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.: PACTR202008524310568 Date of Approval: 11/08/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title AFRO II Demonstration Project
Official scientific title Evaluating the feasibility and impact of community-based house screening as an additional vector control intervention on malaria transmission in southern Africa: A study protocol for a household randomized demonstration study.
Brief summary describing the background and objectives of the trial Malaria vector control using long lasting insecticidal nets (LLINs) and indoor residual spraying (IRS) has had a substantial impact on malaria transmission in the past two decades. However, progress made using these tools has stalled because of development of mosquito resistance and behavioural resilience to pyrethroids used in LLINs and IRS. Therefore, it is essential that complementary tools are developed to tackle malaria transmission when and where the limits of these primary vector control measures have been defined. This study will evaluate the additional impact of house screening to LLINs in reducing household clinical malaria cases and mosquito densities in three Southern African countries. Clinical, entomological and socio-economic endpoints will be evaluated to assess the additional impact of house-screening to LLIN use on malaria transmission in Zambia, Zimbabwe and Mozambique. In addition, that cost-effectiveness as well as the feasibility of scale up of this intervention will be evaluated.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) AFRO II
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Malaria
Purpose of the trial Additional impact of house screening to LLINs on malaria transmission
Anticipated trial start date 01/06/2017
Actual trial start date 17/09/2018
Anticipated date of last follow up 30/04/2022
Actual Last follow-up date 30/06/2022
Anticipated target sample size (number of participants) 2400
Actual target sample size (number of participants)
Recruitment status 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 Simple randomization using a randomization 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 House screening arm The houses will be screened once and followed up over a two year period to assess the status of the house screens. Two malaria transmission seasons (2 years) This is a two-armed household randomized study. Semi-modern houses will be used as the unit of randomization. A total of 2400 semi-modern houses will be enrolled from the study areas in three southern African countries, Zambia, Zimbabwe and Mozambique. After a baseline period of one year (pre-intervention), where baseline clinical, entomological and socio-economic indices will be collected, 1200 houses will be randomly assigned to the house screening arm of the study. All potential mosquito entry spaces in these houses will be screened using a poly vinyl coated (PVC) fibre glass netting. During the 2 year follow up period, clinical, entomological and socio-economic indices will be collected and compared to the pre-intervention period to assess the effect of house screening. The condition of the house screens will be assessed and replaced if deteriorated. 1200
Control Group Control arm The houses will not be screened over the two year project period. Two malaria transmission seasons (2 years) This is a two-armed household randomized study. Semi-modern houses will be used as the unit of randomization. A total of 2400 semi-modern houses will be enrolled from the study areas in three southern African countries, Zambia, Zimbabwe and Mozambique. After a baseline period of one year (pre-intervention), where baseline clinical, entomological and socio-economic indices will be collected, 1200 houses will be randomly assigned to the control arm of the study. All potential mosquito entry spaces in these houses will be left open. During the 2 year follow up period, clinical, entomological and socio-economic indices will be collected and compared to the pre-intervention period. 1200 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Houses are partly modern with potential spaces for mosquito entry and screening potential. • Houses are at least 50 meters apart • Houses have at least 2 children between 6 months and 13 years of age that reside and sleep in them. • Houses in which potential spaces for mosquito entry are screened. • Houses are less than 50 meters apart • Houses that do not have at least 2 children between 6 months and 13 years of age that reside and sleep in them. Child: 6 Year-12 Year,Infant: 13 Month(s)-24 Month(s),Preschool Child: 2 Year-5 Year 6 Month(s) 13 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 22/09/2017 WHO AFRO Ethics Review Committee
Ethics Committee Address
Street address City Postal code Country
World Health Organization - Regional Office for Africa Brazzaville 00000 Congo
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Vector adult density inside and outside screened houses will be compared with houses that use LLINs alone. Vector densities will be measured pre and post intervention through out the study period.
Secondary Outcome Sporozoite rates, human biting index and entomological inoculation rates both indoors and outdoors in screened houses will be compared to houses that use LLINs alone. Sporozoite rates, human biting index and entomological inoculation rates will be measured pre and post intervention throughout the study period.
Primary Outcome Clinical malaria in children between 6 months and 13 years measured using rapid diagnostic tests, dry blood spots and thick and thin blood smears in screened houses compared to houses that use LLINs only. At the beginning and end of each malaria transmission season i.e. every 6 months in a year, making a total of 6 cross-sectional parasitological surveys throughout the study period.
Secondary Outcome Parasite infection rate and parasite density in children between 6 months and 13 years in screened houses compared to houses that use LLINs only. At the beginning and end of each malaria transmission season i.e. every 6 months in a year, making a total of 6 cross-sectional parasitological surveys throughout the study period.
Primary Outcome Assess the incremental cost of house screening in houses where this intervention has been implemented. This will be measured once at the end of the study.
Secondary Outcome 1. Evaluate the acceptability of house screening as a malaria control tool in the community. 2. Identify the barriers and opportunities for scale of house screening and advocate for the adoption of this intervention as a policy in national malaria control programmes of the study countries. Community acceptability of this intervention will be measured twice at the start and end of the study. Advocacy for house screening will be done once at the end of the study.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
National Malaria Elimination Centre Ministry of Health Zambia Chainama Hills Hospital Grounds Lusaka Zambia
Chokwe Health Research and Training Centre National Institute of Health Mozambique Annex to the Rural Hospital of Chokwe Chokwe Mozambique
National Malaria Control Programme Ministry of Health and Child Care Zimbabwe Kaguvi Building, 4th Floor Central Avenue Harare Zimbabwe
FUNDING SOURCES
Name of source Street address City Postal code Country
World Health Organization Regional Office for Africa P.O.Box 06 Brazzaville Djoue 00000 Congo
United Nation Enviroment Programme United Nations Avenue, Gigiri PO Box 30552, 00100 Nairobi 00100 Kenya
Global Environment Facility 1899 Pennsylvania Avenue NW, Washington, DC 20006, Washington DC 20006 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor World Health Organization Regional Office for Africa P.O.Box 06 Brazzaville Djoue Brazzaville 00000 Congo Funding Agency
COLLABORATORS
Name Street address City Postal code Country
National Malaria Elimination Centre Ministry of Health Zambia Chainama Hills Hospital Grounds Lusaka 00000 Zambia
Chokwe Health Research and Training Centre National Institute of Health Mozambique Annex to the Rural Hospital of Chokwe Chokwe 1204 Mozambique
World Health Organization Zimbabwe Country Office CY 348 Causeway Harare Harare 00000 Zimbabwe
National Malaria Control Centre Ministry of Health and Child Care Kaguvi Building, 4th Floor Central Avenue Harare 00000 Zimbabwe
World Health Organization Zambia Office PO Box 32346 10101 - Lusaka Lusaka 00000 Zambia
World Health Organization Mozambique Country Office CP 377 Rua Pereira Marinho, 280 Maputo Maputo 0101 Mozambique
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Clifford Mutero cmutero@icipe.org +254208632255 International Centre of Insect Physiology and Ecology, Duduville Campus Nairobi
City Postal code Country Position/Affiliation
Nairobi 00100 Kenya Consultant Scientist
Role Name Email Phone Street address
Scientific Enquiries Ulrike Filinger ufilinger@icipe.org +25420863331 International Centre of Insect Physiology and Ecology Thomas Odhiambo Mbita Campus
City Postal code Country Position/Affiliation
Mbita 40305 Kenya Scientist
Role Name Email Phone Street address
Public Enquiries Peter Sangoro psangoro@icipe.org +254208632098 International Centre of Insect Physiology and Ecology Duduville Campus Nairobi
City Postal code Country Position/Affiliation
Nairobi 00100 Kenya Postdoctoral Research Fellow
Role Name Email Phone Street address
Public Enquiries Theresia Nkya tnkya@icipe.org +254208632254 International Centre of Insect Physiology and Ecology Duduville Campus Nairobi
City Postal code Country Position/Affiliation
Nairobi 00100 Kenya Postdoctoral Research Fellow
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures and appendices). Informed Consent Form,Statistical Analysis Plan Beginning 6 months and ending 5 years after article publication. Data sharing will be as per the guidelines of the ICIPE Database and Knowledge Management Unit.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
http://www.icipe.org/research/technology-transfer-unit/database-and-knowledge-management 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