An interventional study of Education and Hand Sanitizer in Respiratory Tract Infections and Common Cold, sponsored by Centers for Disease Control and Prevention. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2026-05-05.
Sponsored by Centers for Disease Control and Prevention · Not applicable, Interventional, and Prevention
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.
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
219 studies on the registry are indexed under Common Cold; 23 are open to participants now.
This study's enrollment of 2,788 is above the median of 150 across 184 interventional studies indexed under Common Cold.
Browse Common Cold studies →Centers for Disease Control and Prevention is the lead sponsor of 275 studies on the registry; 2 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 8 (73%) have results posted.
Compared within Common Cold, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Respiratory Tract Infections. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Participants received written educational materials (English or Spanish) on prevention and treatment of upper respiratory infections (URIs) and influenza.
Behavioral: Education
Participants received the same educational materials plus alcohol-based hand sanitizer (multiple sizes) for use at home, work, and school.
Behavioral: Education · Device: Hand Sanitizer
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 · Device: Hand Sanitizer · Device: Face Masks
Educational materials (English or Spanish) on prevention and treatment of upper respiratory infections (URIs) and influenza.
Alcohol-based hand sanitizer provided in multiple sizes for use at home, work, and school.
Surgical face masks with instructions for use when a household member develops influenza-like illness (ILI).
Rates of virologically confirmed influenza and influenza vaccination
Incidence of laboratory-confirmed influenza based on nasal swab specimens analyzed by viral culture or PCR; vaccination rates assessed via participant report.
Time frame: Throughout 19-month follow-up period
Rates of influenza-like symptoms
Incidence of ILI episodes defined using CDC criteria (fever ≥37.8°C with cough and/or sore throat).
Time frame: 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.
Change in knowledge, attitudes, and practices (KAP) score based on a 10-item survey assessing understanding of transmission, prevention, and treatment.
Time frame: Baseline and end of study (up to 19 months)
The record gives a start of Nov 2006, a primary completion of Jun 2008 and a completion of Jun 2008. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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