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.: PACTR201807166695568 Date of Approval: 11/07/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title IMPACT OF POPULATION BASED INDOOR RESIDUAL SPRAYING IN COMBINATION WITH CHEMOTHERAPY ON KEY MALARIA INDICATORS IN A HIGH TRANSMISSION SETTING IN NORTH EASTERN UGANDA
Official scientific title IMPACT OF POPULATION BASED INDOOR RESIDUAL SPRAYING IN COMBINATION WITH CHEMOTHERAPY ON KEY MALARIA INDICATORS IN A HIGH TRANSMISSION SETTING IN NORTH EASTERN UGANDA
Brief summary describing the background and objectives of the trial Uganda, as a highly endemic country, faces the challenge of charting a rapid, safe and effective route from high transmission to pre-elimination. Robust vector control with indoor residual spraying (IRS) + long lasting insecticidal nets (LLINs), may still leave lots of residual transmission, and IRS use is resource limited. Mass drug administration (MDA) is one possible means to accelerate vector control impact, aiding efforts towards elimination. The objective of the trial is to assess the impact of four rounds of population based IRS with pirimiphos methyl, alone or in combination with MDA with dihydroartemisinin-piperaquine (DP), on malaria transmission, prevalence and incidence.
Type of trial CCT
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 01/08/2016
Actual trial start date 03/10/2016
Anticipated date of last follow up 30/11/2020
Actual Last follow-up date 30/11/2020
Anticipated target sample size (number of participants) 50000
Actual target sample size (number of participants) 50000
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 Non-randomised 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 Mass drug administration plus indoor residual spraying every six months two years Madd drug administration with dihydroartemisinin piperaquine and indoor residual spraying with pirimiphos methyl 18000
Experimental Group indoor residual spraying every six months two years indoor residual spraying with pirimiphos methyl 15000
Control Group standard of care routine two years long lasting insectcide bed nets 16000 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
all adults all children pregnant women children six months and belowindividuals with chrinic liver and kidney disease known allergies to artemisinins 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 6 Month(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 19/08/2015 Makerere University School of Public Health Research and Ethics Committe
Ethics Committee Address
Street address City Postal code Country
Milago Hill Complex Kampala 00256 Uganda
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Prevalence of asexual parasitaemia in the community measured by crossectional surveys. every six months post interventions
Primary Outcome Parasite positivity rate at health facilities and in the community measured by routine collection of health facility data routine collection of health management information system data
Primary Outcome Entomologic inoculation rate monthly collection of mosiquitoes from selected house holds in the study area
Secondary Outcome acceptability of interventions two qualitative surveys
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Toroma and Kapujan subcounties Katakwi district Katakwi 00256 Uganda
FUNDING SOURCES
Name of source Street address City Postal code Country
Bill and Melinda Gates Foundation 440 5th N, Av Seattle 00206 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Pilgrim Africa 27 Bandali Rise Kampala 00256 Uganda Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Adoke Yeka yadoke@yahoo.com +256772473533 Mulago Hill Complex
City Postal code Country Position/Affiliation
Kampala 00256 Uganda Lecturer Makerere University
Role Name Email Phone Street address
Principal Investigator Dorothy Echodu dorothy@pilgrimafrica.org +2066047465 Seattle
City Postal code Country Position/Affiliation
Seattle 00206 United States of America Cheif Executive Officer Pilgrim Africa
Role Name Email Phone Street address
Public Enquiries April Celements april@pilgrimafrica.org +12063692075 Seattle
City Postal code Country Position/Affiliation
Seattle 00120 United States of America Administrator Pilgrim Africa
Role Name Email Phone Street address
Scientific Enquiries Adoke Yeka yadoke@yahoo.com +256772473533 Mulago Hill Complex
City Postal code Country Position/Affiliation
Kampala 00256 Uganda Lecturer Makerere University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Undecided
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