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

Study Overview
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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.

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

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

Conditions
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Polio, Polio Sero Conversion, Polio Sero Prevalence, Immunization Coverage

Intervention / Treatment
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* Behavioral: Enhanced Community mobilization
* Biological: Combined Oral Polio Vaccine and Inject able Polio Vaccine during SIA


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Group A<br>Routine Polio Program activities will be carried out with out any active intervention | |
| Experimental: Group B<br>Expanded intervention with following components Community support groups for both male and female at village/community level Enhanced communication package and involvement of local social networks for group counseling on promotion of nutrition, hygiene and Expanded Program of Immunization (EPI) vaccinations Involvement of Private sector (General Physicians,health care providers etc.) through advocacy and inclusion in Supplementary Immunization activities (SIAs) Delivery of interventions & commodities through low cost health camps during National Immunization days (NIDs) and SIAs (will also assist in mop-up campaigns) | Behavioral: Enhanced Community mobilization<br> <br> |
| Experimental: Group C<br>All Interventions of Group A and B Plus combined bOPV/IPV strategy in the SIAs during the project | Behavioral: Enhanced Community mobilization<br> <br> Biological: Combined Oral Polio Vaccine and Inject able Polio Vaccine during SIA<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improved immunization coverage | Improved coverage in both routine immunization and polio campaign Immunization compared to Baseline | At the completion of all recruitment and follow ups which will take an average time of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improved Polio Sero prevalence | Population bases Immunity level for polio antibodies will be assessed by Sero prevalance and conversion at various time points | The immunity levels will be assessed at the time of recruitment, six weeks after recruitment and 18 weeks after recruitment | 
| Quantification of Polio virus in stool samples | Quantification of Polio virus will be assessed in stool samples collected at day 28, day 35 and day 49 after recruitment | The stool samples will be collected and analysed at day 28, day 35 and day 49 after recruitment | 
| Shedding of Polio virus in stool samples | Shedding of Polio virus in stool samples will be assessed at day day 28, day 35 and day 49 after recruitment | The stool samples will be collected and analysed at day 28, day 35 and day 49 after recruitment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Polio disease, Intervention Package, Polio sero prevalence and sero conversion, Polio high risk areas of Pakistan