Increasing the uptake of Intermittent Preventive Treatment of malaria in pregnancy using Sulfadoxine-Pyrimethamine (IPTp-SP) through seasonal malaria chemoprevention channel delivery: protocol of a multicenter cluster randomized implementation trial in Mali and Burkina Faso

Author:

Koita Kadiatou1,Bognini Joel D.2,Agboraw Efundem3,Dembele Mahamadou1,Yabre Seydou2,Bihoun Biebo2,Coulibaly Oumou1,Niangaly Hamidou4,N’Takpe Jean-Batiste5,Lesosky Maia6,Scaramuzzi Dario7,Worrall Eve6,Hill Jenny6,Briand Valérie8,Tinto Halidou2,Kayentao Kassoum1

Affiliation:

1. University of Sciences Techniques and Technologies of Bamako

2. Institut de Recherche en Sciences de la Santé (IRSS), Unité de Recherche Clinique de Nanoro

3. Liverpool School of Tropical Medicine, Vector Biology

4. Institut National de Recherche en Santé Publique, Recherches Médicale et Communautaire

5. University of Bordeaux, National Institute for Health and Medical Research

6. Liverpool School of Tropical Medicine, Department of Clinical Sciences

7. R-Evolution Worldwide Srl Impresa Sociale (REvoWWIS)

8. University of Bordeaux, National Institute for Health and Medical Research (INSERM) UMR 1219, Bordeaux Population Health Centre

Abstract

Abstract Background The uptake of Intermittent Preventive Treatment of malaria in pregnancy using Sulfadoxine-Pyrimethamine (‎IPTp-SP)‎ remains unacceptably low, with more than two-thirds of pregnant women in sub-Saharan Africa still not accessing the three or more doses recommended by the World Health Organisation (WHO). In contrast, the coverage of Seasonal Malaria Chemoprevention (SMC), a more recent strategy recommended by the WHO for malaria prevention in children under five years living in Sahelian countries with seasonal transmission, including Mali and Burkina-Faso, is high (up to 90%). We hypothesized that IPTp-SP delivery to pregnant women through SMC alongside antenatal care (ANC) will increase IPTp-SP coverage, boost ANC attendance, and increase public health impact. This protocol describes the approach to assess acceptability, feasibility, effectiveness, and cost-effectiveness of the integrated strategy. Methods and Analysis : This is a multicentre, cluster-randomized, implementation trial of IPTp-SP delivery through ANC + SMC vs ANC alone in 40 health facilities and their catchment populations (20 clusters per arm). The intervention will consist of monthly administration of IPTp-SP through four monthly rounds of SMC during the malaria transmission season (July to October), for two consecutive years. Effectiveness of the strategy to increase coverage of three or more doses of IPTp-SP (IPTp3+) will be assessed using household surveys and ANC exit interviews. Statistical analysis of IPT3 + and four or more ANC uptake will use a generalized linear mixed model. Feasibility and acceptability will be assessed through in-depth interviews and focus group discussions with health workers, pregnant women, and women with a child < 12 months. Discussion This multicentre cluster randomized implementation trial powered to detect a 45% and 22% increase in IPTp-SP3 + uptake in Mali and Burkina-Faso, respectively, will generate evidence on the feasibility, acceptability, effectiveness, and cost-effectiveness of IPTp-SP delivered through the ANC + SMC channel. The intervention is designed to facilitate scalability and translation into policy by leveraging existing resources, while strengthening local capacities in research, health, and community institutions. Findings will inform the local national malaria control policies. Trial registration : Retrospectively registered on August 11th, 2022; registration # PACTR202208844472053

Publisher

Research Square Platform LLC

Reference29 articles.

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2. World malaria report. 2022 [Internet]. [cited 2023 Jan 29]. Available from: https://www.who.int/teams/global-malaria-programme/reports/world-malaria-report-2022.

3. World Health Organization. Intermittent preventive Treatment of malaria in pregnancy using Sulfadoxine-Pyrimethamine (IPTp-SP): Updated WHO Policy Recommendation (No. WHO/HTM/GMP. 2012.05) [Internet]. World Helath Organization. 2012 [cited 2022 Oct 28]. Available from: https://apps.who.int/iris/bitstream/handle/10665/337990/WHO-HTM-GMP-2012.05-eng.pdf.

4. World Health Organization. World malaria day 2017: malaria prevention works, let’s close the gap [Internet]. 2017 [cited 2022 Nov 6]. Available from: https://apps.who.int/iris/handle/10665/254991.

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