Evaluating a Caregiver SMS Reminder Intervention to Reduce Immunization Drop-out in Arua, Uganda

November 23, 2019 updated by: Daniel Ehlman, Centers for Disease Control and Prevention

Evaluating a Caregiver SMS Reminder Intervention to Reduce Immunization Drop-out in Arua, Uganda-a Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1962

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Standard of Care + SMS text reminders
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)
Behavioral: SMS text reminders
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.
No Intervention: Standard of Care
*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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
through study completion, an average of 12 months in the study

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
through study completion, an average of 12 months in the study
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
through study completion, an average of 12 months in the study
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
through study completion, an average of 12 months in the study
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
through study completion, an average of 12 months in the study
Cost per additional child that is up-to-date with vaccination
Time Frame: through study completion, an average of 12 months in the study
From the MOH perspective, what is the cost-effectiveness of the SMS reminder system per additional child that is up-to-date with vaccination?
through study completion, an average of 12 months in the study
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
through study completion, an average of 12 months in the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centers for Disease Control and Prevention

Collaborators

Bill and Melinda Gates Foundation
Ministry of Health, Uganda
African Field Epidemiology Network
Health Information Systems Programme-Uganda

Investigators

  • Principal Investigator: Daniel C Ehlman, MPH, Centers for Disease Control and Prevention

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2016

Primary Completion (Actual)

December 4, 2017

Study Completion (Actual)

December 4, 2017

Study Registration Dates

First Submitted

November 5, 2019

First Submitted That Met QC Criteria

November 23, 2019

First Posted (Actual)

November 26, 2019

Study Record Updates

Last Update Posted (Actual)

November 26, 2019

Last Update Submitted That Met QC Criteria

November 23, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6721

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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