uptake and adherence in HIV-co-infected patients. End-stage liver disease is a leading cause of mortality in HIV-infected persons as a result of high rates of untreated chronic HCV-co-infection. HCV infection can be cured and the effectiveness of HCV treatment has dramatically increased with the FDA approval of two HCV protease inhibitors in May 2011. The uptake of HCV treatment in HIV/HCV-co-infected patients remains, however, unacceptably low (estimated at 10%) despite the fact that testing has been standard of care for all HIV-infected persons for over 10 years. Progress in developing effective behavioral interventions to successfully engage and retain HIV-co-infected patients who are already engaged in HIV care in HCV care has not kept pace with the significant pharmacologic advances in HCV treatment.

There are multiple barriers to HCV treatment initiation at patient, provider, and structural levels. As HCV treatment becomes more effective and more clinics overcome the structural and provider barriers, there will be an increasing need for a structured means to assess patient-level barriers and provide effective interventions in order to increase HCV treatment initiation, adherence, and cure rates in HIV/HCV-co-infected patients.

Based on formative prior NIH research (K23MH71177), the investigators have developed the "Psychosocial Readiness Evaluation and Preparation for hepatitis C treatment (PREP-C)". PREP-C is a web-based structured clinical interview that healthcare providers of diverse disciplines can be trained to administer. It provides an assessment of a client's psychosocial readiness to begin HCV treatment and identifies domains of functioning which require tailored intervention to improve treatment readiness. PREP-C has to date been administered by the PI (Weiss) to 97 patients and a telemedicine resource for health care providers was launched in July 2012 (PrepC.org).

Specific aims:

1. To formally adapt existing behavioral medicine interventions based on PREP-C assessment to target individual barriers (Information, Motivation, and Behavior Skills) to HCV treatment initiation in HIV/HCV-co-infected patients who are medically eligible for HCV treatment, pilot test and refine the tailored intervention in 15 HIV/HCV-co-infected patients, and finalize the intervention manual.
2. To conduct a pilot randomized clinical trial with 60 HIV/HCV-co-infected patients who are medically eligible for HCV treatment, comparing the nurse-delivered PREP-C intervention (n=30) with attention control (n=30) in order to evaluate patient acceptance, patient satisfaction, enrollment and retention, as well as preliminary efficacy (initiation of HCV treatment within 6 months of randomization and persistence and adherence to the first 12 weeks of treatment in those who do initiate treatment).