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Completed

NCT Number: NCT01251679

Household Influenza Transmission Study

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

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Key information

Age range

1 month–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Queen Sirikit National Institute of Child Health

Ratchathewi, Bangkok, 10400, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hand washing

Behavioral

hand washing education and material

Hand washing and surgical mask

Device

hand washing education and material and paper surgical face masks

Primary outcomes

  1. Secondary influenza infection in household members

    Time frame: 21 days

    To determine the secondary attack rate (SAR) in households with a child with laboratory-confirmed influenza infection.

Sponsors and collaborators

Lead sponsor

Centers for Disease Control and Prevention

Fed

Collaborators

  • Armed Forces Research Institute of Medical Sciences, Thailand
  • Ministry of Health, Thailand

Registry information

Official study title

Study to Assess Effectiveness of Nonpharmaceutical Interventions (Handwashing, Face Mask Use) to Prevent Influenza Transmission in Households

Acronym: HITS

Important dates

Study start
2008
Primary completion
2012
Study completion
2013
First posted
Dec 2, 2010
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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