Implementation research of a cluster randomized trial evaluating the implementation and effectiveness of intermittent preventive treatment for malaria using dihydroartemisinin-piperaquine on reducing malaria burden in school-aged children in Tanzania: methodology, challenges, and mitigation

Abstract

Background: It has been more than 20 years since the malaria epidemiologic shift to school-aged children was noted. In the meantime, school-aged children (5-15 years) have become increasingly more vulnerable with asymptomatic malaria prevalence reaching up to 70%, making them reservoirs for subsequent transmission of malaria in the endemic communities. Intermittent Preventive Treatment of malaria in schoolchildren (IPTsc) has proven to be an effective tool to shrink this reservoir. As of 3^rd June 2022, the World Health Organization recommends IPTsc in moderate and high endemic areas. Even so, for decision-makers, the adoption of scientific research recommendations has been stifled by real-world implementation challenges. This study presents methodology, challenges faced, and mitigations used in the evaluation of the implementation of IPTsc using dihydroartemisinin-piperaquine (DP) in three councils (Handeni District Council (DC), Handeni Town Council (TC) and Kilindi DC) of Tanga Region, Tanzania so as to understand the operational feasibility and effectiveness of IPTsc on malaria parasitaemia and clinical malaria incidence.

Methods: The study deployed an effectiveness-implementation hybrid design to assess feasibility and effectiveness of IPTsc using DP, the interventional drug, against standard of care (control). Wards in the three study councils were the randomization unit (clusters). Each ward was randomized to implement IPTsc or not (control). In all wards in the IPTsc arm, DP was given to schoolchildren three times a year in four-month intervals. In each council, 24 randomly selected wards (12 per study arm, one school per ward) were chosen as representatives for intervention impact evaluation. Mixed design methods were used to assess the feasibility and acceptability of implementing IPTsc as part of a more comprehensive health package for schoolchildren. The study reimagined an existing school health programme for Neglected Tropical Diseases (NTD) control include IPTsc implementation.

Results: The study shows IPTsc can feasibly be implemented by integrating it into existing school health and education systems, paving the way for sustainable programme adoption in a cost-effective manner.

Conclusions: Through this article other interested countries may realise a feasible plan for IPTsc implementation. Mitigation to any challenge can be customized based on local circumstances without jeopardising the gains expected from an IPTsc programme. Trial registration clinicaltrials.gov, NCT04245033. Registered 28 January 2020, https://clinicaltrials.gov/ct2/show/NCT04245033.

Keywords: Anaemia; Cluster randomized trial; Dihydroartemisinin-piperaquine; Effectiveness; Evaluation; Implementation research; Malaria; Mitigation; Operation challenges.

Fig. 1

Map of Tanzania (A) and Tanga Region showing malaria endemicity (B) Population density (C) and elevation (D). The table shows population distribution in each council of Tanga Region categorized per malaria endemicity

Fig. 2

Malaria cases and rainfall trends per council

Fig. 3

Study design and ward allocation for intervention in three councils of Handeni DC, Handeni TC and Kilindi DC, Tanga, Tanzania

Fig. 4

Strategic approach for community engagement to IPTsc implementation. Legend; (CHMT = Council Health Management Team, WEO = Ward Education Officer, CO = Clinical officer)

Fig. 5

IPTsc effectiveness assessment flow chart. Legend: IPTsc = intermittent preventive treatment in school-aged children; DP = dihydroartemisinin-piperaquine; Hb = Haemoglobin concentration in g/dl; BS = Blood slide; ITT = intention-to-treat analysis; PP = per-protocol analysis