mHealth Intervention for Improving Vaccination Coverage in Bangladesh

NCT07510971 | Not Yet Recruiting

• 1 other identifier: C-T2025-0695
• Study Type: interventional
• Target: 7,800
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

mHealth Intervention; SMS

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Vaccination coverage

  1 year

• Cost-effectiveness of the intervention

  1 year after

Study Arms (3)

Automatic voice call

EXPERIMENTAL

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

Text with behavior change messages

EXPERIMENTAL

The study participant will receive the text message 3 and 1 days before the vaccination schedule

Behavioral: Text with behavior change message

Control

ACTIVE COMPARATOR

The participant of the control group will receive only standard care.

Other: Control

Interventions

Automated voice reminders with behavior change messages BEHAVIORAL

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.

Automatic voice call

Control OTHER

The participant of the control group will receive only standard care.

Control

Text with behavior change message BEHAVIORAL

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.

Text with behavior change messages

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• You are the infant's caregiver (mother, father, or legal guardian).
• The infant is less than 4 weeks (28 days) old at the time of enrollment.
• You reside within the jurisdiction of the designated community health center and have no plans to move within the next 12 months.
• 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.)
• You understand the content of this study and have completed the required informed consent form.

You may not qualify if:

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

Sponsors & Collaborators

• Japan Institute for Health Secutiry: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The intervention consists of two components: phone call, and text message. An automatic voice call and 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. The caregivers of intervention groups will receive either voice call or text messages in local language.

Study Record Dates

• First Submitted: March 29, 2026
• First Posted: April 6, 2026
• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 31, 2028
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share