DeMONSTRATE-TB Study in Ethiopia

NCT06719193 | Recruiting Phase 2 DMC

• 2 other identifiers: 37.202272066320CA00009
• Study Type: interventional
• Target: 131,438
• Locations: 1 country
• Sites: 2

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.

Conditions

Reducing Tuberculosis Incidence

Keywords

tuberculosis prevalence; tuberculosis incidence; tuberculosis elimination; tuberculosis preventive therapy; quasi experimental; ethiopia

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (1)

• Change in TB treatment outcomes

  Baseline and at 2 years

Other Outcomes (1)

• Improved Knowledge, attitude and practices (KAP) regarding tuberculosis among participants in intervention sites (woredas).

  Baseline and at 2 years

Study Arms (2)

Enhanced community-wide TB intervention

EXPERIMENTAL

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

Combination Product: Enhanced community-wide TB intervention

Routine TB program activities

ACTIVE COMPARATOR

TB standard of care per Ethiopia's national guidelines

Combination Product: Routine TB program activities

Interventions

Enhanced community-wide TB intervention COMBINATION_PRODUCT

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.

Enhanced community-wide TB intervention

Routine TB program activities COMBINATION_PRODUCT

In the control arm, the standard of care will continue per the national guideline.

Routine TB program activities

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults:
• Greater than or equal to 18 years old
• Provides consent
• Living in study site area (woreda)
• Children
• Aged 12 to 17 years
• Living in the study site area (woreda)
• Assent to enrollment
• Guardian provides consent for enrollment
• Younger children:
• Less than 12 years old
• Living in the study site area (woreda)
• Consent for enrollment provided by the guardian

You may not qualify if:

• 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
• 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
• Younger Children
• Guardian does not provide consent

Sponsors & Collaborators

• Management Sciences for Health: lead
• KNCV Tuberculosis Foundation: collaborator

Study Sites (2)

Gedebe Hassassa woreda

West Arsi Zone, Ormoia Regional State, Ethiopia

RECRUITING

Boloso Bombe woreda

Wolayita Zone, South Ethiopia Regional State, Ethiopia

RECRUITING

Central Study Contacts

Oumer Ali, PhD

CONTACT

617-250-9500; oumer.ali@kncvtbc.org

Zewdu Dememew, MD, PhD

CONTACT

617-250-9500; zgashu@msh.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 20, 2024
• First Posted: December 5, 2024
• Study Start: February 27, 2023
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: December 5, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

ET (2)