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| ID | Type | Description | Link |
|---|---|---|---|
| 72066320CA00009 | Other Grant/Funding Number | USAID |
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| Name | Class |
|---|---|
| KNCV Tuberculosis Foundation | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enhanced community-wide TB intervention | Experimental | Enhanced community-wide TB intervention strategy with intensive screening and health education |
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| Routine TB program activities | Active Comparator | TB standard of care per Ethiopia's national guidelines |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enhanced community-wide TB intervention | Combination Product | Interventions in the intervention arms consist of the following key components:
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| Measure | Description | Time Frame |
|---|---|---|
| Population-level TB prevalence | 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. | Semi-annual screening (up to 2 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in TB treatment outcomes | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Improved Knowledge, attitude and practices (KAP) regarding tuberculosis among participants in intervention sites (woredas). | The tuberculosis (TB) knowledge, attitude and practices (KAP) survey tool (both open and close ended questions) will be administered at baseline and at year two to measure health seeking behaviors, TB knowledge and awareness, TB attitudes and care-seeking behaviors, TB attitudes and stigma, and TB awareness and sources of information among the participants in the intervention sites and control sites. The investigators will compare improvements in reports of knowledge from the KAP survey tool between baseline and at 2 years across both the control and intervention sites to understand if there are higher improvements at the intervention sites. |
Inclusion Criteria:
Adults:
Children
Younger children:
Exclusion Criteria:
Adults:
Children
Younger Children
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Oumer Ali, PhD | Contact | 617-250-9500 | oumer.ali@kncvtbc.org | |
| Zewdu Dememew, MD, PhD | Contact | 617-250-9500 | zgashu@msh.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gedebe Hassassa woreda | Recruiting | West Arsi Zone | Ormoia Regional State | Ethiopia |
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A sequential exploratory mixed-method study with a dominant controlled before-after (or quasi-experimental) design will be the main design of this study, followed by qualitative methods. The aim of the qualitative component is to explore whether the ETB intervention package is feasible and helps achieve TB elimination in Ethiopia. In-depth interviews (IDIs) and focus-group discussions (FGDs) with TB program managers and health extensions workers, community leaders, and selected heads of households involved the study will be conducted.
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| Routine TB program activities | Combination Product | In the control arm, the standard of care will continue per the national guideline. |
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| Baseline and at 2 years |
| Baseline and at 2 years |
| Boloso Bombe woreda | Recruiting | Wolayita Zone | South Ethiopia Regional State | Ethiopia |
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