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Effectiveness of Mass Drug Administration for Reducing Seasonal Malaria Transmission in Zanzibar (MaDrAZ)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02721186
Recruitment Status : Completed
First Posted : March 29, 2016
Last Update Posted : October 5, 2017
Sponsor:
Collaborators:
Mahidol Oxford Tropical Medicine Research Unit
RTI International
The President’s Malaria Initiative
University of California, San Francisco
Uppsala University
Zanzibar Malaria Elimination Programme
Information provided by (Responsible Party):
Ulrika Morris, Karolinska Institutet

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.

Condition or disease Intervention/treatment Phase
Malaria Plasmodium Infections Drug: MDA with DHAp and SLD Primaquine Not Applicable

Detailed Description:

Study design: This is a cluster-randomised controlled study with two arms: an intervention arm with two rounds of MDA with dihydroartemisinin-piperaquine (DHAp) + single low dose (SLD) primaquine, and a control arm with no MDA.

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effectiveness of Mass Drug Administration (MDA) for Reducing Seasonal Malaria Transmission Towards Its Elimination in Hotspot Areas in Zanzibar - a Cluster-randomised Controlled Trial
Actual Study Start Date : April 30, 2016
Actual Primary Completion Date : December 31, 2016
Actual Study Completion Date : September 30, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

Arm Intervention/treatment
Experimental: 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.
Drug: MDA with DHAp and SLD Primaquine
Other Names:
  • Mass drug administration with DHAp and SLD Primaquine
  • MDA with Dihydroartemisinin-Piperaquine and SLD Primaquine
  • MDA with D-ARTEPP and single low dose Primaquine

No Intervention: 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.



Primary Outcome Measures :
  1. Cumulative notified malaria incidence in the MDA and control Shehias [ Time Frame: 6 months after second round of MDA ]
    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.


Secondary Outcome Measures :
  1. PCR determined community prevalence of Plasmodium infections in the MDA and control Shehias [ Time Frame: Baseline and 3 months after second round of MDA ]
    PCR determined community prevalence of Plasmodium infections determined by cross-sectional screening in every other household in the study area at the time of the first round of MDA, and at six months after the second round of MDA.


Other Outcome Measures:
  1. Population coverage of the MDA intervention at each round [ Time Frame: Through completion of first and second round of MDA, i.e. 15 days and 48 days after initiation of MDA, respectively. ]
    MDA coverage determined as the number of administered DHAp and SLD primaquine doses during the first and second round of MDA, over over the Shehia population size determined by population enumeration at the time of the intervention.

  2. Proportion of population receiving two rounds of MDA [ Time Frame: Through completion of the second round of MDA, i.e. 48 days after initiation of MDA. ]
    The proportion of the population having received zero, one or two rounds of MDA. Refusal and reason for refusal to participate will be recorded.

  3. Population compliance to the MDA intervention at each round [ Time Frame: 7 days after both first and second round of MDA ]
    MDA compliance, i.e. the proportion of the population that have taken one, two or all three doses of DHAp + SLD primaquine, will be evaluated in a subset of the population by post-MDA surveys conducted seven days after the initiation of each MDA round. The post MDA surveys will include both a questionnaire and finger prick blood sampling for measuring piperaquine blood concentrations.

  4. Occurence of adverse events after MDA with DHAp and SLD primaquine [ Time Frame: 14 days after both first and second round of MDA ]
    A brief questionnaire will be conducted in a subset of the population during post-MDA surveys conducted seven days after the initiation of each MDA round. The questionnaire will include specific questions regarding adverse events such as vomiting, nausea, gastrointestinal upset, rash and fatigue. Severe adverse events, especially symptoms of haemolysis, will be captured at health facilities where haemoglobin and dark urine (representing haemolysis) will be measured and reported using the pharmacovigilance forms and the Primaquine Roll Out Monitoring Pharmacovigilance Tool (PROMPT) developed by the Global Health Group at University of California San Francisco.

  5. Cumulative notified malaria incidence in the MDA and control Shehias during the following high transmission season. [ Time Frame: 15 months after second round of MDA ]
    Cumulative notified malaria incidence during the following high transmission season, monitored through the malaria case notification system, to assess the long-term effectivness of MDA.



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Ages Eligible for Study:   6 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Additional exclusion criteria for treatment with SLD Primaquine:

  • Pregnancy (all trimesters, assessed by a specific set of questions designed to exclude pregnancy)
  • Women breast feeding infants aged < 6months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02721186


Locations
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Tanzania
Zanzibar Malaria Elimination Programme
Mwanakwerekwe, Urban District, Zanzibar, Tanzania
Sponsors and Collaborators
Ulrika Morris
Mahidol Oxford Tropical Medicine Research Unit
RTI International
The President’s Malaria Initiative
University of California, San Francisco
Uppsala University
Zanzibar Malaria Elimination Programme
Investigators
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Principal Investigator: Anders Björkman, MD, PhD Karolinska Institutet
Principal Investigator: Abdullah S Ali, Programme Manager Zanzibar Malaria Elimination Programme

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ulrika Morris, Postdoc, Study Coordinator, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT02721186    
Other Study ID Numbers: MaDrAZ-001
ZAMREC/0001/January/2016 ( Other Identifier: Zanzibar Medical Research Ethical Committee )
First Posted: March 29, 2016    Key Record Dates
Last Update Posted: October 5, 2017
Last Verified: October 2017
Keywords provided by Ulrika Morris, Karolinska Institutet:
Malaria
Plasmodium
Mass drug administration
Malaria elimination
Zanzibar
Dihydroartemisinin-Piperaquine
Single low dose Primaquine
Additional relevant MeSH terms:
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Malaria
Protozoan Infections
Parasitic Diseases
Primaquine
Piperaquine
Dihydroartemisinin
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents