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.: PACTR202303628822064 Date of Approval: 22/03/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The Routine Immunisation Buddy System (RIBS) Initiative
Official scientific title Peer support and economic empowerment interventions to increase routine immunisation uptake in Kaduna State: A cluster-randomized controlled trial
Brief summary describing the background and objectives of the trial In sub-Saharan Africa, vaccine-preventable diseases affect almost 31 million children under the age of 5 every year, resulting in more than half a million deaths due to lack of access to the required vaccines. In Nigeria, vaccine-preventable deaths account for approximately 22% of mortality among children under 5 years old, while the Routine Immunisation coverage in the country has remained low over the years. A recent survey revealed that Nigeria has a Penta 3 coverage of 50%, which is far below the national target of 90%. Additionally, Northern Nigeria has the highest burden of unimmunized children, with low Penta 3 coverage of 54%, 37%, and 29% in the central, eastern and west zones, respectively, compared to the south-eastern, south-southern, and south-western zones, which have higher Penta 3 coverage of 83%, 70%, and 74%, respectively. The objective of the study is to test the effectiveness of the Routine Immunization Buddy System (RIBS) - which translates intention to behavior by increasing caregivers’ knowledge, motivation, and capability to demand immunisation services to increase uptake.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) RIBS
Disease(s) or condition(s) being studied Behavioural modification for immunisation uptake
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Psychosocial
Anticipated trial start date 01/08/2020
Actual trial start date 01/11/2020
Anticipated date of last follow up 10/12/2021
Actual Last follow-up date 30/12/2021
Anticipated target sample size (number of participants) 960
Actual target sample size (number of participants) 916
Recruitment status Completed
Publication URL N/A
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 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 Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Control 1 year The group did not involve any intervention in the form of knowledge sharing or support. The participants were allowed to continue their natural situation throughout the study, with contact only occurring at the Baseline (beginning of the study) and Endline (end of the study) assessments. 289 Placebo
Experimental Group Peer support group They held Buddy meetings once a month led by lead mothers 1 year The group participated in a peer knowledge-sharing intervention, specifically focused on immunization and child health, which was facilitated by a lead mother. During the intervention, caregivers shared information and knowledge with each other, utilizing a visual immunization hand tool and a theme song to support their learning and understanding. 296
Experimental Group Peer Support and Economic Empowerment Group The group held meetings ones a month, led by the lead mother 1 year The group received two forms of interventions; 1) The group participated in a peer knowledge-sharing intervention, specifically focused on immunization and child health, which was facilitated by a lead mother. During the intervention, caregivers shared information and knowledge with each other, utilizing a visual immunization hand tool and a theme song to support their learning and understanding. 2) Economic empowerment group involved caregivers that were provided financial literacy training and business advisory, in addition to micro-loans (via a cooperative scheme) for members to start and or stimulate new or existing businesses. 331
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
i. Women of child bearing age ii. Must be an adult with the ability to give concent (above 18 year) iii. Must have at least 1 child less than 24 months old iv. Economically disadvantaged women – Low to no income earning housewife v. Husband must give permission for wife's participation i. Women with no eligible children ii. Women whose gave written and signed consent ii. Women whose husbands did not permit though she gave her consent Adult: 19 Year-44 Year,Infant: 0 Month-23 Month,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 20 Year(s) Female
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 28/02/2021 Kaduna State Ministry of Health and Human Services
Ethics Committee Address
Street address City Postal code Country
Independence Way, P.M.B 2014, Kaduna Kaduna PMB 2014 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Proportion of children 0-24 months that are appropriately immunized for age At baseline and the end of the program
Secondary Outcome Change in knowledge of routine childhood immunization schedule At baseline and the end of the program
Secondary Outcome Completion of all age-appropriate vaccines At baseline and the end of the program
Secondary Outcome Change in immunization drop out At baseline and the end of the program
Secondary Outcome Retention of vaccination cards At baseline and the end of the program
Secondary Outcome Establishment of viable livelihood for mother sustained for at least 6 months. At baseline and the end of the program
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Settlements Jemaa Local Government Area Kaduna Nigeria
Settlement Soba Local Government Areas Kaduna Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Bill and Melinda Gates Foundation Seattle Washington United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Kaduna State Primary Healthcare Development Agency Independence Way, P.M.B 2014 Kaduna Nigeria Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
Kaduna State Primary Healthcare Development Agency Independence Way Kaduna PMB 2014 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Muyi Aina muyi.aina@solinagroup.com 08052172789 8 Libreville Street, Off Aminu Kano Crescent, Wuse II, Abuja
City Postal code Country Position/Affiliation
Federal Capital Territory 900288 Nigeria Managing Partner and CEO
Role Name Email Phone Street address
Scientific Enquiries Eric Aigbogun eric.aigbogun@solinagroup.com +2349096775698 8 Libreville Cresent, Wuse II, Abuja
City Postal code Country Position/Affiliation
Federal Capital Territory 904101 Nigeria SCIDaR Knowledge Management and Learning Lead
Role Name Email Phone Street address
Public Enquiries Raihanah Ibrahim raihanah.ibrahim@solinagroup.com +2348093677969 Libreville Street, Off Aminu Kano Crescent. Wuse II, Abuja
City Postal code Country Position/Affiliation
Federal Capital Territory 904101 Nigeria Project Management
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All the individual participant data collected during the trial, after they have been deidentified. Analytic Code,Informed Consent Form,Statistical Analysis Plan,Study Protocol Immediately following publication, No end date. The data and codes for cleaning, management, and analysis will be uploaded to a repository. Anyone who wishes to access it
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