Table 2 Study objectives, outcomes, methods, and timeline
Study objectives | Outcomes | Methods | Timeline |
|---|---|---|---|
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 |