Immunization Reminder Bracelets Study

NCT03310762 | Completed

• 1 other identifier: 027562-746846- 0303
• Study Type: interventional
• Target: 1,445
• Locations: 1 country
• Sites: 4

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.

Conditions

Immunization; Infection

Keywords

immunization coverage; silicon bracelet; immunization reminders

Outcome Measures

Primary Outcomes (2)

• Increase in immunization coverage in intervention versus control

  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.

  The outcome will be measured after at least 9 months of follow up of the last participant enrolled

• Increase in timeliness of immunization in intervention versus control

  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.

  The outcome will be measured after at least 9 months of follow up of the last participant enrolled

Secondary Outcomes (1)

• Comparison of timely immunization coverage rates between treatment groups

  The outcome will be measured after at least 9 months of follow up of the last participant enrolled

Study Arms (3)

Alma Sana Bracelet Arm

EXPERIMENTAL

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

Simple Silicon Bracelet Arm

EXPERIMENTAL

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

Control Arm

NO INTERVENTION

Subjects in this arm will not receive any bracelet/intervention.

Interventions

Alma Sana Bracelet OTHER

Every time a child receives a vaccine, vaccinators will hole punchers to perforate shapes denoting the particular vaccine a child has received.

Alma Sana Bracelet Arm

Simple Silicon Bracelet OTHER

Every time a child receives a vaccine, vaccinators will hole punchers to perforate shapes denoting the particular vaccine a child has received.

Simple Silicon Bracelet Arm

Eligibility Criteria

• Age: Up to 3 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.
• Parents plan to go to a different center for completing the vaccination course

Sponsors & Collaborators

• Interactive Research and Development: lead
• Harvard Medical School (HMS and HSDM): collaborator

Study Sites (4)

Future Colony

Karachi, Sindh, Pakistan

Location

KMC Maternity Home

Karachi, Sindh, Pakistan

Location

MCH-36B

Karachi, Sindh, Pakistan

Location

Urban Health Center

Karachi, Sindh, Pakistan

Location

Related Publications (2)

• Siddiqi DA, Ali RF, Munir M, Shah MT, Khan AJ, Chandir S. Effect of vaccine reminder and tracker bracelets on routine childhood immunization coverage and timeliness in urban Pakistan (2017-18): a randomized controlled trial. BMC Public Health. 2020 Jul 11;20(1):1086. doi: 10.1186/s12889-020-09088-4.

  PMID: 32652969 DERIVED

• Siddiqi DA, Munir M, Shah MT, Khan AJ, Chandir S. Effect of vaccine reminder and tracker bracelets on routine childhood immunization coverage and timeliness in urban Pakistan: protocol for a randomized controlled trial. BMC Public Health. 2019 Oct 30;19(1):1421. doi: 10.1186/s12889-019-7667-3.

  PMID: 31666039 DERIVED

MeSH Terms

Conditions

Infections

Study Officials

• Danya A Siddiqi, MSc

  Interactive Research and Development

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The allocation sequence will be concealed from the study staff responsible for screening and enrolling participants in serially numbered, opaque, sealed envelopes.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Program Manager

Model Details: 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.

Study Record Dates

• First Submitted: September 22, 2017
• First Posted: October 16, 2017
• Study Start: July 19, 2017
• Primary Completion: October 16, 2018
• Study Completion: October 31, 2018
• Last Updated: February 19, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

PA (4)