Community Engagement and Conditional Incentives to Accelerate Polio

NCT ID: NCT05721274

Last Updated: 2024-04-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 840 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-01
• Study Completion Date: 2024-03-31

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.

Conditions

Polio; Immunization; Infection; Incentives

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Community mobilization and Conditional community incentives

Intervention Type: BEHAVIORAL

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

Control arm

This would be the standard of care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Thise not willing to participate in study

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 59 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Aga Khan University

OTHER

Sponsor Role: lead

Responsible Party

Dr Jai Kumar Das

Assistant Professor and Assistant Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Jai Das

Karachi, Sindh, Pakistan

Countries

Pakistan

References

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.

Reference Type: DERIVED

PMID: 37736966 (View on PubMed)

Other Identifiers

2022-7125-20666

Identifier Type: -

Identifier Source: org_study_id