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.: PACTR201906720882512 Date of Registration: 20/06/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Rectal Artesunate Information Education and Communication implementation study (RASIEC) - a cohort study to evaluation the impact on patient referal through the introduction of a quality IEC toolkit.
Official scientific title A cohort study in Malawi assessing whether access to targeted Rectal Artesunate Information Education and Communication (RASIEC) increases early presentation for RAS pre-referral treatment by caregivers and treatment with onward referral by front line village health workers.
Brief summary describing the background and objectives of the trial The overall goal of MMV's study is to support the continuum of care from the community to the referral health centre through the introduction of a quality IEC toolkit which the study hypothesizes will increase early presentation at the HSA for RAS pre-referral treatment, will improve CHW/HSA diagnosis, treatment and referral of danger signs and in turn enhance prompt compliance with referral instructions by caregivers.
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 Education /Training
Anticipated trial start date 05/04/2019
Actual trial start date
Anticipated date of last follow up 27/09/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 114
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 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
Experimental Group Salima 6 months The HSA intervention group will be exposed to job aids available at the VHCs and during the intervention refresher sensitization on RAS using the info booklet and the jobaids within the toolkit. The caregiver/household intervention group: will be exposed to IEC posters mounted in appropriate locations throughout the target communities. 92
Control Group Ntchisi control arm 6 months In the unexposed site (Ntchisi), the community and the HSAs will receive no RAS IEC as none is currently provided by the Ministry of Health or partners in this area. 22 Historical
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Household survey (HHS): • Household parent / primary caregiver of children 5 years and under • Signed consent form from parent / guardian • Household within catchment population of selected VHC Health Surveillance Assistant Survey (HSAS): Health Surveillance Assistant at the eligible village health clinic: • HSA must be resident in the catchment area of the VHC and available day and night and cannot reside outside of the VHC catchment area. Note: This is essential to be able to generalise the findings to other settings where CHWs are resident, unlike other sites in Malawi where HSAs are not resident & reside in trading posts. • VHC must be > 5 kilometres from the referral health facility • VHC must be operational – as indicated by current up to date records of children five years and under. • HSA must have signed the consent form. Tracking: • Caregiver of child 5 years and under • History of fever plus danger signs indicative of severe febrile illness / suspected severe malaria, according to local iCCM guidelines. • Signed full consent form from parent / guardian Household survey (HHS): • Parents / primary caregivers with no children over 5 years • Parents / primary caregivers with no permanent residence in project area • Parents / primary caregivers who do not consent Health Surveillance Assistant Survey (HSAS): • HSAs working or living outside project area • Newly transferred HSA not enrolled at Baseline • Not resident full time in the catchment area throughout the study • VHC <5 km from referral facility Tracking: • Children 5 years or under • Children not residing in project area • Caregiver under 16 years • Non-consenting caregiver 80 and over: 80+ Year,Adolescent: 13 Year(s)-17 Year(s),Adult: 18 Year(s)-44 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 99 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 12/02/2019 College of Medicine Research Support Center
Ethics Committee Address
Street address City Postal code Country
Private Bag 360 Chichiri Blantyre 0000 Malawi
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Health seeking behaviour - improvement of severe malaria referal post RAS administration monthly
Secondary Outcome Awareness of severe malaria symptoms and health seeking behavior monthly
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
RASIEC Field Office Senga Bay Baptist Mission Centre Salima Distict Malawi
RASIEC Field Office Training Support for Partners Ntchisi Field Office Mponela Ntchisi Malawi
FUNDING SOURCES
Name of source Street address City Postal code Country
Unitaid Chemin du Pommier 40 Geneva 1218 Switzerland
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Medicines for Malaria venture Route de Pre Bois 20 Geneva Switzerland Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
John Phuka College of medicine Blantyre Malawi
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Monique Oliff monique.oliff@wellsense-iphc.com 254728928757 PO Box 150
City Postal code Country Position/Affiliation
Kilifi Kenya International Public Health Consultant
Role Name Email Phone Street address
Public Enquiries Maud Majeres majeresm@mmv.org 0041225550335 route de pre bois 20
City Postal code Country Position/Affiliation
Geneva Switzerland Project manager
Role Name Email Phone Street address
Scientific Enquiries Monique Oliff monique.oliff@wellsense-iphc.com 254728928757 PO Box 150
City Postal code Country Position/Affiliation
Kilifi Kenya International Public Health Consultant
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes MMV will share individual participant data and data dictionaries within the required timelines Study Protocol The data will be available at study completion - estimated November 2019 Qualitative data available upon written request to Medicines Malaria Ventures
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