A Home-Based Approach to Tuberculosis Preventive Treatment Management

March 13, 2026 updated by: Temesgen Leka Lerango, Dilla University

Evaluating the Effectiveness of a Home-Based Approach to Tuberculosis Preventive Treatment Management Among Child Household Contacts in Gedeo Zone, Southern Ethiopia: A Cluster-Randomized Trial

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Ethiopia
    • Gedeo
      • Dīla, Gedeo, Ethiopia
        • Gedeo Zone

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A home-based approach
Other: A home-based approach to TB preventive treatment management
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.
No Intervention: A facility-based (usual) care
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Initiation of TPT
Time Frame: 6 months
The proportion of children under 15 years of age declared by index patients who initiate TB preventive treatment.
6 months
Completion of TPT
Time Frame: 6 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of child contacts identified
Time Frame: 6 months
Number of child contacts under 15 years of age identified per index case.
6 months
Proportion of children screened
Time Frame: 6
Number of children screened for TB among child contacts declared by index case.
6
Proportion of children eligible for TPT
Time Frame: 6 months
Number of children eligible for TB preventive treatment among screened child contacts.
6 months
Proportion of children with presumptive TB
Time Frame: 1 month
Number of children under 15 years of age presenting TB-suggestive symptoms among those screened.
1 month
Proportion of children diagnosed with TB
Time Frame: 1 month
Number of children diagnosed with TB among those presenting TB-suggestive symptoms.
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dilla University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 15, 2026

Primary Completion (Estimated)

October 14, 2027

Study Completion (Estimated)

October 14, 2027

Study Registration Dates

First Submitted

March 13, 2026

First Submitted That Met QC Criteria

March 13, 2026

First Posted (Actual)

March 18, 2026

Study Record Updates

Last Update Posted (Actual)

March 18, 2026

Last Update Submitted That Met QC Criteria

March 13, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • duirb/014/2026-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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