Azithromycin for Child Survival in Niger: Delivery Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 10,925
- 试验地点
- 1
- 主要终点
- Treatment Coverage
研究概览
简要总结
This cluster-randomized trial aims to compare the impact of different delivery approaches to azithromycin distribution on coverage, costs, and feasibility outcomes. The investigators hypothesize that door-to-door delivery will have higher coverage and costs and similar feasibility and acceptability compared to fixed-point delivery.
详细描述
Azithromycin distribution has been shown to reduce mortality in children 1-59 months. This trial aims to contribute evidence on viable approaches to implementation as high mortality countries consider this intervention to improve child survival. From a pool of eligible rural and peri-urban communities in the Dosso Region in Niger, 80 will be randomly selected and randomized to receive door-to-door or fixed-point delivery of a single dose of azithromycin distribution to children 1-59 months of age via community health workers biannually. Treatment coverage, costs and cost-effectiveness, and feasibility and acceptability will be compared by arm.
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
- None
盲法说明
In the delivery trial, participants, implementers, and outcome assessors will not be actively masked from the delivery approach given the nature of the intervention.
入排标准
- 年龄范围
- 1 Month 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •At the community-level, eligibility includes:
- •Location in one of the 80 Dosso communities randomly selected for the delivery trial
- •Population 250 to 2,499*
- •Distance > 5 km from the district headquarters town
- •Verbal consent of community leader(s)
- •At the individual-level, eligibility includes:
- •Age 1-59 months
- •Primary residence in a study community
- •Verbal consent of caregiver/guardian for study participation
- •Weight ≥ 4 kg
排除标准
- •At the community-level, eligibility includes:
- •Inaccessible or unsafe for study team
- •"Quartier" designation on national census *Population size as estimated from the most recent national census or projections
- •At the individual-level, eligibility includes:
- •Known allergy to macrolides
研究组 & 干预措施
Azithro 1-59 fixed point
Azithromycin distribution to children 1-59 months of age using a fixed-point delivery approach via existing community health workers
干预措施: Azithromycin for Oral Suspension (Drug)
Azithro 1-59 door-to-door
Azithromycin distribution to children 1-59 months of age using a door-to-door delivery approach via existing community health workers
干预措施: Azithromycin for Oral Suspension (Drug)
结局指标
主要结局
Treatment Coverage
时间窗: 6 months
Treatment coverage as defined by the number of doses of azithromycin administered in each community divided by the total eligible population
次要结局
- Fidelity of intervention rollout(6 months)
- Program Costs(6 months)
- Acceptability of intervention(6 months)