A cluster randomised controlled trial of two rounds of mass drug administration in Zanzibar, a malaria pre-elimination setting—high coverage and safety, but no significant impact on transmission
Abstract Background Mass drug administration (MDA) has the potential to interrupt malaria transmission and has been suggested as a tool for malaria elimination in low-endemic settings. This study aimed to determine the effectiveness and safety of two rounds of MDA in Zanzibar, a pre-elimination sett...
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| Format: | Article |
| Language: | English |
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BMC
2018-12-01
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| Series: | BMC Medicine |
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| Online Access: | http://link.springer.com/article/10.1186/s12916-018-1202-8 |
| _version_ | 1828453714338250752 |
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| author | Ulrika Morris Mwinyi I. Msellem Humphrey Mkali Atiqul Islam Berit Aydin-Schmidt Irina Jovel Shija Joseph Shija Mwinyi Khamis Safia Mohammed Ali Lamija Hodzic Ellinor Magnusson Eugenie Poirot Adam Bennett Michael C. Sachs Joel Tarning Andreas Mårtensson Abdullah S. Ali Anders Björkman |
| author_facet | Ulrika Morris Mwinyi I. Msellem Humphrey Mkali Atiqul Islam Berit Aydin-Schmidt Irina Jovel Shija Joseph Shija Mwinyi Khamis Safia Mohammed Ali Lamija Hodzic Ellinor Magnusson Eugenie Poirot Adam Bennett Michael C. Sachs Joel Tarning Andreas Mårtensson Abdullah S. Ali Anders Björkman |
| author_sort | Ulrika Morris |
| collection | DOAJ |
| description | Abstract Background Mass drug administration (MDA) has the potential to interrupt malaria transmission and has been suggested as a tool for malaria elimination in low-endemic settings. This study aimed to determine the effectiveness and safety of two rounds of MDA in Zanzibar, a pre-elimination setting. Methods A cluster randomised controlled trial was conducted in 16 areas considered as malaria hotspots, with an annual parasite index of > 0.8%. The areas were randomised to eight intervention and eight control clusters. The intervention included two rounds of MDA with dihydroartemisinin-piperaquine and single low-dose primaquine 4 weeks apart in May–June 2016. Primary and secondary outcomes were cumulative confirmed malaria case incidences 6 months post-MDA and parasite prevalences determined by PCR 3 months post-MDA. Additional outcomes included intervention coverage, treatment adherence, occurrence of adverse events, and cumulative incidences 3, 12, and 16 months post-MDA. Results Intervention coverage was 91.0% (9959/10944) and 87.7% (9355/10666) in the first and second rounds, respectively; self-reported adherence was 82.0% (881/1136) and 93.7% (985/1196). Adverse events were reported in 11.6% (147/1268) and 3.2% (37/1143) of post-MDA survey respondents after both rounds respectively. No serious adverse event was reported. No difference in cumulative malaria case incidence was observed between the control and intervention arms 6 months post-MDA (4.2 and 3.9 per 1000 population; p = 0.94). Neither was there a difference in PCR-determined parasite prevalences 3 months post-MDA (1.4% and 1.7%; OR = 1.0, p = 0.94), although having received at least the first MDA was associated with reduced odds of malaria infection (aOR = 0.35; p = 0.02). Among confirmed malaria cases at health facilities, 26.0% and 26.3% reported recent travel outside Zanzibar in the intervention and control shehias (aOR ≥ 85; p ≤ 0.001). Conclusions MDA was implemented with high coverage, adherence, and tolerability. Despite this, no significant impact on transmission was observed. The findings suggest that two rounds of MDA in a single year may not be sufficient for a sustained impact on transmission in a pre-elimination setting, especially when the MDA impact is restricted by imported malaria. Importantly, this study adds to the limited evidence for the use of MDA in low transmission settings in sub-Saharan Africa. Trial registration ClinicalTrials.gov, NCT02721186 (registration date: March 29, 2016) |
| first_indexed | 2024-12-11T00:11:45Z |
| format | Article |
| id | doaj.art-7b4a3be0d0714832850288b4f3774dbf |
| institution | Directory Open Access Journal |
| issn | 1741-7015 |
| language | English |
| last_indexed | 2024-12-11T00:11:45Z |
| publishDate | 2018-12-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Medicine |
| spelling | doaj.art-7b4a3be0d0714832850288b4f3774dbf2022-12-22T01:28:08ZengBMCBMC Medicine1741-70152018-12-0116111510.1186/s12916-018-1202-8A cluster randomised controlled trial of two rounds of mass drug administration in Zanzibar, a malaria pre-elimination setting—high coverage and safety, but no significant impact on transmissionUlrika Morris0Mwinyi I. Msellem1Humphrey Mkali2Atiqul Islam3Berit Aydin-Schmidt4Irina Jovel5Shija Joseph Shija6Mwinyi Khamis7Safia Mohammed Ali8Lamija Hodzic9Ellinor Magnusson10Eugenie Poirot11Adam Bennett12Michael C. Sachs13Joel Tarning14Andreas Mårtensson15Abdullah S. Ali16Anders Björkman17Department of Microbiology, Tumor, and Cell Biology, Karolinska InstitutetZanzibar Malaria Elimination Programme, Ministry of HealthZanzibar Malaria Elimination Programme, Ministry of HealthDepartment of Microbiology, Tumor, and Cell Biology, Karolinska InstitutetDepartment of Microbiology, Tumor, and Cell Biology, Karolinska InstitutetDepartment of Microbiology, Tumor, and Cell Biology, Karolinska InstitutetZanzibar Malaria Elimination Programme, Ministry of HealthZanzibar Malaria Elimination Programme, Ministry of HealthZanzibar Malaria Elimination Programme, Ministry of HealthDepartment of Microbiology, Tumor, and Cell Biology, Karolinska InstitutetDepartment of Microbiology, Tumor, and Cell Biology, Karolinska InstitutetMalaria Elimination Initiative, Global Health Group, University of California San FranciscoMalaria Elimination Initiative, Global Health Group, University of California San FranciscoBiostatistics Unit, Institute of Environmental Medicine, Karolinska InstitutetMahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical MedicineDepartment of Women’s and Children’s Health, International Maternal and Child Health, Uppsala UniversityZanzibar Malaria Elimination Programme, Ministry of HealthDepartment of Microbiology, Tumor, and Cell Biology, Karolinska InstitutetAbstract Background Mass drug administration (MDA) has the potential to interrupt malaria transmission and has been suggested as a tool for malaria elimination in low-endemic settings. This study aimed to determine the effectiveness and safety of two rounds of MDA in Zanzibar, a pre-elimination setting. Methods A cluster randomised controlled trial was conducted in 16 areas considered as malaria hotspots, with an annual parasite index of > 0.8%. The areas were randomised to eight intervention and eight control clusters. The intervention included two rounds of MDA with dihydroartemisinin-piperaquine and single low-dose primaquine 4 weeks apart in May–June 2016. Primary and secondary outcomes were cumulative confirmed malaria case incidences 6 months post-MDA and parasite prevalences determined by PCR 3 months post-MDA. Additional outcomes included intervention coverage, treatment adherence, occurrence of adverse events, and cumulative incidences 3, 12, and 16 months post-MDA. Results Intervention coverage was 91.0% (9959/10944) and 87.7% (9355/10666) in the first and second rounds, respectively; self-reported adherence was 82.0% (881/1136) and 93.7% (985/1196). Adverse events were reported in 11.6% (147/1268) and 3.2% (37/1143) of post-MDA survey respondents after both rounds respectively. No serious adverse event was reported. No difference in cumulative malaria case incidence was observed between the control and intervention arms 6 months post-MDA (4.2 and 3.9 per 1000 population; p = 0.94). Neither was there a difference in PCR-determined parasite prevalences 3 months post-MDA (1.4% and 1.7%; OR = 1.0, p = 0.94), although having received at least the first MDA was associated with reduced odds of malaria infection (aOR = 0.35; p = 0.02). Among confirmed malaria cases at health facilities, 26.0% and 26.3% reported recent travel outside Zanzibar in the intervention and control shehias (aOR ≥ 85; p ≤ 0.001). Conclusions MDA was implemented with high coverage, adherence, and tolerability. Despite this, no significant impact on transmission was observed. The findings suggest that two rounds of MDA in a single year may not be sufficient for a sustained impact on transmission in a pre-elimination setting, especially when the MDA impact is restricted by imported malaria. Importantly, this study adds to the limited evidence for the use of MDA in low transmission settings in sub-Saharan Africa. Trial registration ClinicalTrials.gov, NCT02721186 (registration date: March 29, 2016)http://link.springer.com/article/10.1186/s12916-018-1202-8Mass drug administrationMalariaEliminationLow transmissionDihydroartemisinin-piperaquineSingle low-dose primaquine |
| spellingShingle | Ulrika Morris Mwinyi I. Msellem Humphrey Mkali Atiqul Islam Berit Aydin-Schmidt Irina Jovel Shija Joseph Shija Mwinyi Khamis Safia Mohammed Ali Lamija Hodzic Ellinor Magnusson Eugenie Poirot Adam Bennett Michael C. Sachs Joel Tarning Andreas Mårtensson Abdullah S. Ali Anders Björkman A cluster randomised controlled trial of two rounds of mass drug administration in Zanzibar, a malaria pre-elimination setting—high coverage and safety, but no significant impact on transmission BMC Medicine Mass drug administration Malaria Elimination Low transmission Dihydroartemisinin-piperaquine Single low-dose primaquine |
| title | A cluster randomised controlled trial of two rounds of mass drug administration in Zanzibar, a malaria pre-elimination setting—high coverage and safety, but no significant impact on transmission |
| title_full | A cluster randomised controlled trial of two rounds of mass drug administration in Zanzibar, a malaria pre-elimination setting—high coverage and safety, but no significant impact on transmission |
| title_fullStr | A cluster randomised controlled trial of two rounds of mass drug administration in Zanzibar, a malaria pre-elimination setting—high coverage and safety, but no significant impact on transmission |
| title_full_unstemmed | A cluster randomised controlled trial of two rounds of mass drug administration in Zanzibar, a malaria pre-elimination setting—high coverage and safety, but no significant impact on transmission |
| title_short | A cluster randomised controlled trial of two rounds of mass drug administration in Zanzibar, a malaria pre-elimination setting—high coverage and safety, but no significant impact on transmission |
| title_sort | cluster randomised controlled trial of two rounds of mass drug administration in zanzibar a malaria pre elimination setting high coverage and safety but no significant impact on transmission |
| topic | Mass drug administration Malaria Elimination Low transmission Dihydroartemisinin-piperaquine Single low-dose primaquine |
| url | http://link.springer.com/article/10.1186/s12916-018-1202-8 |
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