REACH Côte d'Ivoire: Feasibility and Acceptability of Integrating Mass Distribution of Azithromycin to Children 1-11 Months Into a Trachoma Mass Drug Administration Campaign to Reduce Child Mortality
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- FHI 360
- 入组人数
- 1,735
- 试验地点
- 1
- 主要终点
- Proportion of children 1 to 11 months reached with single-dose azithromycin
研究概览
简要总结
The aim of the study is to gather preliminary evidence on the operational feasibility and acceptability of integrating bi-annual mass drug administration (MDA) of single-dose azithromycin for children ages 1 to 11 months in high child mortality settings in Côte. The cross-sectional study will be carried out in conjunction with a single trachoma MDA in selected villages within one health district. Data on feasibility and acceptability will be collected through three main activities:
- Analyses of existing routine monitoring, process, and adverse drug reaction data from the trachoma MDA platform into which the pilot activities are being integrated
- A cross-sectional, post-MDA coverage survey
- Qualitative data collection among targeting parents or primary caregivers of children ages 1 to 11 months in the pilot districts, and district-level MDA implementers, regarding the proposed azithromycin program.
详细描述
Purpose: The aim of the study is to gather preliminary evidence on the operational feasibility and acceptability of integrating bi-annual mass drug administration (MDA) of single-dose azithromycin for children ages 1 to 11 months in high child mortality settings in Côte d'Ivoire into the existing trachoma MDA platform to inform large scale implementation.
Design: The cross-sectional study will be carried out in conjunction with a single trachoma MDA in selected villages within one health district. Data on feasibility and acceptability will be collected through three main activities:
- Analyses of existing routine monitoring, process, and adverse drug reaction data from the trachoma MDA platform into which the pilot activities are being integrated
- A cross-sectional, post-MDA coverage survey
- Qualitative data collection among targeting parents or primary caregivers of children ages 1 to 11 months in the pilot districts, and district-level MDA implementers, regarding the proposed azithromycin program.
Population: For expanded use of azithromycin: Infants ages 1 to 5 months who reside in one pilot district in high under-5 years child mortality regions in Côte d'Ivoire (approximately 2,800 to be enrolled).
Post-MDA coverage survey and interviews for acceptability: Parents/primary caregivers of infants aged 1 to 11 months who reside in the two pilot districts will be targeted for the post-MDA coverage survey and in-depth interviews (n=up to 24) to explore acceptability (approximately 275 to be enrolled).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 1 Month 至 5 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Child aged 1 month (at least 30 days) to less than 6 months at the beginning of the week of the MDA intervention
- •Resident in study communities
排除标准
- •Children below 3.0 kg
- •Appears severely ill at the time of the MDA (per the CDD's assessment)
- •Unable to swallow liquid delivered through a needle-less syringe because of physical limitations
- •Known allergy to macrolides, including azithromycin, based on the primary caregiver's report of prior adverse reaction to medication likely to be a macrolide
研究组 & 干预措施
Azithromycin
All children ages 1 to 5 months in the targeted health district will be offered a single dose of azithromycin suspension dosed at 20 mg per kg of weight in place of the standard tetracycline ointment, during a mass drug administration targeting trachoma prevention and treatment. All children ages 6 months and older, and all adults already receive the single dose of azithromycin during the MDA event. For this pilot study, single dose of azithromycin is being extended to include the 1 to 5 month old population as well.
干预措施: Azithromycin (Drug)
结局指标
主要结局
Proportion of children 1 to 11 months reached with single-dose azithromycin
时间窗: 1 week
The proportion of children 1 to 11 months of age who receive a single dose of azithromycin during the MDA in the target health district.
次要结局
未报告次要终点