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Timeliness of Immunization and Compliance Assessment Study

Timeliness of Immunization and Compliance Assessment Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03428776
Acronym
TICA
Enrollment
2065
Registered
2018-02-12
Start date
2018-04-25
Completion date
2019-09-25
Last updated
2019-09-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vaccinations

Brief 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. 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.

Interventions

BEHAVIORALStandard Compliance-linked incentives

Standard mobile-phone reminders and compliance-linked incentives Electronic immunization records on cloud-based software platform and use of biometric identification

BEHAVIORALIntelligent Compliance-linked incentives

Intelligent mobile-phone reminders and compliance-linked incentives Electronic immunization records on cloud-based software platform and use of biometric identification

OTHERRecord keeping

Electronic immunization records on cloud-based software platform and use of biometric identification

Sponsors

Bill and Melinda Gates Foundation
CollaboratorOTHER
Bal Umang Drishya Sanstha (BUDS), India
CollaboratorOTHER
Royal Datamatics Pvt. Ltd. (RDPL), India
CollaboratorUNKNOWN
St. Louis University
CollaboratorOTHER
Johns Hopkins University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Investigator, Outcomes Assessor)

Intervention model description

Single blinded prospective study

Eligibility

Sex/Gender
ALL
Age
No minimum to 24 Months
Healthy volunteers
Yes

Inclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Timeliness of immunization12-15 monthsDefined as the proportion of immunizations administered before the scheduled date or within 14 days of the after scheduled date.

Secondary

MeasureTime frameDescription
Immunization rate12-15 monthsCalculated 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.).

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026