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.: PACTR202102846261362 Date of Approval: 17/02/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Using community influencer groups to address COVID-19 misinformation and potential vaccine hesitancy in Uganda
Official scientific title Using community influencer groups to address COVID-19 misinformation and potential vaccine hesitancy in Uganda: a prospective, comparative, two-arm, quasi-experimental study
Brief summary describing the background and objectives of the trial Coronavirus Disease 19 (COVID-19) misinformation has been reported globally. Uganda has not spared this phenomenon. COVID19 misinformation has the potential to influence public risk perception and reduce the acceptance of COVID-19 vaccine in the future. This study aims to determine the prevalence of COVID-19 misinformation and potential COVID-19 vaccine hesitancy in Buikwe district. The study will also pilot a social mobilization intervention using community influencers and determine its effect on COVID-19 misinformation and COVID-19 vaccine hesitancy.
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 COVID-19
Purpose of the trial Prevention: Vaccines
Anticipated trial start date 01/02/2021
Actual trial start date 22/02/2021
Anticipated date of last follow up 30/09/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 632
Actual target sample size (number of participants)
Recruitment status Not yet 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 Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Community influencer groups 6 months Community groups of social influencers will be implemented to address COVID-19 misinformation in the community. One community group of ten members, 5 men and 5 women, will be formed per village. Each group will consist of influential community members such as village local council leaders, religious leaders of all major religious denominations, cultural leaders, village health team members, and other opinion leaders. Community influencers will be selected through participatory stakeholder engagements, involving community members, leaders, district immunization program team members and the district COVID-19 task force. The identified community influencers will be educated about COVID-19 and trained to respond to misinformation and vaccine hesitancy in their communities. Training will be conducted virtually using a blended learning approach. Instructor-led training will be done using live and pre-recorded sessions and relayed via a videoconferencing system. Interactive methods such as group discussions, case studies, role-playing and quizzes will also be used. The training will provide the influencers with information on COVID-19 prevention measures, the available COVID-19 vaccines and address any misinformation identified in the baseline study. It will also cover effective communication, teamwork and leadership. Training will be done over five days and facilitated by two trainers separate from the project team. Additional training sessions will be organized routinely over the course of the project to address specific knowledge gaps identified. The influencers will be expected to perform information, education and communication (IEC) roles in their communities using outdoor community radios where these are available and megaphones and IEC material developed to address misinformation. They will also sensitise and educate their communities through public addresses at their routine permitted gatherings including religious services, weddings and funeral ceremonies. 316
Control Group Control 6 months Community influencer groups will not be formed in the two control villages. Sensitization and education activities will continue as programmed by the Ministry of Health. 316 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Healthy men and women aged 18 years to 65 years older who normally reside in households in the selected villages, domestic servants who have slept for five nights a week or more in the households, and visitors who have slept in the household for at least the past four weeks will be eligible to participate in the study. Men and women from households that are under COVID-19 isolation or quarantine at the time of data collection will be excluded from the study if they do not have access to a phone for phone interviews to be conducted. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 65 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 07/12/2020 Makerere University School of Health Sciences Research and Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Upper Mulago Hill Road Kampala 7072 Uganda
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The proportion of community members with COVID-19 misinformation. 6 months
Primary Outcome The proportion of community members with hesitancy towards a future COVID-19 vaccine 6 months
Secondary Outcome The psychological antecedents of vaccination: confidence, complacency, constraints, calculations and collective responsibility. 6 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Makerere University School of Health Sciences New Mulago Gate Road Kampala 000 Uganda
FUNDING SOURCES
Name of source Street address City Postal code Country
Sabin Vaccine Institute 2175 K Street Washington DC United States of America
Makerere University University Road Kampala Uganda
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Makerere University New Mulago Gate Road Kampala Uganda University
COLLABORATORS
Name Street address City Postal code Country
Uganda National Expanded Program on Immunization Ministry of Health Plot 6, Lourdel Road Kampala Uganda
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Freddy Kitutu kitutufred@gmail.com +256705791777 New Mulago Gate Road
City Postal code Country Position/Affiliation
Kampala Uganda Project Lead
Role Name Email Phone Street address
Principal Investigator Jacquellyn Nambi Ssanyu sanyukajacque@gmail.com +256783279549 New Mulago Gate Road
City Postal code Country Position/Affiliation
Kampala Uganda Project Coordinator
Role Name Email Phone Street address
Public Enquiries Freddy Kitutu kitutufred@gmail.com +256705791777 New Mulago Gate Road
City Postal code Country Position/Affiliation
Kampala Uganda Project Lead
Role Name Email Phone Street address
Scientific Enquiries Freddy Kitutu kitutufred@gmail.com +256705791777 New Mulago Gate Road
City Postal code Country Position/Affiliation
Kampala Uganda Project Lead
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All individual participant data collected during the study will be made available after deidentification. Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol 6 months after publication. No end date. Data will be available to anyone who wishes to access the data upon reasonable request.
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