Examining Hepatitis C Reinfection Rates in Kenya

Hepatitis C Reinfection in an Injection Drug Using Population in Kenya: A Follow-up to the TLC-IDU Hepatitis C V Supplement Study.

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.

Study Overview

• Status: Completed
• Conditions: Hepatitis C

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 Type: Observational
• Enrollment (Actual): 101

Contacts and Locations

Study Locations

• Kenya
  • Nairobi, Kenya
    • NASCOP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study is taking place in the Mombasa province in Coastal Kenya and Nairobi, Kenya's capital. Participants were also in the parent study, were infected with HVC, have completed HVC treatment.

Description

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).

Exclusion Criteria:

Not in the above inclusion criteria.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Yale University
• Investigators: Principal Investigator: Ann Kurth, PhD, Yale University School of Nursing

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Actual): February 1, 2021
• Study Completion (Actual): February 1, 2021

Study Registration Dates

• First Submitted: June 11, 2018
• First Submitted That Met QC Criteria: June 11, 2018
• First Posted (Actual): June 21, 2018

Study Record Updates

• Last Update Posted (Actual): April 20, 2021
• Last Update Submitted That Met QC Criteria: April 19, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Disease Attributes; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; Recurrence; Hepatitis; Hepatitis A; Hepatitis C; Reinfection
• Other Study ID Numbers: 1512016965_B

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes