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

Hepatitis B Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04177485
• Other study ID #: 6721
• Status: Completed
• Phase: N/A
• Start date: February 1, 2016
• Est. completion date: December 4, 2017

Study information

• Verified date: November 2019
• Source: Centers for Disease Control and Prevention
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1962
• Est. completion date: December 4, 2017
• Est. primary completion date: December 4, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diphtheria
• Haemophilus Infections
• Haemophilus Influenzae Type b Infection
• Hepatitis B
• Measles
• Pertussis
• Polio
• Tetanus

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (5)

Lead Sponsor	Collaborator
Centers for Disease Control and Prevention	African Field Epidemiology Network, Bill and Melinda Gates Foundation, Health Information Systems Programme-Uganda, Ministry of Health, Uganda

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants who received MCV by 12 months of age as assessed by data abstraction of home-based records at endline survey.		through study completion, an average of 12 months in the study
Secondary	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.		through study completion, an average of 12 months in the study
Secondary	Number of participants who received Penta3 within 12 weeks of Penta1 as assessed by data abstraction of home-based records at endline survey.		through study completion, an average of 12 months in the study
Secondary	Number of participants who received MCV by 10 months of age as assessed by data abstraction of home-based records at endline survey.		through study completion, an average of 12 months in the study
Secondary	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.		through study completion, an average of 12 months in the study
Secondary	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?	through study completion, an average of 12 months in the study
Secondary	Number of participants who received Penta3 by 12 months of age as assessed by data abstraction of home-based records at endline survey.		through study completion, an average of 12 months in the study