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

May 1, 2017 updated by: Icahn School of Medicine at Mount Sinai

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

85

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10029
        • ICAHN School of Medicine at Mount Sinai

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Prep-C
Four session nurse administered behavioral intervention.
Behavioral: 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.
Active Comparator: Educational Control
Attention Control
Behavioral: Educational Control
Attention Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hepatitis C Treatment Initiation
Time Frame: 6 months post intervention
Whether or not subject has initiated Hepatitis C treatment within 6 months of study randomization.
6 months post intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence to Hepatitis C Treatment
Time Frame: up to 6 months
Adherence to Hepatitis C medications will be assessed for subjects who initiate Hepatitis C treatment.
up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Icahn School of Medicine at Mount Sinai

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Jeffrey J Weiss, PhD, ICAHN School of Medicine at Mount Sinai

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (Actual)

April 28, 2017

Study Completion (Actual)

April 28, 2017

Study Registration Dates

First Submitted

November 17, 2014

First Submitted That Met QC Criteria

November 17, 2014

First Posted (Estimate)

November 19, 2014

Study Record Updates

Last Update Posted (Actual)

May 2, 2017

Last Update Submitted That Met QC Criteria

May 1, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GCO 12-0693
  • R34MH099930-02 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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