Evaluating the Effects of Community Delivery of Malaria Intermittent Preventive Treatment on Pregnant Women and Babies

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Malaria in Pregnancy

Intervention / Treatment
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* Behavioral: Community distribution of SP for IPTp


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: Anyone considered to be a minor in their country. Not willing to provide informed consent

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Districts in high malaria transmission zones were assigned to intervention and comparison areas.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Phase 1 Intervention<br>Phase 1 intervention communities will be offered Community distribution of SP for IPTp in addition to routine ANC IPTp distribution throughout the project. | Behavioral: Community distribution of SP for IPTp<br>* SP is distributed to eligible pregnant women by trained Community Health Workers (CHWs) at community level. Demand creation activities are implemented within the community as well.<br>* Other names: C-IPTp-SP;|
| Active Comparator: Phase 1 Comparison/Phase 2 Intervention<br>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. | Behavioral: Community distribution of SP for IPTp<br>* SP is distributed to eligible pregnant women by trained Community Health Workers (CHWs) at community level. Demand creation activities are implemented within the community as well.<br>* Other names: C-IPTp-SP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IPTp3 Coverage | Proportion of women who had a pregnancy ending in the past 12 months and have received three or more doses of IPTp-SP | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IPTp1 Coverage | 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 | 1 year | 
| ANC 4 coverage | • Proportion of women who have had a pregnancy that ended in the past 12 months and have attended ANC clinics four times | 1 year | 
| ANC 1 Coverage | Proportion of women who have had a pregnancy that ended in the past 12 months and have attended ANC clinics at least once | 1 year | 
| Early ANC Coverage | Proportion of pregnant women attending the first ANC visit before or at week 14 | 1 year | 
| C-IPTp Knowledge | Proportion of women who have had a pregnancy that ended in the past 12 months who know about the IPTp service provided by CHWs | 1 year |