Background In sub-Saharan Africa (SSA), millions of pregnant women are exposed to malaria infection. The cornerstone of the WHO strategy to prevent malaria in pregnancy in moderate to high-transmission areas is the administration of intermittent preventive treatment (IPTp) with sulfadoxine-pyrimethamine at each scheduled antenatal care (ANC) visit. However, overall coverage remains low. ‘Transforming IPT for Optimal Pregnancy’ (TIPTOP) project aims at delivering IPTp at the community level (C-IPTp) to complement ANC provision with the goal of increasing IPTp coverage and improving maternal and infant’s health. This protocol describes the approach to measure the effect of this strategy through household surveys (HHS) in four SSA countries: Democratic Republic of Congo (DRC), Madagascar, Mozambique and Nigeria.
Methods and analysis A quasi-experimental evaluation has been designed. Delivery of C-IPTp will start first in one area per country, and later it will be extended to two more areas per country. HHS will be carried out before C-IPTp implementation in all study sites, at midterm in initial implementation areas, and after the implementation in all project areas. A multistage cluster sampling method will be followed for the selection of participants. Women of reproductive age who had a pregnancy that ended in the 6 or 12 months prior to the interview, depending on the survey, will be invited to participate by responding to a questionnaire. The main indicators will be coverage of three or more doses of IPTp and attendance to at least four ANC visits. A difference-in-difference analysis will be performed to evaluate the effectiveness of C-IPTp.
Ethics and dissemination The project has been reviewed by the ethics committees of WHO, Hospital Clinic of Barcelona and all project country boards. Project results will be disseminated to in-country stakeholders and at regional and international meetings. TIPTOP project aims to develop and disseminate global recommendations for C-IPTp delivery.
Trial registration number NCT03600844; Pre-results.
- infectious diseases
- infection control
- preventive medicine
- maternal medicine
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Contributors Conceived and designed the study: CP-D, ML, FP, CM and RG. Gave inputs to protocol methodology: CP-D, ML, SS, MR, SM, ER, MT, FP, CM and RG. Wrote the first draft of the manuscript: CP-D and RG. Wrote and approved the paper: CP-D, ML, SS, MR, SM, ER, MT, FP, CM and RG.
Funding This work was supported by UNITAID (2017-13-TIPTOP) through a sub-award signed with Jhpiego (17-SBA-101); the Spanish Ministry of Science and Innovation through the 'Centro de Excelencia Severo Ochoa 2019–2023' Programme (CEX2018-000806-S); the Generalitat de Catalunya through the CERCA Programme; and the Spanish Ministry of Education and Vocational Training (FPU15/03548 to CP-D).
Competing interests None declared.
Patient and public involvement statement Patients or the public will not be involved in the design, conduct, reporting, or dissemination plans of this research.
Patient consent for publication Not required.
Provenance and peer review Not commissioned; externally peer reviewed.
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