VaccinesNCT06470919
The Next Generation Vaccine Card: Innovative Technology to Improve Vaccine Equity in Rural and Urban Settings in East Africa
A study testing SMS reminders for upcoming vaccination(s) in people with Vaccines, run by University of Michigan at 2 sites in 2 countries.
Trial summary
The research team of investigators from University of Michigan and the African Population and Health Research Center will implement and evaluate a newly-developed digital vaccine card and accompanying mobile application and electronic immunization registry. Read more about this study
- Who is it for?
- Ages 1 day to 24 months
- Conditions the study is for
- Vaccines
- What is being tested?
- SMS reminders for upcoming vaccination(s)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,522 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 6 Nov 2024to 29 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 1 day to 24 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 1 day to 24 months old
Who cannot join
- Sites not included in the study
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Kenya1 site
African Population and Health Reseach Center
Nairobi, Kenya, 10787-00100
About this study
The research team of investigators from University of Michigan and the African Population and Health Research Center will implement and evaluate a newly-developed digital vaccine card and accompanying mobile application and electronic immunization registry. This will take place in rural Uganda and urban Kenya Health and Demographic Surveillance Systems (HDSS) and the study team will analyze its feasibility, impacts, cost through process, and economic evaluations. The study team will also assess the data quality and equity of the digital vaccine registry and card system.
Read the detailed description
This study design has three parts or aims for this project, however, only the third aim is considered to be the trial portion and is included in this registration.
- Conditions
- Vaccines
- Being tested
- SMS reminders for upcoming vaccination(s)
- Keywords
- Kenya, Uganda, Vaccine coverage, Vaccine completion, Vaccine timeliness, Digital health interventions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMS reminders for upcoming vaccination(s)Other
All parents/caregivers of children in participating villages will receive access to a digital vaccine card. This will be used for record-keeping application (digital vaccine registry). Selected parents/caregivers of children will receive SMS messages and reminders related to vaccination.
| Study group | Role | What they receive |
|---|---|---|
| Next Generation digital vaccine card with SMS reminders for upcoming vaccination(s) | Experimental | Not described Receives: Other: SMS reminders for upcoming vaccination(s) |
| Pre-intervention cohort | No intervention | This group will be compared to the post-intervention group to assess the digital vaccine card. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diphtheria, pertussis, and tetanus first dose (DPT1) coverage
Percent (%) of all children born in the intervention period that received the first dose of DPT vaccine (Continuous measure, 0-100%).
Measured: 18 months of the intervention period
Diphtheria, pertussis, and tetanus first dose (DPT3) coverage
Percent of all children born in the first 15 months of the intervention period that received the third dose of DPT vaccine (Continuous measure, 0-100%).
Measured: 15 months of the intervention period (last 15 months of the intervention period)
Dropout rate from DPT1 to DPT3
Difference in the proportion of children born in the first 15 months of the intervention period that received the first and third doses of the DPT vaccine (Continuous measure, 0-100%)
Measured: 15 months of the intervention period (last 15 months of the intervention period)
Secondary outcomes (8)
Bacillus Calmette-Guerin (BCG) coverage
Percent of all children born in the intervention period that received the BCG vaccine (Continuous measure, 0-100%).
Measured: 18 months of the intervention period (full intervention period)
Measles coverage
Percent of all children born in the first 9 months of the intervention period that received the Measles vaccine (Continuous measure, 0-100%).
Measured: 9 months of the intervention period (second half of the intervention)
Completion of basic immunizations
Percent of all children born in the first 9 months of the intervention period that received all basic recommended immunizations (BCG, oral polio vaccine (OPV), DPT1, DPT2, DPT3, OPV1, OPV2, OPV3, Pneumococcal Conjugate (PCV)1, PCV2, PCV3, rotavirus (Rota)1, Rota2, Rota3, Measles)
Measured: 9 months of the intervention period (second half of the intervention)
Dropout rate from DPT1 to Measles
Difference in the proportion of children born in first 9 months of the intervention period that received the first dose of the DPT vaccine and the Measles vaccine (Continuous measure, 0-100%)
Measured: 9 months of the intervention period (second half of the intervention)
Timeliness of BCG vaccination
Percent of all children born in the intervention period that received the BCG vaccine by 4 weeks (Continuous measure, 0-100%).
Measured: 18 months of the intervention period (full intervention period)
Timeliness of DPT1 vaccination
Percent of all children born in the intervention period that received the first dose of DPT vaccine by 10 weeks (Continuous measure, 0-100%).
Measured: 15 months of the intervention period (last 15 months of the intervention period)
Timeliness of DPT3 vaccination
Percent of all children born in the intervention period that received the third dose of DPT vaccine by 18 weeks (Continuous measure, 0-100%).
Measured: 15 months of the intervention period (last 15 months of the intervention period)
Timeliness of Measles vaccination
Percent of all children born in the intervention period that received the Measles vaccine by 10 months (Continuous measure, 0-100%).
Measured: 9 months of the intervention period (second half of the intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2024
- Study start6 Nov 2024
- Primary completion29 Oct 2025
- Study completion29 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VaccinesStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Mothers will be randomized to receive the digital vaccine card access with short message service (SMS) reminders versus mothers who did not receive digital vaccine card access with SMS reminders (treatment/control).
- Masking
- None (open label)
- Enrolment
- 3,522 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- African Population and Health Research Center
- Responsible party
- Principal investigator, Emily Treleaven, University of Michigan
- Investigators
- Emily Treleaven, PhD, MPH, Principal investigator, University of MichiganGershim Asiki, MBChB, MSc, PhD, Principal investigator, African Population and Health Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06470919
- Sponsor's protocol ID
- HUM00237101
- Status last verified
- Nov 2025
- First submitted
- 17 Jun 2024
- Last updated
- 3 Dec 2025
- Results posted
- 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 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Next Generation Vaccine Card: Innovative Technology to Improve Vaccine Equity in Rural and Urban Settings in East Africa
- ClinicalTrials.gov ID
- NCT06470919
- Acronym / sponsor ID
- HUM00237101
- Conditions
- Vaccines
- Keywords
- Kenya, Uganda, Vaccine coverage, Vaccine completion, Vaccine timeliness, Digital health interventions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,522 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- African Population and Health Research Center
- Study start
- 6 Nov 2024 (actual)
- Primary completion
- 29 Oct 2025 (actual)
- Study completion
- 29 Oct 2025 (actual)
- First posted
- 24 Jun 2024 (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.
The research team of investigators from University of Michigan and the African Population and Health Research Center will implement and evaluate a newly-developed digital vaccine card and accompanying mobile application and electronic immunization registry. This will take place in rural Uganda and urban Kenya Health and Demographic Surveillance Systems (HDSS) and the study team will analyze its feasibility, impacts, cost through process, and economic evaluations. The study team will also assess the data quality and equity of the digital vaccine registry and card system.
Detailed description
This study design has three parts or aims for this project, however, only the third aim is considered to be the trial portion and is included in this registration.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Mothers will be randomized to receive the digital vaccine card access with short message service (SMS) reminders versus mothers who did not receive digital vaccine card access with SMS reminders (treatment/control).
| Arm | Type | Receives |
|---|---|---|
| Next Generation digital vaccine card with SMS reminders for upcoming vaccination(s) | Experimental | Other: SMS reminders for upcoming vaccination(s) |
| Pre-intervention cohort | No intervention | –This group will be compared to the post-intervention group to assess the digital vaccine card. |
Who may qualify
- Ages
- 1 day to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 1 day to 24 months old
Key exclusion criteria (1 listed)
- Sites not included in the study
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 |
|---|---|---|
| SMS reminders for upcoming vaccination(s)All parents/caregivers of children in participating villages will receive access to a digital vaccine card. This will be used for record-keeping application (digital vaccine registry). Selected parents/caregivers of children will receive SMS messages and reminders related to vaccination. | Other | Next Generation digital vaccine card with SMS reminders for upcoming vaccination(s) |
Primary outcome
Diphtheria, pertussis, and tetanus first dose (DPT1) coverage
Time frame: 18 months of the intervention period
Percent (%) of all children born in the intervention period that received the first dose of DPT vaccine (Continuous measure, 0-100%).
Diphtheria, pertussis, and tetanus first dose (DPT3) coverage
Time frame: 15 months of the intervention period (last 15 months of the intervention period)
Percent of all children born in the first 15 months of the intervention period that received the third dose of DPT vaccine (Continuous measure, 0-100%).
Dropout rate from DPT1 to DPT3
Time frame: 15 months of the intervention period (last 15 months of the intervention period)
Difference in the proportion of children born in the first 15 months of the intervention period that received the first and third doses of the DPT vaccine (Continuous measure, 0-100%)
8 secondary outcomes
Bacillus Calmette-Guerin (BCG) coverage
Time frame: 18 months of the intervention period (full intervention period)
Measles coverage
Time frame: 9 months of the intervention period (second half of the intervention)
Completion of basic immunizations
Time frame: 9 months of the intervention period (second half of the intervention)
Dropout rate from DPT1 to Measles
Time frame: 9 months of the intervention period (second half of the intervention)
Timeliness of BCG vaccination
Time frame: 18 months of the intervention period (full intervention period)
Timeliness of DPT1 vaccination
Time frame: 15 months of the intervention period (last 15 months of the intervention period)
Timeliness of DPT3 vaccination
Time frame: 15 months of the intervention period (last 15 months of the intervention period)
Timeliness of Measles vaccination
Time frame: 9 months of the intervention period (second half of the intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
- 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. This study is not recruiting at the moment.
Emily Treleaven, PhD, MPH principal investigator
University of Michigan
Gershim Asiki, MBChB, MSc, PhD principal investigator
African Population and Health Research Center
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SMS reminders for upcoming vaccination(s) in people with Vaccines, run by University of Michigan at 2 sites in 2 countries.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Kenya, Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Diphtheria, pertussis, and tetanus first dose (DPT1) coverage (time frame: 18 months of the intervention period). The study lists 3 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 3 Dec 2025.