NCT04369326: CHIP-TB

Community Initiated Preventive Therapy for TB

Completed NA Last updated 14 August 2023

What this trial tests

NA trial testing Community-Based TPT Initiation in Tuberculosis in 1,168 participants. Completed in 30 June 2023.

Timeline

7 September 2021

Primary endpoint
31 March 2023

30 June 2023

Quick facts

Lead sponsor	Johns Hopkins University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	1,168
Start date	7 September 2021
Primary completion	31 March 2023
Estimated completion	30 June 2023
Sites	1 location across Ethiopia

Drugs / interventions tested

• Community-Based TPT Initiation

Conditions studied

• Tuberculosis — all drugs for Tuberculosis →

Sponsor

Johns Hopkins University

Who can join

Adults 0 Days to 14, any sex, with Tuberculosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background: The World Health Organization (WHO) currently recommends household contact investigation for new tuberculosis (TB) patients in low- and middle-income countries, with an emphasis on pediatric contacts. Although the aim of this policy is to find previously undetected TB patients and reduce transmission, such investigations represent a missed opportunity to start contacts without TB on preventive therapy (TPT). The WHO guidelines do not address the optimal implementation of contact investigation. The standard of care (SOC) in most settings, passive referral of pediatric contacts to the clinic by the index TB patient, has largely remained unsuccessful in practice. In 2017, the WHO estimated only 23% of eligible child contacts were started on TB preventive therapy. Household contact investigation has been shown to have a higher yield in active TB case finding, but is labor intensive, and may be challenging to implement in densely populated urban settings or informal settlements/slums. The WHO recently endorsed the use of a new TPT regimen (rifapentine and isoniazid weekly (3HP)) for both children and adults in high burden settings, and the programmatic roll out of this regimen offers the opportunity to simultaneously examine new strategies to improve the identification and treatment of pediatric TB household contacts.

Objective: To compare the effectiveness of community-based versus facility-based child contact investigation and delivery of TB preventive care to inform the optimal implementation strategy for investigating pediatric household TB contacts.

Study Design: Cluster-randomized trial in 32 clinics (16 clinics per arm) divided equally among South Africa and Ethiopia (8 clinics per arm per country).

Methods: Newly diagnosed qualifying TB index patients (determined by South African or Ethiopian National TB guidelines) and participants' household child contacts will be recruited to participate. Local staff, including the relevant nurses and community health workers in the intervention and control clinics, will be trained to conduct contact investigation with a symptom-based approach for all child contacts under 15 years old in home and at the clinic. Data will be collected using routine medical files and then retrospectively abstracted by the research team. Thirty-two primary health clinics will be stratified (by TB case notification and by country) and randomized in 1:1 fashion to either community-based or facility-based delivery of care. Household child contacts under 15 years of age who screen negative for TB disease will be initiated on TPT by a healthcare worker (nurse, community health worker, etc.) either in the home or clinic setting. Children in the intervention arm who screen positive will first be sent to the nurse at the clinic for repeat screening. Children who have a persistently positive screen in the intervention arm and those with a positive screen in the control arm using South Africa's or Ethiopia's pediatric symptom screening tool will be referred to a physician at the district hospital for further investigation of TB disease, as is the standard of care in both settings. Investigators will compare clinic-level outcomes including proportion of household TB contacts under 15 years of age that were screened, initiated on TPT, and who completed TPT, and reasons for not completing TPT including loss to follow up and incident TB disease while on TPT.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Pragmatic cluster-randomized trial of home-based preventive treatment for TB in Ethiopia and South Africa (CHIP-TB).
   Malhotra A, Nonyane BAS, Shirey E, Mulder C, et al · · 2023 · cited 5× · PMID 37491264 · DOI 10.1186/s13063-023-07514-7
2. Improving access to tuberculosis preventive treatment for children in Ethiopia: designing a home-based contact management intervention for the CHIP-TB trial through formative research.
   Salazar-Austin N, Bergman AJ, Mulder C, Tudor C, et al · · 2024 · cited 4× · PMID 39252005 · DOI 10.1186/s12913-024-11451-9
3. Cost and cost-effectiveness of pediatric home-based versus facility-based TB Preventive Treatment in Ethiopia (CHIP-TB).
   Malhotra A, Bedru A, Mulatu F, Nonyane BAS, et al · · 2025 · cited 3× · PMID 40305495 · DOI 10.1371/journal.pgph.0004466
4. Effectiveness of a Home-based Approach to Child Contact Investigation and Tuberculosis Preventive Treatment Management by Community Health Workers in Ethiopia: A Pragmatic Cluster-randomized Trial.
   Salazar-Austin N, Cohn S, Nonyane BAS, Mulder C, et al · · 2025 · cited 2× · PMID 40376825 · DOI 10.1093/cid/ciaf203