A Study of Exclusion Criteria in a University Population

NCT ID: NCT01472536

Last Updated: 2016-01-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2013-08-31

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.

Conditions

Influenza

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

3-day sequestration

Students will be sequestered within their residence hall room for 3 days following influenza like illness symptoms

Group Type: EXPERIMENTAL

Sequestration

Intervention Type: BEHAVIORAL

Students will be sequestered within their residence hall room for 3 days following influenza like illness symptoms.

Control

No intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Sequestration

Students will be sequestered within their residence hall room for 3 days following influenza like illness symptoms.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centers for Disease Control and Prevention

FED

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Allison Aiello

Associate Professor, Epidemiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Allison E Aiello, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Arnold S Monto, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

University of Michigan

Ann Arbor, Michigan, United States

Countries

United States

Other Identifiers

1U01CK000185-01

Identifier Type: NIH

Identifier Source: org_study_id

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