DeMONSTRATE-TB Study in Ethiopia

Management Sciences for Health

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Reducing Tuberculosis Incidence

Treatments: Combination Product: Routine TB program activities; Combination Product: Enhanced community-wide TB intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06719193

37.2022

72066320CA00009 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 131,438 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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131,438 participants in 2 patient groups

Enhanced community-wide TB intervention

Experimental group

Description:

Enhanced community-wide TB intervention strategy with intensive screening and health education

Treatment:

Combination Product: Enhanced community-wide TB intervention

Routine TB program activities

Active Comparator group

Description:

TB standard of care per Ethiopia's national guidelines

Treatment:

Combination Product: Routine TB program activities