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

Completed · Not applicable

Conditions studied: HIV, Hepatitis C, Co-Infection

In brief

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.

Key facts

Study ID

NCT02294136

Run by

Icahn School of Medicine at Mount Sinai

People needed

85

Starts

2013-12-01

Expected to finish

2017-04-28

Last updated by the study team

2017-05-02

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Icahn School of Medicine at Mount Sinai — New York, New York, United States

Full record on ClinicalTrials.gov

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