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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Not in the above inclusion criteria.
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Ann Kurth, PhD | Yale University School of Nursing | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NASCOP | Nairobi | Kenya |
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| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
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Research staff will obtain a sample of capillary or venous blood from participants at the treatment site and send specimens to Kenya Medical Research Institute (KEMRI) laboratory in Kisumu, Kenya for a Hepatitis C V RNA test. If viral load is detectable confirmatory samples will be sent to the Center for Disease Control (CDC) laboratory for next generation sequencing, to guide treatment. Samples will be collected at two time points post SVR and if re-treated in this study, 12 weeks after treatment completion to determine SVR.
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |