mHealth Intervention for Improving Vaccination Coverage in Bangladesh

Mobile Health Solutions Combined With Behavior Change Approaches to Improve Vaccination Coverage and Timeliness in Bangladesh: a Cluster Randomized Controlled Trial

Noncompliance and delay in vaccination have caused millions of preventable deaths worldwide particularly in low-and middle-income countries (LMICs). The main reasons for delay in vaccinations or dropout from vaccination programs are vaccine hesitancy, lack of knowledge, forgetting due date, lack of trust, and religious and social barriers. Recently, various mobile health (mHealth) interventions such as voice call, text message reminders have been implemented in LMICs to improve awareness of vaccine availability and provide timely reminders. However, the implication and impact assessment of mHealth interventions with behavior change message for improving vaccination coverage and timeliness is limited. In this project, a three-armed cluster randomized controlled trial (cRCT) will be conducted to assess the impact and cost-effectiveness of mHealth interventions with behavioral change approach on vaccination coverage and timeliness in Bangladesh. A total of 7800 caregivers of children aged less than 4 weeks will be recruited and randomly allocated equally to each arm: control, voice call, and short message service (SMS) reminders with behavioral change message. The primary outcomes will include coverage of full immunization among children in first year of life, and secondary outcomes will be coverage for each vaccine, timeliness, and infant mortality.

Study Overview

• Status: Not yet recruiting
• Conditions: SMS; mHealth Intervention
• Intervention / Treatment: Behavioral: Automated voice reminders with behavior change messages; Behavioral: Text with behavior change message; Other: Control

• Study Type: Interventional
• Enrollment (Estimated): 7800
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. You are the infant's caregiver (mother, father, or legal guardian).
2. The infant is less than 4 weeks (28 days) old at the time of enrollment.
3. You reside within the jurisdiction of the designated community health center and have no plans to move within the next 12 months.

4. Depending on your assigned group, you can do one of the following:

   • You can read Bengali SMS messages yourself.
   • You can receive support from a family member living with you who reads Bengali aloud.

   (Note: For the voice call group, literacy is not an issue.)

5. You understand the content of this study and have completed the required informed consent form.

Exclusion Criteria:

1. Caregivers of children aged 4 weeks or older at the time of enrollment
2. Children who have received any vaccine other than BCG or polio at birth
3. The caregiver plans to move out of the study area within the next six months.
4. The caregiver does not want to receive the vaccination at the intervention health center.
5. The caregiver (father, mother, or other family member) does not have a phone.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Automatic voice call; An automatic voice call will be sent on 3 days and one day before the scheduled visit at 6 weeks, 10 weeks, and 14 weeks for the three doses of DPT vaccine and age 9 months for MCV1 vaccine.	Behavioral: Automated voice reminders with behavior change messages; An automatic voice call with behavior change messages will be sent on 3 days and one day before the scheduled visit at 6 weeks, 10 weeks, and 14 weeks for the three doses of DPT vaccine and age 9 months for MCV1 vaccine. The reminder will be sent in local language.
Experimental: Text with behavior change messages; The study participant will receive the text message 3 and 1 days before the vaccination schedule	Behavioral: Text with behavior change message; SMS will be sent on 3 days and one day before the scheduled visit at 6 weeks, 10 weeks, and 14 weeks for the three doses of DPT vaccine and age 9 months for MCV1 vaccine.
Active Comparator: Control; The participant of the control group will receive only standard care.	Other: Control; The participant of the control group will receive only standard care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Full vaccination	Full vaccination coverage by 12 months of age is defined as receiving all scheduled vaccines (BCG, 3 doses of DPT, 3 doses of polio, and 1 dose of MCV1).	1 year
Vaccine Timeliness	Timeliness of vaccination: measured by whether each vaccine was administered within 2 weeks of the recommended schedule (at ages 6 weeks, 10 weeks, 14 weeks, and 9 months)	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vaccination coverage	Coverage of individual vaccines, including BCG, DPT1-3, polio1-3, and MCV1	1 year
Cost-effectiveness of the intervention	Cost-effectiveness (assessed by calculating the cost per additional fully vaccinated child in each intervention group)	1 year after

Collaborators and Investigators

• Sponsor: Japan Institute for Health Secutiry

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: March 29, 2026
• First Submitted That Met QC Criteria: March 29, 2026
• First Posted (Actual): April 6, 2026

Study Record Updates

• Last Update Posted (Actual): April 14, 2026
• Last Update Submitted That Met QC Criteria: April 9, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: C-T2025-0695

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