NCT06719193 DeMONSTRATE-TB Study in Ethiopia
| NCT ID | NCT06719193 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Management Sciences for Health |
| Condition | Reducing Tuberculosis Incidence |
| Study Type | INTERVENTIONAL |
| Enrollment | 131,438 participants |
| Start Date | 2023-02-27 |
| Primary Completion | 2025-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 131,438 participants in total. It began in 2023-02-27 with a primary completion date of 2025-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06719193 clinical trial?
This trial is open to participants of all sexes, studying Reducing Tuberculosis Incidence. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06719193 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06719193 currently recruiting?
Yes, NCT06719193 is actively recruiting participants. Contact the research team at oumer.ali@kncvtbc.org for enrollment information.
Where is the NCT06719193 trial being conducted?
This trial is being conducted at West Arsi Zone, Ethiopia, Wolayita Zone, Ethiopia.
Who is sponsoring the NCT06719193 clinical trial?
NCT06719193 is sponsored by Management Sciences for Health. The trial plans to enroll 131,438 participants.