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.: PACTR202006878245287 Date of Approval: 24/06/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Combining long-lasting insecticidal nets, House screening and Push-Pull agricultural technology for malaria prevention in Ethiopia: study protocol for a Household randomized controlled trial
Official scientific title Combining long-lasting insecticidal nets, House screening and Push-Pull agricultural technology for malaria prevention in Ethiopia: study protocol for a Household randomized controlled trial
Brief summary describing the background and objectives of the trial The combined application of LLINs and IRS has led to mixed results with some studies reporting a significant reduction in malaria incidence and others reporting no as such real impact as compared to using either tool alone. Such studies are lacking regarding the combined effect of HS and LLINs. On the other hand, Agriculture and health are interconnected in many ways. Increasing agricultural productivity improves the overall livelihoods of communities (good health, improved nutrition, and improved livestock). Thus, the primary objective of this study is 1) evaluate the combined effect of LLINs and HS on entomological parameters 2) evaluate the combined effect of LLINs, HS, and Push-pull technology (PPT), which was designed to improve farmers agricultural productivity and 3) evaluate the efficacy of LLINs alone. A four-armed, household, cluster-randomized, controlled study will be conducted to assess whether improved housing, PPT, and LLINs combine to provide better protection against clinical malaria in children than LLINs alone in Ethiopia. In this study, a total of 167, 246, 250, and 175 houses will be included in four different treatments, treatment 1 (control or LLINs only), treatment 2 (LLINs+HS), and treatment 3 (LLINs+HS+PPt), and treatment 4 (LLINs+PPT) respectively. One resident child will be enrolled from each house and followed up for two consecutive years. Fifty-two (52) houses from each treatment arm will be randomly selected for seasonal entomological monitoring. Episodes of clinical malaria, the prevalence of anemia, density of malaria vector mosquitoes, sporozoite infection rate, a cost-effectiveness analysis will be the endpoints of this study. Documenting the combined impact of LLINs, HS, and PPT in clinical malaria prevalence will be the first of its kind and deep insight to forge collaborations between Agriculture and health sectors.
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 Combination of House screening, LLINs and PPT
Anticipated trial start date 01/07/2020
Actual trial start date 01/09/2020
Anticipated date of last follow up 31/12/2022
Actual Last follow-up date 31/12/2022
Anticipated target sample size (number of participants) 500
Actual target sample size (number of participants) 500
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
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
Parallel: different groups receive different interventions at same time during study Randomised Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification 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
Control Group Long lasting Insecticidal Nets Every night 2 years DuraNet® (Shobikaa Impex pvt Ltd, Karur, Tamil Nadu 639006, India) will be provided to all households (treatment and control) at the rate of the one-bed net for two people following the NMCP and per WHO recommended universal net coverage (WHO, 2019, PMI, 2019). The nets will be provided by NMCP district office and will be distributed to study households in the first week of July 2020. Study participants will receive new LLINs free of charge at the beginning of the intervention regardless of the previous ownership, with householders maintaining their existing nets at the time of distribution. 167 Active-Treatment of Control Group
Experimental Group House screening 24 hours per day 2 years Four hundred ninety-six (496) houses will be screened for this trial. Household owners will be trained on the care needed to keep the screens intact and effective and avoid activities that could result in making holes in the mesh or cause the screen to slide and create spaces that could allow mosquito entries into the houses. Other routine procedures to be used to reduce mosquito entry into houses such as closing windows and doors early will be emphasized and adherence to this practice monitored passively by the study team. As part of the intervention all the windows, doors and eves will be screened using polyethylene material (POLYTEX INTERNATIONAL (UK) LIMITED, 14 Rutherford Way, Drayton Fields, Daventry, Northants, NN11 8XW, United Kingdom) 496
Experimental Group Push pull 24 hours per day 2 years Push-pull technology is a biological control method of pests of crops like stem borer and weeds like Striga by pushing and pulling method. It is a novel technology in which a repellent intercrop and attractive trap plant are used simultaneously. Insect pests are repelled from the food crop and simultaneously attracted to a trap crop. It has three components which include the push, the pull, and the intercropped plant. The push component refers to a Desmodium plant commonly known as the silver leaf and green leaf Desmodium. The pull component refers to the Brachiaria grass which is usually planted at the periphery of the plot. The detailed application of PPT is described elsewhere (Khan et al., 2006). Thus, as part of the intervention training will be provided to selected farmers on the concept of PPT and how to use it. This includes plot preparation, sowing, establishing, managing, animal feeding, and seed harvesting. A total of 250 farmers who successfully completed the training and who been selected to house screening treatment will be provided PPT plant seeds namely Mulato II Hybrid Brachiaria, (3kg/ha, Barenbrug, 26 Prosperity Way Dandenong South VIC 3175, Australia) and Desmodium intortum 3-5kg/Ha from the same company. The amount of Kg provided to each farmer will be decided on the size of the plot made ready by the farmer. 250
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Resident in rural areas of Jabi Tehnan district, Northwestern Ethiopia 2. Having at least one child (under 14 age) in their family. 1. Urban resident in Jabi Tehnan district, Nortwestern Ethiopia 2. All household members are aged above 14 Adolescent: 13 Year-18 Year,Child: 6 Year-12 Year,Infant: 0 Month-23 Month,Infant: 1 Month-23 Month,New born: 0 Day-1 Month,Preschool Child: 2 Year-5 Year 1 Year(s) 14 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 17/04/2019 Amhara Public Health Research Ethics Review Committee
Ethics Committee Address
Street address City Postal code Country
Felege Hiwot RD Bahir Dar 6000 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Malaria incidence Twice a month
Primary Outcome Mosquito density Twice a year
Primary Outcome Entomological Inoculation rate Twice a year
Primary Outcome Cost of intervention Once a year
Secondary Outcome Seasonal variation of malaria incidence Every month
Secondary Outcome Blood Haemoglobin level Every Month
Secondary Outcome Indoor and Outdoor Mosquito density Twice a year
Primary Outcome Physical Integrity of House screening Twice a year
Primary Outcome Land use ratio Once a year
Primary Outcome Maize yield/hector Once a year
Secondary Outcome Animal Foder Once a year
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Jabi Tehnan District Health Bureau First Road Finote Selam Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
The Norwegian Development Cooperation Bygdoy alle 2, 0257 Oslo Oslo 1303 Norway
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor International Center of Insect Physiology and Ecology Kasarani Rd Nairobi 30772 Kenya Inter-governmental Research Institute
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Abebe Asale aasale@icipe.org +251911692122 Gurd Shola, ILRI Campus
City Postal code Country Position/Affiliation
Addis Ababa 1000 Ethiopia Project Coordinator
Role Name Email Phone Street address
Public Enquiries Zewdu Ayalew zabro@icipe.org +251900462970 Gurd Shola
City Postal code Country Position/Affiliation
Addis Ababa 1000 Ethiopia Consultant
Role Name Email Phone Street address
Scientific Enquiries Clifford Mutero cmutero@icipe.org +254704835177 Kasarani
City Postal code Country Position/Affiliation
Nairobi Kenya Project Manager
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes For this study, each household will be provided with a specific identification (ID) number. The child who included in the study from each household will receive a unique personal, three-digit ID number (village number/household number/person number). All forms and datasets will identify participants by their unique identifier numbers, and names will not be used. Informed Consent Form,Statistical Analysis Plan,Study Protocol This is a two-year trial. The study team will provide the first trial progress report in June 2021 and the final report in June 2022. Data will be stored in two forms, i.e, hard and soft copies in compliance with the principles of good clinical practice protecting the confidentiality of participants. Specimens of mosquitoes, blood film slides and genotype print of PCR outcomes will be maintained by the principal investigator and be available upon request from authorized representatives, regulatory bodies. The results of the study will be made publicly available through peer-reviewed journals.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information