Project to Investigate Ways to Reduce the Spread of Influenza in Schools and Households With Children (PIPP)
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|ClinicalTrials.gov Identifier: NCT00446628|
Recruitment Status : Completed
First Posted : March 13, 2007
Last Update Posted : January 27, 2016
|Condition or disease||Intervention/treatment||Phase|
|Influenza||Behavioral: behaviors reducing spread of influenza||Not Applicable|
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):
- 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.
- 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.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3360 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pittsburgh Influenza Prevention Project|
|Study Start Date :||January 2007|
|Actual Primary Completion Date :||May 2009|
|Actual Study Completion Date :||September 2009|
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.
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
|United States, Pennsylvania|
|University of Pittsburgh|
|Pittsburgh, Pennsylvania, United States, 15213|
|Principal Investigator:||Donald S Burke, MD||University of Pittsburgh|
|Principal Investigator:||Sam Stebbins, MD, MPH||University of Pittsburgh School of Public Health|