Examining Hepatitis C Reinfection Rates in Kenya

Study Overview
=================
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.

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.

Conditions
-----------------
Hepatitis C

Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Injection drug users with HCV<br>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 |