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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202010817398162 Date of Registration: 06/10/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title To Test and Deploy the Mobile Training and Support Service for Community Health Workers in Bo and Kambia Districts
Official scientific title To Test and Deploy the Mobile Training and Support Service for Community Health Workers in Bo and Kambia Districts
Brief summary describing the background and objectives of the trial Current hypothesis: MOTs improve knowledge/behaviors of CHWS compared to CHWs who receive no mobile training
Type of trial CCT
Acronym (If the trial has an acronym then please provide) MOTS
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Ebola
Purpose of the trial Education /Training
Anticipated trial start date 01/03/2019
Actual trial start date 23/04/2020
Anticipated date of last follow up 31/10/2020
Actual Last follow-up date 31/12/2020
Anticipated target sample size (number of participants) 600
Actual target sample size (number of participants) 600
Recruitment status Closed to recruitment,follow-up continuing
Publication URL
Secondary Ids Issuing authority/Trial register
12032017 Ministry of Health Sierra Leone
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
Crossover: all participants receive all interventions in different sequence 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 Mobile Training and support service for CHWs staring with the vaccination module 10 units of the module 2 Weeks CHWs receive the module in unties 200
Experimental Group Mobile training and support service for CHWs with the Outbreak response CHWs sent modules 2 weeks CHWs are sent the module, but also assessed pre and post after every unit 200
Control Group No Module sent These only do pre and post but no module is given until after the other treatment areas have done both modules 2 weeks None 200 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
a. Community Health Workers i. Willing to fully participate in the pilot ii. Must be reporting to the PHU iii. Must have a functional mobile phone iv. Should be based in the geographical location b. In-charges i. Must have a smart phone ii. Should be supervising the CHWs c. District Health Management Team (DHMT) Level 1 Administrator i. Must have a functional laptop ii. Internet connectivity d. Ministry of Health and Sanitation (MoHS) Level 2 Administrator i. Must have a functional laptop ii. Have supervisory roles to the geographical location e. Community Members i. Must be residents in the geographical location ii. Should have been visited by the CHW who has been included in the study iii. Willing to participate in the study 1. Community Health Workers a. Are not willing to fully participate in the pilot b. Does not have a functional mobile phone c. Is not resident in the geographical location d. Is not attached to the PHU of choice 2. In-charges a. Does not have a functional Smart phone 3. District Health Management Team (DHMT) Level 1 Administrator a. Does not have an internet enabled functional laptop b. Does not have supervision role to the geographical location of interest 4. Ministry of Health and Sanitation (MoHS) Level 2 Administrator a. Does not have an internet enabled computer b. Does not have a supervision role for the location of interest 5. Community Members a. Is not a resident in the location of interest b. Has not been visited by the CHW in the last 2 months c. Not willing to participate in the study Adult: 18 Year(s)-44 Year(s),Aged: 65 Year(s)-79 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 19 Year(s) 70 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 03/10/2019 Ministry of Health
Ethics Committee Address
Street address City Postal code Country
Brrokfield freetown 00232 Sierra Leone
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Secondary Outcome Improve the knowledge and behavior of CHWs related to vaccinations and outbreaks End of Study
Primary Outcome Order of the module (vaccination and outbreaks) matter on knowledge and behavior change end of study
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
EBODAC Freetown Freetown 232 Sierra Leone
Kambia Chief Dom road Kambia 232 Sierra Leone
FUNDING SOURCES
Name of source Street address City Postal code Country
EBODAC World Vision Sierra Leone/ Graamen foundation FreeTown 00232 Sierra Leone
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Jensen and jensen Belgium Antwep Belgium Funding Agency
COLLABORATORS
Name Street address City Postal code Country
Ministry of Health Brookfield Freetown 002323 Sierra Leone
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Frederick Kamara fredrick_kamara@wvi.org 0023276913539 freetown
City Postal code Country Position/Affiliation
Freetown Sierra Leone Research Coordinator EBODAC
Role Name Email Phone Street address
Scientific Enquiries Alliue S. Bangura allieusbangura@yahoo.com 00256706356376 Wilkinson Road
City Postal code Country Position/Affiliation
FreeTown Sierra Leone Health and Nutrition Advisor
Role Name Email Phone Street address
Public Enquiries Kanwagi Robert Robert_Kanwagi@wvi.org 0023279104931 wilkinson
City Postal code Country Position/Affiliation
freetown 00232 Sierra Leone study coordinator
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes There is a plan to share with MoH, the public, and the donor and scientific publication. Statistical Analysis Plan One year after results are analysed The report will be published
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