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Khushi Baby (KB): Novel Mobile Health Solution for Vaccination Record Keeping in India

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02518178
Recruitment Status : Unknown
Verified August 2015 by Khushi Baby Inc..
Recruitment status was:  Enrolling by invitation
First Posted : August 7, 2015
Last Update Posted : August 7, 2015
Sponsor:
Collaborators:
Indian Institute of Health Management Research (IIHMR)
Seva Mandir, India
Johns Hopkins Bloomberg School of Public Health
Information provided by (Responsible Party):
Khushi Baby Inc.

Brief Summary:

This is a three arm cluster randomized controlled trial where the unit of randomization is the immunization camp. Immunization camps are the sole provider of vaccinations in our study area and have catchment areas of several villages. The 96 immunization camps will be randomized evenly to one of three arms:

  1. control arm; where near field communication (NFC) stickers will be placed on existing immunization booklets. These stickers can be scanned using a mobile phone with an installed application whereby information can be entered onto the phone and then scanned onto the sticker
  2. pendant only; where the same NFC technology will be placed into a pendant that is worn by the infant, and
  3. pendant as described above with voice reminders sent 15 days, 1 day prior, and the day of the scheduled immunization camp dates.

Condition or disease Intervention/treatment Phase
DTP Vaccine Series Completion Device: NFC Necklace Device: Voice Reminder Device: NFC Sticker Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Khushi Baby (KB): Efficacy and Impact Assessment of Novel Mobile Health Solution for Vaccination Record Keeping in Rural Udaipur, Rajasthan, India
Study Start Date : August 2015
Estimated Primary Completion Date : April 2016
Estimated Study Completion Date : April 2016

Arm Intervention/treatment
Active Comparator: NFC Sticker
Participants will receive an NFC (Near Field Communication) sticker, placed on their existing immunization (MAMTA) card. This will serve as a comparator to the NFC necklace while still allowing for patient data to be digitized and utilized by the health service provider, Seva Mandir.
Device: NFC Sticker
NFC Sticker on existing immunization card (MAMTA card) serves as a comparator to the pendant and pendant+voice call arms.

Experimental: NFC Necklace
Participants will receive a necklace with an NFC pendant, which interfaces with the Khushi Baby mobile application to digitize the data. This arm will allow for the assessment of peer influence effects of the necklace as a social symbol.
Device: NFC Necklace
Other Names:
  • Khushi Baby Necklace
  • Khushi Baby Pendant

Experimental: NFC Necklace + Voice Reminder
In addition to the NFC necklace, mothers of the participants in this arm will receive dialect-specific voice call reminders, informing them about the next camp and the importance of vaccinations.
Device: NFC Necklace
Other Names:
  • Khushi Baby Necklace
  • Khushi Baby Pendant

Device: Voice Reminder
Dialect-specific reminders will be issued to the mother's cell phone, informing about the upcoming immunization camp and the importance of vaccination
Other Names:
  • Voice Call Reminder
  • Voice Message




Primary Outcome Measures :
  1. 20% increase in DTP3 coverage [ Time Frame: 6 camps after DTP1 receipt (6 months) ]
    Comparing necklace (with or without voice call reminders) to control arm infants


Secondary Outcome Measures :
  1. Increase in DTP3 coverage for necklace + voice reminder arm compared to other 2 arms [ Time Frame: 6 camps after DTP1 receipt (6 months) ]
  2. Improved camp attendance rates [ Time Frame: Over 6 camp period after DTP1 receipt (6 months) ]
    Comparing camps randomized to receive necklace (with or without voice reminders) to control arm infants.

  3. Retention of pendant compared to that of NFC stickered MAMTA card [ Time Frame: 6 camps after DTP1 receipt (6 months) ]
  4. Increased time efficiency of NFC system (both stickers and pendants) compared to existing paper-based system of recording immunization [ Time Frame: Paper log books (status quo control) will be used to establish a baseline for timeliness during first 2 months of the study. In the latter 2 months, the KB app digitization will be timed. ]
    The surveyor will categorize the times separately for new and follow-up patients. The analysis will consider average times for new registrants and follow up registrants in KB app vs. logbook for each health worker (GNM). These indicators will be used to compile a composite measure of time efficiency.

  5. Increased accuracy between NFC system (both stickers and pendants) compared to existing paper-based system of recording immunization [ Time Frame: In the first 2 months, the logbook records will be digitized and de-identified for each camp. In the latter 2 months, the digitization of records will take place exclusively through the KB app. ]
    At the end of each camp the number of child-specific syringes and complete vaccine vials will be counted by the Surveyor; these will serve as the gold standards. The analysis will examine the frequency of underreporting and overreporting of total vaccines (as determined by syringes) and of individual vaccines (as determined by complete vaccine vials when available); rates of underreporting and overreporting will be examined at the camp level (n=2 for each camp) and after clubbing all camps per month (n= 2 months). These indicators will be used to compile a composite accuracy outcome measure.

  6. Survey-based outcomes: user satisfaction, socio-demographic profile of infants, vaccine awareness of mothers and the differential effects on vaccination adherence [ Time Frame: Intake survey at enrollment + follow-up surveys at each camp (approximately once a month during follow-up period) ]
  7. Failure rate of the Khushi Baby mobile application [ Time Frame: Throughout study period of 9 months ]
    time series data to be collected from the app itself (error logs and internal counters for each replacement); number of entries in backup logbook will be digitized and added



Information from the National Library of Medicine

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Ages Eligible for Study:   42 Days to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Mother/ Primary Caregiver has an infant between the age of 42 days (minimum age for DTP1 administration per WHO guidelines) and 6 months of age; there is no age restriction for inclusion. In the very rare instance that a male is the primary caregiver, they will also be invited to participate in the study. Survey questions are not gender or age specific, but wil require the caregiver to answer questions about his/her children, socioeconomic and health status, and vaccine awareness.
  • Self-identified resident within one of the villages associated with the immunization camp
  • Willing to give informed consent (sign or thumbprint)

Exclusion Criteria:

  • Infant has received at least 1 dose of DTP vaccine
  • Caregiver and infant intends to move before the next 6 camps have been completed (in the next 6-9 months)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02518178


Sponsors and Collaborators
Khushi Baby Inc.
Indian Institute of Health Management Research (IIHMR)
Seva Mandir, India
Johns Hopkins Bloomberg School of Public Health
Investigators
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Principal Investigator: Mohammad Shahnawaz, PhD cand Indian Institute of Health Management Research (IIHMR)
Additional Information:
Publications of Results:
Other Publications:
WHO, UNICEF, World Bank. State of the world's vaccines and immunization. 3rd edition. Geneva: World Health Organization; 2009.
Coverage Evaluation Survey India 2009
District Level Health Survey Round 3, 2008-09 India.
Annual Health Survey 2012-13 Fact Sheet: Rajasthan. Rajasthan Ministry of Health.
Shekhar, C. & Yadav, D. India's Universal Immunisation Programme to prevent children from preventable disease: retention and dropout approach. The Lancet. 2013; 381: S151.
The World Bank. Information and communications for development 2012: Maximizing mobile. Washington, DC: The World Bank; 2012.
Hayes, R.J. and Moulton, L.H. Clustered Randomised Trials. 2009, Chapman & Hall/CRC Press.

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Responsible Party: Khushi Baby Inc.
ClinicalTrials.gov Identifier: NCT02518178    
Other Study ID Numbers: 109440
First Posted: August 7, 2015    Key Record Dates
Last Update Posted: August 7, 2015
Last Verified: August 2015
Keywords provided by Khushi Baby Inc.:
NFC
randomization
RCT
mHealth
maternal and child health