Stopping Upper Respiratory Infections and Flu in the Family: The Stuffy Trial (STUFFY)

April 30, 2026 updated by: Centers for Disease Control and Prevention

Stopping URIs and Flu in the Family: The Stuffy Trial

Colds and flu cause much loss of work and school. The purpose of this study is to try to reduce the transmission of colds and flu among household members with one of three interventions: some educational material, educational material and use of alcohol hand sanitizers, and educational material and use of alcohol hand sanitizers as well as face masks when somebody has symptoms of the flu. We will recruit 450 households in Northern Manhattan and each household will be randomly assigned to one of these three groups. We will then follow these households for 15 months to see how often they get cold and flu symptoms. We will also look at antibiotic use practices for symptoms of colds and influenza ; household member knowledge of prevention and treatment strategies for pandemic influenza and viral URIs; and rates of influenza vaccination among household members. When someone in the study has serious flu symptoms such as a high fever and cough or sore throat, we will also obtain a nasal culture (by swabbing the nose) to see if there is flu virus present.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Although 'colds' and seasonal influenza are clinically very different diseases from pandemic influenza, they share common transmission pathways and the community level interventions needed to reduce both seasonal flu, common viral upper respiratory infections and pandemic influenza are likely to be similar.

Aims of this project are to compare the impact of two household level interventions (an alcohol based hand sanitizer with or without face masks) on six outcomes: incidence and strains of virologically confirmed influenza in study households; rates of symptoms; number of secondary cases in households; antibiotic use practices for symptoms of influenza and other viral upper respiratory infections; household member knowledge of prevention and treatment strategies for pandemic influenza and viral upper respiratory infections; and rates of influenza vaccination among household members.

450 households in northern Manhattan (primarily recently immigrated Hispanics) will be randomized to three groups: control (receiving only a pamphlet on influenza prevention), alcohol hand sanitizer, and sanitizer plus face masks. Symptoms of influenza will be monitored daily for 15 months using ecological momentary assessment technology. Virologic cultures will be obtained from persons with flu symptoms (fever >100 degrees F., sore throat and/or cough). Antibiotic use practices, knowledge, and vaccination rates will be assessed by survey using piloted, psychometrically sound instruments. For this cluster randomization design with randomized intervention on the household level, outcomes will be measured at the individual and household level using generalized linear mixed model for counts response with a Poisson distribution and other appropriate multivariate techniques to control for confounding.

Comparison(s): The purpose of this study is to try to reduce the transmission of colds and flu among household members with one of three interventions: comparison of transmission in groups receiving educational material only to a group receiving educational material and instructed to use alcohol hand sanitizers to a group receiving educational material and instructed to use alcohol hand sanitizers as well as face masks when somebody has symptoms of the flu

Study Type

Interventional

Enrollment (Actual)

2788

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • Columbia University School of Nursing

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Households with at least three members
  • At least one preschool or elementary school-aged child in the household
  • Residence in Northern Manhattan
  • Ability to speak English or Spanish
  • Access to a telephone
  • Willingness to participate in regular symptom reporting and home visits
  • Not routinely using alcohol-based hand sanitizer at baseline

Exclusion Criteria:

  • Households with fewer than three members
  • No preschool or elementary school-aged child in the household
  • Inability to communicate in English or Spanish
  • No access to a telephone
  • Unwillingness or inability to comply with study procedures
  • Routine use of alcohol-based hand sanitizer prior to enrollment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Education (Control Group)
Participants received written educational materials (English or Spanish) on prevention and treatment of upper respiratory infections (URIs) and influenza.
Behavioral: Education
Educational materials (English or Spanish) on prevention and treatment of upper respiratory infections (URIs) and influenza.
Other: Education + Hand Sanitizer
Participants received the same educational materials plus alcohol-based hand sanitizer (multiple sizes) for use at home, work, and school.
Behavioral: Education
Educational materials (English or Spanish) on prevention and treatment of upper respiratory infections (URIs) and influenza.
Device: Hand Sanitizer
Alcohol-based hand sanitizer provided in multiple sizes for use at home, work, and school.
Other: Education + Hand Sanitizer + Face Masks
Participants received educational materials, hand sanitizer, and surgical face masks with instructions for use when a household member developed influenza-like illness (ILI).
Behavioral: Education
Educational materials (English or Spanish) on prevention and treatment of upper respiratory infections (URIs) and influenza.
Device: Hand Sanitizer
Alcohol-based hand sanitizer provided in multiple sizes for use at home, work, and school.
Device: Face Masks
Surgical face masks with instructions for use when a household member develops influenza-like illness (ILI).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rates of virologically confirmed influenza and influenza vaccination
Time Frame: Throughout 19-month follow-up period
Incidence of laboratory-confirmed influenza based on nasal swab specimens analyzed by viral culture or PCR; vaccination rates assessed via participant report.
Throughout 19-month follow-up period
Rates of influenza-like symptoms
Time Frame: Throughout 19-month follow-up period (symptoms reported at least twice weekly)
Incidence of ILI episodes defined using CDC criteria (fever ≥37.8°C with cough and/or sore throat).
Throughout 19-month follow-up period (symptoms reported at least twice weekly)
Knowledge and attitudes about influenza and the common cold and antibiotic use practices.
Time Frame: Baseline and end of study (up to 19 months)
Change in knowledge, attitudes, and practices (KAP) score based on a 10-item survey assessing understanding of transmission, prevention, and treatment.
Baseline and end of study (up to 19 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centers for Disease Control and Prevention

Investigators

  • Principal Investigator: Elaine Larson, RN,PhD, Columbia University School of Nursing

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

March 16, 2007

First Submitted That Met QC Criteria

March 16, 2007

First Posted (Estimated)

March 19, 2007

Study Record Updates

Last Update Posted (Actual)

May 5, 2026

Last Update Submitted That Met QC Criteria

April 30, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDC-NCEZID-5033
  • 1U01CI000442-01 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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