Intervention to Improve HCV Treatment Uptake and Adherence in HIV/HCV Coinfection
2 other identifiers
interventional
85
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable hiv
Started Dec 2013
Typical duration for not_applicable hiv
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2013
CompletedFirst Submitted
Initial submission to the registry
November 17, 2014
CompletedFirst Posted
Study publicly available on registry
November 19, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 28, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 28, 2017
CompletedMay 2, 2017
May 1, 2017
3.4 years
November 17, 2014
May 1, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hepatitis C Treatment Initiation
Whether or not subject has initiated Hepatitis C treatment within 6 months of study randomization.
6 months post intervention
Secondary Outcomes (1)
Adherence to Hepatitis C Treatment
up to 6 months
Study Arms (2)
Prep-C
EXPERIMENTALFour session nurse administered behavioral intervention.
Educational Control
ACTIVE COMPARATORAttention Control
Interventions
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.
Eligibility Criteria
You may qualify if:
- Co-infected with HIV and HCV
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jeffrey J Weiss, PhD
Icahn School of Medicine at Mount Sinai
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 17, 2014
First Posted
November 19, 2014
Study Start
December 1, 2013
Primary Completion
April 28, 2017
Study Completion
April 28, 2017
Last Updated
May 2, 2017
Record last verified: 2017-05