Actively Recruiting

Phase 2
Phase 3
All Genders
Healthy Volunteers
NCT06719193

DeMONSTRATE-TB Study in Ethiopia

Led by Management Sciences for Health · Updated on 2024-12-05

131438

Participants Needed

2

Research Sites

96 weeks

Total Duration

On this page

Sponsors

M

Management Sciences for Health

Lead Sponsor

K

KNCV Tuberculosis Foundation

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

DeMONSTRATE-TB Study in Ethiopia

Who Can Participate

All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  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
Not Eligible

You will not qualify if you...

  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

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 2 locations

1

Gedebe Hassassa woreda

West Arsi Zone, Ormoia Regional State, Ethiopia

Actively Recruiting

2

Boloso Bombe woreda

Wolayita Zone, South Ethiopia Regional State, Ethiopia

Actively Recruiting

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Research Team

O

Oumer Ali, PhD

CONTACT

Z

Zewdu Dememew, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

PREVENTION

Number of Arms

2

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DeMONSTRATE-TB Study in Ethiopia | DecenTrialz