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

Malaria Journal

Methodology

Jean-Pierre Van geertruyden¹  Misago D. Seth²  Daniel P. Challe²  Daniel T. R. Minja²  Celine Mandara²  Vito Baraka²  Mathias Kamugisha²  Mercy Chiduo²  Samwel Gesase²  Athanas Mhina²  Method Segeja²  Filbert Francis²  Bruno P. Mmbando²  Edwin Liheluka²  George Mtove²  John P. A. Lusingu³  Geofrey Makenga⁴  Ally Mohamed⁵  Abdallah Lusasi⁵  Anna David⁵  Samwel Lazaro⁵  Frank Chacky⁶  Fabrizio Molteni⁷  Sumaiyya Thawer⁷  Alex Nkayamba⁸ 

[1] Global Health Institute, University of Antwerp, Antwerp, Belgium;National Institute for Medical Research, Tanga Centre, Tanga, Tanzania;National Institute for Medical Research, Tanga Centre, Tanga, Tanzania;Centre for Medical Parasitology, Institute of Medical Microbiology and Immunology, University of Copenhagen, Copenhagen, Denmark;National Institute for Medical Research, Tanga Centre, Tanga, Tanzania;Global Health Institute, University of Antwerp, Antwerp, Belgium;National Malaria Control Programme, Dodoma, Tanzania;National Malaria Control Programme, Dodoma, Tanzania;Global Health Institute, University of Antwerp, Antwerp, Belgium;Swiss Tropical and Public Health Institute, Allschwill, Switzerland;University of Basel, Basel, Switzerland;Tanzania Medicines and Medical Devices Authority, Dar es Salaam, Tanzania;

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

DOI  :  10.1186/s12936-022-04428-8

 received in 2022-06-28, accepted in 2022-12-23,  发布年份 2022

来源: Springer

【 摘 要 】

BackgroundIt 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 3rd 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.MethodsThe 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.ResultsThe 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.ConclusionsThrough 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

【 授权许可】

CC BY   
© The Author(s) 2023

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