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.: PACTR202006832321842 Date of Approval: 17/06/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The use of different communication interventions to create an impact on measles immunization in Bamenda Health District, North West Region of Cameroon.
Official scientific title Impact of communication on measles immunization in Bamenda Health District, North West Region - Cameroon.
Brief summary describing the background and objectives of the trial Measles is highly endemic in the North West Region of Cameroon, with recurrent epidemics. This has been blamed on low measles vaccination coverage as a result of low awareness of measles. Measles vaccination in Cameroon up to the end of 2019 was administered as a single dose, despite the WHO's recommendations in 2001 for every National immunization program to include a second dose of the measles vaccine. Even with the single dose being administered, measles vaccination coverage continue to remain low, thus, giving a focus to this study. This study's objectives include establishing the trends in measles vaccination coverage, measles surveillance and measles epidemics; and assessing awareness of the value and safety of vaccines. This trial will use different communication interventions to reach out to parents and health personnel to improve awareness of measles; and reminders to parents of their children's measles vaccination appointment. The interventions will be the use of Health talks, Tract messages and Mobile phone text messages (mhealth) on a weekly basis for 6 months. This trial has as objective to assess the impact of communication on measles immunization in Bamenda Health District. Eligible participants are community leaders, parents of children aged zero to five years and health personnel; aged 15 years and above. We expect to report on the effect of the communication interventions on awareness of measles and adherence to vaccination appointments. The recruitment center is the Bamenda Health District. The collaborators for the study are Professor Njamnshi Alfred N, Professor Same Ekobo Albert and Professor Assob Jules Clement N. Reporting will be through restitution for the participating communities and through Peer review and Open Access Journals.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) HTMh measles
Disease(s) or condition(s) being studied Infections and Infestations,Respiratory
Sub-Disease(s) or condition(s) being studied Measles
Purpose of the trial Education /Training
Anticipated trial start date 01/04/2020
Actual trial start date 06/04/2020
Anticipated date of last follow up 30/09/2020
Actual Last follow-up date 30/09/2020
Anticipated target sample size (number of participants) 300
Actual target sample size (number of participants) 300
Recruitment status Completed
Publication URL None
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 randomization 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 Health talks Health talks will be delivered to participants at selected venues on weekly basis. The duration will be for six months. Health talks developed on what measles is, cause, the signs and symptoms, prevention by vaccines together with practical measures; case identification for disease surveillance; the safety and the value of measles vaccine and the need for every child to be vaccinated according to the recommended measles vaccination schedule. 50
Experimental Group Tract messages Tract messages will be distributed to the participants at selected venues on weekly basis. This will last for a period of six months. Tracts that carry messages on measles with regards to the cause, signs and symptoms, complications, prevention with vaccine and practical measures, case identification for surveillance and the need to have every child vaccinated as per the required vaccination schedule. 50
Experimental Group Mobile phone text messages Mobile phone text messages will be delivered to participants on a weekly basis. For a period of six months. Mobile phone text messages developed on measles with regards to what measles is, the cause, signs and symptoms, complications, prevention with vaccine and practical measures, case identification for surveillance and the need for every child to be vaccinated as per the required vaccination schedule. 50
Experimental Group Combinations of Health talks Tract messages and Mobile phone text messages. These will be delivered to the participants on a weekly basis. For a period of six months Health talk, Tract messages and Mobile phone text messages will be combined and delivered to participants on a weekly basis, on measles with regards to its cause, signs and symptoms, complications, case identification for disease surveillance, prevention with vaccine and practical measures and the need for every child to be vaccinated as per the required two doses of measles vaccine schedule. 50
Control Group Health talks Nothing will be delivered to participants of the control group. Six months None 50 Historical
Control Group Tract messages Nothing will be delivered to participants Six months. None 50 Historical
Control Group Mobile phone text messages Nothing will be delivered to participants. Six months None 50 Historical
Control Group Combination of Health talks Tract messages and Mobile phone text messages. Nothing will be delivered to participants. Six months None 50 Historical
Experimental Group Mobile phone text message reminder Monthly weekly and every two days Once a month for two months, then weekly for one month and finally every two days till the month due measles vaccine elapses. Mobile phone text message reminders will be sent to parents whose children are registered at targeted health facilities to remind them of their children's measles vaccination appointment on a regular basis. 300
Control Group Mobile phone text message reminder Nothing will be delivered to participants. Six months None 300 Historical
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
To be eligible, a participant must be at least 15 years and above Must be resident in the area for at least one year. He/she must be either a community leader, parent or a health personnel. A participant who is less than 15 years old One who is resident for less than one year in the area One who do not consent to the study. 80 and over: 80+ Year,Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 15 Year(s) 90 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 21/01/2020 Faculty of Health Sciences Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
Buea Cameroon Buea 0063 Cameroon
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 1. An improvement in Knowledge of measles, the value of vaccines, the safety of vaccines and the need to have each child completely vaccinated as per the vaccination calendar. 2. Adherence to measles vaccination appointment. Six months
Secondary Outcome An increase in measles vaccination coverage. . Six months.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Bamenda Health District Service Hospital Roundabout Bamenda Cameroon
FUNDING SOURCES
Name of source Street address City Postal code Country
Principal investigator Wasu Chrispus Nchandone Ndamukong Street, Nkwen Bamenda Cameroon
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Wasu Chrispus Nchandone Ndamukong Street Nkwen Bamenda Cameroon Individual
COLLABORATORS
Name Street address City Postal code Country
Professor Njamnshi Alfred N. Yaounde Central Hospital and lecturer at the Universities of Buea and Yaounde. Yaounde Yaounde Cameroon
Professor Same Ekobo Albert Faculty of Medicine and Biomedical Sciences of the University of Yaounde and lecturer of the Faculty of Health Sciences of the University of Buea.. Yaounde Yaounde Cameroon
Professor Assob Jules Clement N. Post Graduate Program Coordinator Faculty of Health Sciences of the University of Buea. Buea Buea Cameroon
Dr Kum Cletus Higher Teachers Training College University of Bamenda. Bambili Bamenda Cameroon
Benavil Yombi Regional Delegation of Public Health for the North West Region. Nkwen Bamenda Cameroon
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Wasu Chrispus Nchandone chrispusnch205@gmail.com 237677974424 Ndamukong Street Nkwen
City Postal code Country Position/Affiliation
Bamenda Cameroon Regional Delegation of Public Health for the North West Region of Cameroon.
Role Name Email Phone Street address
Public Enquiries Njamnshi Alfred N. alfredknjamnshi@gmail.com 237677619964 Yaounde
City Postal code Country Position/Affiliation
Yaounde Cameroon Yaounde Central Hospital
Role Name Email Phone Street address
Scientific Enquiries Professor Assob Jules Clement juleclement@yahoo.fr 23767923948 Faculty of Health Sciences, University of Buea.
City Postal code Country Position/Affiliation
Buea Cameroon Post graduate program coordinator.
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The findings from this study will be disseminated in the first place through restitution at the participating communities and at the Regional Delegation of Public Health for the North West Region. Secondly, it will be done through Peer Review Journals and Open Access Journals for national and international audiences. Clinical Study Report Six months after completion of study. Personal presence and online access.
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