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Mass drug administration (MDA) of artemisinin-based combination therapy (ACT) is capable of reducing malaria transmission where coverage of control interventions is already high, though the impact is short-lived. Combining ACT with ivermectin, an oral endectocide shown to reduce vector survival, may increase its impact, while also treating ivermectin-sensitive co-endemic diseases and minimising the potential impact of ACT resistance in this context.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>\n                      MATAMAL is a cluster-randomised placebo-controlled trial. The trial is being conducted in 24 clusters on the Bijag\u00f3s Archipelago, Guinea-Bissau, where the peak prevalence of\n                      <jats:italic>Plasmodium falciparum<\/jats:italic>\n                      (\n                      <jats:italic>Pf<\/jats:italic>\n                      ) parasitaemia is approximately 15%. Clusters have been randomly allocated to receive MDA with dihydroartemisinin\u2013piperaquine and either ivermectin or placebo. The primary objective is to determine whether the addition of ivermectin MDA is more effective than dihydroartemisinin\u2013piperaquine MDA alone in reducing the prevalence of\n                      <jats:italic>P. falciparum<\/jats:italic>\n                      parasitaemia, measured during peak transmission season after 2 years of seasonal MDA. Secondary objectives include assessing prevalence after 1 year of MDA; malaria incidence monitored through active and passive surveillance; age-adjusted prevalence of serological markers indicating exposure to\n                      <jats:italic>P. falciparum<\/jats:italic>\n                      and anopheline mosquitoes; vector parous rates, species composition, population density and sporozoite rates; prevalence of vector pyrethroid resistance; prevalence of artemisinin resistance in\n                      <jats:italic>P. falciparum<\/jats:italic>\n                      using genomic markers; ivermectin\u2019s impact on co-endemic diseases; coverage estimates; and the safety of combined MDA.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>The trial has been approved by the London School of Hygiene and Tropical Medicine\u2019s Ethics Committee (UK) (19156) and the Comite Nacional de Eticas de Saude (Guinea-Bissau) (084\/CNES\/INASA\/2020). Results will be disseminated in peer-reviewed publications and in discussion with the Bissau-Guinean Ministry of Public Health and participating communities.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT04844905\">NCT04844905<\/jats:ext-link>\n                      .\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2023-072347","type":"journal-article","created":{"date-parts":[[2023,7,7]],"date-time":"2023-07-07T05:30:36Z","timestamp":1688707836000},"page":"e072347","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":15,"title":["Protocol for a cluster randomised placebo-controlled trial of adjunctive ivermectin mass drug administration for malaria control on the Bijag\u00f3s Archipelago of Guinea-Bissau: the MATAMAL trial"],"prefix":"10.1136","volume":"13","clinical-trial-number":[{"clinical-trial-number":"nct04844905","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-0607-6124","authenticated-orcid":false,"given":"Harry","family":"Hutchins","sequence":"first","affiliation":[{"name":"Clinical Research Department, London School of Hygiene and Tropical Medicine, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John","family":"Bradley","sequence":"additional","affiliation":[{"name":"Clinical Research Department, London School of Hygiene and Tropical Medicine, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elizabeth","family":"Pretorius","sequence":"additional","affiliation":[{"name":"Department of Disease Control, London School of Hygiene and Tropical Medicine, London, 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