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Community Engagement and Conditional Incentives to Accelerate Polio (GLIDE)

Primary Purpose

Polio, Immunization; Infection, Incentives

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Community mobilization and Conditional community incentives
Sponsored by
Aga Khan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Polio focused on measuring Community engagment, Theory of change

Eligibility Criteria

1 Day - 59 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: • Household with at least one child 0-59 months of age Exclusion Criteria: • Thise not willing to participate in study

Sites / Locations

  • Jai DasRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control arm

Arm Description

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.

This would be the standard of care

Outcomes

Primary Outcome Measures

Vaccine refusals
Number of polio vaccine refusals in polio campaign
Fully Immunized Children
This would be children who are fully vaccinated appropriate to the age
IPV coverage
this would be injectable polio vaccine coverage in children below five years of age

Secondary Outcome Measures

Full Information

First Posted
January 12, 2023
Last Updated
July 19, 2023
Sponsor
Aga Khan University
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1. Study Identification

Unique Protocol Identification Number
NCT05721274
Brief Title
Community Engagement and Conditional Incentives to Accelerate Polio
Acronym
GLIDE
Official Title
The Last Mile - Community Engagement and Conditional Incentives to Accelerate Polio Eradication in Conflict-affected Areas of Pakistan
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2022 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
November 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aga Khan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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
Detailed Description
Study Design:The study will adopt a pretest/post-test quasi-experimental approach with two intervention UCs and two control UCs. For each target, intervention SHRUC, a separate, matched control SHRUC of comparable size and location will be identified for eventual pre-post comparison. Children under-five will be eligible for inclusion. Intervention: The intervention package will include community mobilization and incentivization. Clusters will be formed on a population of 2000-2500 in each intervention UC, thus approximately ten clusters in each. Project will form or liaise with community groups or committees (male and female) in each cluster, which are already operational in many parts of the target UCs. However, to focus on reducing polio vaccine refusals, our program will adopt a unique incentivization approach, preceded by trust-building community mobilization. Clusters will be determined based on the existing micro plans of the PPEP. Microplans are a population-based set of components, at UC-level, used by the program for delivering polio vaccination efficiently. Baseline and end-line surveys will be conducted in the target and control UCs. Study Site: The study will be conduucted in district Karachi, Sindh and other in district Bannu, KP. Intervention UCs: Haji Mureed Goth Karchi and Mira-Khel KP COntrol UCs : Nazivmabad UC 49 Karachi and Khwajamad- Bannu) The research team will engage with multiple village/mohalla committees in the intervention UCs to address and eliminate misconceptions about polio. One-to-one meetings and group sessions which will be led by the committee members, to provide messages on childhood immunization with project-specific IEC material, will be held in each targeted cluster. These platforms would be helpful to identify and counsel their underlying fears and socio-psychological factors about the vaccines, such as painful neonatal experiences, mishandling, doubts, fear of vaccine-related side effects, distrust, etc. The community-based incentives will be conditional based on the decrease in vaccine refusal rates within stipulated time. Communities successful in achieving these targets will be rewarded incentives to improve their infrastructure, including sanitation and hygiene, and water resources.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polio, Immunization; Infection, Incentives
Keywords
Community engagment, Theory of change

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The intervention is based on behaviour change theory
Masking
None (Open Label)
Masking Description
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.
Allocation
Randomized
Enrollment
840 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control arm
Arm Type
No Intervention
Arm Description
This would be the standard of care
Intervention Type
Behavioral
Intervention Name(s)
Community mobilization and Conditional community incentives
Intervention Description
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
Primary Outcome Measure Information:
Title
Vaccine refusals
Description
Number of polio vaccine refusals in polio campaign
Time Frame
at 9 months
Title
Fully Immunized Children
Description
This would be children who are fully vaccinated appropriate to the age
Time Frame
at 9 months
Title
IPV coverage
Description
this would be injectable polio vaccine coverage in children below five years of age
Time Frame
at 9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
59 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: • Household with at least one child 0-59 months of age Exclusion Criteria: • Thise not willing to participate in study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jai K Da, MD,MBA
Phone
021-24930051
Ext
69825
Email
jai.das@aku.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Ishrat Abass, MBA
Phone
021-34930051
Ext
8192
Email
ishrat.abass@aku.edu
Facility Information:
Facility Name
Jai Das
City
Karachi
State/Province
Sindh
ZIP/Postal Code
74800
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jai K Das, MD, MBA
Phone
0213486
Ext
69825
First Name & Middle Initial & Last Name & Degree
Ishrat Abass, ACCA
Phone
0213486
Ext
8192
Email
ishrat.abass@aku.edu

12. IPD Sharing Statement

Learn more about this trial

Community Engagement and Conditional Incentives to Accelerate Polio

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