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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Aga Khan University
Sponsor:
Collaborators:
Pakistan Ministry of Health
Trust for Vaccines and Immunization, Pakistan
National Institutes of Health (NIH)Pakistan
Peshawar Medical College PMC
World Health Organization
UNICEF
Bill and Melinda Gates Foundation
Information provided by (Responsible Party):
Mir Asghar Ali Khan, MBA, MPhil, Aga Khan University
ClinicalTrials.gov Identifier:
NCT01908114
First received: July 15, 2013
Last updated: July 24, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Polio
Polio Sero Conversion
Polio Sero Prevalence
Immunization Coverage
Behavioral: Enhanced Community mobilization
Biological: Combined Oral Polio Vaccine and Inject able Polio Vaccine during SIA
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: To Develop, Implement and Evaluate the Polio Demonstration Project Comprising of a Community Based Intervention Package for Polio Eradication in Pakistan

Resource links provided by NLM:


Further study details as provided by Aga Khan University:

Primary Outcome Measures:
  • Improved immunization coverage [ Time Frame: At the completion of all recruitment and follow ups which will take an average time of 1 year ] [ Designated as safety issue: No ]
    Improved coverage in both routine immunization and polio campaign Immunization compared to Baseline


Secondary Outcome Measures:
  • Improved Polio Sero prevalence [ Time Frame: The immunity levels will be assessed at the time of recruitment, six weeks after recruitment and 18 weeks after recruitment ] [ Designated as safety issue: No ]

    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 [ Time Frame: The stool samples will be collected and analysed at day 28, day 35 and day 49 after recruitment ] [ Designated as safety issue: No ]
    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 [ Time Frame: The stool samples will be collected and analysed at day 28, day 35 and day 49 after recruitment ] [ Designated as safety issue: No ]
    Shedding of Polio virus in stool samples will be assessed at day day 28, day 35 and day 49 after recruitment


Estimated Enrollment: 60000
Study Start Date: July 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Group A
Routine Polio Program activities will be carried out with out any active intervention
Experimental: 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)
Behavioral: Enhanced Community mobilization
Experimental: Group C
All Interventions of Group A and B Plus combined bOPV/IPV strategy in the SIAs during the project
Behavioral: Enhanced Community mobilization Biological: Combined Oral Polio Vaccine and Inject able Polio Vaccine during SIA

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

Ages Eligible for Study:   1 Month to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01908114

Contacts
Contact: Zulfiqar A Bhutta, PhD +92 2134864798 zulfiqar.bhutta@aku.edu
Contact: Muhammad Atif Habib, MPH +922134864031 atif.habib@aku.edu

Locations
Pakistan
Aga Khan University Recruiting
Karachi, Sindh, Pakistan
Contact: Zulfiqar A Bhutta, PhD    +92 2134864798    zulfiqar.bhutta@aku.edu   
Contact: Muhammad Atif Habib, MPH    +92 213 4864031    atif.habib@aku.edu   
Principal Investigator: Zulfiqar A Bhutta, PhD         
Sub-Investigator: Muhammad Atif Habib, MPH         
Sub-Investigator: Sajid B Soofi, FCPS         
Sub-Investigator: Najeeb ul Haq, FCPS         
Sub-Investigator: Sohail Zaidi         
Sub-Investigator: Nick Grassly, PhD         
Sub-Investigator: Simon Cousens, PhD         
Sponsors and Collaborators
Mir Asghar Ali Khan, MBA, MPhil
Pakistan Ministry of Health
Trust for Vaccines and Immunization, Pakistan
National Institutes of Health (NIH)Pakistan
Peshawar Medical College PMC
World Health Organization
UNICEF
Bill and Melinda Gates Foundation
Investigators
Principal Investigator: Zulfiqar A Bhutta, PhD Aga Khan University
  More Information

No publications provided

Responsible Party: Mir Asghar Ali Khan, MBA, MPhil, Manager Grants and Administration, Aga Khan University
ClinicalTrials.gov Identifier: NCT01908114     History of Changes
Other Study ID Numbers: 2432-PED-ERC-12
Study First Received: July 15, 2013
Last Updated: July 24, 2013
Health Authority: Pakistan: Research Ethics Committee

Keywords provided by Aga Khan University:
Polio disease
Intervention Package
Polio sero prevalence and sero conversion
Polio high risk areas of Pakistan

Additional relevant MeSH terms:
Poliomyelitis
Myelitis
Central Nervous System Viral Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
Neuromuscular Diseases

ClinicalTrials.gov processed this record on September 11, 2014