Clinical trial NCT01472536: A Study of Exclusion Criteria in a University Population
Official title: A Randomized Study of Exclusion Criteria in a University Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Influenza
Keywords: Influenza
Non pharmaceutical intervention
Sequestration
Social network
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2011-11-16
Enrollment: 1400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: Much of community transmission of seasonal and pandemic influenza occurs in younger individuals, because of their susceptibility and their social interaction patterns.Universities are places where transmission of influenza is facilitated because of the age of individuals involved, their close contact with each other, and low vaccination coverage. Staying home when you are sick (i.e., voluntary sequestration) has been identified as one of the most efficient ways to reduce influenza transmission, but there are still insufficient data on the effects of social distancing to be able to make recommendations for future pandemics or even outbreaks of seasonal influenza.

The investigators are conducting a study on the effect of voluntary sequestration during illness on the transmission of influenza among social networks in University residence housing units at the University of Michigan. The sequestration interventions will be carried out during a period of influenza transmission that is defined by surveillance conducted at the University Health Service. Data will be collected on use of the interventions and the occurrence of influenza and other illnesses. In all selected residence halls, specimens will be collected when illness meeting a case definition for influenza-like illness occurs.

This study in a university population will evaluate the acceptability and magnitude of effect that can be expected from such an intervention, and determine the number of days that sequestration should be practiced.


Eligibility criteria: Inclusion Criteria:

* Live in a participating residence hall at the time of enrollment
* Be at least 18 years of age
* Be willing to report social habits and illness information electronically on a weekly basis
* Be willing to have a throat swab specimen collected if you have signs of illness during the influenza season
* Be willing to nominate close social contacts living in eligible residence halls for participation in the study
* Be willing to participate in a 3-day sequestration protocol as randomly assigned.

Exclusion Criteria:

* Non-residence in selected Residence Halls
* Unwillingness to participate in voluntary sequestration protocol and complete online surveys
* Already study employee

Primary outcomes:
measure: Laboratory confirmed cases of Influenza
timeFrame: 10 weeks
Secondary outcomes:
measure: Cases of influenza like illness
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Allison E Aiello, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Michigan
name: Arnold S Monto, MD
role: PRINCIPAL_INVESTIGATOR
References: