DeMONSTRATE-TB Study in Ethiopia

Demonstrating Multipronged and Optimized Novel Strategies to Reinforce Actions Targeted At Eliminating Tuberculosis (DeMONSTRATE-TB): a Sequential Exploratory Mixed Method Study in Ethiopia

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.

Study Overview

• Status: Recruiting
• Conditions: Reducing Tuberculosis Incidence
• Intervention / Treatment: Combination product: Enhanced community-wide TB intervention; Combination product: Routine TB program activities

• Study Type: Interventional
• Enrollment (Estimated): 131438
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Oumer Ali, PhD; Phone Number: 617-250-9500; Email: oumer.ali@kncvtbc.org
• Study Contact Backup: Name: Zewdu Dememew, MD, PhD; Phone Number: 617-250-9500; Email: zgashu@msh.org

Study Locations

• Ethiopia
  • Ormoia Regional State
    • West Arsi Zone, Ormoia Regional State, Ethiopia
      • Recruiting
      • Gedebe Hassassa woreda
      • Contact: Abu Emma; Phone Number: 617-250-9500; Email: abuemma80@yahoo.com
      • Contact: Mulatu Biru, PhD
  • South Ethiopia Regional State
    • Wolayita Zone, South Ethiopia Regional State, Ethiopia
      • Recruiting
      • Boloso Bombe woreda
      • Contact: Mulatu Biru, PhD
      • Contact: Dereje Alemu; Phone Number: 617-250-9500; Email: derejealemu@msh.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Enhanced community-wide TB intervention; Enhanced community-wide TB intervention strategy with intensive screening and health education	Combination product: Enhanced community-wide TB intervention; Interventions in the intervention arms consist of the following key components: 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;; 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;; community-based enhanced TPT; and; community-based awareness creation and health education using the community social associations.
Active Comparator: Routine TB program activities; TB standard of care per Ethiopia's national guidelines	Combination product: Routine TB program activities; In the control arm, the standard of care will continue per the national guideline.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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.	Baseline and at 2 years

Other Outcome Measures

Outcome Measure	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.	Baseline and at 2 years

Collaborators and Investigators

• Sponsor: Management Sciences for Health
• Collaborators: KNCV Tuberculosis Foundation

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2023
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: November 20, 2024
• First Submitted That Met QC Criteria: December 2, 2024
• First Posted (Estimated): December 5, 2024

Study Record Updates

• Last Update Posted (Estimated): December 5, 2024
• Last Update Submitted That Met QC Criteria: December 2, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: ethiopia; quasi experimental; tuberculosis preventive therapy; tuberculosis incidence; tuberculosis prevalence; tuberculosis elimination
• Additional Relevant MeSH Terms: Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Actinomycetales Infections; Mycobacterium Infections; Tuberculosis
• Other Study ID Numbers: 37.2022; 72066320CA00009 (Other Grant/Funding Number: USAID)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No