Last Updated: 19/12/2024
Evaluating the Effects of Community Delivery of Malaria Intermittent Preventive Treatment on Pregnant Women and Babies
Objectives
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).
The specific objectives of this study are to determine the change in the following indicators during the course of the TIPTOP project:
- 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;
- Acceptability of C-IPTp for community delivery of IPTp (note: results will be disaggregated by provider type, age, gravidity and distance from facility).
ClinicalTrials.gov Identifier: NCT03600844
Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 10602 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Districts in high malaria transmission zones were assigned to intervention and comparison areas.
Masking: None (Open Label)
Primary Purpose: Prevention
Methodology:
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.
Apr 2018 — Oct 2021
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