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DeMONSTRATE-TB Study in Ethiopia

RecruitingPhase 2, Phase 3Ages any - anyAllManagement Sciences for Health
NCT06719193 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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
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What it tests

  • Enhanced community-wide TB intervention
  • Routine TB program activities
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Where

2 sites
Gedebe Hassassa woreda
West Arsi Zone, Ethiopia
Boloso Bombe woreda
Wolayita Zone, Ethiopia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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