Clinical trial NCT06719193: DeMONSTRATE-TB Study in Ethiopia
Official title: Demonstrating Multipronged and Optimized Novel Strategies to Reinforce Actions Targeted At Eliminating Tuberculosis (DeMONSTRATE-TB): a Sequential Exploratory Mixed Method Study in Ethiopia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Reducing Tuberculosis Incidence
Keywords: tuberculosis prevalence
tuberculosis incidence
tuberculosis elimination
tuberculosis preventive therapy
quasi experimental
ethiopia
Lead sponsor: Management Sciences for Health
Sponsor class: OTHER
Collaborators: name: KNCV Tuberculosis Foundation
First posted: 2024-12-05
Enrollment: 131438
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: 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.
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Population-level TB prevalence
timeFrame: Semi-annual screening (up to 2 years)
Secondary outcomes:
measure: Change in TB treatment outcomes
timeFrame: Baseline and at 2 years
Other outcomes:
measure: Improved Knowledge, attitude and practices (KAP) regarding tuberculosis among participants in intervention sites (woredas).
timeFrame: Baseline and at 2 years
Locations:
city: West Arsi Zone
country: Ethiopia
facility: Gedebe Hassassa woreda
state: Ormoia Regional State
city: Wolayita Zone
country: Ethiopia
facility: Boloso Bombe woreda
state: South Ethiopia Regional State
Study officials:
References: