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).

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