Examining Hepatitis C Reinfection Rates in Kenya

Sponsor

Yale University (Other)

Overall Status

Completed

CT.gov ID

NCT03564639

Collaborator

(none)

101

Enrollment

Location

16.1

Actual Duration (Months)

6.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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 Design

Study Type:

Observational

Actual Enrollment :

101 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Oct 1, 2019

Actual Primary Completion Date :

Feb 1, 2021

Actual Study Completion Date :

Feb 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

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.
Evaluate psychoeducational counseling [6 months]
Brief questionnaire on knowledge, attitude and beliefs of each participant.
Examine usage of methadone maintenance [12 months]
Brief questionnaire on services used
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.

Secondary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Inclusion Criteria:

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

Exclusion Criteria:

Not in the above inclusion criteria.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	NASCOP	Nairobi		Kenya

Sponsors and Collaborators

Yale University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yale University

ClinicalTrials.gov Identifier:

NCT03564639

Other Study ID Numbers:

1512016965_B

First Posted:

Jun 21, 2018

Last Update Posted:

Apr 20, 2021

Last Verified:

Apr 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 20, 2021