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Impact of DAA Uptake in Controlling HCV Epidemic and Modeling Interventions for HCV Elimination Among HIV-infected Persons in San Diego

Sponsor
University of California, San Diego (Other)
Overall Status
Recruiting
CT.gov ID
NCT03551002
Collaborator
(none)
450
Enrollment
1
Location
48
Anticipated Duration (Months)
9.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A retrospective and prospective study among people living with HIV (PLWH) that assesses hepatitis C (HCV) treatment uptake during periods before and after direct acting antivirals (DAA) introduction, and its impact on the HCV epidemic among PLWH.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    A study that aims to quantify the state of DAA uptake and its impact on the HCV epidemic among PLWH in San Diego, and to characterize negative predictors of DAA treatment uptake among PLWH in San Diego. Retrospective and prospective data from UCSD Owen Clinic will be utilized to calculate HCV prevalence, primary incidence, and reinfection incidence. Using mathematical epidemic models, the study will assess levels of existing and scaled-up interventions necessary for HCV elimination from PLWH in San Diego.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    450 participants
    Observational Model:
    Cohort
    Time Perspective:
    Other
    Official Title:
    Impact of Direct Acting Antivirals Uptake in Controlling Hepatitis C Epidemic and Modeling Interventions for Hepatitis C Elimination Among HIV-infected Persons in San Diego
    Actual Study Start Date :
    Jan 1, 2018
    Anticipated Primary Completion Date :
    Dec 31, 2021
    Anticipated Study Completion Date :
    Dec 31, 2021

    Arms and Interventions

    Arm Intervention/Treatment
    Retrospective
    Prospective

    Outcome Measures

    Primary Outcome Measures

    1. Annual proportion of HIV-infected patients who initiate direct acting antivirals [2014-2020]

    Secondary Outcome Measures

    1. Annual proportion of PLWH co-infected with HCV who are treatment naïve, previously treated with no sustained virologic response (SVR), or re-infected post-SVR [2008-2020]

    2. Annual HCV chronic prevalence, primary incidence, and reinfection incidence among HIV-infected patients [2008-2020]

    Other Outcome Measures

    1. Estimated HCV prevalence and incidence among PLWH in San Diego using dynamic transmission modeling calibrated to epidemiological data from outcomes described above [2008-2030]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Any adult (≥ 18 years) HIV-infected patient attending the UCSD Owen Clinic

    • With history of acute or chronic HCV infection defined as having a detectable HCV viral load with or without a positive HCV antibody

    Exclusion Criteria:
    • With no history of or current HCV infection defined as having a negative HCV antibody from 2008 to 2020

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Owen Clinic-University of California, San Diego San Diego California United States 92103-8186

    Sponsors and Collaborators

    • University of California, San Diego

    Investigators

    • Principal Investigator: Edward Cachay, MD, MAS, University of California, San Diego

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Edward Cachay, MD, MAS, Associate Professor of Clinical Medicine, University of California, San Diego
    ClinicalTrials.gov Identifier:
    NCT03551002
    Other Study ID Numbers:
    • IN-US-334-4481
    • 171954
    First Posted:
    Jun 11, 2018
    Last Update Posted:
    Sep 5, 2021
    Last Verified:
    Sep 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Edward Cachay, MD, MAS, Associate Professor of Clinical Medicine, University of California, San Diego
    HIV
    Hepatitis C
    Direct acting antivirals
    Hepatitis C modeling
    Additional relevant MeSH terms:
    Hepatitis A
    Hepatitis C
    Hepatitis C, Chronic
    Hepatitis

    Study Results

    No Results Posted as of Sep 5, 2021