Intervention to Improve HCV Treatment Uptake and Adherence in HIV/HCV Coinfection
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|ClinicalTrials.gov Identifier: NCT02294136|
Recruitment Status : Completed
First Posted : November 19, 2014
Last Update Posted : May 2, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|HIV Hepatitis C Co-Infection||Behavioral: Prep-C Behavioral: Educational Control||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||85 participants|
|Intervention Model:||Parallel Assignment|
|Primary Purpose:||Supportive Care|
|Official Title:||Intervention to Improve HCV Treatment Uptake and Adherence in HIV/HCV Coinfection|
|Study Start Date :||December 2013|
|Actual Primary Completion Date :||April 28, 2017|
|Actual Study Completion Date :||April 28, 2017|
Four session nurse administered behavioral intervention.
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
Behavioral: Educational Control
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02294136
|United States, New York|
|Icahn School of Medicine at Mount Sinai|
|New York, New York, United States, 10029|
|Principal Investigator:||Jeffrey J Weiss, PhD||Icahn School of Medicine at Mount Sinai|