VaccinationNCT05520736
Mhealth Supported Bundle to Improve Vaccination Completion
A study testing Appointment reminders, motivational interviewing and targeted vaccine drives in people with Vaccination, run by Indiana University at 1 site in Nigeria.
Trial summary
Supported be a digital vaccine registry the investigators will test the impact of automated appointment reminders, real time appointment reminders, motivational interviewing and targeted vaccine on routine childhood vaccine completion rates. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Vaccination
- What is being tested?
- Appointment reminders, motivational interviewing and targeted vaccine drives
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,855 participants
- Where
- 1 siteNigeria
- Study dates
- 1 Nov 2022to 1 Sep 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- All parents or caregivers of patients who bring their child to the vaccine clinic to receive immunization for their first vaccine visit.
Who cannot join
- Parents or caregivers not willing to participate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Implementing a Mobile Health Supported Bundle to Improve Routine Vaccination Completion Rate in a Low-resource Setting
Supported be a digital vaccine registry the investigators will test the impact of automated appointment reminders, real time appointment reminders, motivational interviewing and targeted vaccine on routine childhood vaccine completion rates.
Read the detailed description
Bundling three high-impact mHealth interventions (a digital vaccine registry (supply side), a reminder system (demand side), and targeted vaccine drive (demand and supply-side) will be feasible, acceptable, carried out with fidelity, and result in a 10% improvement in vaccine completion rates compared to the year prior to implementation.
- Conditions
- Vaccination
- Being tested
- Appointment reminders, motivational interviewing and targeted vaccine drives
- Keywords
- Vaccination, Childhood, Low- and middle-income country
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Appointment reminders, motivational interviewing and targeted vaccine drivesBehavioural
Automated and real time phone call reminders, motivational interviewing and targeted vaccine drives applied in sequence
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Prospectively received appointment reminders, motivational interviews and targeted vaccine drives. Receives: Behavioral: Appointment reminders, motivational interviewing and targeted vaccine drives |
What is being measured
The primary outcome is the main question the study is designed to answer.
DPT3 vaccine completion rate
The proportion of enrolled subjects who complete the Diphtheria, pertussis, and tetanus vaccine (DPT3) vaccine series when assessed at 15 months of age.
Measured: 15 Months
Measles vaccine completion rate
The proportion of enrolled subjects who complete the measles vaccine series when assessed at 15 months of age.
Measured: 15 Months
Number of eligible subjects enrolled
Vaccine clinic records will be reviewed to identify the total number of eligible patients in the clinic (defined as those presenting to the vaccine clinic with a child receiving their first vaccine) and the number who agreed to participate during the study period.
Measured: 15 Months
Provider Adoption
A modified intervention acceptability, perception and system usability assessment using a Likert scale questionnaire.
Measured: 15 Months
Protocol Adherence
The proportion of eligible subjects who received a real-time phone call reminder, counselling, and targeted vaccine drive when indicated
Measured: 15 Months
Project Cost
The cost of administering each component of the mHealth bundle will be documented, such as cost of targeted drive and cost of real time phone calls. This will assist in determining the cost to scale the project.
Measured: 15 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2022
- Study start1 Nov 2022
- Primary completion1 Sep 2025
- Study completion1 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VaccinationStudies 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Cohort study
- Masking
- None (open label)
- Enrolment
- 2,855 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Principal investigator, Osayame Ekhaguere, Indiana University
- Investigators
- Osayame A Ekhaguere, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05520736
- Sponsor's protocol ID
- 15107
- Other IDs
- KL2TR002530, UL1TR002529
- Status last verified
- Feb 2026
- First submitted
- 26 Aug 2022
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Publish a study protocol in an open access journal. Provider study data set on request.
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing a Mobile Health Supported Bundle to Improve Routine Vaccination Completion Rate in a Low-resource Setting
- ClinicalTrials.gov ID
- NCT05520736
- Acronym / sponsor ID
- 15107
- Conditions
- Vaccination
- Keywords
- Vaccination, Childhood, Low- and middle-income country
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,855 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- 1 Sep 2025 (actual)
- First posted
- 30 Aug 2022 (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.
Supported be a digital vaccine registry the investigators will test the impact of automated appointment reminders, real time appointment reminders, motivational interviewing and targeted vaccine on routine childhood vaccine completion rates.
Detailed description
Bundling three high-impact mHealth interventions (a digital vaccine registry (supply side), a reminder system (demand side), and targeted vaccine drive (demand and supply-side) will be feasible, acceptable, carried out with fidelity, and result in a 10% improvement in vaccine completion rates compared to the year prior to implementation.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Cohort study
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Appointment reminders, motivational interviewing and targeted vaccine drivesProspectively received appointment reminders, motivational interviews and targeted vaccine drives. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All parents or caregivers of patients who bring their child to the vaccine clinic to receive immunization for their first vaccine visit.
Key exclusion criteria (1 listed)
- Parents or caregivers not willing to participate.
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 |
|---|---|---|
| Appointment reminders, motivational interviewing and targeted vaccine drivesAutomated and real time phone call reminders, motivational interviewing and targeted vaccine drives applied in sequence | Behavioural | Intervention |
Primary outcome
DPT3 vaccine completion rate
Time frame: 15 Months
The proportion of enrolled subjects who complete the Diphtheria, pertussis, and tetanus vaccine (DPT3) vaccine series when assessed at 15 months of age.
Measles vaccine completion rate
Time frame: 15 Months
The proportion of enrolled subjects who complete the measles vaccine series when assessed at 15 months of age.
Number of eligible subjects enrolled
Time frame: 15 Months
Vaccine clinic records will be reviewed to identify the total number of eligible patients in the clinic (defined as those presenting to the vaccine clinic with a child receiving their first vaccine) and the number who agreed to participate during the study period.
Provider Adoption
Time frame: 15 Months
A modified intervention acceptability, perception and system usability assessment using a Likert scale questionnaire.
Protocol Adherence
Time frame: 15 Months
The proportion of eligible subjects who received a real-time phone call reminder, counselling, and targeted vaccine drive when indicated
Project Cost
Time frame: 15 Months
The cost of administering each component of the mHealth bundle will be documented, such as cost of targeted drive and cost of real time phone calls. This will assist in determining the cost to scale the project.
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 12 Feb 2026.
- Individual participant dataSharing planned: Yes. Publish a study protocol in an open access journal. Provider study data set on request.
Related trials for Vaccination
RecruitingPhase 1/2
Safety and Immunogenicity of Recombinant Varicella Zoster Virus Vaccine in People With HIV Who Have a CD4 Count Less Than 300 or Greater Than or Equal to 300 and a Healthy Control Population
Herpes Zoster
Active, not recruitingObservational study
Korean Post Marketing Surveillance for Comirnaty Injection (Bretovameran)
COVID-19 Vaccination
Recruiting
Culturally Targeted Health Communication and Receptivity to the Human Papillomavirus Vaccine Among Parents in Flint, MI
HPV Vaccination
Active, not recruitingPhase 3
PREVENT HPV -Related Cancers Trial
HPV Vaccination, Uptake Vaccination
Active, not recruiting
HPV Multilevel Intervention Strategies Targeting Immunization in Community Settings (HPV MISTICS)
Human Papilloma Virus (HPV) Vaccine
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.
Osayame A Ekhaguere principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Appointment reminders, motivational interviewing and targeted vaccine drives in people with Vaccination, run by Indiana University at 1 site in Nigeria.
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 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nigeria. 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?
DPT3 vaccine completion rate (time frame: 15 Months). The study lists 6 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 12 Feb 2026.