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

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.

Study Overview

• Status: Unknown
• Conditions: Polio; Polio Sero Conversion; Polio Sero Prevalence; Immunization Coverage
• Intervention / Treatment: 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

• Study Type: Interventional
• Enrollment (Anticipated): 60000
• Phase: Phase 4

Contacts and Locations

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan
      • Aga Khan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 5 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: FACTORIAL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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
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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Aga Khan University
• Collaborators: Bill and Melinda Gates Foundation; World Health Organization; UNICEF; Peshawar Medical College; Pakistan Ministry of Health; Trust for Vaccines and Immunization, Pakistan; National Institutes of Health, Pakistan

Publications and helpful links

General Publications

• 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. Erratum In: Lancet Glob Health. 2017 Aug;5(8):e758. Lancet Glob Health. 2017 Sep;5(9):e873.

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2013
• Primary Completion (ACTUAL): July 1, 2017
• Study Completion (ANTICIPATED): December 1, 2021

Study Registration Dates

• First Submitted: July 15, 2013
• First Submitted That Met QC Criteria: July 24, 2013
• First Posted (ESTIMATE): July 25, 2013

Study Record Updates

• Last Update Posted (ACTUAL): February 18, 2021
• Last Update Submitted That Met QC Criteria: February 16, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Polio disease; Intervention Package; Polio sero prevalence and sero conversion; Polio high risk areas of Pakistan
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; RNA Virus Infections; Virus Diseases; Infections; Neuromuscular Diseases; Central Nervous System Infections; Enterovirus Infections; Picornaviridae Infections; Spinal Cord Diseases; Myelitis; Poliomyelitis; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: 2432-PED-ERC-12