A Study of Exclusion Criteria in a University Population (eX-FLU)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Allison Aiello, University of Michigan
ClinicalTrials.gov Identifier:
NCT01472536
First received: November 11, 2011
Last updated: January 23, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention
Influenza
Behavioral: Sequestration

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized Study of Exclusion Criteria in a University Population

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Laboratory confirmed cases of Influenza [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cases of influenza like illness [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 1400
Study Start Date: November 2011
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 3-day sequestration
Students will be sequestered within their residence hall room for 3 days following influenza like illness symptoms
Behavioral: Sequestration
Students will be sequestered within their residence hall room for 3 days following influenza like illness symptoms.
No Intervention: Control
No intervention

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01472536

Locations
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Allison E Aiello, PhD University of Michigan
Principal Investigator: Arnold S Monto, MD University of Michigan
  More Information

No publications provided

Responsible Party: Allison Aiello, Associate Professor, Epidemiology, University of Michigan
ClinicalTrials.gov Identifier: NCT01472536     History of Changes
Other Study ID Numbers: 1-U01-CK-000185-01
Study First Received: November 11, 2011
Last Updated: January 23, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan:
Influenza
Non pharmaceutical intervention
Sequestration
Social network

ClinicalTrials.gov processed this record on October 20, 2014