TuberculosisNCT07479030
A Home-Based Approach to Tuberculosis Preventive Treatment Management
A study testing A home-based approach to TB preventive treatment management in people with Tuberculosis, run by Dilla University at 1 site in Ethiopia.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 14 years
- Conditions the study is for
- Tuberculosis
- What is being tested?
- A home-based approach to TB preventive treatment management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,300 participants
- Where
- 1 siteEthiopia
- Study dates
- 15 Apr 2026to 14 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Up to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read more
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.
- Conditions
- Tuberculosis
- Being tested
- A home-based approach to TB preventive treatment management
- Keywords
- Effectiveness, Household contacts, Home-based approach, Tuberculosis preventive treatment, Contact investigation, Children, Health Extension Workers, Ethiopia
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| A home-based approach | Experimental | Not described Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Initiation of TPT
The proportion of children under 15 years of age declared by index patients who initiate TB preventive treatment.
Measured: 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.
Measured: 6 months
Secondary outcomes (5)
Proportion of child contacts identified
Number of child contacts under 15 years of age identified per index case.
Measured: 6 months
Proportion of children screened
Number of children screened for TB among child contacts declared by index case.
Measured: 6
Proportion of children eligible for TPT
Number of children eligible for TB preventive treatment among screened child contacts.
Measured: 6 months
Proportion of children with presumptive TB
Number of children under 15 years of age presenting TB-suggestive symptoms among those screened.
Measured: 1 month
Proportion of children diagnosed with TB
Number of children diagnosed with TB among those presenting TB-suggestive symptoms.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2026
- Study start15 Apr 2026 (estimated)
- Primary completion14 Oct 2027 (estimated)
- Study completion14 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dilla University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Temesgen Leka Lerango, Dilla University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07479030
- Sponsor's protocol ID
- duirb/014/2026-02
- Status last verified
- Mar 2026
- First submitted
- 13 Mar 2026
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07479030
- Acronym / sponsor ID
- duirb/014/2026-02
- Conditions
- Tuberculosis
- Keywords
- Effectiveness, Household contacts, Home-based approach, Tuberculosis preventive treatment, Contact investigation, Children, Health Extension Workers, Ethiopia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,300 participants (estimated)
- Lead sponsor
- Dilla UniversityUniversity, hospital or other
- Study start
- 15 Apr 2026 (estimated)
- Primary completion
- 14 Oct 2027 (estimated)
- Study completion
- 14 Oct 2027 (estimated)
- First posted
- 18 Mar 2026 (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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- Up to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
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 |
|---|---|---|
| A home-based approach to TB preventive treatment managementHealth 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. | Other | A home-based approach |
Primary outcome
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.
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.
5 secondary outcomes
Proportion of child contacts identified
Time frame: 6 months
Proportion of children screened
Time frame: 6
Proportion of children eligible for TPT
Time frame: 6 months
Proportion of children with presumptive TB
Time frame: 1 month
Proportion of children diagnosed with TB
Time frame: 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A home-based approach to TB preventive treatment management in people with Tuberculosis, run by Dilla University at 1 site in Ethiopia.
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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ethiopia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Temesgen L Lerango, MPH (+251913353404, maopharm@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Initiation of TPT (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Mar 2026.