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DeMONSTRATE-TB Study in Ethiopia

NCT06719193 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 131438

Last updated 2024-12-05

No results posted yet for this study

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

Interventions

COMBINATION_PRODUCT

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.

COMBINATION_PRODUCT

Routine TB program activities

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

Sponsors & Collaborators

  • KNCV Tuberculosis Foundation

    collaborator OTHER

  • Management Sciences for Health

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SEQUENTIAL

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-02-27
Primary Completion
2025-01-01
Completion
2025-01-01

Countries

  • Ethiopia

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06719193 on ClinicalTrials.gov