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.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03564639

Enrollment

101

Registered

2018-06-21

Start date

2019-10-01

Completion date

2021-02-01

Last updated

2021-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Secondary

Measure	Time frame	Description
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.

Countries

Kenya

Outcome results