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Controlled Clinical Trial
. 2023 Feb 22;22(1):63.
doi: 10.1186/s12936-023-04488-4.

A non-randomized controlled trial to assess the protective effect of SMC in the context of high parasite resistance in Uganda

Anthony Nuwa  1 , Kevin Baker  2   3 , Craig Bonnington  2 , Musa Odongo  4 , Tonny Kyagulanyi  4 , John Baptist Bwanika  4 , Sol Richardson  2   5 , Jane Nabakooza  6 , Jane Achan  2 , Richard Kajubi  4 , David Salandini Odong  4 , Maureen Nakirunda  4 , Godfrey Magumba  4 , Geofrey Beinomugisha  4 , Madeleine Marasciulo-Rice  7 , Hilda Abio  4 , Christian Rassi  2 , Damian Rutazaana  6 , Denis Rubahika  6 , James Tibenderana  2 , Jimmy Opigo  6
Affiliations
Controlled Clinical Trial

A non-randomized controlled trial to assess the protective effect of SMC in the context of high parasite resistance in Uganda

Anthony Nuwa et al. Malar J. .

Abstract

Background: Until recently, due to widespread prevalence of molecular markers associated with sulfadoxine-pyrimethamine (SP) and amodiaquine (AQ) resistance in east and southern Africa, seasonal malaria chemoprevention (SMC) has not been used at scale in this region. This study assessed the protective effectiveness of monthly administration of SP + AQ (SPAQ) to children aged 3-59 months in Karamoja sub-region, Uganda, where parasite resistance is assumed to be high and malaria transmission is seasonal.

Methods: A two-arm quasi-experimental, open-label prospective non-randomized control trial (nRCT) was conducted in three districts. In two intervention districts, 85,000 children aged 3-59 months were targeted to receive monthly courses of SMC using SPAQ during the peak transmission season (May to September) 2021. A third district served as a control, where SMC was not implemented. Communities with comparable malaria attack rates were selected from the three districts, and households with at least one SMC-eligible child were purposively selected. A total cohort of 600 children (200 children per district) were selected and followed using passive surveillance for breakthrough confirmed malaria episodes during the five-month peak transmission season. Malaria incidence rate per person-months and number of malaria episodes among children in the two arms were compared. Kaplan-Meier failure estimates were used to compare the probability of a positive malaria test. Other factors that may influence malaria transmission and infection among children in the two arms were also assessed using multivariable cox proportional hazards regression model.

Results: The malaria incidence rate was 3.0 and 38.8 per 100 person-months in the intervention and control groups, respectively. In the intervention areas 90.0% (361/400) of children did not experience any malaria episodes during the study period, compared to 15% (29/200) in the control area. The incidence rate ratio was 0.078 (95% CI 0.063-0.096), which corresponds to a protective effectiveness of 92% (95% CI 90.0-94.0) among children in the intervention area.

Conclusion: SMC using SPAQ provided high protective effect against malaria during the peak transmission season in children aged 3-59 months in the Karamoja sub-region of Uganda.

Keywords: Malaria case; Malaria episode; Protective efficacy; Resistance markers; Season malaria chemoprevention.

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Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Maps showing Karamoja region in Uganda (A) and the study districts in Karamoja region (B)
Fig. 2
Fig. 2
Schematic flow diagram of enrolment and follow-up
Fig. 3
Fig. 3
Proportion of malaria episodes observed during the follow-up period
Fig. 4
Fig. 4
Kaplan Meir plots comparing malaria infection among intervention and control districts
See this image and copyright information in PMC

References

    1. WHO. World Malaria report. Geneva, World Health Organization. 2021.
    1. WHO. World malaria report 2019. Geneva: World Health Organization. 2019.
    1. Uganda National Malaria Control Division (NMCD), Uganda Bureau of Statistics (UBOS) and I. Uganda Malaria Indicator Survey 2018–19. Kampala, Uganda, 2020.
    1. Uganda Ministry of Health. The Uganda Health Management information system. Kampala. Uganda, 2019.
    1. Nambuusi BB, Ssempiira J, Makumbi FE, Kasasa S, Vounatsou P. The effects and contribution of childhood diseases on the geographical distribution of all-cause under-five mortality in Uganda. Parasite Epidemiol Control. 2019;5:e00089. doi: 10.1016/j.parepi.2019.e00089. - DOI - PMC - PubMed

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