Examining Hepatitis C Reinfection Rates in Kenya

Completed

• Conditions: Hepatitis C

• Registration Number: NCT03564639
• Lead Sponsor: Yale University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2018-06-11
• Study First Submitted QC: 2018-06-11
• Study First Posted: 2018-06-21
• Study Start: 2019-10-01
• Primary Completion: 2021-02-01
• Study Completion: 2021-02-01
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-19
• Last Update Posted: 2021-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

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).

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Exclusion Criteria

Not in the above inclusion criteria.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Examine usage of needle exchange programs	12 months	Brief questionnaire on services used
Evaluate psychoeducational counseling	12 months	Brief questionnaire on knowledge, attitude and beliefs of each participant.
Examine usage of methadone maintenance	12 months	Brief questionnaire on services used
HCV Reinfection	6-18 months post sustained virologic response (SVR) to HCV treatment.	The reinfection of patients with hepatitis C after completion of a previous HCV infection treatment.

Secondary Outcome Measures

Name	Time	Method
HCV reinfection referrals for treatment at Kenyetta National Hospital	9-16 months post treatment	Confirmed HCV reinfection cases will receive referrals to Kenyatta National Hospital and Coast General Hospital for treatment and management.

Trial Locations

Locations (1)

NASCOP; 🇰🇪 Nairobi, Kenya