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Immunization Reminder Bracelets Study

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ClinicalTrials.gov Identifier: NCT03310762
Recruitment Status : Active, not recruiting
First Posted : October 16, 2017
Last Update Posted : February 16, 2018
Sponsor:
Collaborator:
Harvard Medical School
Information provided by (Responsible Party):
Danya Arif, Interactive Research and Development

Brief Summary:

Pakistan has one of the highest infant mortality rates in the world in part, due to the low coverage (54%) for all basic vaccinations. Low uptake, lack of awareness among parents to complete the recommended immunization schedule and inability to remember vaccine appointments are some of the key factors hindering improvement in uptake of immunization services. On the supply side, ineffective methods to track children's' vaccine doses means that there is no reliable mechanism to verify vaccine administration and estimate accurate immunization coverage.

This study proposes to develop and test two types of silicon bracelets for children to stimulate immunization demand and simultaneously address supply side verification issues. These bracelets use a combination of numbers and symbols to denote the age of the child and due vaccines and are designed for illiterate or uneducated mothers; are low-cost and adaptable to most local settings. At the time of vaccine administration, the appropriate symbol denoting the vaccine on the bracelets is punched and therefore the bracelets can serve as effective reminders for mothers for timely immunization of their child and as a tool for vaccinators to verify vaccine administration and coverage.

An individually randomized, three-arm parallel group design randomized control trial will be conducted with equal allocation in the two treatment groups and control group. Children in intervention group A will receive the simple silicon bracelets, children in intervention group B will receive the bracelets developed by Alma Sana Inc. and children in the Control group will not receive any intervention. The impact of these immunization reminder bracelets on immunization coverage and timeliness will be evaluated through a randomized control trial (RCT) across 4 immunization centers in Karachi. To evaluate the bracelets' impact, variables of interest-coverage and timeliness rates of pentavalent-3/PCV-3/polio-3 and Measles 1 vaccine will be compared between Group A and the Control Group and Group B and the Control Group.

Proposed results include increase in immunization coverage and timeliness of Pentavalent-3/Pneumococcal Conjugate Vaccine (PCV-3)/Polio-3 and Measles-1 in the intervention versus control group.

The study will provide evidence of the bracelet's effectiveness for the global health community and provide a simple tool for strengthening routine immunization efforts in Pakistan.


Condition or disease Intervention/treatment Phase
Immunization; Infection Other: Alma Sana Bracelet Other: Simple Silicon Bracelet Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1445 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is an individually randomized, three-arm parallel group design randomized control trial with equal allocation in the two treatment groups and control group. Children in intervention group A will receive the simple silicon bracelets, children in intervention group B will receive the bracelets developed by Alma Sana Inc. and children in the Control group will not receive any intervention.
Masking: None (Open Label)
Masking Description: The allocation sequence will be concealed from the study staff responsible for screening and enrolling participants in serially numbered, opaque, sealed envelopes.
Primary Purpose: Health Services Research
Official Title: The Effect of Using Vaccine Reminder and Tracker Bracelets to Improve Routine Childhood Immunization Coverage and Timeliness in Pakistan: a Randomized Control Trial.
Actual Study Start Date : July 19, 2017
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : November 2018

Arm Intervention/treatment
Experimental: Alma Sana Bracelet Arm
Subjects in this arm will receive a vaccine reminder and tracker bracelet developed by Alma Sana Inc. This bracelet uses a combination of symbols and numbers to denote the entire vaccine schedule a child is supposed to receive before the age of 2 years. Shapes indicate vaccines, and numbers signify the child's age.
Other: Alma Sana Bracelet
Every time a child receives a vaccine, vaccinators will hole punchers to perforate shapes denoting the particular vaccine a child has received.

Experimental: Simple Silicon Bracelet Arm
Subjects in this arm will receive a simple silicon bracelet. This bracelet has six symbols to remind parents that their child needs to get at least six vaccination visits before he reaches 2 years of age. The first five symbols are represented by a crescent shape and the sixth symbol is represented by a star shape to denote that the child is fully immunized.
Other: Simple Silicon Bracelet
Every time a child receives a vaccine, vaccinators will hole punchers to perforate shapes denoting the particular vaccine a child has received.

No Intervention: Control Arm
Subjects in this arm will not receive any bracelet/intervention.



Primary Outcome Measures :
  1. Increase in immunization coverage in intervention versus control [ Time Frame: The outcome will be measured after at least 9 months of follow up of the last participant enrolled ]
    The primary outcome measure is the increase in coverage (i.e. the proportion of children getting vaccinated for) Pentavalent-3/PCV-3/polio-3 and Measles 1 vaccine in intervention versus control arm.

  2. Increase in timeliness of immunization in intervention versus control [ Time Frame: The outcome will be measured after at least 9 months of follow up of the last participant enrolled ]
    The primary outcome measure is the increase in timeliness of Pentavalent-3/PCV-3/polio-3 and Measles 1 vaccine in intervention versus control arm. Timeliness is defined as the proportion of children getting vaccinated for a particular antigen within the specified time duration i.e. a timely dose of Pentavalent-3/PCV-3/polio-3 is administered when the child is between 14 weeks and 22 weeks of age.


Secondary Outcome Measures :
  1. Comparison of timely immunization coverage rates between treatment groups [ Time Frame: The outcome will be measured after at least 9 months of follow up of the last participant enrolled ]
    Compare the proportion of children receiving timely doses of Pentavalent-3/PCV-3/polio-3 and Measles 1 vaccine in the Alma Sana group and the simple silicon bracelets group.



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 3 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Child is visiting the center for BCG or Pentavalent-1/Polio-1/PCV-1 vaccination.
  2. Child is healthy
  3. Child's caregiver has been a resident of study area for more than 6 months
  4. Child is accompanied by a primary caregiver (mother and/or father)

Exclusion Criteria:

  1. Child's age is more than 3 months. The average age of children for Penta-1 vaccine visit in Pakistan is 2.2 months (approximately 10 weeks). Children older than 3 weeks will be excluded on account of exceeding the average age for Penta-1 administration.
  2. Parents plan to go to a different center for completing the vaccination course

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): NCT03310762


Locations
Pakistan
Future Colony
Karachi, Sindh, Pakistan
KMC Maternity Home
Karachi, Sindh, Pakistan
MCH-36B
Karachi, Sindh, Pakistan
Urban Health Center
Karachi, Sindh, Pakistan
Sponsors and Collaborators
Interactive Research and Development
Harvard Medical School
Investigators
Principal Investigator: Danya A Siddiqi, MSc Interactive Research and Development

Responsible Party: Danya Arif, Program Manager, Interactive Research and Development
ClinicalTrials.gov Identifier: NCT03310762     History of Changes
Other Study ID Numbers: 027562-746846- 0303
First Posted: October 16, 2017    Key Record Dates
Last Update Posted: February 16, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by Danya Arif, Interactive Research and Development:
immunization coverage
silicon bracelet
immunization reminders

Additional relevant MeSH terms:
Vaccines
Silicon
Immunologic Factors
Physiological Effects of Drugs
Trace Elements
Micronutrients
Growth Substances