Examining Hepatitis C Reinfection Rates in Kenya

NCT ID: NCT03564639

Last Updated: 2021-04-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

101 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-10-01

Study Completion Date

2021-02-01

Brief Summary

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The goal of this research project is to build upon the Testing and Linkage to Care for Injecting Drug Users (TLC-IDU) parent study and describe post-cure HCV reinfection in a population of people who inject drugs (PWIDs) in Kenya.

Detailed Description

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In addition to describing reinfection in a substance using cohort, we will identify individual predictors of HCV reinfection in Kenya, as well as identifying individual utilization intervention approaches and dosing that reduce reinfection risk and treatment cite level risk factors (frequency of visits, community vs hospital location etc.). Determining the risk factors specific to reinfection and understanding the impact of concurrent harm reduction interventions will guide service delivery and implementation of HCV elimination strategies in Kenya and throughout the region.

Conditions

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Hepatitis C

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Injection drug users with HCV

People who inject drugs who were confirmed positive for HCV and initiated treatment in the parent study beginning in September 2017.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Live in Nairobi or coastal Mombasa (Coast Province including Malindi), Kenya;
2. Are injection drug users (IDUs) that ever injected any non-prescribed drugs; and able and willing to provide informed consent.
3. Participates are in the parent study;
4. Complete treatment protocol; and achieve a sustained virologic response (SVR).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yale University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ann Kurth, PhD

Role: PRINCIPAL_INVESTIGATOR

Yale University School of Nursing

Locations

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NASCOP

Nairobi, , Kenya

Site Status

Countries

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Kenya

Other Identifiers

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1512016965_B

Identifier Type: -

Identifier Source: org_study_id

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