Article Text

Community delivery of malaria intermittent preventive treatment in pregnancy: protocol of a quasi-experimental evaluation through multistage cluster sampling household surveys in four sub-Saharan African countries
  1. Clara Pons-Duran1,2,
  2. Mireia Llach1,
  3. Sergi Sanz1,
  4. Máximo Ramírez1,
  5. Susana Méndez1,
  6. Elaine Roman3,
  7. Maya Tholandi3,
  8. Franco Pagnoni1,
  9. Clara Menendez1,2,
  10. Raquel González1,2
  1. 1ISGlobal, Hospital Clínic - Universitat de Barcelona, Barcelona, Spain
  2. 2CIBER Epidemiología y Salud Pública (CIBERESP), Madrid, Spain
  3. 3Jhpiego, Baltimore, Maryland, USA
  1. Correspondence to Dr Raquel González; raquel.gonzalez{at}


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
  • epidemiology
  • 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.

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.

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