Stopping Upper Respiratory Infections and Flu in the Family: The Stuffy Trial
Stopping Upper Respiratory Infections 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.
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
Inclusion Criteria:

 -  Households which include at least three persons, at least one of whom is a preschool
 child, living in Northern Manhattan, have a telephone, speak Spanish or English