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.: PACTR201612001891179 Date of Approval: 28/11/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Reducing indoor malaria transmission through improved housing
Official scientific title Reducing indoor malaria transmission through improved housing
Brief summary describing the background and objectives of the trial House is the major site for malaria infection where most human-vector contact takes places. Hence, houses screening might reduce the risk of malaria infection by limiting house entry of vectors. This study was assessed the impact of screening doors and windows on indoor density, sporozoite and entomological inoculation rate (EIR) of malaria vectors, and on malaria transmission in Gebeya Dar and Georges sub-Kebeles (Kebele-smallest administrative unit in Ethiopia) of Arba Minch town, southwest Ethiopia.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
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 01/07/2015
Actual trial start date 01/07/2015
Anticipated date of last follow up 30/04/2016
Actual Last follow-up date 30/04/2016
Anticipated target sample size (number of participants) 98
Actual target sample size (number of participants) 92
Recruitment status Completed
Publication URL manuscript preparation
Secondary Ids Issuing authority/Trial register
SERO-042-12-2015 Ethiopian Public Health Institute (EPHI)
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 Simple randomisation using a radomisation table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomisation using a radomisation table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomisation using a radomisation table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Screening doors and windows to reduce house entry of malaria vectors Once February to April 2016 Pre-and post-intervention mosquito collection was done by Center for Disease Control and Prevention (CDC) light traps. Pre-intervention mosquito sampling was done in 92 randomly selected houses twice per month from July-Dec 2015. The 92 households were randomized into control and intervention groups using the pre-intervention Anopheles mosquito data. The doors and windows of 46 houses were screene 46
Control Group Screening doors and windows to reduce house entry of malaria vectors no screening intervention February to April 2016 The 46 houses were used as control (not screened by wire mesh) 46
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Those households with more than two members and no plan to move out of the sub-Kebele during the study period were included Households at least with one child age 5-14 years were eligible for the study Those households with more than two doors and windows were excluded to reduce the costs of intervention and bias And also households with less than two members were excluded to maximize the chance of getting family member during the visit 1 Year(s) 60 Year(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 09/12/2015 Scientific and Ethical Review Committee of Ethiopian Public Health Insititute
Ethics Committee Address
Street address City Postal code Country
Addis Ababa Addis Ababa 1242 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome variable was the number of malaria vectors per CDC light traps per night, the sporozoite rate, EIR (mean number of infectious mosquitoes bites per person per season) and parasite prevalence in intervention and control groups February 2016 to April 2016
Secondary Outcome One secondary outcome variable was the susceptibility status of the principal malaria vector An. arabiensis. The other secondary outcome variables were bed net use rate both in intervention and control groups, and the durability of screening intervention at the end of study period. March 2016 April 2016
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Arba Minch Town Arba Minch Arba Minch 21 Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
NORHED Ruseløkkveien 26 Oslo 8034 Norway
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Arba Minch University Arba Minch Arba Minch 21 Ethiopia University
Primary Sponsor Solomon Kinde; Fekadu Massebo Arba Minch Arba Minch 21 Ethiopia University
COLLABORATORS
Name Street address City Postal code Country
University of Bergen N-5020 Bergen Bergen 7804 Norway
Bernt Lindtjørn N-5020 Bergen Bergen 7804 Norway
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Solomon Kinde solomonkinde@gmail.com +251912142432 Arba Minch
City Postal code Country Position/Affiliation
Arba Minch 21 Ethiopia MSc student
Role Name Email Phone Street address
Public Enquiries Fekadu Massebo fekadu.massebo@amu.edu.et +251911733885 Arba Minch
City Postal code Country Position/Affiliation
Arba Minch 21 Ethiopia Lecturer; Assistant Professor
Role Name Email Phone Street address
Scientific Enquiries Fekadu Massebo fekadu.massebo@amu.edu.et +251911733885 Arba Minch
City Postal code Country Position/Affiliation
Arba Minch 21 Ethiopia Lecturer; Assistant Professor
Role Name Email Phone Street address
Scientific Enquiries Bernt Lindtjørn Bernt.Lindtjorn@cih.uib.no +47 55588560 N-5020 Bergen
City Postal code Country Position/Affiliation
Bergen 7804 Norway Professor
REPORTING
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Result URL Hyperlinks
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