mHealth InterventionNCT07510971
mHealth Intervention for Improving Vaccination Coverage in Bangladesh
A study testing Automated voice reminders with behavior change messages and Text with behavior change message in people with mHealth Intervention and SMS, run by Japan Institute for Health Secutiry.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- mHealth Intervention, SMS
- What is being tested?
- Automated voice reminders with behavior change messages and Text with behavior change message
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7,800 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2026to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: 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.
- Conditions
- mHealth Intervention, SMS
- Being tested
- Automated voice reminders with behavior change messages, Text with behavior change message, Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Automated voice reminders with behavior change messagesBehavioural
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 messageBehavioural
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.
ControlOther
The participant of the control group will receive only standard care.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Behavioral: Text with behavior change message |
| Control | Active comparator | The participant of the control group will receive only standard care. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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)
Measured: 1 year
Secondary outcomes (2)
Vaccination coverage
Coverage of individual vaccines, including BCG, DPT1-3, polio1-3, and MCV1
Measured: 1 year
Cost-effectiveness of the intervention
Cost-effectiveness (assessed by calculating the cost per additional fully vaccinated child in each intervention group)
Measured: 1 year after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2026
- Study start1 May 2026 (estimated)
- Primary completion1 Sep 2026 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for mHealth InterventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 7,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Japan Institute for Health Secutiry
- Sponsor type
- Other government
- Responsible party
- Principal investigator, ISLAM MD RASHEDUL, Japan Institute for Health Secutiry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07510971
- Sponsor's protocol ID
- C-T2025-0695
- Status last verified
- Apr 2026
- First submitted
- 29 Mar 2026
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Health Solutions Combined With Behavior Change Approaches to Improve Vaccination Coverage and Timeliness in Bangladesh: a Cluster Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07510971
- Acronym / sponsor ID
- C-T2025-0695
- Conditions
- mHealth Intervention, SMS
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 7,800 participants (estimated)
- Lead sponsor
- Japan Institute for Health SecutiryOther government
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 6 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Automatic voice call | Experimental | Behavioral: Automated voice reminders with behavior change messagesAn 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. |
| Text with behavior change messages | Experimental | Behavioral: Text with behavior change messageThe study participant will receive the text message 3 and 1 days before the vaccination schedule |
| Control | Active comparator | Other: ControlThe participant of the control group will receive only standard care. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
- (Note: For the voice call group, literacy is not an issue.)
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Automated voice reminders with behavior change messagesAn 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. | Behavioural | Automatic voice call |
| Text with behavior change messageSMS 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. | Behavioural | Text with behavior change messages |
| ControlThe participant of the control group will receive only standard care. | Other | Control |
Primary outcome
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).
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)
2 secondary outcomes
Vaccination coverage
Time frame: 1 year
Cost-effectiveness of the intervention
Time frame: 1 year after
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Automated voice reminders with behavior change messages and Text with behavior change message in people with mHealth Intervention and SMS, run by Japan Institute for Health Secutiry.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Full vaccination (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.