Timeliness of Immunization and Compliance Assessment Study (TICA)

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.

Study Overview

• Status: Completed
• Conditions: Vaccinations
• Intervention / Treatment: Other: Record keeping; Behavioral: Standard Compliance-linked incentives; Behavioral: Intelligent Compliance-linked incentives

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 Type: Interventional
• Enrollment (Actual): 2065
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Haryana, India, 21287
    • BUDS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 2 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Controls; Self returns	Other: Record keeping; Electronic immunization records on cloud-based software platform and use of biometric identification
Active Comparator: Standard Compliance-linked incentives; Standard mobile-phone reminders and compliance-linked incentives	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
Active Comparator: Intelligent Compliance-linked incentives; Intelligent mobile-phone reminders and compliance-linked incentives	Behavioral: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2018
• Primary Completion (Actual): September 25, 2019
• Study Completion (Actual): September 25, 2019

Study Registration Dates

• First Submitted: February 5, 2018
• First Submitted That Met QC Criteria: February 5, 2018
• First Posted (Actual): February 12, 2018

Study Record Updates

• Last Update Posted (Actual): September 27, 2019
• Last Update Submitted That Met QC Criteria: September 25, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: IRB00161339

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No