Evaluating the Effects of Community Delivery of Malaria Intermittent Preventive Treatment on Pregnant Women and Babies
- Conditions
- Malaria in Pregnancy
- Interventions
- Behavioral: Community distribution of SP for IPTp
- Registration Number
- NCT03600844
- Lead Sponsor
- Jhpiego
- Brief Summary
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).
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 10602
- 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)
- Anyone considered to be a minor in their country.
- Not willing to provide informed consent
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Phase 1 Intervention Community distribution of SP for IPTp Phase 1 intervention communities will be offered Community distribution of SP for IPTp in addition to routine ANC IPTp distribution throughout the project. Phase 1 Comparison/Phase 2 Intervention Community distribution of SP for IPTp During Phase 1 (intervention months 1 through 12), these communities will be offered only usual treatment--SP for IPTp at in facilities during routine ANC. During Phase 2 (intervention month 13 through the end of the project), these communities will be offered Community distribution of SP for IPTp, in addition to routine ANC IPTp distribution.
- Primary Outcome Measures
Name Time Method IPTp3 Coverage 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
- Secondary Outcome Measures
Name Time Method IPTp1 Coverage 1 year Proportion of women who have had a pregnancy that ended in the past 12 months and have received one or more doses of IPTp-SP
ANC 4 coverage 1 year • Proportion of women who have had a pregnancy that ended in the past 12 months and have attended ANC clinics four times
ANC 1 Coverage 1 year Proportion of women who have had a pregnancy that ended in the past 12 months and have attended ANC clinics at least once
Early ANC Coverage 1 year Proportion of pregnant women attending the first ANC visit before or at week 14
C-IPTp Knowledge 1 year Proportion of women who have had a pregnancy that ended in the past 12 months who know about the IPTp service provided by CHWs
Trial Locations
- Locations (6)
Bulungu District, Community Setting
🇨🇩Bulungu, Kwilu, Congo, The Democratic Republic of the
Nhamatanda District, Community Setting
🇲🇿Nhamatanda, Sofala, Mozambique
Community Setting
🇳🇬Akure South, Ondo, Nigeria
Kenge District, Community Setting
🇨🇩Kenge, Kwango, Congo, The Democratic Republic of the
Meconta District, Community Setting
🇲🇿Meconta, Nampula, Mozambique
Mananjary District, Community Setting
🇲🇬Mananjary, Fianarantsoa, Madagascar