To Develop, Implement and Evaluate the Polio Demonstration Project Comprising of a Community Based Intervention Package for Polio Eradication in Pakistan
试验速览
- 阶段
- 4 期
- 入组人数
- 60,000
- 试验地点
- 1
- 主要终点
- Improved immunization coverage
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 1 Month 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Improved immunization coverage
时间窗: 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
次要结局
- Improved Polio Sero prevalence(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(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(The stool samples will be collected and analysed at day 28, day 35 and day 49 after recruitment)
研究者
Dr Zulfiqar Ahmed Bhutta
Founding Director, Centre of Excellence in Women and Child Health
Aga Khan University