Not Yet RecruitingNot Applicable

mHealth Intervention for Improving Vaccination Coverage in Bangladesh

7,800 participantsStarted 2026-05-01

Plain-language 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.

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Full vaccination

Timeframe: 1 year

Vaccine Timeliness

Timeframe: 1 year

Trial details

NCT IDNCT07510971

SponsorJapan Institute for Health Secutiry

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2026-09-01

View on ClinicalTrials.gov More mHealth Intervention trials