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临床试验/NCT03600844
NCT03600844已完成不适用

Evaluation of Community Delivery of Malaria Intermittent Preventive Treatment in Pregnancy (C-IPTp) (TIPTOP Project)

Jhpiego12 个研究点 分布在 4 个国家目标入组 10,602 人开始时间: 2018年4月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Jhpiego
入组人数
10,602
试验地点
12
主要终点
IPTp3 Coverage

研究概览

简要总结

This study evaluates the effectiveness of community delivery of sulfadoxine-pyrimetamine (SP) for intermittent preventive treatment of malaria in pregnancy (IPTp) in increasing the coverage of IPTp among pregnant women in selected districts in Democratic Republic of Congo (DRC), Madagascar, Mozambique and Nigeria, compared to comparison districts where SP for IPTp is distributed as usual in facilities through routine antenatal care (ANC).

详细描述

The specific objectives of this study are to determine the change in the following indicators during the course of the TIPTOP project: 1) Proportion of women who have had a pregnancy that ended in the past 12 months and have received 1 or more, 2 or more and 3 or more doses of IPTp-SP; proportion of women with pregnancy in the past 12 months who attended ANC clinics at least once, and who attended at least four times; proportion of pregnant women attending the first ANC visit before or at week 14; proportion of women who have had a pregnancy that ended in the past 12 months who know about the IPTp service provided by CHWs; and acceptability of C-IPTp for community delivery of IPTp (note: results will be disaggregated by provider type, age, gravidity and distance from facility). To assess these changes, the study will implement structured household surveys targeting potential beneficiaries of the project (pregnant women) in the intervention and comparison areas, implemented at three time points: baseline, mid- and end-points. In each country an initial implementation area (Phase I) and two expansion areas (Phase II) have been selected for the project. This study will establish if community deliver of IPTp is effective and feasible and whether it influences antenatal care service coverage rates. It is expected that the study will provide information to scale up the approach the 4 study countries for the prevention of malaria in pregnancy. This information is also meant to inform global guidelines on community IPTp delivery and may also be used by other countries.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
15 Years 至 49 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • Women who had a pregnancy that ended in the 12 months preceding the survey
  • Being resident in the study area during for at least 4 months before the end of the pregnancy
  • Willing to participate in the household survey (signing informed consent/assent, in line with country guidelines)

排除标准

  • Anyone considered to be a minor in their country.
  • Not willing to provide informed consent

结局指标

主要结局

IPTp3 Coverage

时间窗: 1 year

Proportion of women who had a pregnancy ending in the past 12 months and have received three or more doses of IPTp-SP

次要结局

  • IPTp1 Coverage(1 year)
  • ANC 4 coverage(1 year)
  • ANC 1 Coverage(1 year)
  • Early ANC Coverage(1 year)
  • C-IPTp Knowledge(1 year)

研究者

发起方
Jhpiego
申办方类型
Other
责任方
Sponsor

研究点 (12)

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