Evaluating a Caregiver SMS Reminder Intervention to Reduce Immunization Drop-out in Arua, Uganda
Primary Purpose
Diphtheria, Tetanus, Pertussis
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
SMS text reminders
Sponsored by
About this trial
This is an interventional prevention trial for Diphtheria focused on measuring SMS reminder, vaccination, immunization, vaccination drop-out, vaccination timeliness, text reminder, mHealth, cell phone, mobile phone
Eligibility Criteria
Inclusion Criteria:
- Is a caregiver of a child between the ages of 6 weeks and 6 months of age and presents at one of the study sites for child's Penta1 vaccination
- Access to a personal or household cell phone that can receive text messages
- Lives in Arua district
Exclusion Criteria:
- Does not have access to the cell phone number at time of registration
- Does not agree or is unable to consent to participate in the study
- Does not anticipate being the caregiver through the child's first birthday
- Plans to move out of Arua district in the upcoming year
- Prior enrollment of the caregiver with a different child
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Standard of Care + SMS text reminders
Standard of Care
Arm Description
Standard of Care + SMS text reminders to be sent to caregivers for each of their subsequent vaccination visits, as per the EPI schedule (Penta2/OPV2/PCV2, Penta3/OPV3/PCV3, and MCV)
*Standard of care was defined as the health worker providing vaccination cards (home based records) to caregivers, as available, and providing verbal instruction of when to return for the next visit.
Outcomes
Primary Outcome Measures
Number of participants who received MCV by 12 months of age as assessed by data abstraction of home-based records at endline survey.
Secondary Outcome Measures
Number of participants who received all eligible vaccines (Penta2, PCV2, Polio2, Penta3, PCV3, Polio3, MCV) as assessed by data abstraction of home-based records and caregiver recall at endline survey.
Number of participants who received Penta3 within 12 weeks of Penta1 as assessed by data abstraction of home-based records at endline survey.
Number of participants who received MCV by 10 months of age as assessed by data abstraction of home-based records at endline survey.
Number of participants who would be interested in receiving SMS immunization reminders for their next child, as assessed with a yes/no question at the endline survey.
Cost per additional child that is up-to-date with vaccination
From the MOH perspective, what is the cost-effectiveness of the SMS reminder system per additional child that is up-to-date with vaccination?
Number of participants who received Penta3 by 12 months of age as assessed by data abstraction of home-based records at endline survey.
Full Information
NCT ID
NCT04177485
First Posted
November 5, 2019
Last Updated
November 23, 2019
Sponsor
Centers for Disease Control and Prevention
Collaborators
African Field Epidemiology Network, Ministry of Health, Uganda, Health Information Systems Programme-Uganda, Bill and Melinda Gates Foundation
1. Study Identification
Unique Protocol Identification Number
NCT04177485
Brief Title
Evaluating a Caregiver SMS Reminder Intervention to Reduce Immunization Drop-out in Arua, Uganda
Official Title
Evaluating a Caregiver SMS Reminder Intervention to Reduce Immunization Drop-out in Arua, Uganda-a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
February 1, 2016 (Actual)
Primary Completion Date
December 4, 2017 (Actual)
Study Completion Date
December 4, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centers for Disease Control and Prevention
Collaborators
African Field Epidemiology Network, Ministry of Health, Uganda, Health Information Systems Programme-Uganda, Bill and Melinda Gates Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Faced with high rates of immunization drop-out, Uganda's immunization program requires innovative approaches to address this weakness. Building upon Uganda's growing mHealth infrastructure to pilot a scalable short message service (SMS) system to remind caregivers of their children's upcoming vaccination visits, it was hypothesized that the SMS intervention will increase immunization coverage in a cost-effective and affordable manner that would make it scalable. The study design was an investigator-blinded, multi-center, parallel groups randomized controlled trial with randomization occurring at the caregiver level in select health facilities of Arua District in Uganda. Enrollment took place at the time of Pentavalent 1 vaccination, and both arms included standard of care provided by the health worker. However, in the intervention arm, caregivers also received SMS text messages reminding them to return for their children's second and third doses of Pentavalent vaccine (four and eight weeks after the first dose of Pentavalent vaccine) and measles-containing vaccine (9 months of age). The primary outcome of interest is vaccination coverage at 12 months of age among children enrolled in the study and will be measured by comparing Penta3 and MCV coverage between arms. The study will also examine the SMS impact on timeliness of vaccine receipt, as it is hypothesized that those children receiving the SMS intervention will be more likely to have timely vaccination than those in the control group. The study will also assess caregiver acceptability and cost-effectiveness of the SMS intervention. In addition to assessing its impact on strengthening the immunization program, this intervention has implications for strengthening other programs of the health system through similar health messaging directed toward caregivers.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diphtheria, Tetanus, Pertussis, Polio, Measles, Hepatitis B, Haemophilus Influenzae Type b Infection
Keywords
SMS reminder, vaccination, immunization, vaccination drop-out, vaccination timeliness, text reminder, mHealth, cell phone, mobile phone
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
1962 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard of Care + SMS text reminders
Arm Type
Experimental
Arm Description
Standard of Care + SMS text reminders to be sent to caregivers for each of their subsequent vaccination visits, as per the EPI schedule (Penta2/OPV2/PCV2, Penta3/OPV3/PCV3, and MCV)
Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
*Standard of care was defined as the health worker providing vaccination cards (home based records) to caregivers, as available, and providing verbal instruction of when to return for the next visit.
Intervention Type
Behavioral
Intervention Name(s)
SMS text reminders
Intervention Description
SMS reminders (in English and the local language) for the 2nd dose of Pentavalent vaccine were sent 28, 30 and 32 days after the 1st dose. SMS reminders for the 3rd dose of Pentavalent vaccine were sent 61, 66, and 68 days after the 1st dose. SMS reminders for the measles-containing vaccine were sent 274, 279, and 281 days after the child's date of birth.
Primary Outcome Measure Information:
Title
Number of participants who received MCV by 12 months of age as assessed by data abstraction of home-based records at endline survey.
Time Frame
through study completion, an average of 12 months in the study
Secondary Outcome Measure Information:
Title
Number of participants who received all eligible vaccines (Penta2, PCV2, Polio2, Penta3, PCV3, Polio3, MCV) as assessed by data abstraction of home-based records and caregiver recall at endline survey.
Time Frame
through study completion, an average of 12 months in the study
Title
Number of participants who received Penta3 within 12 weeks of Penta1 as assessed by data abstraction of home-based records at endline survey.
Time Frame
through study completion, an average of 12 months in the study
Title
Number of participants who received MCV by 10 months of age as assessed by data abstraction of home-based records at endline survey.
Time Frame
through study completion, an average of 12 months in the study
Title
Number of participants who would be interested in receiving SMS immunization reminders for their next child, as assessed with a yes/no question at the endline survey.
Time Frame
through study completion, an average of 12 months in the study
Title
Cost per additional child that is up-to-date with vaccination
Description
From the MOH perspective, what is the cost-effectiveness of the SMS reminder system per additional child that is up-to-date with vaccination?
Time Frame
through study completion, an average of 12 months in the study
Title
Number of participants who received Penta3 by 12 months of age as assessed by data abstraction of home-based records at endline survey.
Time Frame
through study completion, an average of 12 months in the study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Is a caregiver of a child between the ages of 6 weeks and 6 months of age and presents at one of the study sites for child's Penta1 vaccination
Access to a personal or household cell phone that can receive text messages
Lives in Arua district
Exclusion Criteria:
Does not have access to the cell phone number at time of registration
Does not agree or is unable to consent to participate in the study
Does not anticipate being the caregiver through the child's first birthday
Plans to move out of Arua district in the upcoming year
Prior enrollment of the caregiver with a different child
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel C Ehlman, MPH
Organizational Affiliation
Centers for Disease Control and Prevention
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33625372
Citation
Ehlman DC, Magoola J, Tanifum P, Wallace AS, Behumbiize P, Mayanja R, Luzze H, Yukich J, Daniels D, Mugenyi K, Baryarama F, Ayebazibwe N, Conklin L. Evaluating a Mobile Phone-Delivered Text Message Reminder Intervention to Reduce Infant Vaccination Dropout in Arua, Uganda: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2021 Feb 24;10(2):e17262. doi: 10.2196/17262.
Results Reference
derived
Learn more about this trial
Evaluating a Caregiver SMS Reminder Intervention to Reduce Immunization Drop-out in Arua, Uganda
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