We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00446628
Recruitment Status : Completed
First Posted : March 13, 2007
Last Update Posted : January 27, 2016
Sponsor:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Influenza Behavioral: behaviors reducing spread of influenza

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Pittsburgh Influenza Prevention Project
Study Start Date : January 2007
Primary Completion Date : May 2009
Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot
U.S. FDA Resources

Arms and Interventions

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.


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   6 Months and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00446628


Locations
United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
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
More Information

Responsible Party: Kiren Mitruka, Medical officer, Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT00446628     History of Changes
Other Study ID Numbers: CDC-NCPDCID-CC-0612047
CDC-U01 CI000435-01 ( Other Grant/Funding Number: CDC )
First Posted: March 13, 2007    Key Record Dates
Last Update Posted: January 27, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Kiren Mitruka, Centers for Disease Control and Prevention:
Non-pharmaceutical
influenza
pandemic

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases