TuberculosisCONTACTNCT03832023
Community-based Tuberculosis Tracing and Preventive Therapy
A study testing Screening and initiating preventive therapy in communities in people with Tuberculosis, run by Elizabeth Glaser Pediatric AIDS Foundation at 25 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Tuberculosis
- What is being tested?
- Screening and initiating preventive therapy in communities
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,400 participants
- Where
- 25 sitesin 2 countries
- Study dates
- 14 Oct 2019to 1 Aug 2022
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
25 sites in 2 countries.
25 sites in 2 countries
Uganda15 sites
Ishongororo HC IV
Ibanda
Ruhoko HC IV
Ibanda
Kabwohe Clinical Research Center HC II
Kabwohe
Kabwohe HC IV
Kabwohe
Kitagata Hospital
Kitagata
Bubaare HC III
Mbarara
Bwizibwera HC IV
Mbarara
Kakoba HC III
Mbarara
Mbarara Municipal Council HC IV
Mbarara
Bwongyera HC III
Ntungamo
Itojo Hospital
Ntungamo
Kitwe HC IV
Ntungamo
Ntungamo Ngoma HC III
Ntungamo
Rubaare HC IV
Ntungamo
Rwashamaire HC IV
Ntungamo
Cameroon10 sites
Hôpital de district Bonassama
Bonabéri
Hôpital de district Log-Baba
Douala
Centre Médical d'arrondissement Delangue
Edéa
Hôpital de district Mbalmayo
Mbalmayo
Hôpital de district Mfou
Mfou
Hôpital régional Nkongsamba
Nkongsamba
Hôpital de district Okola
Okola
Hôpital de district Olembe
Olembé
Hôpital de district St Jean de Malte
Penja
Hôpital de district Yoko
Yoko
About this study
Official title: Community Intervention for Tuberculosis Active Contact Tracing and Preventive Therapy - a Cluster Randomized Study (CONTACT)
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.
Read the 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:
- 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.
- To assess the number of adult contact cases diagnosed with TB through the community-based screening.
- 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
- Being tested
- Screening and initiating preventive therapy in communities
- 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
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Screening and initiating preventive therapy in communitiesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Facility-based model | No intervention | Standard of care of each country |
| Community-based model | Experimental | Screening and initiating preventive therapy in communities Receives: Other: Screening and initiating preventive therapy in communities |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (30)
Proportion of children screened
Number of children screened among child contacts <5 years or HIV-infected 5-14 years declared by the index case
Measured: 6 months
Proportion of children eligible for PT
Number of children eligible for PT among screened children
Measured: 6 months
Proportion of children started on PT
Number of children started on PT among those eligible for PT
Measured: 6 months
Proportion of children who did not complete PT
Number of children who did not complete PT among those started on PT
Measured: 6 months
Proportion of children with presumptive TB
Number of children with symptoms suggestive of TB among screened children (< 15 years)
Measured: 1 month
Proportion of children investigated for TB
Number of children with presumptive TB investigated for TB
Measured: 1 month
Proportion of children diagnosed with TB
Number of children diagnosed with TB among those with symptoms suggestive of TB
Measured: 1 month
Proportion of children started on TB treatment
Number of children with TB diagnosis who are started on TB treatment
Measured: 1 month
Proportion of adult contacts screened
Number of adult contacts screened among household identified adult contacts
Measured: 1 month
Proportion of adults presumptive TB cases
Number of adults with symptoms suggestive of TB among those screened for TB
Measured: 1 month
Proportion of adults diagnosed with TB
Number of adults presumptive TB cases diagnosed with TB
Measured: 1 month
Proportion of children with serious adverse events
Number of children with serious adverse events among children started on PT
Measured: 6 months
Proportion of children with adverse event of interest
Number of children with adverse event of interest (peripheral neuropathy, clinical hepatotoxicity) among children on PT
Measured: 6 months
Treatment adherence
Ratio of PT dose taken by the child over the total number of doses prescribed
Measured: 6 months
Treatment outcomes of children started on TB treatment
- Cured
- Treatment completed
- Failure
- Death
- Lost to follow up
- Transferred out
Measured: 6 months
Proportion of children diagnosed with TB
Number of children diagnosed with TB after initiation of PT or children not initiated on PT and not diagnosed with TB at baseline
Measured: 6 months
TB case detection during pre-intervention period
Number of patients registered in the facility TB register one year before intervention
Measured: 2 years
Proportion of children among all registered TB cases during pre-intervention period
Number of children among all patients diagnosed with TB and registered in the facility TB register one year before intervention
Measured: 2 years
TB treatment outcome of registered TB patients during pre-intervention period
- Cured
- Treatment completed
- Failure
- Death
- Lost to follow up
- Transferred out
Measured: 2 years
Number of children started on PT during pre-intervention period
Number of children started on PT from the facility PT register one year before intervention
Measured: 2 years
Completion rate of children started on PT intervention during pre-intervention period
Number of children who completed PT among those started on PT from the facility PT register one year before
Measured: 2 years
Number of household visits by CHW
Number of visits by the CHW to the household for contact screening per household
Measured: 2 years
Proportion of parents/guardians who accept household visit
Acceptability of household visit for contact screening
Measured: 2 years
Reasons of refusal of household visit
Description of screening failures
Measured: 2 years
Preference for household visit versus facility visit
This outcome measures whether the parent/guardian prefers bringing child to the facility rather than having someone coming to his household
Measured: 2 years
Critical events experienced by CHW during household visit
Description of critical events during house visit and how these where dealt with
Measured: 2 years
Transport cost for household visit by CHW
Cost of transportation for the CHW to go from the health facility to a household
Measured: 2 years
Transport cost for parents/guardian for facility-based screening
Cost supported by families to bring child contact to the facility for screening
Measured: 2 years
Time spent to perform household contact screening visit
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
Measured: 2 years
Proportion of delivered activities compared to the intended activities of the model
This outcome will assess fidelity to study procedures
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2019
- Study start14 Oct 2019
- Primary completion1 Aug 2022
- Study completion1 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 1,400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elizabeth Glaser Pediatric AIDS Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Epicentre, University of Sheffield, Institut de Recherche pour le Developpement
- Responsible party
- Principal investigator, Maryline Bonnet, Institut de Recherche pour le Developpement
- Investigators
- Boris Tchounga, MD, PHD, Principal investigator, Elisabeth Glaser Pediatric AIDS FoundationDaniel Atwine, MD, PhD, Principal investigator, Epicentre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03832023
- Sponsor's protocol ID
- EG0211
- Acronym
- CONTACT
- Status last verified
- Feb 2023
- First submitted
- 24 Jan 2019
- Last updated
- 16 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25622087Rutherford 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.
PubMed 22862994Triasih 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.
PubMed 25270649Mandalakas 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.
PubMed 22717944Szkwarko 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.
PubMed 28763500Graham 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.
PubMed 27910720Egere 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.
PubMed 28123958Bonnet 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.
PubMed 37918417Vasiliu 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.
PubMed 35148800Vasiliu 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.
PubMed 33653385
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Intervention for Tuberculosis Active Contact Tracing and Preventive Therapy - a Cluster Randomized Study (CONTACT)
- ClinicalTrials.gov ID
- NCT03832023
- Acronym / sponsor ID
- CONTACT / EG0211
- Conditions
- Tuberculosis
- Keywords
- Children, Contact tracing, Preventive therapy, Prophylaxis, Community health workers, Community-based distribution, Standard of care, Screening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,400 participants (actual)
- Lead sponsor
- Elizabeth Glaser Pediatric AIDS FoundationUniversity, hospital or other
- Collaborators
- Epicentre, University of Sheffield, Institut de Recherche pour le Developpement
- Study start
- 14 Oct 2019 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 6 Feb 2019 (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 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:
- 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.
- To assess the number of adult contact cases diagnosed with TB through the community-based screening.
- 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Facility-based model | No intervention | –Standard of care of each country |
| Community-based model | Experimental | Other: Screening and initiating preventive therapy in communitiesScreening and initiating preventive therapy in communities |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Screening and initiating preventive therapy in communitiesSymptom-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. | Other | Community-based model |
Primary outcome
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 children of 5-14 years of age declared by the index case
30 secondary outcomes
Proportion of children screened
Time frame: 6 months
Proportion of children eligible for PT
Time frame: 6 months
Proportion of children started on PT
Time frame: 6 months
Proportion of children who did not complete PT
Time frame: 6 months
Proportion of children with presumptive TB
Time frame: 1 month
Proportion of children investigated for TB
Time frame: 1 month
Proportion of children diagnosed with TB
Time frame: 1 month
Proportion of children started on TB treatment
Time frame: 1 month
Proportion of adult contacts screened
Time frame: 1 month
Proportion of adults presumptive TB cases
Time frame: 1 month
Proportion of adults diagnosed with TB
Time frame: 1 month
Proportion of children with serious adverse events
Time frame: 6 months
Proportion of children with adverse event of interest
Time frame: 6 months
Treatment adherence
Time frame: 6 months
Treatment outcomes of children started on TB treatment
Time frame: 6 months
Proportion of children diagnosed with TB
Time frame: 6 months
TB case detection during pre-intervention period
Time frame: 2 years
Proportion of children among all registered TB cases during pre-intervention period
Time frame: 2 years
TB treatment outcome of registered TB patients during pre-intervention period
Time frame: 2 years
Number of children started on PT during pre-intervention period
Time frame: 2 years
Completion rate of children started on PT intervention during pre-intervention period
Time frame: 2 years
Number of household visits by CHW
Time frame: 2 years
Proportion of parents/guardians who accept household visit
Time frame: 2 years
Reasons of refusal of household visit
Time frame: 2 years
Preference for household visit versus facility visit
Time frame: 2 years
Critical events experienced by CHW during household visit
Time frame: 2 years
Transport cost for household visit by CHW
Time frame: 2 years
Transport cost for parents/guardian for facility-based screening
Time frame: 2 years
Time spent to perform household contact screening visit
Time frame: 2 years
Proportion of delivered activities compared to the intended activities of the model
Time frame: 2 years
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 16 Feb 2023.
- Background: PubMed 25622087Mandalakas 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.
- Background: PubMed 22862994Rutherford 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.
- Background: PubMed 25270649Triasih 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.
- Background: PubMed 22717944Mandalakas 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.
- Background: PubMed 28763500Szkwarko 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.
- Background: PubMed 27910720Graham 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.
- Background: PubMed 28123958Egere 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.
- Derived from this study: PubMed 37918417Bonnet 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.
- Derived from this study: PubMed 35148800Vasiliu 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.
- Derived from this study: PubMed 33653385Vasiliu 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.
- Individual participant dataSharing planned: No
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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.
Boris Tchounga, MD, PHD principal investigator
Elisabeth Glaser Pediatric AIDS Foundation
Daniel Atwine, MD, PhD principal investigator
Epicentre
25 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Screening and initiating preventive therapy in communities in people with Tuberculosis, run by Elizabeth Glaser Pediatric AIDS Foundation at 25 sites in 2 countries.
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 11 inclusion and 7 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 16 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in Uganda, Cameroon. 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?
Completion of preventive therapy (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03832023, which also lists 10 linked publications.
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 16 Feb 2023.