Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201604001501493 Date of Approval: 03/03/2016
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Evaluation of the effect of larval source management and housing improvement when added to an existing malaria control strategy
Official scientific title Majete Malaria Project larval source management and housing improvement trial
Brief summary describing the background and objectives of the trial Current malaria interventions are effect, but additional interventions are needed for further transmission reduction in highly endemic settings. The Majete Malaria Project (MMP) is a collaborative effort to reduce the burden of malaria in the perimeter area around the Majete Wildlife Reserve in Chikhwawa district. The project places a heavy emphasis on community engagement, empowerment and involvement in malaria control, using an integrated intervention strategy. Two interventions with a high potential for reducing malaria transmission in this setting are larval source management (LSM; controlling the vector mosquitoes at their breeding habitats) and house improvement (HI; to reduce vector mosquito entry into houses). The primary objective of the trial is to determine the impacts of house improvement and larval source management on malaria parasite prevalence and entomological inoculation rate over a 24 mo period, when implemented alone or in combination, in addition to the Malawi National Malaria Control Program interventions implemented at the Scale Up for Impact coverage targets.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) RCT
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Malaria
Purpose of the trial Prevention
Anticipated trial start date 01/05/2016
Actual trial start date 01/05/2016
Anticipated date of last follow up 30/04/2018
Actual Last follow-up date
Anticipated target sample size (number of participants) 6480
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
P.05/15/1731 University of Malawi College of Medicine Research and Ethics Committee
U1111-1179-7205 WHO International Clinical Trials Registry Platform
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised 2-stage cluster randomization within 3 separate blocks. Treatments were assigned to clusters using simple randomization with a raffle drawing at a community event in each of the 3 blocks. Using an opaque container Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Standard prevention with LLINs target 1.8 LLIN for every 2 people 2 years 4244 Active-Treatment of Control Group
Experimental Group LSM + HI (in addition to LLINs) Same as for LSM-only and HI-only groups 2 years Both larval source management and house improvement 4400
Experimental Group Larval Source Management (in addition to LLINs) Target to drain and fill all unnecessary mosquito breeding habitats; treating remaining breeding habitats with 300 grams of larvicide per hectare 2 years Draining, filling or treatment with larvicide of mosquito breeding sites 6801
Experimental Group House Improvement (in addition to LLINs) Target to close all eaves and screen all windows on all houses 2 years Preventing mosquito entry into houses by closing eaves and screening windows 4568
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All villages in the demarcated study site will initially be eligible for full participation in the trial. All households in trial villages will be eligible for entomological and epidemiological monitoring to assess trial outcomes. Within these households, children aged 6 to 59 months with informed consent from a guardian will be eligible for assessing parasitemia. A buffer zone around each trial village, necessary for preventing contamination bias, will lead to the exclusion of some villages in the study site from the trial. This will be kept to a minimum, and done randomly by applying a spatial restriction to the village selection procedure. 6 Month(s) 59 Month(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 27/08/2015 College of Medicine Research and Ethics Committee
Ethics Committee Address
Street address City Postal code Country
P/Bag 360 Blantyre 3 Malawi
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Entomological inoculation rate 2-monthly measurements over 2 years
Primary Outcome Prevalence of anaemia in children aged 6-59 months 2-monthly measurements over 2 years
Secondary Outcome Malaria vector community composition 2-monthly measurements over 2 years
Secondary Outcome Malaria vector human blood index 2-monthly measurements over 2 years
Secondary Outcome Peak malaria vector biting time 2-monthly measurements over 2 years
Secondary Outcome Larval mosquito density 2-monthly measurements over 2 years
Secondary Outcome Parasite prevalence in children aged 6-59 months 2-monthly measurements over 2 years
Secondary Outcome Incidence of clinical malaria in children aged 6-59 months 2 cohorts followed for 1 year each
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Chikhwawa District Chikhwawa Malawi
FUNDING SOURCES
Name of source Street address City Postal code Country
Dioraphte Foundation Kuipershaven 169 Dordrecht 3300 AG Netherlands
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Wageningen University and Research Centre Droevendaalsesteeg 1 Wageningen 6708 PB Netherlands University
Secondary Sponsor College of Medicine Mahatma Ghandhi Road Blantyre 3 Malawi University
COLLABORATORS
Name Street address City Postal code Country
Michael Chipeta Pembroke Place Liverpool L3 5QA United Kingdom
Alinune Kabaghe Meibergdreef 9 Amsterdam 1105 AZ Netherlands
Monicah Mburu Droevendaalsesteeg 1 Wageningen 6708 PB Netherlands
Kamija Phiri Mahatma Ghandhi Road Blantyre 3 Malawi
Anja Terlouw Mahatma Ghandhi Road Blantyre 3 Malawi
Michèle van Vugt Meibergdreef 9 Amsterdam 1105 AZ Netherlands
Henk van den Berg Droevendaalsesteeg 1 Wageningen 6708 PB Netherlands
Robert McCann Droevendaalsesteeg 1 Wageningen 6708 PB Netherlands
Peter Diggle Bailrigg Lancaster LA1 4YW United Kingdom
Tumaini Malenga Mahatma Ghandhi Road Blantyre 3 Malawi
Themba Mzilahowa Mahatma Ghandhi Road Blantyre 3 Malawi
Willem Takken Droevendaalsesteeg 1 Wageningen 6708 PB Netherlands
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Robert McCann robert.mccann@wur.nl +265 994292300 Droevendaalsesteeg 1
City Postal code Country Position/Affiliation
Wageningen 6708 PB Netherlands Postdoc / Wageningen University
Role Name Email Phone Street address
Public Enquiries Willem Takken willem.takken@wur.nl +31 317 48 46 52 Droevendaalsesteeg 1
City Postal code Country Position/Affiliation
Wageningen 6708 PB Netherlands Professor / Wageningen University
Role Name Email Phone Street address
Scientific Enquiries Robert McCann robert.mccann@wur.nl +265 994292300 Droevendaalsesteeg 1
City Postal code Country Position/Affiliation
Wageningen 6708 PB Netherlands Postdoc / Wageningen University
REPORTING
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information