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OpenTrials
Completed

NCT Number: NCT03180138

Enhancing Health Care Access With Cellular Technology

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.

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Key information

Conditions

Age range

Up to 24 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Reminders alone

Behavioral

Automated reminders (text and /or voice in local language) for upcoming vaccination visit(s) will be provided via cell-phone to the subject (mother / caregiver) or pregnant woman.

Compliance-linked incentives

Behavioral

Automated compliance-linked incentives (as cell-phone minutes) will be provided via cell-phone to the subject (mother / caregiver) or pregnant woman.

Primary outcomes

  1. Immunization Rate

    Time frame: 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 outcomes

  1. Timeliness of Vaccinations

    Time frame: 12 months

    The percent of immunizations administered before or within 14 days after the scheduled date for the immunization. Calculated for each cohort.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • Bal Umang Drishya Sanstha (BUDS), India
  • Ministry of Science and Technology, India
  • National Institute for Biomedical Imaging and Bioengineering (NIBIB)
  • Royal Datamatics Pvt. Ltd. (RDPL), India
  • St. Louis University

Registry information

Official study title

Enhancing Health Care Access With Cellular Technology: Networked and Mobile Technologies to Improve Uptake and Coverage of Vaccinations

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jun 8, 2017
Registry last updated
Jun 25, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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