Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07510971

mHealth Intervention for Improving Vaccination Coverage in Bangladesh

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

mHealth Intervention SMS

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

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.

Control

Other

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

Primary outcomes

  1. Full vaccination

    Time frame: 1 year

    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).

  2. Vaccine Timeliness

    Time frame: 1 year

    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)

Secondary outcomes

  1. Vaccination coverage

    Time frame: 1 year

    Coverage of individual vaccines, including BCG, DPT1-3, polio1-3, and MCV1

  2. Cost-effectiveness of the intervention

    Time frame: 1 year after

    Cost-effectiveness (assessed by calculating the cost per additional fully vaccinated child in each intervention group)

Sponsors and collaborators

Lead sponsor

Japan Institute for Health Secutiry

Other Gov

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2028
First posted
Apr 6, 2026
Registry last updated
Apr 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.