This trial is active, not recruiting.

Condition influenza
Treatments hand washing, hand washing and surgical mask
Sponsor Centers for Disease Control and Prevention
Collaborator Ministry of Health, Thailand
Start date April 2008
End date February 2013
Trial size 2920 participants
Trial identifier NCT01251679, CDC-NCIRD-5288


The purpose of this study is to determine whether nonpharmaceutical interventions (i.e., handwashing and masks) reduce secondary transmission of influenza in households.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
(No Intervention)
Control: nutrition, physical activity and smoking cessation education
Intervention 1: hand washing education and material
hand washing
hand washing education and material
Intervention 2: hand washing education and material AND paper surgical face masks
hand washing and surgical mask
hand washing education and material and paper surgical face masks

Primary Outcomes

Secondary influenza infection in household members
time frame: 21 days

Eligibility Criteria

Male or female participants from 1 month up to 15 years old.

Inclusion Criteria: - Child, 1 month through 15 years of age - Resident of Bangkok Metropolitan Area - Outpatient of Queen Sirikit National Institute of Child Health Children's - Hospital seen during HITS' active study period - Positive influenza rapid test result from patient presenting with influenza-like illness - In addition to the index case, consent must be obtained from at least 2 household members ≥1 month of age who plan to sleep inside the house for a period of at least 21 days from the time of enrollment Exclusion Criteria: - Illness onset 48 hours or more before presentation and influenza testing at Queen Sirikit National Institute of Child Health Children's Hospital - Treatment with influenza antiviral medications since it may decrease secondary attack rate - Children who are at high risk for severe influenza disease (e.g., chronic lung disease, renal disease, chemotherapy for cancer, long-term aspirin therapy) - A history of influenza-like illness in another household member that precedes the index case by 7 days or less will lead to exclusion of the household because the source of influenza infection for secondary cases is uncertain. - Receipt of influenza vaccine by any household member during the preceding 12 months. - Prior participation in HITS.

Additional Information

Official title Study to Assess Effectiveness of Nonpharmaceutical Interventions (Handwashing, Face Mask Use) to Prevent Influenza Transmission in Households
Principal investigator Sonja J Olsen, PhD
Description HITS is a multi-year project that will prospectively identify laboratory-confirmed influenza infected children. Secondary influenza infection will then be examined among members of the child's household and effectiveness of non-pharmaceutical interventions to decrease secondary infection will be assessed. The pediatric influenza-infected index case will be identified by rapid influenza testing and their household will then be enrolled and randomized to one of three study arms: control, hand washing (Intervention 1), and hand washing and mask use (Intervention 2). Following enrollment, at days 0, 3 and 7, all household participants will be tested: the index case will be assessed for influenza viral shedding and household members will be assessed for secondary influenza infection. This study is being conducted at Queen Sirikit Institute for Child Health in Bangkok.
Trial information was received from ClinicalTrials.gov and was last updated in September 2012.
Information provided to ClinicalTrials.gov by Centers for Disease Control and Prevention.