- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05721274
Community Engagement and Conditional Incentives to Accelerate Polio (GLIDE)
The Last Mile - Community Engagement and Conditional Incentives to Accelerate Polio Eradication in Conflict-affected Areas of Pakistan
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Sindh
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Karachi, Sindh, Pakistan, 74800
- Jai Das
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
• Household with at least one child 0-59 months of age
Exclusion Criteria:
• Thise not willing to participate in study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention
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. |
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
|
|
No Intervention: Control arm
This would be the standard of care
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Vaccine refusals
Time Frame: at 9 months
|
Number of polio vaccine refusals in polio campaign
|
at 9 months
|
|
Fully Immunized Children
Time Frame: at 9 months
|
This would be children who are fully vaccinated appropriate to the age
|
at 9 months
|
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IPV coverage
Time Frame: at 9 months
|
this would be injectable polio vaccine coverage in children below five years of age
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at 9 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022-7125-20666
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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