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.: PACTR202306667462566 Date of Approval: 13/06/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title A community-based trial to reduce malaria by improving homes and treating cattle in southwest Ethiopia.
Official scientific title Assessing the impact of housing improvement and ivermectin administration to cattle on malaria transmission in southwest Ethiopia: a community-based cluster randomized control trial
Brief summary describing the background and objectives of the trial Malaria and other vector-borne diseases most affect low-income people who live in poorly constructed houses and unsatisfactorily managed environments. A recent review on housing and vector-borne diseases indicates that housing improvement protects people against malaria and dengue infection. Interestingly, improved housing protects everybody inside the house, can easily be integrated with existing interventions, reduces exposure to pollutants, and can improve indoor ventilation. Our previous studies on housing intervention reduced the indoor density of vectors and malaria incidence. Today, it is encouraged to integrate multiple interventions to maximise the benefit. To this end, the housing intervention we consider the pushing factor (diverting mosquitoes away from where people live) is supplemented by interventions that attract mosquitoes (pulling factors). Ivermectin is widely used to control endo- and ectoparasites of animals and treatment of filarial nematode parasites of humans. Several studies have also shown the efficacy of ivermectin against malaria vectors. To our knowledge, no community trials have been conducted to prevent malaria using a combination of these two interventions. Although there is some evidence of the cost-effectiveness of house screening intervention against malaria, combining house screening with Ivermectin cattle care still needs to be determined. Therefore, it is important to estimate the incremental cost and cost-effectiveness of house screening and Ivermectin cattle treatment individually and in combination. Such cost-effectiveness pieces of evidence are important for policy and enhancing resource utilisation in countries with limited access. We hypothesise that these novel push-pull malaria control interventions can make a measurable change in malaria incidence, the indoor and outdoor density of malaria vectors, and human exposure, reducing household poverty due to less sickness. Therefore, the primary objective of this trial is to determine whether house screening and ivermectin administration to households with cattle reduce malaria incidence among all age groups compared to the groups using conventional malaria control tools. The primary outcome variable of the study will be the incidence of malaria among all age groups in intervention groups compared with the control arm. Epidemiologic and serologic endpoints will be measured by screening study participants every four months for two consecutive years. Furthermore, a bimonthly entomological assessment will be done in each arm for two years. We shall also measure human exposure to mosquito bites and malaria parasites by assessing serological markers and the entomological indices of malaria. The interventions' durability, community acceptance, and cost-effectiveness will be assessed. Multidimensional household poverty reduction due to malaria intervention will be assessed.
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 01/07/2023
Actual trial start date
Anticipated date of last follow up 30/06/2025
Actual Last follow-up date
Anticipated target sample size (number of participants) 9000
Actual target sample size (number of participants)
Recruitment status Active, not recruiting
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 Permuted block randomization Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Housing improvement House screening initially 2 years In the house screening arm, 15 clusters will receive house screening intervention to block entry of malaria vectors. Following discussions with communities and household heads, metal wire mesh will be permanently fixed on windows externally. Ventilation holes will be covered by wire mesh with good sizes for good air flow. Wire-mesh doors that automatically close and open to the outside will be fixed. Wire mesh will be painted with anti-rust to protect from corrosion damage. 2250
Experimental Group Ivermectin administration to cattle Injectable ivermectin (0.2 mg/kg) at two months intervals 2 years Veterinarians working in the villages will treat all cattle in the endocticide drug (ivermectin) clusters with injectable ivermectin (0.2 mg/kg) at two-month intervals. Ivermectin is a licenced medicine used to treat endoparasites and ectoparasites in cattle in order to improve animal productivity and health. 2250
Experimental Group Combination of house improvment and ivermectin administration to cattle 2 years 15 clusters will get house screening and ivermectin administration to cattle to prevent malaria vector entry by house screening and diverting them to cattle treated with ivermectin. Following discussions with communities and household heads, metal wire mesh will be permanently installed on windows on the outside. Ventilation holes shall be covered by wire mesh of sufficient size to allow for adequate air passage. Automatically shutting wire mesh doors that open to the exterior will be permanently installed. Wire mesh will be anti-rust painted to prevent corrosion damage. Veterinarians working in the villages will treat all cattle in the endocticide drug (ivermectin) clusters with injectable ivermectin (0.2 mg/kg) at two monthly intervals. 2250
Control Group Basic malaria interventions like ITNs 2 years The control arm (15 clusters) will continue with the Ministry of Health's basic malaria interventions. In this study, ITNs, the current best practice in malaria control, will serve as the comparator. 2250 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All households and members in the clusters assigned to either of the interventions or control and willing to sign informed consent to participate in the malaria study for two years will be included. Villages close to the shores of the two Rift Valley lakes and endemic for malaria will be included in the study to minimize the variation between villages. The flight distance of mosquitoes will be considered in selecting clusters for the study to reduce the diversion effect of the intervention and contamination due to mosquito movement. All cattle except lactating cows and those planned to be used for meat in the near future will be involved in the study. Those households that refuse to participate in the study or whose house structures are unsuitable for screening will be excluded. Children below one year will not been enrolled in the study 80 and over: 80+ Year,Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Child: 6 Year-12 Year,Middle Aged: 45 Year(s)-64 Year(s),Preschool Child: 2 Year-5 Year 1 Year(s) 80 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 24/03/2023 Institutional Reveiw Board of Arba Minch University
Ethics Committee Address
Street address City Postal code Country
Arba Minch, Ethiopia Arba Minch 21 Ethiopia
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 15/05/2023 Animal Research Ethics Review Committee of Arba Minch University
Ethics Committee Address
Street address City Postal code Country
Arba Minch Arba Minch 21 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Malaria incidence in all age groups above 1 year Prevalence of malaria in all age groups above 1 year Three times each year for two years
Secondary Outcome • indoor and outdoor density of malaria mosquitoes • prevalence of antibody against salivary gland antigens • seroprevalence of malaria parasites • cost-effectiveness of the intervention • household multidimensional poverty reduction • prevalence of gametocyte carriage in human hosts • parasite density of symptomatic and asymptomatic malaria cases • prevalence of anemia in children age between1-5 years • spatio-temporal clustering of malaria in control and intervention arms • sporozoite infection rate • entomological inoculation rate • blood meal index • mosquito biting rates • proportion of freshly fed mosquitoes with gametocyte • malaria sero-conversion rate among children • effectiveness of serological biomarkers in monitoring vector control • community acceptance of the intervention • durability of house screening • ITNs use rate • human night activities and sleeping patterns (time) Two years follow-up period
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Arba Minch Zuria District Arba Minch, Ethiopia Arba Minch 21 Ethiopia
Mirab Abaya District Mirab Abaya Birbir Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
The Norwegian Programme for Capacity Development in Higher Education and Research for Development. 0257 Oslo, Norway Oslo Pb. 1303 Norway
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor The Norwegian Programme for Capacity Development in Higher Education and Research for Development. 0257 Oslo, Norway Oslo Pb. 1303 Norway Funding Agency
COLLABORATORS
Name Street address City Postal code Country
University of Bergen 5020 Bergen Bergen Norway
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Fekadu Massebo fekadu.massebo@amu.edu.et +251911733885 Arbaaa Minch, Ethiopia
City Postal code Country Position/Affiliation
Arba Minch 21 Ethiopia Research team leader and lecturer
Role Name Email Phone Street address
Scientific Enquiries Bernt Lindtjorn bernt.lindtjorn@uib.no +4795056812 5009 Bergen
City Postal code Country Position/Affiliation
Bergen 7804 Norway Professor
Role Name Email Phone Street address
Public Enquiries Alemayehu Chufama alemayehu.chufama@amu.edu.et +251935956420 Arba Minch, Ethiopia
City Postal code Country Position/Affiliation
Arba Minch 21 Ethiopia Vice President for Academic Affairs
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes After de-identification, all individual participant data acquired during the course of the study will be provided. Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol The data will be made available soon after publication Anyone with access to the data can use it for any purpose. The information will be available indefinitely (We provide a link.)
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