Demonstrating Multipronged and Optimized Novel Strategies to Reinforce Actions Targeted At Eliminating Tuberculosis (DeMONSTRATE-TB): a Sequential Exploratory Mixed Method Study in Ethiopia
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 131,438
- 试验地点
- 2
- 主要终点
- Population-level TB prevalence
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Greater than or equal to 18 years old
- •Provides consent
- •Living in study site area (woreda)
- •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
排除标准
- •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
- •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
研究组 & 干预措施
Enhanced community-wide TB intervention
Enhanced community-wide TB intervention strategy with intensive screening and health education
干预措施: Enhanced community-wide TB intervention (Combination Product)
Routine TB program activities
TB standard of care per Ethiopia's national guidelines
干预措施: Routine TB program activities (Combination Product)
结局指标
主要结局
Population-level TB prevalence
时间窗: 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.
次要结局
- Change in TB treatment outcomes(Baseline and at 2 years)