Field Studies on the Feasibility of Interrupting the Transmission of Soil-transmitted Helminths (STH) DeWorm3 Project
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 357,716
- 试验地点
- 3
- 主要终点
- STH transmission interruption
研究概览
简要总结
Over 1.5 billion people are infected with soil-transmitted helminths (STH). Global STH guidelines recommend MDA (mass drug administration) of albendazole or mebendazole to targeted populations, including pre-school age children and school-age children. However mathematical models suggests that current MDA strategies are not sufficient for interrupting disease transmission in most areas. Meanwhile many lymphatic filariasis (LF) programs have successfully treated entire populations with albendazole (in combination with ivermectin or diethylcarbamazine) and are transitioning to a state of post-MDA surveillance. This project will conduct a series of community-based cluster randomized trials in India, Malawi, and Benin to determine if maintaining three years of MDA with albendazole to entire communities following the cessation of LF programs can interrupt STH transmission in focal geographic areas. Additionally, this study aims to compare the efficacy of community-wide MDA versus targeted MDA of children in interrupting the transmission of STH. Nested implementation science research will be used to optimize the intervention, identify contextual factors influencing trial efficacy, and evaluate the feasibility of sustaining and scaling community-wide MDA for STH. These data will provide evidence necessary to inform future guidelines, policies, and operational plans as country partners engage in intensified approaches to eliminate these disabling diseases.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Mass drug administration intervention is not blinded to study participants but investigators and outcome assessors remain blind to link between allocation and outcome data
入排标准
- 年龄范围
- 12 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Treatment Inclusion Criteria:
- •Ages 12 months and older
排除标准
- •Children under 12 months of age
- •Pregnant women in their first trimester
- •History of adverse reaction to benzimidazoles
- •Outcome Sampling Inclusion Criteria:
- •Resident of study clusters
- •Ages 12 months and older
- •Willingness of adult aged 18 years and above (or age as per country specific ethical guidelines) or parent/guardian of child to provide written informed consent
- •Provision of written assent to participate from children aged 8 years and above (or age as per country specific ethical guidelines)
- •Outcome Sampling Exclusion Criteria:
- •Less than 12 months of age
- •Individuals who do not typically reside in the study cluster
- •Nonconsenting or assenting individuals, as applicable
研究组 & 干预措施
Community-wide deworming
Twice-yearly community-wide treatment delivered by drug distributors door to door or via community gatherings, depending upon the format of the prior LF program, for three years. All individuals above the age of 12 months will receive a single dose of albendazole.
干预措施: Albendazole (Drug)
Targeted deworming
Pre-school (pre-SAC) and school-age children (SAC) 12 months of age and older will receive albendazole delivered in accordance with national Ministry of Health guidelines for three years.
干预措施: Albendazole (Drug)
结局指标
主要结局
STH transmission interruption
时间窗: 5 years (Three years of drug administration and two years of surveillance)
Prevalence of STH infection ≤2% 24 months following the final round of mass drug administration with albendazole
次要结局
未报告次要终点
研究者
Judd Walson
Professor in Departments of Global Health, Medicine (Infectious Disease), Pediatrics and Epidemiology
University of Washington