Recruiting

NCT Number: NCT06719193

DeMONSTRATE-TB 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.

Recruiting

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Key information

Conditions

Reducing Tuberculosis Incidence

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Gedebe Hassassa woreda, West Arsi Zone, Ormoia Regional State, Ethiopia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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
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

Treatment and study plan

Enhanced community-wide TB intervention

Combination Product

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.

Routine TB program activities

Combination Product

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

Primary outcomes

Population-level TB prevalence

Time frame: Semi-annual screening (up to 2 years)

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.

Secondary outcomes

Change in TB treatment outcomes

Time frame: Baseline and at 2 years

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.

Other outcomes

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

Time frame: Baseline and at 2 years

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Oumer Ali, PhD

CONTACT

[email protected]

617-250-9500

Zewdu Dememew, MD, PhD

CONTACT

[email protected]

617-250-9500

Sponsors and collaborators

Lead sponsor

Management Sciences for Health

Other

Collaborators

KNCV Tuberculosis Foundation

Registry information

Official study title

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

Important dates

Study start: 2023
Primary completion: 2025
Study completion: 2025
First posted: Dec 5, 2024
Registry last updated: Dec 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.