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.: PACTR201808527428720 Date of Registration: 23/08/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Tracking demographic movements and immunization status to improve children access to immunization
Official scientific title Tracking demographic movements and immunization status to improve children access to immunization
Brief summary describing the background and objectives of the trial The objective of the Expanded Program on Immunization (EPI) in Cameroon is to administer 15 doses of vaccines in 5 contacts to each child before that age of 12 months while respecting the interval between doses. Based on the report of EPI in 2016, the rate of completeness of immunization calendar among children aged 12-24 months remains very low(about 70%) in Cameroon. Among the causes of incomplete immunization include the non-mastery of the immunization calendar by the parents, migration of children with their parents to different localities and community deliveries. The objective of this project is to assess the effect of community-based tracking, registration and follow-up of children’s immunization status and migration/demography on the completeness, timeliness and coverage of immunization among children 0-11 months. This will be a randomized controlled field trial in which the different communities of the Foumban Health District will be randomly assigned to two arms (intervention and control groups). In the intervention group, community volunteers will track and register the immunization status and demographics of children 0-11 months of age. They will lien with the health facility vaccination teams by communicating this information to them through whatsapps and the team will use it to program immunization sessions in the communities. The community volunteers in turn will contact the children parents in their respective home to inform them of the immunization sessions (place and time) and to educate them on the importance of immunization. On the other hand, the control group will be left to be function as they do in the routine. One baseline survey and two immunization coverage surveys will be conducted (at 6 and 12 month in-process) to assess the effect of the intervention on the immunization timeliness, completeness and coverage.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) TDM IAI
Disease(s) or condition(s) being studied Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention: Vaccines
Anticipated trial start date 01/05/2018
Actual trial start date
Anticipated date of last follow up 30/04/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 5400
Actual target sample size (number of participants)
Recruitment status 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 Randomised Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification 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 community based registery and followup 12 months community volunteers will track and register the immunization status and demographics of children 0-59 months of age. They will lien with the health facility vaccination teams by communicating this information to them through whatsapps and the team will use it to program immunization sessions in the communities. The community volunteers in turn will contact the children parents in their respective home to inform them of the immunization sessions and to educate them on immunization related matters. 30
Control Group no inetrvetion 1 year will be allowed to vaccinate their children without community based tracking as in the routine 30 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
all children from 0-59 months Routine immunization is conterindicated Infant: 0 Month(s)-12 Month(s),Infant: 13 Month(s)-24 Month(s),New born: 0 Day-1 Month 0 Month(s) 23 Month(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 10/07/2018 Cameroon National Ethics committee
Ethics Committee Address
Street address City Postal code Country
Hygiene Mobile, Messa Yaounde 1937 Cameroon
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome timeliness of immunization 6 months and 12 months
Secondary Outcome completeness of immunization 6 months and 12 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Fouban Health dostrict Fouban Health dostrict Foumban Cameroon
FUNDING SOURCES
Name of source Street address City Postal code Country
Bill and Melinda Gates Foundation 1835 73rd Ave NE, Medina Washington United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Meilleur Acces Aux Soins de Sante Biyem Assi lac opposite Wisdom academic Yaounde 33490 Cameroon Other Collaborative Groups
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Jerome Ateudjieu jateudjieu@masante-cam.org +23799701011 Biyem-Assi lac
City Postal code Country Position/Affiliation
Yaounde 33490 Cameroon Meilleur Acces Aux Soins de Sante
Role Name Email Phone Street address
Scientific Enquiries Jerome Ateudjieu jateudjieu@masante-cam.org +23799701011 Biyem-Assi lac
City Postal code Country Position/Affiliation
Yaounde 33490 Cameroon Meilleur Acces Aux Soins de Sante
Role Name Email Phone Street address
Public Enquiries Martin Yakum myakum@masante-cam.org +237694792362 Biyem-Assi lac
City Postal code Country Position/Affiliation
Yaounde 33490 Cameroon Meilleur Acces Aux Soins de Sante
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Undecided
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