Timeliness of Immunization and Compliance Assessment Study (TICA)

• ClinicalTrials.gov Identifier: NCT03428776
• Recruitment Status: Completed
• First Posted: February 12, 2018
• Last Update Posted: September 27, 2019
• Sponsor: Johns Hopkins University
• Collaborators: Bill and Melinda Gates Foundation; Bal Umang Drishya Sanstha (BUDS), India; Royal Datamatics Pvt. Ltd. (RDPL), India; St. Louis University
• Information provided by (Responsible Party): Johns Hopkins University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Vaccinations	Behavioral: Standard Compliance-linked incentives; Behavioral: Intelligent Compliance-linked incentives; Other: Record keeping	Not Applicable

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

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 2065 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Single blinded prospective study
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Health Services Research
• Official Title: Timeliness of Immunization and Compliance Assessment Study
• Actual Study Start Date: April 25, 2018
• Actual Primary Completion Date: September 25, 2019
• Actual Study Completion Date: September 25, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. Immunization rate [ Time Frame: 12-15 months ]
   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.).

Eligibility Criteria

• Ages Eligible for Study: up to 24 Months (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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.

Contacts and Locations

Locations

India

BUDS

Haryana, India, 21287

Sponsors and Collaborators

Johns Hopkins University

Bill and Melinda Gates Foundation

Bal Umang Drishya Sanstha (BUDS), India

Royal Datamatics Pvt. Ltd. (RDPL), India

St. Louis University

Investigators

• Principal Investigator: Sanjay K Jain, MD; Johns Hopkins University

More Information

• Responsible Party: Johns Hopkins University
• ClinicalTrials.gov Identifier: NCT03428776
• Other Study ID Numbers: IRB00161339
• First Posted: February 12, 2018
• Last Update Posted: September 27, 2019
• Last Verified: September 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No