Enhancing Health Care Access With Cellular Technology

Not Applicable

Completed

• Conditions: Vaccination
• Interventions: Behavioral: Reminders alone; Behavioral: Compliance-linked incentives

• Registration Number: NCT03180138
• Lead Sponsor: Johns Hopkins University

Brief Summary

Despite the impressive economic progress in developing countries, significant proportion of young children and pregnant women living in low-resource settings remain inadequately immunized. Progressive decline in immunizations are in large part attributable to poor follow-up and compliance. National and international pediatric bodies, recommend a time sensitive schedule for childhood immunizations, boosting immunity with each subsequent cycle, leading to adequate levels of immune protection. Due to inadequate protective immunity, resulting from poor vaccination compliance, outbreaks of vaccine-preventable diseases are rampant, making childhood mortality in this group among the highest in the world. Major challenges of vaccination programs include maintaining / tracking records, linked to positive identification of individual children, and strategies to improve follow-up and compliance. Novel cellular technology based approaches targeting behavior modifications can therefore significantly impact health outcomes in these communities. In this proposal, the investigators will evaluate a novel software platform, utilizing biometric identification of subjects, paired with cell-phone reminders and compliance-linked incentives to improve uptake and coverage of primary vaccinations in young children and pregnant women.

Detailed Description

A web-based, biometric-linked vaccination record, cell-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) Web-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 automated text message reminders and compliance-linked incentives.

Study Timeline

• Study Start: 2016-07-11
• Study First Submitted: 2017-06-05
• Study First Submitted QC: 2017-06-07
• Study First Posted: 2017-06-08
• Primary Completion: 2017-07-20
• Study Completion: 2017-07-20
• Results First Submitted: 2018-04-04
• Status Verified: 2018-06
• Results First Submitted QC: 2018-06-20
• Last Update Submitted: 2018-06-20
• Results First Posted: 2018-06-25
• Last Update Posted: 2018-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 608

Inclusion Criteria

Mother-child (or caregiver-child) units with child <2 years of age OR Pregnant women

Exclusion Criteria

Family does not have cell-phone OR cannot provide informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Reminders alone	Reminders alone	-
Reminders + compliance-linked incentives	Reminders alone	-
Reminders + compliance-linked incentives	Compliance-linked incentives	-

Primary Outcome Measures

Name	Time	Method
Immunization Rate	12 months	Percent of the total number of immunizations received divided by the total number of immunizations required at the time of measurement for each child. Calculated for each child and in each cohort.

Secondary Outcome Measures

Name	Time	Method
Timeliness of Vaccinations	12 months	The percent of immunizations administered before or within 14 days after the scheduled date for the immunization. Calculated for each cohort.