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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
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Icahn School of Medicine at Mount Sinai

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 85 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
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United States, New York
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Jeffrey J Weiss, PhD Icahn School of Medicine at Mount Sinai

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Responsible Party: Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT02294136     History of Changes
Other Study ID Numbers: GCO 12-0693
R34MH099930-02 ( U.S. NIH Grant/Contract )
First Posted: November 19, 2014    Key Record Dates
Last Update Posted: May 2, 2017
Last Verified: May 2017
Keywords provided by Icahn School of Medicine at Mount Sinai:
HIV
HCV
Adherence
Psychiatric
Behavioral
Intervention
Additional relevant MeSH terms:
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Coinfection
Hepatitis C
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Infection
Parasitic Diseases