Effectiveness of Mass Drug Administration for Reducing Seasonal Malaria Transmission in Zanzibar
NCT ID: NCT02721186
Last Updated: 2017-10-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
22500 participants
INTERVENTIONAL
2016-04-30
2017-09-30
Brief Summary
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Detailed Description
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Study site and study population: The study will be conducted in 16 hotspot Shehias (8 Shehias randomly allocated to each arm), in three districts (West, Central and South districts) in Unguja Island, Zanzibar. Hotspot Shehias \[Shehia being the smallest administrative structure in Zanzibar\] are defined as Shehias with an annual malaria incidence of \>0.8%, calculated as the number of confirmed malaria infections notified at health facilities and during active case detection in 2015 / Shehia projected population for 2015. The study population will include all consenting residents of the selected Shehias, reaching approximately 24000 people.
Study implementation: Two rounds of MDA with DHAp (D-ARTEPP, Guilin Pharmaceutical (Shanghai) Co., Ltd., China) and SLD (0.25mg/kg) primaquine (Primaquine, Remedica Ltd.,Cyprus ) will be conducted approximately four weeks apart in the intervention Shehias, at the anticipated lowest point of malaria transmission prior to the onset of malaria transmission associated with the main rains in April-June 2016. The first drug dose including DHAp and SLD primaquine will be given under supervision whenever possible; the other two doses of the standard once daily DHAp regimen will be taken unsupervised at home. Labelled packets containing all three doses will be left with the head of household with clear instructions for individuals not present at the time of the household visit.
Study objectives: The primary objective of the study is to determine the effectiveness of two rounds of MDA with DHAp + SLD primaquine for reducing seasonal malaria transmission in Shehias considered hotspots on Unguja Island, Zanzibar. The secondary objectives of the study include determining MDA coverage, compliance, and safety after one and two rounds of DHAp + SLD primaquine.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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MDA with DHAp and SLD Primaquine
MDA will be conducted at two time points with an approximate four-week interval. All consenting and eligible community members will be administered age-appropriate treatment dose of dihydroartemisinin-piperaquine (D-ARTEPP, Guilin Pharmaceutical (Shanghai) Co., Ltd., China) and single low dose (0.25mg/kg) primaquine (Primaquine, Remedica Ltd., Cyprus) in house-to-house campaigns.
MDA with DHAp and SLD Primaquine
Control
The control arm (no MDA) will have the standard care offered by the Ministry of Health and Social welfare which applies to both arms. This includes passive case detection of individuals seeking treatment at local health facilities, and universal coverage of long lasting insecticide treated bed nets and indoor residual spraying in the study areas.
No interventions assigned to this group
Interventions
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MDA with DHAp and SLD Primaquine
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Provision of informed consent (refusal must be recorded)
* Age \>6 months
Exclusion Criteria
* Severe disease that requires immediate referral to health facility or hospital
* Concurrent antimalarial treatment at time of MDA or during the last 14 days
* Inability to take oral medication
* Pregnancy (all trimesters, assessed by a specific set of questions designed to exclude pregnancy)
* Women breast feeding infants aged \< 6months
6 Months
ALL
Yes
Sponsors
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Mahidol Oxford Tropical Medicine Research Unit
OTHER
RTI International
OTHER
The President's Malaria Initiative
UNKNOWN
University of California, San Francisco
OTHER
Uppsala University
OTHER
Zanzibar Malaria Elimination Programme
OTHER_GOV
Ulrika Morris
OTHER
Responsible Party
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Ulrika Morris
Postdoc, Study Coordinator
Principal Investigators
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Anders Björkman, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Karolinska Institutet
Abdullah S Ali, Programme Manager
Role: PRINCIPAL_INVESTIGATOR
Zanzibar Malaria Elimination Programme
Locations
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Zanzibar Malaria Elimination Programme
Mwanakwerekwe, Urban District, Zanzibar, Tanzania
Countries
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References
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Shah MP, Hwang J, Choi L, Lindblade KA, Kachur SP, Desai M. Mass drug administration for malaria. Cochrane Database Syst Rev. 2021 Sep 29;9(9):CD008846. doi: 10.1002/14651858.CD008846.pub3.
Morris U, Msellem MI, Mkali H, Islam A, Aydin-Schmidt B, Jovel I, Shija SJ, Khamis M, Ali SM, Hodzic L, Magnusson E, Poirot E, Bennett A, Sachs MC, Tarning J, Martensson A, Ali AS, Bjorkman A. 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 Med. 2018 Dec 10;16(1):215. doi: 10.1186/s12916-018-1202-8.
Other Identifiers
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ZAMREC/0001/January/2016
Identifier Type: OTHER
Identifier Source: secondary_id
MaDrAZ-001
Identifier Type: -
Identifier Source: org_study_id