To Develop, Implement and Evaluate the Polio Demonstration Project Comprising of a Community Based Intervention Package for Polio Eradication in Pakistan

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

60000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2021-12-31

Brief Summary

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The objective of the projects is to Develop and implement a Package of interventions that will comprise of an augmented communication and counseling strategy coupled with private sector involvement and a combined Oral Polio Vaccine and Inject able Polio Vaccine approach during the Polio campaigns followed by the evaluation of this project for acceptability, feasibility and effectiveness of the intervention Package.

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Detailed Description

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This particular project has been designed to address the bottlenecks through innovations to address community mobilization and demand creation on one hand and assess the synergistic immune enhancement potential of combining Inject able Polio Vaccine (IPV) and Oral Polio Vaccine (OPV) in at-risk children. This project will be implemented in high risk union councils of Karachi, district Kashmore in Sindh and Bajaur Agency in Federally administered Tribal areas (FATA)

This will be a three cell cluster randomized trial to achieve the objectives of the study. The first cell of the study will receive all the routine activities being carried out by the polio program, the second cell will receive an expanded intervention with community support groups, enhanced communication package, education and counseling and involvement of private sector. While the third cell will receive all of the interventions of second cell with a combined OPV IPV approach during the polio immunization campaign through child health camps.

We have calculated a total sample size of 120 clusters, 40 clusters per group for each study area i-e 120 for Karachi, 120 for Kashmore and 120 for Bajaur. Polio program in Pakistan has well established and demarcated vaccination areas assigned to a vaccination team, each vaccination area usually covers about 200 children therefore the area of vaccination team will be considered as one cluster in the proposed study.

The implementation of the project will be followed by impact assessment activities that will include post vaccination coverage surveys and Immunity assessment activities and Environmental sample collection. A total sample size of 5310 children has been calculated for the immunity studies for seroprevalance and 5130 for stool virus shedding

Conditions

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Polio Polio Sero Conversion Polio Sero Prevalence Immunization Coverage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Group A

Routine Polio Program activities will be carried out with out any active intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Group B

Expanded intervention with following components

1. Community support groups for both male and female at village/community level
2. Enhanced communication package and involvement of local social networks for group counseling on promotion of nutrition, hygiene and Expanded Program of Immunization (EPI) vaccinations
3. Involvement of Private sector (General Physicians,health care providers etc.) through advocacy and inclusion in Supplementary Immunization activities (SIAs)
4. Delivery of interventions \& commodities through low cost health camps during National Immunization days (NIDs) and SIAs (will also assist in mop-up campaigns)

Group Type EXPERIMENTAL

Enhanced Community mobilization

Intervention Type BEHAVIORAL

Group C

All Interventions of Group A and B Plus combined bOPV/IPV strategy in the SIAs during the project

Group Type EXPERIMENTAL

Enhanced Community mobilization

Intervention Type BEHAVIORAL

Combined Oral Polio Vaccine and Inject able Polio Vaccine during SIA

Intervention Type BIOLOGICAL

Interventions

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Enhanced Community mobilization

Intervention Type BEHAVIORAL

Combined Oral Polio Vaccine and Inject able Polio Vaccine during SIA

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Healthy children aged 1 month to 5 years that reside within the study sites, and do not plan to travel away during entire the study period.

Exclusion Criteria

* Children with known thrombocytopenia or bleeding disorders; children acutely ill or with signs of acute infection (e.g. fever ≥ 101 F) at the time of NID and a diagnosis or suspicion of immunodeficiency disorder.

Minimum Eligible Age

1 Month

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes