Clinical trial NCT01908114: To Develop, Implement and Evaluate the Polio Demonstration Project Comprising of a Community Based Intervention Package for Polio Eradication in Pakistan
Official title: To Develop, Implement and Evaluate the Polio Demonstration Project Comprising of a Community Based Intervention Package for Polio Eradication in Pakistan
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Polio
Polio Sero Conversion
Polio Sero Prevalence
Immunization Coverage
Keywords: Polio disease
Intervention Package
Polio sero prevalence and sero conversion
Polio high risk areas of Pakistan
Lead sponsor: Aga Khan University
Sponsor class: OTHER
Collaborators: name: Pakistan Ministry of Health
name: Trust for Vaccines and Immunization, Pakistan
name: National Institutes of Health, Pakistan
name: Peshawar Medical College
name: World Health Organization
name: UNICEF
name: Bill and Melinda Gates Foundation
First posted: 2013-07-25
Enrollment: 60000
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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

Eligibility criteria: 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.

Primary outcomes:
measure: Improved immunization coverage
timeFrame: At the completion of all recruitment and follow ups which will take an average time of 1 year
Secondary outcomes:
measure: Improved Polio Sero prevalence
timeFrame: The immunity levels will be assessed at the time of recruitment, six weeks after recruitment and 18 weeks after recruitment
measure: Quantification of Polio virus in stool samples
timeFrame: The stool samples will be collected and analysed at day 28, day 35 and day 49 after recruitment
measure: Shedding of Polio virus in stool samples
timeFrame: The stool samples will be collected and analysed at day 28, day 35 and day 49 after recruitment
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Aga Khan University
state: Sindh
Study officials:
affiliation: Aga Khan University
name: Zulfiqar A Bhutta, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Habib MA, Soofi S, Cousens S, Anwar S, Haque NU, Ahmed I, Ali N, Tahir R, Bhutta ZA. Community engagement and integrated health and polio immunisation campaigns in conflict-affected areas of Pakistan: a cluster randomised controlled trial. Lancet Glob Health. 2017 Jun;5(6):e593-e603. doi: 10.1016/S2214-109X(17)30184-5.