Hepatitis CNCT03564639
Examining Hepatitis C Reinfection Rates in Kenya
An observational study of Hepatitis C, run by Yale University at 1 site in Kenya.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C
- How many people
- 101 participants
- Where
- 1 siteKenya
- Study dates
- 1 Oct 2019to 1 Feb 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- Not in the above inclusion criteria.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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.
- Conditions
- Hepatitis C
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
HCV Reinfection
The reinfection of patients with hepatitis C after completion of a previous HCV infection treatment.
Measured: 6-18 months post sustained virologic response (SVR) to HCV treatment.
Evaluate psychoeducational counseling
Brief questionnaire on knowledge, attitude and beliefs of each participant.
Measured: 6 months
Examine usage of methadone maintenance
Brief questionnaire on services used
Measured: 12 months
Examine usage of needle exchange programs
Brief questionnaire on services used
Measured: 12 months
Evaluate psychoeducational counseling
Brief questionnaire on knowledge, attitude and beliefs of each participant.
Measured: 12 months
Secondary outcomes (1)
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.
Measured: 9-16 months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2018
- Study start1 Oct 2019
- Primary completion1 Feb 2021
- Study completion1 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ann Kurth, PhD, Principal investigator, Yale University School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03564639
- Sponsor's protocol ID
- 1512016965_B
- Status last verified
- Apr 2021
- First submitted
- 11 Jun 2018
- Last updated
- 20 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03564639
- Acronym / sponsor ID
- 1512016965_B
- Conditions
- Hepatitis C
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 1 Feb 2021 (actual)
- First posted
- 21 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (1 listed)
- Not in the above inclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Evaluate psychoeducational counseling
Time frame: 6 months
Brief questionnaire on knowledge, attitude and beliefs of each participant.
Examine usage of methadone maintenance
Time frame: 12 months
Brief questionnaire on services used
Examine usage of needle exchange programs
Time frame: 12 months
Brief questionnaire on services used
Evaluate psychoeducational counseling
Time frame: 12 months
Brief questionnaire on knowledge, attitude and beliefs of each participant.
1 secondary outcome
HCV reinfection referrals for treatment at Kenyetta National Hospital
Time frame: 9-16 months post treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ann Kurth, PhD principal investigator
Yale University School of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis C, run by Yale University at 1 site in Kenya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HCV Reinfection (time frame: 6-18 months post sustained virologic response (SVR) to HCV treatment.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2021.