Status:
COMPLETED
Community-based Tuberculosis Tracing and Preventive Therapy
Lead Sponsor:
Elizabeth Glaser Pediatric AIDS Foundation
Collaborating Sponsors:
Epicentre
University of Sheffield
Conditions:
Tuberculosis
Eligibility:
All Genders
Phase:
NA
Brief Summary
The many gaps observed in the cascade of care of tuberculosis (TB) child contacts occur mostly in the screening, preventive therapy (PT) initiation and PT completion steps and the main drivers of thes...
Detailed Description
The primary study objective is to compare the proportion of household child TB contacts eligible for PT (under-5 years and HIV-infected children 5-14 years without active TB) who initiate and complete...
Eligibility Criteria
Inclusion
- Inclusion of the index cases
- Age \> 15 years
- Newly bacteriologically confirmed TB case (less than a month since diagnosis)
- Reports child contact(s)
- Written informed consent signed by the index case and by parents/guardians for minors or incapacitated people
- Inclusion of contacts
- Household contact
- Age
- Facility-based model in Cameroon: \< 5 years or HIV infected 5-14 years and all self-referred adults or children\*.
- Facility-based model in Uganda and community-based model on both countries: all ages
- Written informed consent signed by adult contacts and by parents/guardians for minors or incapacitated people
- Written assent for children \> 7 years in Cameroon and ≥8 years in Uganda
- Under the facility-based model in Cameroon, although there is no systematic request to screen adults or HIV-negative child contacts 5-14 years old, first inclusions showed that some of them came by themselves for TB screening. This justifies their inclusion in the study in order to ensure the completeness of data for all contacts screened under the facility-based model.
Exclusion
- \- Exclusion of index cases
- Index cases who do not have child household contacts living in the catchment area of one of the study clusters
- Index cases diagnosed with rifampicin resistance, multidrug-resistant (MDR) or extensively drug-resistant (XDR) TB \*Index cases from a household screened within the CONTACT study and that does not declare child contacts from another household.\*
- Index cases that are prisoners
- TB confirmed adult contacts cases living in the same household as an index case already enrolled in the study will not be included as new index cases unless they declare additional contacts from another household
- \- Exclusion of the contacts
- If the contact is already on PT or on TB treatment
Key Trial Info
Start Date :
October 14 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2022
Estimated Enrollment :
1400 Patients enrolled
Trial Details
Trial ID
NCT03832023
Start Date
October 14 2019
End Date
August 1 2022
Last Update
February 16 2023
Active Locations (25)
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1
Hôpital de district Bonassama
Bonabéri, Cameroon
2
Hôpital de district Log-Baba
Douala, Cameroon
3
Centre Médical d'arrondissement Delangue
Edéa, Cameroon
4
Hôpital de district Mbalmayo
Mbalmayo, Cameroon