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Examining Hepatitis C Reinfection Rates in Kenya

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03564639
Recruitment Status : Not yet recruiting
First Posted : June 21, 2018
Last Update Posted : October 26, 2018
Information provided by (Responsible Party):
Yale University

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
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.

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Study Type : Observational
Estimated Enrollment : 170 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.
Estimated Study Start Date : November 2018
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

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.

Primary Outcome Measures :
  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 Outcome Measures :
  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.

Biospecimen Retention:   Samples Without DNA
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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03564639

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Contact: Abbe Muller 860-833-5053
Contact: Ann Kurth, p 203-785-2393

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

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Responsible Party: Yale University Identifier: NCT03564639     History of Changes
Other Study ID Numbers: Muller_06.05.18
First Posted: June 21, 2018    Key Record Dates
Last Update Posted: October 26, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections