Impact of DAA Uptake in Controlling HCV Epidemic and Mode... | NCT03551002

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

NCT03551002

Sponsor

University of California, San Diego

Status

Unknown status

Last Update Posted

Sep 5, 2021Actual

Enrollment

450Estimated

Phase

Not provided

Conditions

Hepatitis C
Hepatitis C, Chronic
HIV/AIDS

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
171954	Other Identifier	UCSD Human Research Protections Program

Status Module

Record Verification Date

Sep 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2018Actual

Primary Completion Date

Dec 31, 2021Estimated

Completion Date

Dec 31, 2021Estimated

First Submitted Date

May 23, 2018

First Submission Date that Met QC Criteria

May 23, 2018

First Posted Date

Jun 11, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 1, 2021

Last Update Posted Date

Sep 5, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Edward Cachay, MD, MAS, Associate Professor of Clinical Medicine, University of California, San DiegoPrincipal Investigator

Lead Sponsor

University of California, San DiegoOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

450Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Annual proportion of HIV-infected patients who initiate direct acting antivirals		2014-2020

Secondary Outcomes

Measure	Description	Time Frame
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
Annual HCV chronic prevalence, primary incidence, and reinfection incidence among HIV-infected patients

Other Outcomes

Measure	Description	Time Frame
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 Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

People living with HIV, with history of or current HCV infection, who receive care at the UCSD Owen Clinic from 2008 to 2020

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Edward Cachay, MD, MAS	Contact	(619)543-3882		ecachay@ucsd.edu

Overall Officials

Name	Affiliation	Role
Edward Cachay, MD, MAS	University of California, San Diego	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Owen Clinic-University of California, San Diego	Recruiting	San Diego	California	92103-8186	United States

Condition Browse Module

MeSH Terms

ID	Term
D006526	Hepatitis C
D019698	Hepatitis C, Chronic
D000163	Acquired Immunodeficiency Syndrome

Ancestor Terms

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D006525	Hepatitis, Viral, Human

Browse Leaves

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Browse Branches

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