Back to results

Household Influenza Transmission Study (HITS)

Primary Purpose

Influenza

Status

Unknown status

Phase

Not Applicable

Locations

Thailand

Study Type

Interventional

Intervention

Hand washing

Hand washing and surgical mask

About this trial

This is an interventional prevention trial for Influenza focused on measuring handwashing, masks, infectious disease transmission

Eligibility Criteria

1 Month - 15 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Queen Sirikit National Institute of Child Health

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Arm Label

Control

Hand washing

Hand washing and surgical mask

Arm Description

Control: nutrition, physical activity and smoking cessation education

Intervention 1: hand washing education and material

Intervention 2: hand washing education and material AND paper surgical face masks

Outcomes

Primary Outcome Measures

Secondary influenza infection in household members

Secondary Outcome Measures

Full Information

NCT ID

NCT01251679

First Posted

December 1, 2010

Last Updated

September 10, 2012

Sponsor

Centers for Disease Control and Prevention

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT01251679

Brief Title

Household Influenza Transmission Study

Acronym

HITS

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2012

Overall Recruitment Status

Unknown status

Study Start Date

April 2008 (undefined)

Primary Completion Date

February 2013 (Anticipated)

Study Completion Date

February 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centers for Disease Control and Prevention

Collaborators

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

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Influenza

Keywords

handwashing, masks, infectious disease transmission

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

2920 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Control

Arm Type

No Intervention

Arm Description

Control: nutrition, physical activity and smoking cessation education

Arm Title

Hand washing

Arm Type

Experimental

Arm Description

Intervention 1: hand washing education and material

Arm Title

Hand washing and surgical mask

Arm Type

Experimental

Arm Description

Intervention 2: hand washing education and material AND paper surgical face masks

Intervention Type

Behavioral

Intervention Name(s)

Hand washing

Intervention Description

hand washing education and material

Intervention Type

Device

Intervention Name(s)

Hand washing and surgical mask

Intervention Description

hand washing education and material and paper surgical face masks

Primary Outcome Measure Information:

Title

Secondary influenza infection in household members

Time Frame

21 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Month

Maximum Age & Unit of Time

15 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sonja J Olsen, PhD

Organizational Affiliation

Centers for Disease Control and Prevention

Official's Role

Principal Investigator

Facility Information:

Facility Name

Queen Sirikit National Institute of Child Health

City

Ratchathewi

State/Province

Bangkok

ZIP/Postal Code

10400

Country

Thailand

12. IPD Sharing Statement

Citations:

PubMed Identifier

20879867

Citation

Simmerman JM, Suntarattiwong P, Levy J, Gibbons RV, Cruz C, Shaman J, Jarman RG, Chotpitayasunondh T. Influenza virus contamination of common household surfaces during the 2009 influenza A (H1N1) pandemic in Bangkok, Thailand: implications for contact transmission. Clin Infect Dis. 2010 Nov 1;51(9):1053-61. doi: 10.1086/656581.

Results Reference

result

PubMed Identifier

19949356

Citation

Suntarattiwong P, Jarman RG, Levy J, Baggett HC, Gibbons RV, Chotpitayasunondh T, Simmerman JM. Clinical performance of a rapid influenza test and comparison of nasal versus throat swabs to detect 2009 pandemic influenza A (H1N1) infection in Thai children. Pediatr Infect Dis J. 2010 Apr;29(4):366-7. doi: 10.1097/INF.0b013e3181c6f05c.

Results Reference

result

Learn more about this trial

Household Influenza Transmission Study

We'll reach out to this number within 24 hrs