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Community-based Tuberculosis Tracing and Preventive Therapy (CONTACT)

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.
 
ClinicalTrials.gov Identifier: NCT03832023
Recruitment Status : Not yet recruiting
First Posted : February 6, 2019
Last Update Posted : February 6, 2019
Sponsor:
Collaborators:
Epicentre
University of Sheffield
Institut de Recherche pour le Developpement
Information provided by (Responsible Party):
Maryline Bonnet, Institut de Recherche pour le Developpement

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.


Condition or disease Intervention/treatment Phase
Tuberculosis Other: Screening and initiating preventive therapy in communities Not Applicable

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.
  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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Clusters were selected among facilities participating in the first phase of the CAP-TB project following an initial facility assessment for participating in the CAP-TB project. Facilities with diagnostic and treatment capacity and detecting and minimum of 50 bacteriologically confirmed pulmonary TB cases per year in a rural/semi-rural or semi-urban setting were selected. The facilities correspond to district hospitals in Cameroon and health center IV or district hospitals in Uganda.

Twenty clusters will be randomized between the intervention and the facility-based model. The randomization unit (cluster) will be the facility where TB cases (index cases) are diagnosed and its catchment area.

Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Community Intervention for Tuberculosis Active Contact Tracing and Preventive Therapy - a Cluster Randomized Study (CONTACT)
Estimated Study Start Date : July 1, 2019
Estimated Primary Completion Date : April 14, 2021
Estimated Study Completion Date : April 14, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tuberculosis

Arm Intervention/treatment
No Intervention: Facility-based model
Standard of care of each country
Experimental: Community-based model
Screening and initiating preventive therapy in communities
Other: 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.




Primary Outcome Measures :
  1. Completion of preventive therapy [ Time Frame: 6 months ]
    Proportion of child TB contacts <5 years of age and HIV-infected children of 5-14 years of age who initiate and complete the PT of all child contacts <5 years of age and HIV-infected/exposed children of 5-14 years of age declared by the index case


Secondary Outcome Measures :
  1. Proportion of children screened [ Time Frame: 6 months ]
    Number of children screened among child contacts <5 years or HIV-infected/exposed 5-14 years declared by the index case

  2. Proportion of children eligible for PT [ Time Frame: 6 months ]
    Number of children eligible for PT among screened children

  3. Proportion of children started on PT [ Time Frame: 6 months ]
    Number of children started on PT among those eligible for PT

  4. Proportion of children who did not complete PT [ Time Frame: 6 months ]
    Number of children who did not complete PT among those started on PT

  5. Proportion of children with presumptive TB [ Time Frame: 1 month ]
    Number of children with symptoms suggestive of TB among screened children

  6. Proportion of children investigated for TB [ Time Frame: 1 month ]
    Number of children with presumptive TB investigated for TB

  7. Proportion of children diagnosed with TB [ Time Frame: 1 month ]
    Number of children diagnosed with TB among those with symptoms suggestive of TB

  8. Proportion of children started on TB treatment [ Time Frame: 1 month ]
    Number of children with TB diagnosis who are started on TB treatment

  9. Proportion of adult contacts screened [ Time Frame: 1 month ]
    Number of adult contacts screened among household identified adult contacts

  10. Proportion of adults presumptive TB cases [ Time Frame: 1 month ]
    Number of adults with symptoms suggestive of TB among those screened for TB

  11. Proportion of adults diagnosed with TB [ Time Frame: 1 month ]
    Number of adults presumptive TB cases diagnosed with TB

  12. Proportion of children with serious adverse events [ Time Frame: 6 months ]
    Number of children with serious adverse events among children started on PT

  13. Proportion of children with adverse event of interest [ Time Frame: 6 months ]
    Number of children with adverse event of interest (peripheral neuropathy, clinical hepatotoxicity) among children on PT

  14. Treatment adherence [ Time Frame: 6 months ]
    Ratio of PT dose taken by the child over the total number of doses prescribed

  15. Treatment outcomes of children started on TB treatment [ Time Frame: 6 months ]
    • Cured
    • Treatment completed
    • Failure
    • Death
    • Lost to follow up
    • Transferred out

  16. Proportion of children diagnosed with TB after initiation of PT [ Time Frame: 6 months ]
    Number of children diagnosed with TB after initiation of PT

  17. TB case detection during pre-intervention period [ Time Frame: 2 years ]
    Number of patients registered in the facility TB register one year before intervention

  18. Proportion of children among all registered TB cases during pre-intervention period [ Time Frame: 2 years ]
    Number of children among all patients diagnosed with TB and registered in the facility TB register one year before intervention

  19. TB treatment outcome of registered TB patients during pre-intervention period [ Time Frame: 2 years ]
    • Cured
    • Treatment completed
    • Failure
    • Death
    • Lost to follow up
    • Transferred out

  20. Number of children started on PT during pre-intervention period [ Time Frame: 2 years ]
    Number of children started on PT from the facility PT register one year before intervention

  21. Completion rate of children started on PT intervention during pre-intervention period [ Time Frame: 2 years ]
    Number of children who completed PT among those started on PT from the facility PT register one year before

  22. Number of household visits byCHW [ Time Frame: 2 years ]
    Number of visits by the CHW to the household for contact screening per household

  23. Proportion of parents/guardians who accept household visit [ Time Frame: 2 years ]
    Acceptability of household visit for contact screening

  24. Reasons of refusal of household visit [ Time Frame: 2 years ]
    • Stigma around TB
    • Fear TB status disclosure
    • Lack of time
    • Not a priority: child is well

  25. Preference for household visit versus facility visit [ Time Frame: 2 years ]
    This outcome measures whether the parent/guardian prefers bringing child to the facility rather than having someone coming to his household

  26. Critical events experienced by CHW during household visit [ Time Frame: 2 years ]
    • Rudeness of parents/guardian
    • Empty household
    • Refusal of screening by the parent/guardian
    • Lack of time to screen all contacts
    • Difficulties to find the household
    • Long distance

  27. Transport cost for household visit by CHW [ Time Frame: 2 years ]
  28. Transport cost for parents/guardian for facility-based screening [ Time Frame: 2 years ]
    Cost supported by families to bring child contact to the facility for screening

  29. Time spent to perform household contact screening visit [ Time Frame: 2 years ]
    It includes the time to reach the household, the time spent in the household and the time to go back to the facility for CHW



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 given by the index case
  • Inclusion of contacts

    • Household contact
    • Age < 15 years
    • Facility-based model in Cameroon: < 5 years or HIV infected/exposed 5-14 years
    • Facility-based model in Uganda and community-based model on both countries <15 years
    • Written informed consent signed by adult contacts and by parents/guardians for children contacts
    • Written assent for children > 7 years

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 that are prisoners
  • Exclusion of the contacts

    • If the contact is already on PT or on TB treatment

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 ClinicalTrials.gov identifier (NCT number): NCT03832023


Contacts
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Contact: Maryline Bonnet, MD, PhD +256793328744 maryline.bonnet@ird.fr

Locations
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Cameroon
Hôpital de district Bonassama Not yet recruiting
Bonabéri, Cameroon
Contact: Boris Tchakounte    +237690909743    btchakounte@pedaids.org   
Hôpital de district Log-Baba Not yet recruiting
Douala, Cameroon
Contact: Boris Tchakounte    +237690909743    btchakounte@pedaids.org   
Centre Médical d'arrondissement Delangue Not yet recruiting
Edéa, Cameroon
Contact: Boris Tchakounte    +237690909743    btchakounte@pedaids.org   
Hôpital de district Mbalmayo Not yet recruiting
Mbalmayo, Cameroon
Contact: Boris Tchakounte    +237690909743    btchakounte@pedaids.org   
Hôpital de district Mfou Not yet recruiting
Mfou, Cameroon
Contact: Boris Tchakounte    +237690909743    btchakounte@pedaids.org   
Hôpital régional Nkongsamba Not yet recruiting
Nkongsamba, Cameroon
Contact: Boris Tchakounte    +237690909743    btchakounte@pedaids.org   
Hôpital de district Okola Not yet recruiting
Okola, Cameroon
Contact: Boris Tchakounte    +237690909743    btchakounte@pedaids.org   
Hôpital de district Olembe Not yet recruiting
Olembe, Cameroon
Contact: Boris Tchakounte    +237690909743    btchakounte@pedaids.org   
Hôpital de district St Jean de Malte Not yet recruiting
Penja, Cameroon
Contact: Boris Tchakounte    +237690909743    btchakounte@pedaids.org   
Hôpital de district Yoko Not yet recruiting
Yoko, Cameroon
Contact: Boris Tchakounte    +237690909743    btchakounte@pedaids.org   
Uganda
Ishongororo HC IV Not yet recruiting
Ibanda, Uganda
Contact: Bob Ssekyanzi    +256792456305    bob.ssekyanzi@epicentre.msf.org   
Ruhoko HC IV Not yet recruiting
Ibanda, Uganda
Contact: Bob Ssekyanzi    +256792456305    bob.ssekyanzi@epicentre.msf.org   
Kabwohe Clinical Research Center HC II Not yet recruiting
Kabwohe, Uganda
Contact: Bob Ssekyanzi    +256792456305    bob.ssekyanzi@epicentre.msf.org   
Kabwohe HC IV Not yet recruiting
Kabwohe, Uganda
Contact: Bob Ssekyanzi    +256792456305    bob.ssekyanzi@epicentre.msf.org   
Kitagata Hospital Not yet recruiting
Kitagata, Uganda
Contact: Bob Ssekyanzi    +256792456305    bob.ssekyanzi@epicentre.msf.org   
Bubaare HC III Not yet recruiting
Mbarara, Uganda
Contact: Bob Ssekyanzi    +256792456305    bob.ssekyanzi@epicentre.msf.org   
Bwizibwera HC IV Not yet recruiting
Mbarara, Uganda
Contact: Bob Ssekyanzi    +256792456305    bob.ssekyanzi@epicentre.msf.org   
Kakoba HC III Not yet recruiting
Mbarara, Uganda
Contact: Bob Ssekyanzi    +256792456305    bob.ssekyanzi@epicentre.msf.org   
Mbarara Municipal Council HC IV Not yet recruiting
Mbarara, Uganda
Contact: Bob Ssekyanzi    +256792456305    bob.ssekyanzi@epicentre.msf.org   
Bwongyera HC III Not yet recruiting
Ntungamo, Uganda
Contact: Bob Ssekyanzi    +256792456305    bob.ssekyanzi@epicentre.msf.org   
Itojo Hospital Not yet recruiting
Ntungamo, Uganda
Contact: Bob Ssekyanzi    +256792456305    bob.ssekyanzi@epicentre.msf.org   
Kitwe HC IV Not yet recruiting
Ntungamo, Uganda
Contact: Bob Ssekyanzi    +256792456305    bob.ssekyanzi@epicentre.msf.org   
Ntungamo Ngoma HC III Not yet recruiting
Ntungamo, Uganda
Contact: Bob Ssekyanzi    +256792456305    bob.ssekyanzi@epicentre.msf.org   
Rubaare HC IV Not yet recruiting
Ntungamo, Uganda
Contact: Bob Ssekyanzi    +256792456305    bob.ssekyanzi@epicentre.msf.org   
Rwashamaire HC IV Not yet recruiting
Ntungamo, Uganda
Contact: Bob Ssekyanzi    +256792456305    bob.ssekyanzi@epicentre.msf.org   
Sponsors and Collaborators
Elizabeth Glaser Pediatric AIDS Foundation
Epicentre
University of Sheffield
Institut de Recherche pour le Developpement
Investigators
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Principal Investigator: Boris Tchounga, MD, PHD Elisabeth Glaser Pediatric AIDS Foundation
Principal Investigator: Daniel Atwine, MD, PhD Epicentre

Publications:

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Responsible Party: Maryline Bonnet, Research Director, MD PhD, Institut de Recherche pour le Developpement
ClinicalTrials.gov Identifier: NCT03832023     History of Changes
Other Study ID Numbers: EG0211
First Posted: February 6, 2019    Key Record Dates
Last Update Posted: February 6, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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.: No
Keywords provided by Maryline Bonnet, Institut de Recherche pour le Developpement:
Contact tracing
Children
Preventive therapy
Prophylaxis
Community health workers
Community-based distribution
Standard of care
Screening
Randomized controlled trial
Cameroon
Uganda
Patient outcome assessment
Additional relevant MeSH terms:
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Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections