Scaling up the Use of Sulphadoxine-Pyrimethamine for the Preventive Treatment of Malaria in Pregnancy: Results and Lessons on Scalability, Costs and Program From Three Local Government Areas in Sokoto State, Nigeria
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31,493
- 主要终点
- Percentage of participants that got SP coverage among all pregnant women
研究概览
简要总结
The purpose of this study is to test the feasibility of the scale-up of sulphadoxine- pyrimethamine (SP) for the preventive treatment of malaria in pregnancy in three Local Government Areas (LGAs) in Sokoto State, Nigeria. The scale-up strategy tested included the introduction of community-based distribution of SP in addition to ongoing health facility distribution during antenatal care (ANC) visits. In addition, the study examined for the effect of SP use by participants during pregnancy on the head circumference of live newborns and on the odds of a baby being a stillborn. Finally, the investigators also sought to quantify the costs associated with program scale up SP to deliver at least three doses of SP per participant via a government operated distribution program.
详细描述
Study Objectives
The study objectives were to:
- Examine scale-up mechanisms that enable increased SP coverage through community-based primary health care delivery, without reducing facility uptake of SP.
- Examine community acceptance of SP and the likelihood of long-term community-sustained demand.
- Document associations, if any, between increased SP coverage and improved intrauterine conditions for newborn, as measured by head circumference increments and declines in still birth rates.
- Estimate the costs of delivering SP at scale per woman for a three doses or higher regimen.
Study Location and Relevant Contextual Information
The study was undertaken in four LGAs: Dange Shuni Goronyo and Silame (combined 2015 population, according to official Sokoto State estimates = 661,606) LGAs which were purposively selected as intervention LGAs; and Yabo LGA, the fourth (2015 population, according to official Sokoto State estimates = 167,971), was purposively selected as the counterfactual LGA. The selection criteria were that all LGAs had a high prevalence of malaria in pregnancy and that at one LGA each in the intervention group, was selected from each of the State's three senatorial zones.
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
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Participants must be pregnant.
- •Pregnant participants must have experienced quickening in course of gestation.
- •Participants must reside in an intervention or a counterfactual LGA.
排除标准
- •Non-pregnant residents in a counterfactual or an intervention LGA.
- •Non-residents of counterfactual or intervention LGA.
研究组 & 干预措施
Community distribution of SP
All the eligible pregnant women were reached with SP either at health clinic and/or at community/household level with sulphadoxine-pyrimethamine (SP). Alerts and reminders were sent to them by community-based health volunteers ahead of subsequent SP doses.
干预措施: Community distribution of SP (Drug)
结局指标
主要结局
Percentage of participants that got SP coverage among all pregnant women
时间窗: Up to 7 months
The percentage SP coverage among all pregnant participants and by number of SP doses ingested. The outcome form will be used to obtain an aggregate number of women that received SP. The total number of eligible women will be obtained from either an enumeration of eligible women in the intervention LGA, or by population estimation in the counterfactual LGA.
次要结局
- Cost per Woman served with SP in Nigeria Naira(Up to 7 months)
- Cost per SP dose delivered in Nigeria Naira(Up to 12 months)
- Incidence of Stillbirths in stillbirths per 1000 term births(Up to 7 months)
- Head circumference of Newborn in millimeters(Up to 7 months)
研究者
Nosa Orobaton
Senior Advisor, Global Health/Chief of Party
JSI Research & Training Institute, Inc.