Intervention to Improve HCV Treatment Uptake and Adherence in HIV/HCV Coinfection
Intervention to Improve HCV Treatment Uptake and Adherence in HIV/HCV Coinfection
End-stage liver disease, predominantly due to hepatitis C virus (HCV) infection, is one of
 the leading causes of death in person living with HIV infection. While HCV is curable and
 recent advances in treatment have increased the rates of cure, few patients with HIV and HCV
 are being treated to cure HCV. Based on formative research, the investigators developed the
 "Psychosocial Readiness Evaluation and Preparation for hepatitis C treatment (PREP-C)".
 PREP-C is a 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 intervention to
 improve treatment readiness. PREP-C (www.prepC.org) is also a telemedicine resource for
 health care providers. Under this protocol, the existing PREP-C clinical interview (or
 assessment) is incorporated with a behavioral intervention. This study tests the integrated
 assessment-behavioral intervention to increase HCV treatment initiation among HIV-co-infected
 patients. The assessment-behavioral intervention under this protocol is conducted in two
 phases, an Intervention Development phase and a Pilot Randomized Clinical Trial (RCT) phase.

 Findings from this vanguard study will inform the design parameters of a larger, more
 rigorous evaluation in an R01 application, if results are promising. The PREP-C web-based
 assessment and intervention package is designed to be scalable and can be disseminated
 through the live PrepC.org web site. The proposed study is innovative in that it seeks to
 develop the first web-based intervention for health care providers to use to increase HCV
 treatment initiation in HIV/HCV-co-infected persons. The study can have a major public health
 impact by providing needed structured resources for health care providers to increase rates
 of HCV treatment initiation in HIV/HCV-co-infected persons, thereby reducing mortality due to
 end-stage liver disease.
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).

 Hypothesis: The PREP-C intervention will increase Motivation, Information, and Self-Efficacy
 leading to higher rates of HCV treatment initiation, persistence and adherence in the PREP-C
 intervention arm.

 The intervention to be studied is guided by the Information-Motivation-Behavioral Skills
 Model of health behavior to adapt Motivational Interviewing and Cognitive-Behavioral Therapy
 techniques (e.g., cognitive restructuring) to the specific needs of this patient population.
 In this study, a nurse will be trained to administer the PREP-C integrated
 assessment-behavioral intervention. This four-session integrated assessment-intervention
 includes administration of already developed PREP-C assessment in session one, and tailored
 interventions targeting Motivation, Information and Behavioral Skills in sessions 2-4 to be
 developed in this study. The research will take place at a major academic medical center in
 which HIV/HCV-co-infected patients are actively being treated for HCV infection.

 Findings from this vanguard study will inform the design parameters of a larger, more
 rigorous evaluation in an R01 application, if results are promising. The PREP-C web-based
 assessment and intervention package is designed to be scalable and can be disseminated
 through the live PrepC.org web site. The proposed study is innovative in that it seeks to
 develop the first web-based intervention for health care providers to use to increase HCV
 treatment initiation in HIV/HCV-co-infected persons. The study can have a major public health
 impact by providing needed structured resources for health care providers to increase rates
 of HCV treatment initiation in HIV/HCV-co-infected persons, thereby reducing mortality due to
 end-stage liver disease.
Inclusion Criteria:

 -  Co-infected with HIV and HCV

 -  21 years and older

 -  Primary language is English or Spanish

 -  Two most recent HIV RNA levels are both <1000 copies/mL

 -  Has attended appointment with HIV PCP in previous 6 months

 -  Has not attended appointment with HCV Provider in last year

 Exclusion Criteria:

 -  Presence of active malignancy (except for squamous or basal cell skin cancers), not
 otherwise in remission

 -  Chronic kidney disease in hemodialysis or peritoneal dialysis

 -  Decompensated cirrhosis