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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
60,000
Aga Khan University
Karachi, Sindh, Pakistan
Improved immunization coverage
Improved coverage in both routine immunization and polio campaign Immunization compared to Baseline
Time frame: At the completion of all recruitment and follow ups which will take an average time of 1 year
Improved Polio Sero prevalence
Population bases Immunity level for polio antibodies will be assessed by Sero prevalance and conversion at various time points
Time frame: 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
Time frame: 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
Time frame: The stool samples will be collected and analysed at day 28, day 35 and day 49 after recruitment
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