DeMONSTRATE-TB Study in Ethiopia

Phase 2

Recruiting

• Conditions: Reducing Tuberculosis Incidence

• Registration Number: NCT06719193
• Lead Sponsor: Management Sciences for Health

Brief Summary

Ending the TB epidemic by 2035 in Ethiopia would be possible if TB notification declines by an annual factor of at least 15% from the current notification rate of 132 per 100,000 population. This requires highly effective strategies to reduce TB transmission and maximize TB prevention among populations at risk of developing TB, such as Household contacts and people living with HIV.

The investigators hypothesize that community wide administration of enhanced TPT will accelerate decline in TB incidence rates when combined with an optimized currently recommended comprehensive TB prevention and care packages described below. The investigators further hypothesize that such intervention packages will be acceptable to the community, providers and policy makers, and that they will be cost-effective.

Based on the study results, a TB elimination framework in high burden TB regions and woredas in Ethiopia will be developed, and local evidence to enhance the shift toward TB elimination will be provided as input to the appropriate allocation of resources.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-27
• Study First Submitted: 2024-11-20
• Status Verified: 2024-12
• Study First Submitted QC: 2024-12-02
• Last Update Submitted: 2024-12-02
• Study First Posted: 2024-12-05
• Last Update Posted: 2024-12-05
• Primary Completion: 2025-01-01
• Study Completion: 2025-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 131438

Inclusion Criteria

1. Adults:

   • Greater than or equal to 18 years old
   • Provides consent
   • Living in study site area (woreda)

2. Children

   • Aged 12 to 17 years
   • Living in the study site area (woreda)
   • Assent to enrollment
   • Guardian provides consent for enrollment

3. Younger children:

   • Less than 12 years old
   • Living in the study site area (woreda)
   • Consent for enrollment provided by the guardian

Exclusion Criteria

1. Adults:

   • Does not provide consent
   • Declines to provide contact information
   • Less than 18 years
   • Living outside of the study site area
   • Declines to allow study staff to contact them by phone and in person if they miss a study visit

2. Children

   • Does not provide assent
   • Guardian does not provide consent
   • Guardian declines to provide contact information
   • Not within 12 to 17 years
   • Living outside of the study site area
   • Guardian declines to allow study staff to contact them by phone and in person if they miss a study visit

3. Younger Children

   • Guardian does not provide consent
   • Guardian declines to provide contact information
   • Not less than 12 years
   • Living outside of the study site area
   • Guardian declines to allow study staff to contact them by phone and in person if they miss a study visit

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Population-level TB prevalence	Semi-annual screening (up to 2 years)	Demonstrate the impact and feasibility of a community wide TPT in reducing TB incidence when administered in combination with intensified active TB case finding, improved diagnostic capacity, and general awareness creation. Ultimately, the evidence generated will be used to develop a TB elimination framework for broader application.

Secondary Outcome Measures

Name	Time	Method
Change in TB treatment outcomes	Baseline and at 2 years	TB treatment outcomes are classified as cured, treatment completed, treatment failure, died, loss-to-follow up, and not evaluated based on the World Health Organization (WHO) definition and reporting framework for tuberculosis. Baseline TB treatment outcome will be collected at the start through a baseline prevalence survey to understand the baseline status of TB outcomes. This data on TB treatment outcomes will then be compared after two years of intervention in both intervention and control woredas to understand if there is an improvement in favorable TB treatment outcomes (i.e., cured or treatment completed) and decrease in less favorable TB treatment outcomes (i.e., treatment failed, died, loss-to-follow up) in the intervention sites compared to the standard of care control sites.

Trial Locations

Locations (2)

Gedebe Hassassa woreda; 🇪🇹 West Arsi Zone, Ormoia Regional State, Ethiopia

Boloso Bombe woreda; 🇪🇹 Wolayita Zone, South Ethiopia Regional State, Ethiopia