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NCT02294136 · ClinicalTrials.gov registry record · NA

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

A NA study, sponsored by Icahn School of Medicine at Mount Sinai.

Completed
Registry status
NA
Development phase
85
Enrollment target

NCT02294136: Completed NA study, sponsored by Icahn School of Medicine at Mount Sinai.

NCT02294136 is a NA study that has completed, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 85 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02294136, a NA study, has completed, sponsored by Icahn School of Medicine at Mount Sinai.

COMPLETED
Registry status
NA
Development phase
85 participants
Enrollment target

Study 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

Primary Outcome

Whether or not subject has initiated Hepatitis C treatment within 6 months of study randomization.

Interventions

  • BEHAVIORAL Educational Control
  • BEHAVIORAL Prep-C

Trial Details

FieldValue
Enrollment Target 85 participants
Start Date 2013-12
Est. Completion 2017-04-28
Phase NA

What the finished NCT02294136 record still lists

NCT02294136 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 85 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower).

The record links to 0 conditions, and to 2 interventions - of which Educational Control is the first listed.

NCT02294136 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02294136 about?

NCT02294136 is a clinical study titled "Intervention to Improve HCV Treatment Uptake and Adherence in HIV/HCV Coinfection". 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 ...

What is the current status of trial NCT02294136?

This trial is currently completed. It is a NA study. The enrollment target is 85 participants. The study started on 2013-12. Estimated completion is 2017-04-28.

What interventions are being tested in trial NCT02294136?

The interventions under investigation include: Educational Control (BEHAVIORAL), Prep-C (BEHAVIORAL).

Who is sponsoring clinical trial NCT02294136?

This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02294136's enrollment target sits among peer trials

85 980th of 2000 higher than 1,018 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02294136, the US trial registry maintained by the National Library of Medicine. NCT02294136 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.