Community-based Tuberculosis Tracing and Preventive Therapy

NCT03832023 | Completed

• 1 other identifier: EG0211
• Study Type: interventional
• Target: 1,400
• Locations: 2 countries
• Sites: 25

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.

Conditions

Tuberculosis

Keywords

Children; Contact tracing; Preventive therapy; Prophylaxis; Community health workers; Community-based distribution; Standard of care; Screening; Randomized controlled trial; Cameroon; Uganda; Patient outcome assessment

Outcome Measures

Primary Outcomes (1)

• Completion of preventive therapy

  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 children of 5-14 years of age declared by the index case

  6 months

Secondary Outcomes (30)

• Proportion of children screened

  6 months

• Proportion of children eligible for PT

  6 months

• Proportion of children started on PT

  6 months

• Proportion of children who did not complete PT

  6 months

• Proportion of children with presumptive TB

  1 month

Study Arms (2)

Facility-based model

NO INTERVENTION

Standard of care of each country

Community-based model

EXPERIMENTAL

Screening and initiating preventive therapy in communities

Other: Screening and initiating preventive therapy in communities

Interventions

Screening and initiating preventive therapy in communities 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.

Community-based model

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

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

Sponsors & Collaborators

• Elizabeth Glaser Pediatric AIDS Foundation: lead
• Epicentre: collaborator
• University of Sheffield: collaborator
• Institut de Recherche pour le Developpement: collaborator

Study Sites (25)

Hôpital de district Bonassama

Bonabéri, Cameroon

Location

Hôpital de district Log-Baba

Douala, Cameroon

Location

Centre Médical d'arrondissement Delangue

Edéa, Cameroon

Location

Hôpital de district Mbalmayo

Mbalmayo, Cameroon

Location

Hôpital de district Mfou

Mfou, Cameroon

Location

Hôpital régional Nkongsamba

Nkongsamba, Cameroon

Location

Hôpital de district Okola

Okola, Cameroon

Location

Hôpital de district Olembe

Olembé, Cameroon

Location

Hôpital de district St Jean de Malte

Penja, Cameroon

Location

Hôpital de district Yoko

Yoko, Cameroon

Location

Ishongororo HC IV

Ibanda, Uganda

Location

Ruhoko HC IV

Ibanda, Uganda

Location

Kabwohe Clinical Research Center HC II

Kabwohe, Uganda

Location

Kabwohe HC IV

Kabwohe, Uganda

Location

Kitagata Hospital

Kitagata, Uganda

Location

Bubaare HC III

Mbarara, Uganda

Location

Bwizibwera HC IV

Mbarara, Uganda

Location

Kakoba HC III

Mbarara, Uganda

Location

Mbarara Municipal Council HC IV

Mbarara, Uganda

Location

Bwongyera HC III

Ntungamo, Uganda

Location

Itojo Hospital

Ntungamo, Uganda

Location

Kitwe HC IV

Ntungamo, Uganda

Location

Ntungamo Ngoma HC III

Ntungamo, Uganda

Location

Rubaare HC IV

Ntungamo, Uganda

Location

Rwashamaire HC IV

Ntungamo, Uganda

Location

Related Publications (10)

• Mandalakas AM, Kirchner HL, Walzl G, Gie RP, Schaaf HS, Cotton MF, Grewal HM, Hesseling AC. Optimizing the detection of recent tuberculosis infection in children in a high tuberculosis-HIV burden setting. Am J Respir Crit Care Med. 2015 Apr 1;191(7):820-30. doi: 10.1164/rccm.201406-1165OC.

  PMID: 25622087 BACKGROUND

• Rutherford ME, Hill PC, Triasih R, Sinfield R, van Crevel R, Graham SM. Preventive therapy in children exposed to Mycobacterium tuberculosis: problems and solutions. Trop Med Int Health. 2012 Oct;17(10):1264-73. doi: 10.1111/j.1365-3156.2012.03053.x. Epub 2012 Aug 5.

  PMID: 22862994 BACKGROUND

• Triasih R, Robertson CF, Duke T, Graham SM. A prospective evaluation of the symptom-based screening approach to the management of children who are contacts of tuberculosis cases. Clin Infect Dis. 2015 Jan 1;60(1):12-8. doi: 10.1093/cid/ciu748. Epub 2014 Sep 30.

  PMID: 25270649 BACKGROUND

• Mandalakas AM, Hesseling AC, Gie RP, Schaaf HS, Marais BJ, Sinanovic E. Modelling the cost-effectiveness of strategies to prevent tuberculosis in child contacts in a high-burden setting. Thorax. 2013 Mar;68(3):247-55. doi: 10.1136/thoraxjnl-2011-200933. Epub 2012 Jun 20.

  PMID: 22717944 BACKGROUND

• Szkwarko D, Hirsch-Moverman Y, Du Plessis L, Du Preez K, Carr C, Mandalakas AM. Child contact management in high tuberculosis burden countries: A mixed-methods systematic review. PLoS One. 2017 Aug 1;12(8):e0182185. doi: 10.1371/journal.pone.0182185. eCollection 2017.

  PMID: 28763500 BACKGROUND

• Graham SM. The management of infection with Mycobacterium tuberculosis in young children post-2015: an opportunity to close the policy-practice gap. Expert Rev Respir Med. 2017 Jan;11(1):41-49. doi: 10.1080/17476348.2016.1267572. Epub 2016 Dec 10.

  PMID: 27910720 BACKGROUND

• Egere U, Sillah A, Togun T, Kandeh S, Cole F, Jallow A, Able-Thomas A, Hoelscher M, Heinrich N, Hill PC, Kampmann B. Isoniazid preventive treatment among child contacts of adults with smear-positive tuberculosis in The Gambia. Public Health Action. 2016 Dec 21;6(4):226-231. doi: 10.5588/pha.16.0073.

  PMID: 28123958 BACKGROUND

• Bonnet M, Vasiliu A, Tchounga BK, Cuer B, Fielding K, Ssekyanzi B, Tchakounte Youngui B, Cohn J, Dodd PJ, Tiendrebeogo G, Tchendjou P, Simo L, Okello RF, Kuate Kuate A, Turyahabwe S, Atwine D, Graham SM, Casenghi M; CONTACT study group. Effectiveness of a community-based approach for the investigation and management of children with household tuberculosis contact in Cameroon and Uganda: a cluster-randomised trial. Lancet Glob Health. 2023 Dec;11(12):e1911-e1921. doi: 10.1016/S2214-109X(23)00430-8. Epub 2023 Oct 30.

  PMID: 37918417 DERIVED

• Vasiliu A, Tiendrebeogo G, Awolu MM, Akatukwasa C, Tchakounte BY, Ssekyanzi B, Tchounga BK, Atwine D, Casenghi M, Bonnet M; CONTACT study group. Feasibility of a randomized clinical trial evaluating a community intervention for household tuberculosis child contact management in Cameroon and Uganda. Pilot Feasibility Stud. 2022 Feb 11;8(1):39. doi: 10.1186/s40814-022-00996-3.

  PMID: 35148800 DERIVED

• Vasiliu A, Eymard-Duvernay S, Tchounga B, Atwine D, de Carvalho E, Ouedraogo S, Kakinda M, Tchendjou P, Turyahabwe S, Kuate AK, Tiendrebeogo G, Dodd PJ, Graham SM, Cohn J, Casenghi M, Bonnet M. Community intervention for child tuberculosis active contact investigation and management: study protocol for a parallel cluster randomized controlled trial. Trials. 2021 Mar 2;22(1):180. doi: 10.1186/s13063-021-05124-9.

  PMID: 33653385 DERIVED

MeSH Terms

Conditions

Tuberculosis

Interventions

Mass Screening; Residence Characteristics

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Diagnostic Services; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Practice; Demography; Population Characteristics; Epidemiologic Measurements

Study Officials

• Boris Tchounga, MD, PHD

  Elisabeth Glaser Pediatric AIDS Foundation

  PRINCIPAL INVESTIGATOR

• Daniel Atwine, MD, PhD

  Epicentre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Director, MD PhD

Model Details: 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.

Study Record Dates

• First Submitted: January 24, 2019
• First Posted: February 6, 2019
• Study Start: October 14, 2019
• Primary Completion: August 1, 2022
• Study Completion: August 1, 2022
• Last Updated: February 16, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (10); UG (15)