Clinical Trials Directory

Trials / Completed

CompletedNCT04177485

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

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
1,962 (actual)
Sponsor
Centers for Disease Control and Prevention · Federal
Sex
All
Age
14 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALSMS text remindersSMS 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.

Timeline

Start date
2016-02-01
Primary completion
2017-12-04
Completion
2017-12-04
First posted
2019-11-26
Last updated
2019-11-26

Source: ClinicalTrials.gov record NCT04177485. Inclusion in this directory is not an endorsement.