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

January 26, 2016 updated by: Kiren Mitruka

Pittsburgh Influenza Prevention Project

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

  1. 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
  2. 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.
  3. 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.
  4. Measure the effectiveness of NPIs in reducing secondary spread of ILI within classrooms of participating schools.

  5. Assess adoption of NPI behaviors and activities in classrooms of intervention schools.

    Secondary: Home-Based

  6. Measure the effectiveness of NPIs in reducing secondary cases of ILI within families of enrolled school children with influenza.

  7. Assess adherence of families of enrolled school children with influenza to isolation-related NPI behaviors and activities.

    Tertiary

  8. Measure correlation between rapid flu testing and PCR testing for influenza.
  9. Collect and archive influenza specimens for future molecular epidemiological studies.
  10. Contribute a sample of influenza-positive specimens to the CDC for national influenza surveillance purposes.

Study Type

Interventional

Enrollment (Actual)

3360

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: intervention
Five elementary school received intervention consistin of training in hand and respiratory hygiene, and access to hand sanitizer
Behavioral: behaviors reducing spread of influenza
Non-pharmaceutical interventions for flu prevention
No Intervention: control
Five elementary school received no training or hand sanitizer.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kiren Mitruka

Investigators

  • Principal Investigator: Donald S Burke, MD, University of Pittsburgh
  • Principal Investigator: Sam Stebbins, MD, MPH, University of Pittsburgh School of Public Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

May 1, 2009

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

March 12, 2007

First Submitted That Met QC Criteria

March 12, 2007

First Posted (Estimate)

March 13, 2007

Study Record Updates

Last Update Posted (Estimate)

January 27, 2016

Last Update Submitted That Met QC Criteria

January 26, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDC-NCPDCID-CC-0612047
  • CDC-U01 CI000435-01 (Other Grant/Funding Number: CDC)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe