Timeliness of Immunization and Compliance Assessment Study

NCT03428776 | Completed

• 1 other identifier: IRB00161339
• Study Type: interventional
• Target: 2,065
• Locations: 1 country
• Sites: 1

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.

Conditions

Vaccinations

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Immunization rate

  12-15 months

Study Arms (3)

Controls

SHAM COMPARATOR

Self returns

Other: Record keeping

Standard Compliance-linked incentives

ACTIVE COMPARATOR

Standard mobile-phone reminders and compliance-linked incentives

Behavioral: Standard Compliance-linked incentives

Intelligent Compliance-linked incentives

ACTIVE COMPARATOR

Intelligent mobile-phone reminders and compliance-linked incentives

Behavioral: Intelligent Compliance-linked incentives

Interventions

Standard Compliance-linked incentives BEHAVIORAL

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

Standard Compliance-linked incentives

Intelligent Compliance-linked incentives BEHAVIORAL

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

Intelligent Compliance-linked incentives

Record keeping OTHER

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

Controls

Eligibility Criteria

• Age: Up to 24 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Mother (or caregiver) with one or more children ≤24 months in their family will be enrolled

Sponsors & Collaborators

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

Study Sites (1)

BUDS

Haryāna, 21287, India

Location

Study Officials

• Sanjay K Jain, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single blinded prospective study

Study Record Dates

• First Submitted: February 5, 2018
• First Posted: February 12, 2018
• Study Start: April 25, 2018
• Primary Completion: September 25, 2019
• Study Completion: September 25, 2019
• Last Updated: September 27, 2019

Record last verified: 2019-09

Locations

IN (1)