Background
Methods/Designs
Objectives and hypothesis
Study design
Study population
Inclusion criteria
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Clusters: Government and community owned HFs.
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Participants living in the catchment area of selected government and community HFs in the study sites/clusters.
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Participants’ written informed consent.
Exclusion criteria
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Private HFs, ANC attendees of private HFs and staff of private HFs.
Sampling methods
Study site
Randomization and treatment allocation
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Intervention arm
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Control arm
Sample size calculation
Primary endpoint – IPTp3 + at endline
Sample size – IPTp-SP and SMC coverages at baseline
Country | Outcomes | Estimated sample size | Estimated number of households to be visiteda | |
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Mali | Estimated IPTp3 + | 28%, up to 40% | 775 | 3,875 |
Estimated SMC coverage 4 doses | 54% | 802 | 802 | |
Burkina Faso | Estimated IPTp3 + | 58% | 786 | 3,930 |
Estimated SMC coverage 4 doses | 90% | 290 | 290 |
Sample size – SMC coverage at endline
Secondary endpoints
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Feasibility and acceptability
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Systems effectiveness
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Exploratory COVID
Data collection
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Primary endpoints—Household surveys for IPTp-SP, SMC, and ANC
Secondary endpoints
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Feasibility and acceptability
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Exploratory COVID
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Systems effectiveness: ANC exit interview
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Process evaluation
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Clinical outcomes
Study objectives | Outcomes | Methods | Timeline |
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1. To compare the delivery of IPTp-SP through the integrated strategy (ANC + SMC) with standard care (ANC) | The proportion of women who received at least 3 doses of IPTp-SP during pregnancy | • Household survey of women with a child < 12 months | • Baseline • Endline |
2. To assess the acceptability and feasibility of ANC + SMC delivery of IPTp-SP compared to standard care (ANC) among health providers, CHWs, and pregnant women and women with a child < 12 months | Major themes emerging through thematic analysis using a theory of acceptability (developed a priori) | • In-depth interviews • Focus group discussions | • Endline |
3. To assess the systems effectiveness of the integrated delivery of IPTp-SP | Cumulative systems effectiveness of IPTp-SP delivery at ANC + SMC | • ANC exit interview of ANC attendees | • Endline |
4. To assess any increase or decrease in ANC uptake following the integrated ANC + SMC IPTp-SP delivery | The proportion of women with 4 + ANC visits during pregnancy | • Household surveys of women with a child < 12 months • Routine data collection: individual facility data on ANC attendance | • Baseline • Endline • Throughout the trial |
5. To assess any increase or decrease in SMC uptake following the integrated ANC + SMC IPTp-SP delivery | The proportion of children 3–59 months who received 4 doses of SMC | • Household surveys of mothers of children 3–59 months | • Baseline • Endline |
6. To estimate the number of malaria cases in both children and pregnant women over the course of the trial, by arm | Confirmed malaria • incidence rates and malaria positivity (RDT + /RDT performed) ratios | • Routine data collection: individual facility data on malaria cases for pregnant women and children 3–59 months | • Throughout the trial |
7. To estimate the number of poor birth outcomes in women over the course of the trial, by arm | • The proportion of women with miscarriage, stillbirth, low birth weight, or preterm birth | • Routine data collection: individual facility data on birth outcomes | • Throughout the trial |
8. To assess care-seeking practices during COVID and the anticipated acceptability of the integrated strategy of ANC + SMC delivery of IPTp-SP | • Major themes emerging through thematic analysis using a theory of acceptability (developed a priori) | • In-depth interviews with healthcare providers • Focus group discussions with women | • Baseline |