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.
Epidemiology
Infectious diseases
Malaria
Maternal and child health
Pregnant women
Tropical medicine
Women with a child less than 12 months of age
Journal
BMC public health
ISSN: 1471-2458
Titre abrégé: BMC Public Health
Pays: England
ID NLM: 100968562
Informations de publication
Date de publication:
02 Jan 2024
02 Jan 2024
Historique:
received:
16
09
2023
accepted:
18
12
2023
medline:
4
1
2024
pubmed:
4
1
2024
entrez:
3
1
2024
Statut:
epublish
Résumé
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. 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. 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. Retrospectively registered on August 11th, 2022; registration # PACTR202208844472053. Protocol v4.0 dated September 04, 2023. Trail sponsor: University of Sciences Techniques and Technologies of Bamako (USTTB), Mali.
Sections du résumé
BACKGROUND
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
METHODS
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
CONCLUSIONS
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
BACKGROUND
Retrospectively registered on August 11th, 2022; registration # PACTR202208844472053. Protocol v4.0 dated September 04, 2023. Trail sponsor: University of Sciences Techniques and Technologies of Bamako (USTTB), Mali.
Identifiants
pubmed: 38166711
doi: 10.1186/s12889-023-17529-z
pii: 10.1186/s12889-023-17529-z
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
43Subventions
Organisme : European and Developing Countries Clinical Trials Partnership
ID : RIA2020S-3302
Organisme : European and Developing Countries Clinical Trials Partnership
ID : RIA2020S-3302
Organisme : European and Developing Countries Clinical Trials Partnership
ID : RIA2020S-3302
Organisme : European and Developing Countries Clinical Trials Partnership
ID : RIA2020S-3302
Organisme : European and Developing Countries Clinical Trials Partnership
ID : RIA2020S-3302
Organisme : European and Developing Countries Clinical Trials Partnership
ID : RIA2020S-3302
Organisme : European and Developing Countries Clinical Trials Partnership
ID : RIA2020S-3302
Organisme : European and Developing Countries Clinical Trials Partnership
ID : RIA2020S-3302
Organisme : European and Developing Countries Clinical Trials Partnership
ID : RIA2020S-3302
Organisme : European and Developing Countries Clinical Trials Partnership
ID : RIA2020S-3302
Organisme : European and Developing Countries Clinical Trials Partnership
ID : RIA2020S-3302
Organisme : European and Developing Countries Clinical Trials Partnership
ID : RIA2020S-3302
Organisme : European and Developing Countries Clinical Trials Partnership
ID : RIA2020S-3302
Organisme : European and Developing Countries Clinical Trials Partnership
ID : RIA2020S-3302
Organisme : European and Developing Countries Clinical Trials Partnership
ID : RIA2020S-3302
Organisme : European and Developing Countries Clinical Trials Partnership
ID : RIA2020S-3302
Informations de copyright
© 2023. The Author(s).
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