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.: PACTR201404000811259 Date of Registration: 13/04/2014
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title SMS for immunization
Official scientific title MORE-i: a protocol for a randomized controlled trial of adding mobile phone text message versus standard of care for improving immunization coverage of children in a rural resource limited-setting
Brief summary describing the background and objectives of the trial Vaccination of children from 0 to 11 months in the Expanded Program on Immunization in Cameroon helps protect against several infectious diseases. The Cameroon national objective is to achieve a immunization coverage of 80%, and in the Far North of this African resource-limited country, a coverage of 90%. This coverage is not always achieved, causing epidemics; such as measles in 2013 in some health districts. Our primary objective is to evaluate text messages as appointment reminder tool versus standard of care, to improve immunization coverage in fix strategy for child accompanied by a caregiver in rural resource-limited setting. We hypothesize that the SMS intervention will remind to caregivers appointment for immunization of their child. The secondary objectives include comparing report of adverse manifestations post-immunization.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) Acronym
Disease(s) or condition(s) being studied Immunization,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 21/05/2014
Actual trial start date
Anticipated date of last follow up 15/10/2014
Actual Last follow-up date
Anticipated target sample size (number of participants) 168
Actual target sample size (number of participants)
Recruitment status Suspended
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 Permuted block randomisation: 4 and 6 Central randomization Masking/blinding used Care giver/Provider,Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group SOC Nothing Fourteen weeks Standard of care, participants will receive nothing 84
Experimental Group SMS 2 text messages for each appointment, 3 times during study Fourteen weeks Participants will receive text messages for remind appointment for immunization of child and for do at health center to report adverse manifestations post-immunization 84
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- Caregiver-new born baby pair - Coming for first contact vaccination for baby - Own or share (in household) a mobile phone. - Inability to read and understand national official languages of Cameroon (French or English) or who not have person in entourage able to do it. - Intention to go out of health area during study period. 9 Year(s) 120 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
No 02/05/2014 Far North Regional Delegation of Public Health of Cameroon
Ethics Committee Address
Street address City Postal code Country
Maroua Downtown Maroua Cameroon
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Presence at appointment for immunization - 6 weeks after first contact - 10 weeks after first contact - 14 weeks after first contact
Secondary Outcome Report of adverse manifestation post-immunization - 6 weeks after first contact - 10 weeks after first contact - 14 weeks after first contact
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Maltam Integrated Health Center Maltam Makary Cameroon
Afadé Integrated Health Center Afadé Makary Cameroon
Hilélé Hilélé Goulfey Cameroon
Amdjagara Integrated Health Center Amdjagara Goulfey Cameroon
Goulfey-Gana Integrated Health Center Goulfey-Gana Goulfey Cameroon
Goulfey District Hospital Goulfey Downtown Goulfey Cameroon
Hilélé Integrated Health Center Hilélé Goulfey Cameroon
Mara Integrated Health Center Mara Goulfey Cameroon
FUNDING SOURCES
Name of source Street address City Postal code Country
Jean Joel Bigna Rim Goulfey Downtown Goulfey Cameroon
Jean Jacques N. Noubiap Edéa Downtown Edéa 100 Cameroon
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Goulfey Health District Unit Goulfey Downtown Goulfey Cameroon Funding Agency
COLLABORATORS
Name Street address City Postal code Country
Jean Jacques N. Noubiap Edéa Downtown Edéa 100 Cameroon
Claudia S. Plottel New-York United States of America
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Jean Joel Bigna Rim bignarimjj@yahoo.fr +23797224938 Goulfey Downtown
City Postal code Country Position/Affiliation
Goulfey Cameroon Goulfey Health District Unit
Role Name Email Phone Street address
Public Enquiries Jean Joel Bigna Rim bignarimjj@yahoo.fr +23797224938 Goulfey Downtown
City Postal code Country Position/Affiliation
Goulfey Cameroon Goulfey Health District Unit
Role Name Email Phone Street address
Scientific Enquiries Jean Joel Bigna Rim bignarimjj@yahoo.fr +23797224938 Goulfey Downtown
City Postal code Country Position/Affiliation
Goulfey Cameroon Goulfey Health District Unit
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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