Timeliness of Immunization and Compliance Assessment Study

Vaccinations Clinical Trial

— TICA  

Official title:

Timeliness of Immunization and Compliance Assessment Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03428776
• Other study ID #: IRB00161339
• Status: Completed
• Phase: N/A
• Start date: April 25, 2018
• Est. completion date: September 25, 2019

Study information

• Verified date: September 2019
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2065
• Est. completion date: September 25, 2019
• Est. primary completion date: September 25, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 24 Months

Eligibility

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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Vaccinations

Intervention

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

Other:
• Record keeping
Electronic immunization records on cloud-based software platform and use of biometric identification

Locations

Country	Name	City	State
India	BUDS	Haryana

Sponsors (5)

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

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Timeliness of immunization	Defined as the proportion of immunizations administered before the scheduled date or within 14 days of the after scheduled date.	12-15 months
Secondary	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.).	12-15 months