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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
Centers for Disease Control and Prevention
About
Eligibility
Locations
Arms
Outcomes
Full info

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

14 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    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
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    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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