Reducing Tuberculosis IncidencePhase 2/3NCT06719193
DeMONSTRATE-TB Study in Ethiopia
A Phase 2/3 study testing Enhanced community-wide TB intervention and Routine TB program activities in people with Reducing Tuberculosis Incidence, run by Management Sciences for Health at 2 sites in Ethiopia.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Reducing Tuberculosis Incidence
- What is being tested?
- Enhanced community-wide TB intervention and Routine TB program activities
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 131,438 participants
- Where
- 2 sitesEthiopia
- Study dates
- 27 Feb 2023to 1 Jan 2025
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Adults:
- Greater than or equal to 18 years old
- Provides consent
- Living in study site area (woreda)
- Children
- Aged 12 to 17 years
Show all 13Show fewer
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Ethiopia2 sites, 2 recruiting
- Recruiting
Gedebe Hassassa woreda
West Arsi Zone, Ormoia Regional State
Abu Emma, 617-250-9500, abuemma80@yahoo.com
Mulatu Biru, PhD
- Recruiting
Boloso Bombe woreda
Wolayita Zone, South Ethiopia Regional State
Dereje Alemu, 617-250-9500, derejealemu@msh.org
Mulatu Biru, PhD
About this study
Official title: 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.
- Conditions
- Reducing Tuberculosis Incidence
- Being tested
- Enhanced community-wide TB intervention, Routine TB program activities
- Keywords
- tuberculosis prevalence, tuberculosis incidence, tuberculosis elimination, tuberculosis preventive therapy, quasi experimental, ethiopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced community-wide TB interventionCombination 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 activitiesCombination product
In the control arm, the standard of care will continue per the national guideline.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced community-wide TB intervention | Experimental | Enhanced community-wide TB intervention strategy with intensive screening and health education Receives: Combination Product: Enhanced community-wide TB intervention |
| Routine TB program activities | Active comparator | TB standard of care per Ethiopia's national guidelines Receives: Combination Product: Routine TB program activities |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Semi-annual screening (up to 2 years)
Secondary outcomes (1)
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.
Measured: Baseline and at 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2024
- Study start27 Feb 2023
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reducing Tuberculosis IncidenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 131,438 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Management Sciences for Health
- Sponsor type
- University, hospital or other
- Collaborators
- KNCV Tuberculosis Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06719193
- Sponsor's protocol ID
- 37.2022
- Other IDs
- 72066320CA00009
- Status last verified
- Dec 2024
- First submitted
- 20 Nov 2024
- Last updated
- 5 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Demonstrating Multipronged and Optimized Novel Strategies to Reinforce Actions Targeted At Eliminating Tuberculosis (DeMONSTRATE-TB): a Sequential Exploratory Mixed Method Study in Ethiopia
- ClinicalTrials.gov ID
- NCT06719193
- Acronym / sponsor ID
- 37.2022
- Conditions
- Reducing Tuberculosis Incidence
- Keywords
- tuberculosis prevalence, tuberculosis incidence, tuberculosis elimination, tuberculosis preventive therapy, quasi experimental, ethiopia
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 131,438 participants (estimated)
- Lead sponsor
- Management Sciences for HealthUniversity, hospital or other
- Collaborators
- KNCV Tuberculosis Foundation
- Study start
- 27 Feb 2023 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 5 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Enhanced community-wide TB intervention | Experimental | Combination Product: Enhanced community-wide TB interventionEnhanced community-wide TB intervention strategy with intensive screening and health education |
| Routine TB program activities | Active comparator | Combination Product: Routine TB program activitiesTB standard of care per Ethiopia's national guidelines |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (13 listed)
- Adults:
- Children
- Younger children:
Key exclusion criteria (19 listed)
- Adults:
- Children
- Younger Children
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enhanced community-wide TB interventionInterventions 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 | Enhanced community-wide TB intervention |
| Routine TB program activitiesIn the control arm, the standard of care will continue per the national guideline. | Combination product | Routine TB program activities |
Primary outcome
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.
1 secondary outcome
Change in TB treatment outcomes
Time frame: Baseline and at 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2024.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Enhanced community-wide TB intervention and Routine TB program activities in people with Reducing Tuberculosis Incidence, run by Management Sciences for Health at 2 sites in Ethiopia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Ethiopia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Oumer Ali, PhD (617-250-9500, oumer.ali@kncvtbc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Population-level TB prevalence (time frame: Semi-annual screening (up to 2 years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2024; AzTrials last refreshed its copy on 28 Oct 2026.