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Project to Investigate Ways to Reduce the Spread of Influenza in Schools and Households With Children (PIPP)

Primary Purpose

Influenza

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
behaviors reducing spread of influenza
Sponsored by
Kiren Mitruka
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Influenza focused on measuring Non-pharmaceutical, influenza, pandemic

Eligibility Criteria

6 Months - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria (student):

  • Students in grades K-8 with a current influenza-like illness (ILI) during flu season.ILI defined as an oral or aural temperature > 100 °F AND either new onset cough or sore throat.Flu season is defined as December, 2006 through March/April, 2007.
  • Parental consent and student assent.

Inclusion Criteria (household members):

  • Shares living space with K-8 child who has current influenza infection.
  • Parental consent and child assent in the case of minors.
  • Individual consent if over the age of 18.
  • Will continue in the study even if student with confirmed influenza withdraws from the study.

Exclusion Criteria (student):

  • The participant has a medical or mental health condition which in the judgment of the investigator is a barrier to safe participation.
  • The participant is unable to tolerate a swab or capillary finger stick.
  • There is a delay in notification or testing such that symptoms have resolved.

Exclusion Criteria (household):

  • The participant has a medical or mental health condition which in the judgment of the investigator is a barrier to safe participation.
  • The participant is younger than 6 months.
  • The participant is unable to tolerate a swab or capillary finger stick.

Sites / Locations

  • University of Pittsburgh

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

intervention

control

Arm Description

Five elementary school received intervention consistin of training in hand and respiratory hygiene, and access to hand sanitizer

Five elementary school received no training or hand sanitizer.

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
March 12, 2007
Last Updated
January 26, 2016
Sponsor
Kiren Mitruka
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1. Study Identification

Unique Protocol Identification Number
NCT00446628
Brief Title
Project to Investigate Ways to Reduce the Spread of Influenza in Schools and Households With Children
Acronym
PIPP
Official Title
Pittsburgh Influenza Prevention Project
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Kiren Mitruka

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to understand the spread of influenza (flu) in schools and households with elementary (K-5) school children, and develop ways to reduce the flu using non-pharmaceutical means.
Detailed Description
Pandemic influenza threatens to cause substantial disability, death, and societal disruption and to overwhelm health care systems in the United States and around the world. Because effective vaccines may not be available during the initial months of a pandemic, and because anti-viral medication is both largely ineffective and in short supply, non-pharmacological personal protection and behavioral changes may be the only means to combat the epidemic. In our computational modeling work (through the Models of Infectious Disease Agent Study network), we have shown the potential value of multiple targeted and layered non-pharmacological interventions in blunting the peak impact and slowing of a pandemic (Nature, in press). Phase 1 of the project will be a pilot study in two elementary schools in the City of Pittsburgh. The project has already obtained agreement to collaborate from the Pittsburgh Public School System and we have assembled a multi-disciplinary team of epidemiologists, systems analysts, modelers, community and minority health workers, and virologists to implement the project. Phase one was in 2 schools. Phase 2 will be similar to Phase 1 with the addition of additional schools and application of a "hygiene" intervention to selected schools and families. Phase 2 is in 10 schools with 3800 students. Specific aims (year 02): Primary Measure the effectiveness of non-pharmaceutical interventions (NPIs) in reducing influenza rates among enrolled students in the intervention and control schools when influenza is known to be circulating in the community. [Note: Enrolled, for purposes of PIPP, will indicate students who present with ILI, consent to participate, and are tested for influenza during the flu season.] Secondary: School-Based Measure number of absentees and determine the reason for absence by using a school based absentee illness surveillance system prior to and through the end of influenza season. Measure the effectiveness of NPIs in reducing absenteeism from all causes, including illness/URI, illness/ILI, illness/other, and illness/GI through the end of influenza season. Measure the effectiveness of NPIs in reducing secondary spread of ILI within classrooms of participating schools. Assess adoption of NPI behaviors and activities in classrooms of intervention schools. Secondary: Home-Based Measure the effectiveness of NPIs in reducing secondary cases of ILI within families of enrolled school children with influenza. Assess adherence of families of enrolled school children with influenza to isolation-related NPI behaviors and activities. Tertiary Measure correlation between rapid flu testing and PCR testing for influenza. Collect and archive influenza specimens for future molecular epidemiological studies. Contribute a sample of influenza-positive specimens to the CDC for national influenza surveillance purposes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
Non-pharmaceutical, influenza, pandemic

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3360 (Actual)

8. Arms, Groups, and Interventions

Arm Title
intervention
Arm Type
Experimental
Arm Description
Five elementary school received intervention consistin of training in hand and respiratory hygiene, and access to hand sanitizer
Arm Title
control
Arm Type
No Intervention
Arm Description
Five elementary school received no training or hand sanitizer.
Intervention Type
Behavioral
Intervention Name(s)
behaviors reducing spread of influenza
Intervention Description
Non-pharmaceutical interventions for flu prevention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria (student): Students in grades K-8 with a current influenza-like illness (ILI) during flu season.ILI defined as an oral or aural temperature > 100 °F AND either new onset cough or sore throat.Flu season is defined as December, 2006 through March/April, 2007. Parental consent and student assent. Inclusion Criteria (household members): Shares living space with K-8 child who has current influenza infection. Parental consent and child assent in the case of minors. Individual consent if over the age of 18. Will continue in the study even if student with confirmed influenza withdraws from the study. Exclusion Criteria (student): The participant has a medical or mental health condition which in the judgment of the investigator is a barrier to safe participation. The participant is unable to tolerate a swab or capillary finger stick. There is a delay in notification or testing such that symptoms have resolved. Exclusion Criteria (household): The participant has a medical or mental health condition which in the judgment of the investigator is a barrier to safe participation. The participant is younger than 6 months. The participant is unable to tolerate a swab or capillary finger stick.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donald S Burke, MD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sam Stebbins, MD, MPH
Organizational Affiliation
University of Pittsburgh School of Public Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Project to Investigate Ways to Reduce the Spread of Influenza in Schools and Households With Children

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