Community-wide intervention to reduce tuberculosis incidence 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
This study is testing a new way to lower tuberculosis rates in Ethiopia by providing special prevention treatments and care to people at high risk, like those living with HIV and their families.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 131438 (estimated) |
| Sex | All |
| Sponsor | Management Sciences for Health Academic / other |
| Locations | 2 sites (West Arsi Zone, Ormoia Regional State and 1 other locations) |
| Trial ID | NCT06719193 on ClinicalTrials.gov |
What this trial studies
This study aims to significantly reduce tuberculosis (TB) incidence in Ethiopia by implementing a community-wide enhanced tuberculosis preventive therapy (TPT) alongside comprehensive TB prevention and care packages. The approach targets high-risk populations, including household contacts and individuals living with HIV, to maximize TB prevention efforts. The study will assess the effectiveness, acceptability, and cost-effectiveness of these interventions in local communities. The ultimate goal is to develop a TB elimination framework based on the findings to aid in the fight against TB in high-burden regions of Ethiopia.
Who should consider this trial
Good fit: Ideal candidates for this study include adults and children living in the study site areas who are at risk of developing TB.
Not a fit: Patients who do not reside in the study site areas or who decline to provide consent or assent will not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could lead to a substantial decrease in TB incidence, contributing to the goal of eliminating TB in Ethiopia by 2035.
How similar studies have performed: Other studies have shown success with community-wide TB interventions, indicating that this approach is promising and builds on existing evidence.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
West Arsi Zone, Ormoia Regional State and 1 other locations
- Gedebe Hassassa woreda — West Arsi Zone, Ormoia Regional State, Ethiopia (Recruiting)
- Boloso Bombe woreda — Wolayita Zone, South Ethiopia Regional State, Ethiopia (Recruiting)
Study contacts
- Study coordinator: Oumer Ali, PhD
- Email: oumer.ali@kncvtbc.org
- Phone: 617-250-9500
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.