Household Influenza Transmission Study (HITS)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Ministry of Health, Thailand
Armed Forces Research Institute of Medical Sciences, Thailand
Information provided by (Responsible Party):
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT01251679
First received: December 1, 2010
Last updated: September 10, 2012
Last verified: September 2012
  Purpose

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


Condition Intervention
Influenza
Behavioral: Hand washing
Device: Hand washing and surgical mask

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Study to Assess Effectiveness of Nonpharmaceutical Interventions (Handwashing, Face Mask Use) to Prevent Influenza Transmission in Households

Resource links provided by NLM:


Further study details as provided by Centers for Disease Control and Prevention:

Primary Outcome Measures:
  • Secondary influenza infection in household members [ Time Frame: 21 days ] [ Designated as safety issue: No ]

Enrollment: 2920
Study Start Date: April 2008
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control
Control: nutrition, physical activity and smoking cessation education
Experimental: Hand washing
Intervention 1: hand washing education and material
Behavioral: Hand washing
hand washing education and material
Experimental: Hand washing and surgical mask
Intervention 2: hand washing education and material AND paper surgical face masks
Device: Hand washing and surgical mask
hand washing education and material and paper surgical face masks

Detailed 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.

  Eligibility

Ages Eligible for Study:   1 Month to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01251679

Locations
Thailand
Queen Sirikit National Institute of Child Health
Ratchathewi, Bangkok, Thailand, 10400
Sponsors and Collaborators
Ministry of Health, Thailand
Armed Forces Research Institute of Medical Sciences, Thailand
Investigators
Principal Investigator: Sonja J Olsen, PhD Centers for Disease Control and Prevention
  More Information

Publications:
Responsible Party: Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT01251679     History of Changes
Other Study ID Numbers: CDC-NCIRD-5288
Study First Received: December 1, 2010
Last Updated: September 10, 2012
Health Authority: United States: Federal Government

Keywords provided by Centers for Disease Control and Prevention:
handwashing
masks
infectious disease transmission

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 20, 2014