Community Engagement and Conditional Incentives to Accelerate Polio

Polio Clinical Trial

— GLIDE  

Official title:

The Last Mile - Community Engagement and Conditional Incentives to Accelerate Polio Eradication in Conflict-affected Areas of Pakistan

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05721274
• Other study ID #: 2022-7125-20666
• Status: Completed
• Phase: N/A
• Start date: December 1, 2022
• Est. completion date: March 31, 2024

Study information

• Verified date: April 2024
• Source: Aga Khan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 840
• Est. completion date: March 31, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Day to 59 Months

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Thise not willing to participate in study

Related Conditions & MeSH terms

• Immunization; Infection
• Incentives
• Polio
• Poliomyelitis

Intervention

Behavioral:
• Community mobilization and Conditional community incentives
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

Locations

Country	Name	City	State
Pakistan	Jai Das	Karachi	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
Aga Khan University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vaccine refusals	Number of polio vaccine refusals in polio campaign	at 9 months
Primary	Fully Immunized Children	This would be children who are fully vaccinated appropriate to the age	at 9 months
Primary	IPV coverage	this would be injectable polio vaccine coverage in children below five years of age	at 9 months