Skip to main content
OpenTrials
Completed

NCT Number: NCT03564639

Examining Hepatitis C Reinfection Rates in Kenya

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hepatitis C Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Hepatitis Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

NASCOP

Nairobi, Kenya

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. HCV Reinfection

    Time frame: 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.

  2. Evaluate psychoeducational counseling

    Time frame: 6 months

    Brief questionnaire on knowledge, attitude and beliefs of each participant.

  3. Examine usage of methadone maintenance

    Time frame: 12 months

    Brief questionnaire on services used

  4. Examine usage of needle exchange programs

    Time frame: 12 months

    Brief questionnaire on services used

  5. Evaluate psychoeducational counseling

    Time frame: 12 months

    Brief questionnaire on knowledge, attitude and beliefs of each participant.

Secondary outcomes

  1. HCV reinfection referrals for treatment at Kenyetta National Hospital

    Time frame: 9-16 months post treatment

    Confirmed HCV reinfection cases will receive referrals to Kenyatta National Hospital and Coast General Hospital for treatment and management.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jun 21, 2018
Registry last updated
Apr 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.