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

• Conditions: Hepatitis C, Chronic; HIV/AIDS; Hepatitis C

• Registration Number: NCT03551002
• Lead Sponsor: University of California, San Diego

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.

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 Timeline

• Study Start: 2018-01-01
• Study First Submitted: 2018-05-23
• Study First Submitted QC: 2018-05-23
• Study First Posted: 2018-06-11
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-01
• Last Update Posted: 2021-09-05
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 450

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Annual proportion of HIV-infected patients who initiate direct acting antivirals	2014-2020

Secondary Outcome Measures

Name	Time	Method
Annual HCV chronic prevalence, primary incidence, and reinfection incidence among HIV-infected patients	2008-2020
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

Trial Locations

Locations (1)

Owen Clinic-University of California, San Diego; 🇺🇸 San Diego, California, United States