NCT05721274

Brief Summary

Immunization is one of the most cost-effective and successful public health strategy in reducing the health, economic and societal burden of many infectious diseases. Pakistan and Afghanistan remain the only countries where polio is endemic, and Pakistan reports the most cases in the world. Although the rate is lower than in previous years, the situation remains alarming. This study objective is to decrease polio vaccine refusals and zero-dose vaccines by motivating behaviour change

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
840

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 12, 2023

Completed
28 days until next milestone

First Posted

Study publicly available on registry

February 9, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2024

Completed
Last Updated

April 26, 2024

Status Verified

April 1, 2024

Enrollment Period

1.3 years

First QC Date

January 12, 2023

Last Update Submit

April 25, 2024

Conditions

Keywords

Community engagmentTheory of change

Outcome Measures

Primary Outcomes (3)

  • Vaccine refusals

    Number of polio vaccine refusals in polio campaign

    at 9 months

  • Fully Immunized Children

    This would be children who are fully vaccinated appropriate to the age

    at 9 months

  • IPV coverage

    this would be injectable polio vaccine coverage in children below five years of age

    at 9 months

Study Arms (2)

Intervention

EXPERIMENTAL

The study will adopt a pretest/post-test quasi-experimental design. The approach of the proposed project is to implement a participatory community engagement and demand creation strategy with trust-building community mobilization and a conditional community-based incentive scheme to reduce the refusals to vaccination and improve polio immunization coverage in intervention UCs. Clusters will be formed on a population of 1500-2000 in each intervention UC. Committees would be formed with approximately 5-7 prominent members of the community. Intervention Non-cash, incentives would be given and decided with consensus by UC committees and aim to improve infrastructure linked to health including water and sanitation and toilets in the community.

Behavioral: Community mobilization and Conditional community incentives

Control arm

NO INTERVENTION

This would be the standard of care

Interventions

Non-cash, incentives would be given to clusters which improve the polio vaccine coverage and reduce the refusals and these incentives would be decided with consensus by community and costs would be shared

Intervention

Eligibility Criteria

Age1 Day - 59 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Household with at least one child 0-59 months of age

You may not qualify if:

  • Thise not willing to participate in study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jai Das

Karachi, Sindh, 74800, Pakistan

Location

Related Publications (1)

  • Das JK, Khan A, Tabassum F, Padhani ZA, Habib A, Mirani M, Rahman AR, Khan ZA, Rizvi A, Ahmed I, Bhutta Z. The Last Mile-Community Engagement and Conditional Incentives to Accelerate Polio Eradication in Pakistan: Study Protocol for a Quasi-Experimental Trial. Methods Protoc. 2023 Sep 8;6(5):83. doi: 10.3390/mps6050083.

MeSH Terms

Conditions

PoliomyelitisInfections

Condition Hierarchy (Ancestors)

MyelitisCentral Nervous System InfectionsEnterovirus InfectionsPicornaviridae InfectionsRNA Virus InfectionsVirus DiseasesCentral Nervous System DiseasesNervous System DiseasesSpinal Cord DiseasesNeuroinflammatory DiseasesNeuromuscular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Project team will keep liaison with key stakeholders, committee members, polio workers/supervisors and other relevant persons. Influential community members will conduct awareness and motivation activities. The messages would address reasons for OPV and routine vaccine refusals in the community and will be disseminated via health promotion materials and support groups organized by committees.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: The intervention is based on behaviour change theory
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor and Assistant Director

Study Record Dates

First Submitted

January 12, 2023

First Posted

February 9, 2023

Study Start

December 1, 2022

Primary Completion

March 31, 2024

Study Completion

March 31, 2024

Last Updated

April 26, 2024

Record last verified: 2024-04

Locations