Community-based Tuberculosis Tracing and Preventive Therapy

NCT ID: NCT03832023

Last Updated: 2023-02-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-14
• Study Completion Date: 2022-08-01

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 these gaps are considered to be the health system infrastructure, limited worker resources and parents' reluctance to bring their children to the facility for screening. There would be great advantages of using a symptom-based screening at community level where only the symptomatic contacts are referred to hospital for further evaluation and asymptomatic contacts are started on PT in the community. Household or community-based screening is likely to improve the uptake and acceptability of child contact screening and management as well as adherence to PT and to reduce cost and workload at facility level.

This study proposes to compare the cascade of care between two models for TB screening and management of household TB child contacts in two high TB burden and limited resource countries, Cameroon and Uganda. In the facility-based model, children will be screened at facility (Cameroon) or household level (Uganda) and preventive therapy initiation, refills of PT therapy and follow-up will be done at facility level. In the intervention group (community-based model), child contacts will be screened in the household by a community health worker (CHW). Those with symptoms suggestive of TB will be referred to the facility for TB investigations. Asymptomatic child contacts from high risk groups (under-5 years or HIV infected 5-14) will be initiated on PT (3 months isoniazid-rifampicin) in the household. Refills of PT therapy will also be done in the communities by the CHW. In both models, symptomatic children requiring further investigations for TB diagnosis will be referred to a health facility.

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 PT using facility-based and decentralized community-based models of care for contact screening and management.

Secondary objectives are:

1. To compare the facility and community-based models in terms of:

• The full cascade of care for the initiation and completion of PT in child TB contacts < 5 years or HIV+ children 5-14 years .
• Cascade of care for the detection and treatment of TB in child contacts (all ages):
• PT tolerability and adherence among eligible child contacts initiated on PT.
• Treatment uptake and outcomes for child contacts diagnosed with TB .
• Child contact outcomes at 6 months after enrollment for all child contacts.
• Acceptability by the parents/guardians, health personnel and community of the different models of care.
• Cost and cost-effectiveness of the different models.
• Fidelity of the implementation of the model activities as compared to the protocol.

2. To assess the number of adult contact cases diagnosed with TB through the community-based screening.

3. To compare between the pre- (baseline assessment) and post-intervention (by model of care) data related to:

• Children diagnosed with TB and registered at facility level and their treatment outcome.
• Adults diagnosed with TB and registered at facility level and their treatment outcome.
• PT initiation and outcomes.

This study will be implemented under the frame of the Catalyzing Pediatric TB Innovation (CaP TB) Project, funded by Unitaid and implemented by the Elizabeth Glaser Pediatric AIDS Foundation (EGPAF). The goal of CaP TB is to improve the pediatric TB morbidity and mortality by catalyzing the wide uptake of the new first-line fixed dose combination drugs for children and optimizing the use of these drugs through improved case detection and innovative models of care. In both models of care, contacts with TB suggestive symptoms will be investigated for TB at the cluster facility that is supported by EGPAF within the CaP TB project. In Cameroon the CaP TB project will be implemented in the Central and Littoral regions and in Uganda in the South-West region.

Conditions

Tuberculosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Facility-based model

Standard of care of each country

Group Type: NO_INTERVENTION

No interventions assigned to this group

Community-based model

Screening and initiating preventive therapy in communities

Group Type: EXPERIMENTAL

Screening and initiating preventive therapy in communities

Intervention Type: OTHER

Symptom-based screening of tuberculosis household child contacts by community health workers; initiation of preventive therapy (3 months of a fixed-dose combination of rifampicin-isoniazid or 6 months isoniazid for HIV+ children on protease inhibitors) in the household by a nurse; follow-up of children under preventive therapy by a community health worker for eligible children at community level, and referral of presumptive tuberculosis cases (children and adults) to the facility.

Interventions

Screening and initiating preventive therapy in communities

Symptom-based screening of tuberculosis household child contacts by community health workers; initiation of preventive therapy (3 months of a fixed-dose combination of rifampicin-isoniazid or 6 months isoniazid for HIV+ children on protease inhibitors) in the household by a nurse; follow-up of children under preventive therapy by a community health worker for eligible children at community level, and referral of presumptive tuberculosis cases (children and adults) to the facility.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Epicentre

OTHER

Sponsor Role: collaborator

University of Sheffield

OTHER

Sponsor Role: collaborator

Institut de Recherche pour le Developpement

OTHER_GOV

Sponsor Role: collaborator

Elizabeth Glaser Pediatric AIDS Foundation

OTHER

Sponsor Role: lead

Responsible Party

Maryline Bonnet

Research Director, MD PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Boris Tchounga, MD, PHD

Role: PRINCIPAL_INVESTIGATOR

Elisabeth Glaser Pediatric AIDS Foundation

Daniel Atwine, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Epicentre

Locations

Hôpital de district Bonassama

Bonabéri, , Cameroon

Hôpital de district Log-Baba

Douala, , Cameroon

Centre Médical d'arrondissement Delangue

Edéa, , Cameroon

Hôpital de district Mbalmayo

Mbalmayo, , Cameroon

Hôpital de district Mfou

Mfou, , Cameroon

Hôpital régional Nkongsamba

Nkongsamba, , Cameroon

Hôpital de district Okola

Okola, , Cameroon

Hôpital de district Olembe

Olembé, , Cameroon

Hôpital de district St Jean de Malte

Penja, , Cameroon

Hôpital de district Yoko

Yoko, , Cameroon

Ishongororo HC IV

Ibanda, , Uganda

Ruhoko HC IV

Ibanda, , Uganda

Kabwohe Clinical Research Center HC II

Kabwohe, , Uganda

Kabwohe HC IV

Kabwohe, , Uganda

Kitagata Hospital

Kitagata, , Uganda

Bubaare HC III

Mbarara, , Uganda

Bwizibwera HC IV

Mbarara, , Uganda

Kakoba HC III

Mbarara, , Uganda

Mbarara Municipal Council HC IV

Mbarara, , Uganda

Bwongyera HC III

Ntungamo, , Uganda

Itojo Hospital

Ntungamo, , Uganda

Kitwe HC IV

Ntungamo, , Uganda

Ntungamo Ngoma HC III

Ntungamo, , Uganda

Rubaare HC IV

Ntungamo, , Uganda

Rwashamaire HC IV

Ntungamo, , Uganda

Countries

Cameroon; Uganda

References

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Other Identifiers

EG0211

Identifier Type: -

Identifier Source: org_study_id