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.: PACTR201901533237287 Date of Approval: 17/01/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of Mobile Phone Text Message Reminders on Improving Completeness and Timeliness of Routine Childhood vaccinations in North-West, Ethiopia: Randomized Controlled Clinical Trial
Official scientific title Effect of Mobile Phone Text Message Reminders on Improving Completeness and Timeliness of Routine Childhood vaccinations in North-West, Ethiopia: Randomized Controlled Clinical Trial
Brief summary describing the background and objectives of the trial Childhood vaccination is one of the most successful and cost effective public health interventions for children to prevent illness, disability and death from vaccine-preventable diseases. To effectively control VPDs, high immunization coverage is required and vaccine effectiveness also depends on the timing of its administration. However, low vaccination coverage and non-attendance for immunization appointments remains a challenge to healthcare providers in Ethiopia . The main challenge in child immunization dropouts and untimely immunization of children are the information gaps both from the service supply and demand sides including forgetfulness of mothers and poor awareness about immunization schedules. Hence, different innovative and cost effective strategies are required to look into for enhancement in vaccination uptake and coverage. This implies that parents would require regular reminders for each immunization visit to increase immunization coverage to the desired level. With a meager scientific evidence of effectiveness in low income countries, mHealth programs continue to spread throughout Africa. However, lack of evidence is one of the contributing factors for the failure of these mhealth programs. Although there is a global consensus that the application of mobile phone-based mHealth approaches may ultimately drive significant advancement in health care, little is known about current practice in developing countries, especially in sub-Sahara Africa where mHealth is a relatively new concept and questions arise regarding the feasibility of the technology used in improving health outcomes. The effectiveness of mobile phone text reminders in improving vaccination coverage’s in Ethiopia is also not well studied so far.Therefore the aim of this study is to examine the effect of mobile phone text message reminders on completeness and timeliness of childhood vaccinations in North-West, Ethiopia.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Testing effectiveness of text message reminders for routine immunization program
Anticipated trial start date 11/02/2019
Actual trial start date
Anticipated date of last follow up 29/03/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 408
Actual target sample size (number of participants)
Recruitment status Not yet 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 Simple randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Standard Care with Mobile Text Message Reminder One reminder message per vaccination schedule A total of four vaccination visits ( Visit 1 at fourth week, visit 2 at tenth week, visit 3 at sixteenth week and visit 4 at ninth month) to be completed before the first birth day of an infant Computerized text message reminder system will be developed for childhood immunization program. The computerized application will be used for text message reminders scheduling and texting messaging. For each routine vaccine dose, the software application will send automatic SMS reminders to mothers about upcoming vaccination sessions. Mothers of children randomized in this intervention group will receive text message reminder to remind them that their child’s immunizations are due date. The reminder messages will be dispatched from an automated web based system on due date at 6, 10 and 14 weeks for polio and pentavalent vaccines and at 9 months for measles vaccine. Messages will be delivered both in English and Amharic languages to the mothers. If child didn't get vaccinated on schedule, re programming will be done to occur after 4 weeks from the previous dose. 204
Control Group Standard Care group Routine reminders will be used per each vaccination schedule at 6 week, 10 week, 16 week and 9 month vaccination schedules Routine reminders will be used for the four vaccination schedules for each infants vaccination to be completed before the first birth day The control group will receive the routine standard care. It includes standard methods of reminding mothers to return for follow up with verbal reminder and appointment date on the immunization card. 204 Dose Comparison
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Mothers aged 18 years up to 45 years • Mothers who have their own working mobile phones • Permanent resident of the study area • If twin infants, the youngest will be included • Mothers providing consent to participate in the study • Plans to move out of the study area in the next one year • Infant has already received immunizations other than birth dose of BCG or polio Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 45 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 28/03/2018 Institutional Ethical Reveiw Board of University of Gondar
Ethics Committee Address
Street address City Postal code Country
Chechela Street Gondar 0196 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Complete Vaccination coverage AT the end of the follow-up
Primary Outcome Full Timely vaccination coverage AT the end of the follow-up
Secondary Outcome Vaccination coverage for each vaccine at each vaccination schedule
Secondary Outcome Timely vaccination coverage for each vaccine At each vaccination schedule
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University Of Gondar Chechela Street Gondar 0196 Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
University of Gondar Chechela Street Gondar 0196 Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University Of Gondar Chechela Street Gondar 0196 Ethiopia University
COLLABORATORS
Name Street address City Postal code Country
Binyam Tilahun Chechela Street Gondar 0196 Ethiopia
Kassahun Alemu Chechela Street Gondar 0196 Ethiopia
Martin Were Chechela Street Gondar 0196 Ethiopia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Zeleke Abebaw Mekonnen zelekeabebaw7@gmail.com +251913747092 Chechela Street
City Postal code Country Position/Affiliation
Gondar 0196 Ethiopia PhD Fellow
Role Name Email Phone Street address
Public Enquiries Binyam Chakilu Tilahun binigcms@gmail.com +251913875066 Chechela Street
City Postal code Country Position/Affiliation
Gondar 0196 Ethiopia PhD and Director of CBMP Project
Role Name Email Phone Street address
Scientific Enquiries Kassahun Alemu Gelaye kassalemu@gmail.com +251911752466 Chechela Street
City Postal code Country Position/Affiliation
Gondar 0196 Ethiopia PhD and Director of Institute of public Health University of Gondar
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
No
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