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

Phase 4

• Conditions: Polio Sero Prevalence; Immunization Coverage; Polio; Polio Sero Conversion
• Interventions: Behavioral: Enhanced Community mobilization; Biological: Combined Oral Polio Vaccine and Inject able Polio Vaccine during SIA

• Registration Number: NCT01908114
• Lead Sponsor: Aga Khan University

Brief Summary

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

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

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-07-15
• Study First Submitted QC: 2013-07-24
• Study First Posted: 2013-07-25
• Primary Completion: 2017-07
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-16
• Last Update Posted: 2021-02-18
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60000

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Group B	Enhanced Community mobilization	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 C	Enhanced Community mobilization	All Interventions of Group A and B Plus combined bOPV/IPV strategy in the SIAs during the project
Group C	Combined Oral Polio Vaccine and Inject able Polio Vaccine during SIA	All Interventions of Group A and B Plus combined bOPV/IPV strategy in the SIAs during the project

Primary Outcome Measures

Name	Time	Method
Improved immunization coverage	At the completion of all recruitment and follow ups which will take an average time of 1 year	Improved coverage in both routine immunization and polio campaign Immunization compared to Baseline

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Aga Khan University; 🇵🇰 Karachi, Sindh, Pakistan