Effectiveness of Mass Drug Administration for Reducing Seasonal Malaria Transmission in Zanzibar
MaDrAZ
2 other identifiers
interventional
22,500
1 country
1
Brief Summary
The overall aim of this study is to determine the effectiveness of two rounds of mass drug administration (MDA) with dihydroartemisinin-piperaquine (DHAp) + single low dose (SLD) primaquine for reducing seasonal malaria transmission in Shehias considered hotspots on Unguja Island, Zanzibar.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 17, 2016
CompletedFirst Posted
Study publicly available on registry
March 29, 2016
CompletedStudy Start
First participant enrolled
April 30, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2017
CompletedOctober 5, 2017
October 1, 2017
8 months
March 17, 2016
October 3, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cumulative notified malaria incidence in the MDA and control Shehias
Cumulative notified malaria incidence determined as the number of confirmed malaria cases notified at health facilities (monitored through the malaria case notification system during the period of six months) over the Shehia population size determined by population enumeration at the time of the intervention.
6 months after second round of MDA
Secondary Outcomes (1)
PCR determined community prevalence of Plasmodium infections in the MDA and control Shehias
Baseline and 3 months after second round of MDA
Other Outcomes (5)
Population coverage of the MDA intervention at each round
Through completion of first and second round of MDA, i.e. 15 days and 48 days after initiation of MDA, respectively.
Proportion of population receiving two rounds of MDA
Through completion of the second round of MDA, i.e. 48 days after initiation of MDA.
Population compliance to the MDA intervention at each round
7 days after both first and second round of MDA
- +2 more other outcomes
Study Arms (2)
MDA with DHAp and SLD Primaquine
EXPERIMENTALMDA 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.
Control
NO INTERVENTIONThe 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.
Interventions
Eligibility Criteria
You may qualify if:
- Permanent or temporary resident of study Shehias (i.e., persons who stayed in the selected household the night before the interview)
- Provision of informed consent (refusal must be recorded)
- Age \>6 months
You may not qualify if:
- Women pregnant in first trimester (assessed by a specific set of questions designed to exclude pregnancy)
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ulrika Morrislead
- Mahidol Oxford Tropical Medicine Research Unitcollaborator
- RTI Internationalcollaborator
- The President's Malaria Initiativecollaborator
- University of California, San Franciscocollaborator
- Uppsala Universitycollaborator
- Zanzibar Malaria Elimination Programmecollaborator
Study Sites (1)
Zanzibar Malaria Elimination Programme
Mwanakwerekwe, Urban District, Zanzibar, Tanzania
Related Publications (2)
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.
PMID: 34585740DERIVEDMorris 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.
PMID: 30526588DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anders Björkman, MD, PhD
Karolinska Institutet
- PRINCIPAL INVESTIGATOR
Abdullah S Ali, Programme Manager
Zanzibar Malaria Elimination Programme
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Postdoc, Study Coordinator
Study Record Dates
First Submitted
March 17, 2016
First Posted
March 29, 2016
Study Start
April 30, 2016
Primary Completion
December 31, 2016
Study Completion
September 30, 2017
Last Updated
October 5, 2017
Record last verified: 2017-10