NCT06719193RecruitingPhase 2/3
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
Source: ClinicalTrials.gov · Last updated 5 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 131438 (estimated)
- First submitted
- 20 Nov 2024
- Start date
- 27 Feb 2023
- Primary completion date
- 1 Jan 2025
- Lead sponsor
- Management Sciences for Health
- Diseases
- Tuberculosis
- NCT number
- NCT06719193
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 131438
- From 27 Feb 2023 to the primary completion date, 1 Jan 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- 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
Who the study is looking for
- 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
Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Gedebe Hassassa woreda Coordinator of this site? Confirm its status | West Arsi Zone | Ethiopia | Recruiting |
| Boloso Bombe woreda Coordinator of this site? Confirm its status | Wolayita Zone | Ethiopia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.