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...
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| Format: | Article |
| Language: | English |
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BMC
2023-01-01
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| Series: | Malaria Journal |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s12936-022-04428-8 |
| _version_ | 1797958823342768128 |
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| author | Geofrey Makenga Misago D. Seth Vito Baraka Bruno P. Mmbando Daniel P. Challe Filbert Francis Athanas Mhina Daniel T. R. Minja Mercy Chiduo Celine Mandara Edwin Liheluka Samwel Gesase Method Segeja George Mtove Mathias Kamugisha Abdallah Lusasi Frank Chacky Anna David Sumaiyya Thawer Ally Mohamed Samwel Lazaro Fabrizio Molteni Alex Nkayamba Jean-Pierre Van geertruyden John P. A. Lusingu |
| author_facet | Geofrey Makenga Misago D. Seth Vito Baraka Bruno P. Mmbando Daniel P. Challe Filbert Francis Athanas Mhina Daniel T. R. Minja Mercy Chiduo Celine Mandara Edwin Liheluka Samwel Gesase Method Segeja George Mtove Mathias Kamugisha Abdallah Lusasi Frank Chacky Anna David Sumaiyya Thawer Ally Mohamed Samwel Lazaro Fabrizio Molteni Alex Nkayamba Jean-Pierre Van geertruyden John P. A. Lusingu |
| author_sort | Geofrey Makenga |
| collection | DOAJ |
| description | 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 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. 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 |
| first_indexed | 2024-04-11T00:24:16Z |
| format | Article |
| id | doaj.art-a3863b70d1014dc78103ae53bfdde915 |
| institution | Directory Open Access Journal |
| issn | 1475-2875 |
| language | English |
| last_indexed | 2024-04-11T00:24:16Z |
| publishDate | 2023-01-01 |
| publisher | BMC |
| record_format | Article |
| series | Malaria Journal |
| spelling | doaj.art-a3863b70d1014dc78103ae53bfdde9152023-01-08T12:05:25ZengBMCMalaria Journal1475-28752023-01-0122111610.1186/s12936-022-04428-8Implementation 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 mitigationGeofrey Makenga0Misago D. Seth1Vito Baraka2Bruno P. Mmbando3Daniel P. Challe4Filbert Francis5Athanas Mhina6Daniel T. R. Minja7Mercy Chiduo8Celine Mandara9Edwin Liheluka10Samwel Gesase11Method Segeja12George Mtove13Mathias Kamugisha14Abdallah Lusasi15Frank Chacky16Anna David17Sumaiyya Thawer18Ally Mohamed19Samwel Lazaro20Fabrizio Molteni21Alex Nkayamba22Jean-Pierre Van geertruyden23John P. A. Lusingu24National Institute for Medical Research, Tanga CentreNational Institute for Medical Research, Tanga CentreNational Institute for Medical Research, Tanga CentreNational Institute for Medical Research, Tanga CentreNational Institute for Medical Research, Tanga CentreNational Institute for Medical Research, Tanga CentreNational Institute for Medical Research, Tanga CentreNational Institute for Medical Research, Tanga CentreNational Institute for Medical Research, Tanga CentreNational Institute for Medical Research, Tanga CentreNational Institute for Medical Research, Tanga CentreNational Institute for Medical Research, Tanga CentreNational Institute for Medical Research, Tanga CentreNational Institute for Medical Research, Tanga CentreNational Institute for Medical Research, Tanga CentreNational Malaria Control ProgrammeNational Malaria Control ProgrammeNational Malaria Control ProgrammeSwiss Tropical and Public Health InstituteNational Malaria Control ProgrammeNational Malaria Control ProgrammeSwiss Tropical and Public Health InstituteTanzania Medicines and Medical Devices AuthorityGlobal Health Institute, University of AntwerpNational Institute for Medical Research, Tanga CentreAbstract 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 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. 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/NCT04245033https://doi.org/10.1186/s12936-022-04428-8MalariaEffectivenessDihydroartemisinin-piperaquineImplementation researchAnaemiaCluster randomized trial |
| spellingShingle | Geofrey Makenga Misago D. Seth Vito Baraka Bruno P. Mmbando Daniel P. Challe Filbert Francis Athanas Mhina Daniel T. R. Minja Mercy Chiduo Celine Mandara Edwin Liheluka Samwel Gesase Method Segeja George Mtove Mathias Kamugisha Abdallah Lusasi Frank Chacky Anna David Sumaiyya Thawer Ally Mohamed Samwel Lazaro Fabrizio Molteni Alex Nkayamba Jean-Pierre Van geertruyden John P. A. Lusingu 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 Malaria Effectiveness Dihydroartemisinin-piperaquine Implementation research Anaemia Cluster randomized trial |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | Malaria Effectiveness Dihydroartemisinin-piperaquine Implementation research Anaemia Cluster randomized trial |
| url | https://doi.org/10.1186/s12936-022-04428-8 |
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