Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2/PHASE3
131438 participants
INTERVENTIONAL
2023-02-27
2025-01-01
Brief Summary
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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
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
PREVENTION
NONE
Study Groups
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Enhanced community-wide TB intervention
Enhanced community-wide TB intervention strategy with intensive screening and health education
Enhanced community-wide TB intervention
Interventions in the intervention arms consist of the following key components:
1. an optimized national recommended set of interventions; such as the implementation of all types of contact investigation, targeted TB screening and diagnosis at key affected population, and optimized HIV screening and TPT for PLHIV;
2. intensive, active, and community-based HH screening and diagnosis of TB using combined TB screening (clinical and X-ray) and X-pert MTB/RIF, as indicated;
3. community-based enhanced TPT; and
4. community-based awareness creation and health education using the community social associations.
Routine TB program activities
TB standard of care per Ethiopia's national guidelines
Routine TB program activities
In the control arm, the standard of care will continue per the national guideline.
Interventions
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Enhanced community-wide TB intervention
Interventions in the intervention arms consist of the following key components:
1. an optimized national recommended set of interventions; such as the implementation of all types of contact investigation, targeted TB screening and diagnosis at key affected population, and optimized HIV screening and TPT for PLHIV;
2. intensive, active, and community-based HH screening and diagnosis of TB using combined TB screening (clinical and X-ray) and X-pert MTB/RIF, as indicated;
3. community-based enhanced TPT; and
4. community-based awareness creation and health education using the community social associations.
Routine TB program activities
In the control arm, the standard of care will continue per the national guideline.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
ALL
Yes
Sponsors
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KNCV Tuberculosis Foundation
OTHER
Management Sciences for Health
OTHER
Responsible Party
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Locations
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Gedebe Hassassa woreda
West Arsi Zone, Ormoia Regional State, Ethiopia
Boloso Bombe woreda
Wolayita Zone, South Ethiopia Regional State, Ethiopia
Countries
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Central Contacts
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Facility Contacts
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Abu Emma
Role: primary
Mulatu Biru, PhD
Role: backup
Dereje Alemu
Role: primary
Mulatu Biru, PhD
Role: backup
Other Identifiers
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72066320CA00009
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
37.2022
Identifier Type: -
Identifier Source: org_study_id