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.: PACTR202310811597445 Date of Approval: 20/10/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Randomized controlled trial of a social media campaign to promote COVID-19 vaccination in Nigeria
Official scientific title Randomized controlled trial of a social media campaign to promote COVID-19 vaccination in Nigeria
Brief summary describing the background and objectives of the trial Background: The COVID-19 pandemic has challenged public health and behavior change programs and has also led to innovative interventions and research. In low -and middle-income countries (LMICs) such as Nigeria, new strategies to promote vaccination, increase pro-vaccination social norms, and reduce vaccine hesitancy have been deployed through social media campaigns and evaluated using digital media platforms. Methods: The aim of this study was to conduct two randomized controlled evaluations of social media content designed to promote COVID-19 vaccination and to complement research on a nationwide vaccination promotion campaign in Nigeria run in 2022. We conducted two studies in March and August 2022 among Nigerians drawn from 31 states that were not the target of the nationwide campaign. Participants were randomized to receive the pro-vaccination social media campaign or not and data were collected at pre- and post-test to evaluate psychosocial predictors of vaccination and vaccination outcomes following a theory of change based on Diffusion of Innovations, Social Norms Theory, and the Motivation, Opportunity, Ability (MOA) Framework. Data were collected through a novel intervention delivery and data collection platform through social media, and this study demonstrates the capability and potential of new social media-based data collection techniques. Results: The study found that pro-vaccination social norms and vaccination rates increased, and vaccine hesitancy decreased, among participants randomized to the social media intervention study arm. Conclusion: Social media campaigns are a promising approach to increasing vaccination at scale in LMICs, and social norms are an important factor in promoting vaccination, which is consistent with the Social Norms Theory. We describe implications for future vaccination campaigns and identify future research priorities in this area. The study was conducted in accordance with the Declaration of Helsinki, and approved by t
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 COVID-19 vaccination
Purpose of the trial Prevention: Vaccines
Anticipated trial start date 01/04/2022
Actual trial start date 01/04/2022
Anticipated date of last follow up 01/10/2022
Actual Last follow-up date 01/10/2022
Anticipated target sample size (number of participants) 700
Actual target sample size (number of participants) 734
Recruitment status Completed
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously 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 COVID19 vaccination social media campaign in Nigeria 10 social media impressions 2 months Social media campaign created by professional designers to promote COVID-19 vaccination among adults in Nigeria who are open to receiving COVID-19 vaccines. 233
Control Group None 0 impressions 2 months No social media content (control to intervention described in this submission) 233 Dose Comparison
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- Reside in Nigeria but not in one of six states that received a nationwide COVID-19 campaign - Be at least 18 years of age at baseline/enrollment - Be unvaccinated at baseline/enrollment - Be open to considering COVID-19 vaccination according to a screening question - Failing the inclusion criteria 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ 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 09/09/2022 George Washington University Institutional Research Board
Ethics Committee Address
Street address City Postal code Country
950 New Hampshire Avenue NW, Washington, DC 20052 Washington 20052 United States of America
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 05/10/2021 National Health Research Ethics Committee in Nigeria
Ethics Committee Address
Street address City Postal code Country
11th floor, Federal Secretariat Complex Phase III, Amadu Bello Way, Abuja, Nigeria Abuja 0 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome COVID-19 vaccination 2 month Follow up
Secondary Outcome Vaccine hesitancy scale Baseline and 2 month follow up
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Virtual Lab online social media recruitment platform None None Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Bill and Melinda Gates Foundation 500 5th Avenue North Seattle 98109 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Bill and Melinda Gates Foundation 500 Fifth Avenue North Seattle 98109 United States of America Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator William Douglas Evans wdevans@gwu.edu +12023519546 950 New Hampshire Avenue
City Postal code Country Position/Affiliation
Washington 20052 United States of America Professor
Role Name Email Phone Street address
Public Enquiries William Douglas Evans wdevans@gwu.edu +12023519546 950 New Hampshire Avenue NW
City Postal code Country Position/Affiliation
Washington 20052 United States of America Professor
Role Name Email Phone Street address
Scientific Enquiries William Douglas Evans wdevans@gwu.edu +12023519546 950 New Hampshire Avenue NW
City Postal code Country Position/Affiliation
Washington 20052 United States of America Professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Trial protocol Study Protocol December 2023 Key personnel on the study under direction of the PI
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 12/10/2023
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 12/10/2023
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information