NCT07479030

Brief Summary

Background: Tuberculosis (TB), though preventable and curable, remains a major public health concern worldwide. While elimination of tuberculosis infection (TBI) is critical to TB elimination, TBI continues to represent a substantial public health burden, particularly among household contacts. In recent years, tuberculosis preventive treatment (TPT) has been recognized as essential to eliminating TB worldwide and is particularly critical for children with TBI or close contacts of individuals with infectious TB. The scale-up of TPT among household contacts has been markedly slow, with only 55% of the coverage target achieved for children under 5 years and only 10% for those over 5 years by 2022, highlighting substantial gaps in preventive intervention implementation. Community- and home-based approaches are proposed solutions to reduce the gaps in early detection and provision of preventive treatment for household contacts in high-TB-burden settings many of whom remain underserved with the usual standard facility care. A home-based approach has not been well evaluated for its effectiveness in real-world settings to inform policy decisions. Given the limited evidence, this study aims to evaluate the effectiveness of a home-based TB contact investigation and preventive treatment management among child household contacts in southern Ethiopia. Objective: This study aims to evaluate the effectiveness of a home-based TB contact investigation and preventive treatment management among child household contacts in Gedeo, South Ethiopia. Methods: A pragmatic, two-arm, parallel, cluster-randomized trial will be conducted in Gedeo, South Ethiopia. The procedures in this trial will be based on eight clinical standards for the diagnosis, treatment, and prevention of TBI, which were defined through a Delphi process by a panel of global experts in tuberculosis care. This trial consists of two study groups: a home-based intervention group and a standard facility-based (usual care) comparison group. Within the intervention group, health extension workers based at health posts in the catchment areas of the selected clusters will receive training focused on the study procedures-the implementation of standardized TB symptom screening protocols, TPT management and adherence support, and safety assessment and reporting. A routine TB care procedure will be implemented in the facilities randomized to the comparison group in accordance with national guidelines. Index patients will be asked to enumerate and bring all children below 15 years of age for TB screening and initiation of preventive treatment or anti-TB treatment accordingly.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,300

participants targeted

Target at P75+ for not_applicable

Timeline
17mo left

Started Apr 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress7%
Apr 2026Oct 2027

First Submitted

Initial submission to the registry

March 13, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 18, 2026

Completed
28 days until next milestone

Study Start

First participant enrolled

April 15, 2026

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 14, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 14, 2027

Last Updated

March 18, 2026

Status Verified

March 1, 2026

Enrollment Period

1.5 years

First QC Date

March 13, 2026

Last Update Submit

March 13, 2026

Conditions

Tuberculosis

Keywords

EffectivenessHousehold contactsHome-based approachTuberculosis preventive treatmentContact investigationChildrenHealth Extension WorkersEthiopia

Outcome Measures

Primary Outcomes (2)

  • Initiation of TPT

    The proportion of children under 15 years of age declared by index patients who initiate TB preventive treatment.

    6 months

  • Completion of TPT

    The proportion of children under 15 years of age declared by index patients who complete TB preventive treatment. Treatment completion is defined as a child receiving at least 80% of the prescribed doses within 133% of the scheduled duration of the respective TPT regimen, while remaining clinically well or asymptomatic throughout the treatment period.

    6 months

Secondary Outcomes (5)

  • Proportion of child contacts identified

    6 months

  • Proportion of children screened

    6

  • Proportion of children eligible for TPT

    6 months

  • Proportion of children with presumptive TB

    1 month

  • Proportion of children diagnosed with TB

    1 month

Study Arms (2)

A home-based approach

EXPERIMENTAL
Other: A home-based approach to TB preventive treatment management

A facility-based (usual) care

NO INTERVENTION

A routine TB care procedure will be implemented in the facilities randomized to the comparison group in accordance with national guidelines. Index patients will be asked to enumerate and bring all children below 15 years of age for TB screening and initiation of preventive treatment at the health facility.

Interventions

A home-based approach to TB preventive treatment managementOTHER

Health Extension Workers (HEWs) will carry out household visits to enumerate all close contacts aged below 15 years. After obtaining informed consent, the HEWs will conduct a tuberculosis screening test in accordance with the clinical algorithm. Based on the assessment, the HEWs and TB focal person will determine the appropriate TPT regimen and dosing. Follow-up visits by HEWs for TPT refills, adherence monitoring, and safety assessments will be integrated into the existing home-based services for children.

A home-based approach

Eligibility Criteria

AgeUp to 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Index patients will be eligible if they are at least eighteen years old, live within the facility's catchment area, have been diagnosed with pulmonary tuberculosis within the last month (either bacteriologically confirmed or clinically diagnosed), report at least one child contact below 15 years of age, and are willing to participate in a home visit and give written informed consent and/or assent.

You may not qualify if:

  • Children will be excluded if there is evidence of drug-resistant tuberculosis based on Xpert MTB/RIF® results. Additionally, children will be excluded if a pediatrician's clinical assessment identifies a contraindication to TPT, where the anticipated risk is deemed to outweigh the potential benefit of initiating therapy. Furthermore, child contacts currently receiving TPT or treatment for active TB will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gedeo Zone

Dīla, Gedeo, Ethiopia

Location

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Central Study Contacts

Temesgen L Lerango, MPH

CONTACT

+251913353404maopharm@gmail.com

Semalgn L Lerango, MD

CONTACT

+251942968694semalgnlele@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer in Epidemiology and Biostatistics

Study Record Dates

First Submitted

March 13, 2026

First Posted

March 18, 2026

Study Start

April 15, 2026

Primary Completion (Estimated)

October 14, 2027

Study Completion (Estimated)

October 14, 2027

Last Updated

March 18, 2026

Record last verified: 2026-03

Locations

ET(1)