NCT01472536

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

November 11, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 16, 2011

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

January 26, 2016

Status Verified

January 1, 2016

Enrollment Period

1.8 years

First QC Date

November 11, 2011

Last Update Submit

January 24, 2016

Conditions

Influenza

Keywords

InfluenzaNon pharmaceutical interventionSequestrationSocial network

Outcome Measures

Primary Outcomes (1)

  • Laboratory confirmed cases of Influenza

    10 weeks

Secondary Outcomes (1)

  • Cases of influenza like illness

    10 weeks

Study Arms (2)

3-day sequestration

EXPERIMENTAL

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

Behavioral: Sequestration

Control

NO INTERVENTION

No intervention

Interventions

SequestrationBEHAVIORAL

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

3-day sequestration

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

Carbon Sequestration

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Carbon CycleOrganic Chemistry PhenomenaChemical PhenomenaEcological and Environmental PhenomenaBiological Phenomena

Study Officials

  • Allison E Aiello, PhD

    University of Michigan

    PRINCIPAL INVESTIGATOR

  • Arnold S Monto, MD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Epidemiology

Study Record Dates

First Submitted

November 11, 2011

First Posted

November 16, 2011

Study Start

November 1, 2011

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

January 26, 2016

Record last verified: 2016-01

Locations

US(1)