NCT04470271

Brief Summary

The purpose of this study is to identify patients with chronic hepatitis C virus (HCV) who were lost of follow up and relinkage them to hepatitis C care

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

July 4, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 14, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2021

Completed
Last Updated

July 14, 2020

Status Verified

July 1, 2020

Enrollment Period

4 months

First QC Date

July 4, 2020

Last Update Submit

July 10, 2020

Conditions

Keywords

viral infectionoutcomeantiviral therapy

Outcome Measures

Primary Outcomes (1)

  • Number of participants who were lost of follow up

    Participants are going to be contacted by phone or email to evaluate if they are under HCV care

    through study completion, an average of 6 months

Study Arms (2)

Patients under routine hepatitis C care

Patients who are routinely followed at the treating institution. Investigators will evaluate baseline demographic, liver fibrosis stage, liver-related complications, and antiviral therapy.

Patients with hepatitis C lost of follow-up

Patients who were lost of follow-up. Participants will be contacted to evaluate if the continued HCV care at another institution, were not routinely followed by a liver-specialist or if they died. Investigators will also evaluate baseline demographic, liver fibrosis stage, liver-related complications, and antiviral therapy.

Other: Patients with hepatitis C lost follow up

Interventions

Patients with chronic HCV who were lost of follow up will be contacted by phone or email. At least 3 phone calls will be made on three different days. In case the patient is not contacted it will be considered lost of follow-up

Patients with hepatitis C lost of follow-up

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients with history of chronic HCV infection who were lost of follow up.

You may qualify if:

  • Patients older than 18 years
  • Patients clinically evaluated at least once in the participating medical center
  • chronic HCV infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Austral

Pilar, Buenos Aires, 1629, Argentina

Location

MeSH Terms

Conditions

Hepatitis CVirus Diseases

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Study Officials

  • Marcelo O Silva, MD

    Austral University, Argentina

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Manuel Mendizabal, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Coordinator

Study Record Dates

First Submitted

July 4, 2020

First Posted

July 14, 2020

Study Start

September 1, 2020

Primary Completion

December 31, 2020

Study Completion

March 31, 2021

Last Updated

July 14, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations