VaccinationsTICANCT03428776
Timeliness of Immunization and Compliance Assessment Study
A study testing Standard Compliance-linked incentives, Intelligent Compliance-linked incentives and Record keeping in people with Vaccinations, run by Johns Hopkins University at 1 site in India.
Trial summary
Although coverage for primary childhood immunizations has improved, a significant proportion of young children and pregnant women living in low-resource settings remain inadequately immunized. While young children receive some primary vaccines, many are never fully vaccinated. Read more about this study
- Who is it for?
- Ages Up to 24 monthsHealthy volunteers can take part
- Conditions the study is for
- Vaccinations
- What is being tested?
- Standard Compliance-linked incentives, Intelligent Compliance-linked incentives and Record keeping
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,065 participants
- Where
- 1 siteIndia
- Study dates
- 25 Apr 2018to 25 Sep 2019
- 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 Up to 24 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Mother (or caregiver) with one or more children ≤24 months in their family will be enrolled
- There will be no exclusion criteria based on race, ethnicity or gender.
Who cannot join
- Participants unable or unwilling to comply with the protocol or with any other condition that would impede compliance or hinder completion of the study (e.g. no mobile-phone in the family), or failure to give informed consent would be the only exclusion criteria.
Trial locations and contacts
1 site in 1 country.
About this study
Although coverage for primary childhood immunizations has improved, a significant proportion of young children and pregnant women living in low-resource settings remain inadequately immunized. While young children receive some primary vaccines, many are never fully vaccinated. Progressive decline in immunizations are in large part attributable to poor follow-up and compliance. Major challenges include maintaining immunization records linked to positive identification of the individual child, incentivizing follow-up and return immunizations and efficiently identifying and targeting non-compliant subjects. Mobile-phone costs have decreased dramatically in the developing world with rapid proliferation of web and mobile-phone connectivity. Novel approaches that integrate these modern technologies with existing resources in low and middle income countries can cost-effectively address these challenges. In this proposal, investigators will evaluate a novel software platform, utilizing biometric identification and of subjects, paired with intelligent and subject-aware, mobile-phone reminders and compliance-linked incentives to improve uptake and coverage of primary vaccinations in young children.
Read the detailed description
A cloud-based, biometric-linked vaccination record, mobile-phone reminder and compliance-linked incentive software platform to provide robust and universal access of vaccinations. The investigators will implement this platform in a low-resource settings with the following features: a) Cloud-based for robust and universal access. b) Biometric-linked for positive identification. c) Digital storage and reporting for transparent view of program operations. d) Global Positioning System (GPS)-linked, allowing rapid assessment of vaccination status of communities. e) Increasing vaccination uptake and coverage by intelligent and subject-aware automated reminders and compliance-linked incentives.
- Conditions
- Vaccinations
- Being tested
- Standard Compliance-linked incentives, Intelligent Compliance-linked incentives, Record keeping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Compliance-linked incentivesBehavioural
Standard mobile-phone reminders and compliance-linked incentives Electronic immunization records on cloud-based software platform and use of biometric identification
Intelligent Compliance-linked incentivesBehavioural
Intelligent mobile-phone reminders and compliance-linked incentives Electronic immunization records on cloud-based software platform and use of biometric identification
Record keepingOther
Electronic immunization records on cloud-based software platform and use of biometric identification
| Study group | Role | What they receive |
|---|---|---|
| Controls | Sham comparator | Self returns Receives: Other: Record keeping |
| Standard Compliance-linked incentives | Active comparator | Standard mobile-phone reminders and compliance-linked incentives Receives: Behavioral: Standard Compliance-linked incentives |
| Intelligent Compliance-linked incentives | Active comparator | Intelligent mobile-phone reminders and compliance-linked incentives Receives: Behavioral: Intelligent Compliance-linked incentives |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timeliness of immunization
Defined as the proportion of immunizations administered before the scheduled date or within 14 days of the after scheduled date.
Measured: 12-15 months
Secondary outcomes (1)
Immunization rate
Calculated for each individual child and defined as the proportion of the total number of immunizations received divided by the total number of immunizations required at the time of measurement (e.g. at enrollment, end of study, etc.).
Measured: 12-15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2018
- Study start25 Apr 2018
- Primary completion25 Sep 2019
- Study completion25 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VaccinationsStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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
- Single blinded prospective study
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 2,065 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, Bal Umang Drishya Sanstha (BUDS), India, Royal Datamatics Pvt. Ltd. (RDPL), India, St. Louis University
- Responsible party
- Sponsor
- Investigators
- Sanjay K Jain, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03428776
- Sponsor's protocol ID
- IRB00161339
- Acronym
- TICA
- Status last verified
- Sep 2019
- First submitted
- 5 Feb 2018
- Last updated
- 27 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Timeliness of Immunization and Compliance Assessment Study
- ClinicalTrials.gov ID
- NCT03428776
- Acronym / sponsor ID
- TICA / IRB00161339
- Conditions
- Vaccinations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,065 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, Bal Umang Drishya Sanstha (BUDS), India, Royal Datamatics Pvt. Ltd. (RDPL), India, St. Louis University
- Study start
- 25 Apr 2018 (actual)
- Primary completion
- 25 Sep 2019 (actual)
- Study completion
- 25 Sep 2019 (actual)
- First posted
- 12 Feb 2018 (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.
Although coverage for primary childhood immunizations has improved, a significant proportion of young children and pregnant women living in low-resource settings remain inadequately immunized. While young children receive some primary vaccines, many are never fully vaccinated. Progressive decline in immunizations are in large part attributable to poor follow-up and compliance. Major challenges include maintaining immunization records linked to positive identification of the individual child, incentivizing follow-up and return immunizations and efficiently identifying and targeting non-compliant subjects. Mobile-phone costs have decreased dramatically in the developing world with rapid proliferation of web and mobile-phone connectivity. Novel approaches that integrate these modern technologies with existing resources in low and middle income countries can cost-effectively address these challenges. In this proposal, investigators will evaluate a novel software platform, utilizing biometric identification and of subjects, paired with intelligent and subject-aware, mobile-phone reminders and compliance-linked incentives to improve uptake and coverage of primary vaccinations in young children.
Detailed description
A cloud-based, biometric-linked vaccination record, mobile-phone reminder and compliance-linked incentive software platform to provide robust and universal access of vaccinations. The investigators will implement this platform in a low-resource settings with the following features: a) Cloud-based for robust and universal access. b) Biometric-linked for positive identification. c) Digital storage and reporting for transparent view of program operations. d) Global Positioning System (GPS)-linked, allowing rapid assessment of vaccination status of communities. e) Increasing vaccination uptake and coverage by intelligent and subject-aware automated reminders and compliance-linked incentives.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Single blinded prospective study
| Arm | Type | Receives |
|---|---|---|
| Controls | Sham comparator | Other: Record keepingSelf returns |
| Standard Compliance-linked incentives | Active comparator | Behavioral: Standard Compliance-linked incentivesStandard mobile-phone reminders and compliance-linked incentives |
| Intelligent Compliance-linked incentives | Active comparator | Behavioral: Intelligent Compliance-linked incentivesIntelligent mobile-phone reminders and compliance-linked incentives |
Who may qualify
- Ages
- Up to 24 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Mother (or caregiver) with one or more children ≤24 months in their family will be enrolled
- There will be no exclusion criteria based on race, ethnicity or gender.
Key exclusion criteria (1 listed)
- Participants unable or unwilling to comply with the protocol or with any other condition that would impede compliance or hinder completion of the study (e.g. no mobile-phone in the family), or failure to give informed consent would be the only exclusion criteria.
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 |
|---|---|---|
| Standard Compliance-linked incentivesStandard mobile-phone reminders and compliance-linked incentives Electronic immunization records on cloud-based software platform and use of biometric identification | Behavioural | Standard Compliance-linked incentives |
| Intelligent Compliance-linked incentivesIntelligent mobile-phone reminders and compliance-linked incentives Electronic immunization records on cloud-based software platform and use of biometric identification | Behavioural | Intelligent Compliance-linked incentives |
| Record keepingElectronic immunization records on cloud-based software platform and use of biometric identification | Other | Controls |
Primary outcome
Timeliness of immunization
Time frame: 12-15 months
Defined as the proportion of immunizations administered before the scheduled date or within 14 days of the after scheduled date.
1 secondary outcome
Immunization rate
Time frame: 12-15 months
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 27 Sep 2019.
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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.
Sanjay K Jain, MD principal investigator
Johns Hopkins 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 Standard Compliance-linked incentives, Intelligent Compliance-linked incentives and Record keeping in people with Vaccinations, run by Johns Hopkins University at 1 site in India.
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 2 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 27 Sep 2019. 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 India. 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. Some participants in this study may receive a placebo. 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?
Timeliness of immunization (time frame: 12-15 months). 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 27 Sep 2019.