Principal Investigator: Joseph Stanford
Keywords: household , epidemiology , influenza , pandemic Department: Family And Preventive Medicine
IRB Number: 00086963
Specialty: Infectious Diseases, Pediatric Infectious Diseases
Sub Specialties: Viral infections,
Recruitment Status: Recruiting

Contact Information

Richard Drake
richard.drake@hsc.utah.edu
801-213-8678

Brief Summary

Main Study

Using representative household data, this study will assess the burden of novel influenza, including non-medically attended respiratory disease associated with influenza infection and asymptomatic influenza infection, and evaluate the use of antiviral agents and effectiveness of influenza vaccines as part of a pandemic response.  This study will provide a source of information on the transmissibility of influenza infection, the characteristics of non-medically attended acute respiratory illness (non-MAARI) associated with laboratory-confirmed influenza, and estimates of vaccine effectiveness and immunogenicity.

Specific objectives of the household community cohort study follow. For each of the three objective domains, the primary objective is listed as the first item, followed by secondary objectives.

 

1. Assess the incidence and transmission of pandemic influenza among a cohort of households.

• Estimate the incidence of primary influenza illnesses among participants (Primary Objective).

• Estimate the risk of secondary transmission of influenza illness within households.

• Estimate the risk of infection with the pandemic virus, including asymptomatic infection, based on sera collected from participants at the start and end of the study.

• Examine the individual, household, and other environmental predictors of susceptibility to and transmission of pandemic influenza virus infections that result in illness.

2. Describe the clinical characteristics and severity of influenza within the household cohort, including the frequency of seeking medical care for influenza illness.

• Determine the proportion of influenza infections that is non-MAARI (Primary Objective)

• Estimate the proportion of influenza infections that is non-MAARI by age group, other demographic groups, and health risk groups.

• Examine the participant and clinical characteristics that predict seeking medical care (including antiviral use) for influenza.

• Examine the incidence of influenza in the household cohort in order to compare to the incidence of more severe influenza outcomes, including hospitalizations and deaths associated with influenza virus infections, from other study and surveillance platforms.

3. Assess influenza VE among households.

• Estimate VE in preventing influenza outcomes, including laboratory-confirmed influenza infection and the incidence of influenza-related MAARI (Primary Objective).

• Examine VE in preventing serious influenza outcomes, including influenza-related hospitalizations and death associated with influenza virus infections.

• Assess VE in reducing the risk of secondary transmission within households.

• Assist in the evaluation of the immunogenicity of influenza vaccines by collecting sera from participants before and after vaccination for serologic testing.

• Assess socio-demographic characteristics, health information, vaccination history, and household and other environmental characteristics that may predict differences in vaccine effectiveness and immunogenicity.

Examine the association between the receipt of current and prior seasonal influenza vaccines and pandemic influenza infection.

• Assist in the evaluation of the cost-effectiveness of pandemic vaccines in preventing influenza-related illness and complications.

Pilot Study

The purpose of this pilot study is to test the logistics and feasibility of participant self-collection of nasal swab for bacterial, viral, and microbiome analysis as compared to staff collection of nasal swabs. We believe that home collection will facilitate greater participation and more timely collection than clinic visits while maintaining adequate sample quality. We also believe that participant-collected samples will cost less than keeping a staff member at the ready to visit homes to collect samples. In a pandemic setting, if we hope to collect many samples, it would be impractical to have sufficient staff resources available to respond quickly with home collection.

Hypothesis: With simple instruction, participant families will collect nasal swab specimens at home that are analytically comparable to concurrent staff-collected samples.

Hypothesis: Participant-collected samples will be less costly in terms of money and time resources than staff-collected samples.

Inclusion Criteria

Main Study

  • A household of at least three persons with at least one child (aged < 18 years old) OR one older adult (aged > 65 years old) living in a common dwelling.

    • A household member is defined as anyone who usually spends at least 4 nights a week in the dwelling, including nuclear family members, relatives, friends and boarders. A dwelling is defined as sharing a common entrance and kitchen facilities.

At least three persons in household willing to enroll, including a responsible adult willing to

  • serve as the household reporter, and

  • Household informant willing to complete twice weekly symptom assessments and have monthly home or telephone contacts over a one-year period.

  • Have internet or a phone with text messaging and/or mobile application capabilities.

  • All adult household members planning to enroll capable of communicating in English with at least one adult fluent in English.

  • Willing to grant access to medical records for all persons enrolled in the protocol.

Household members

All persons living in the common dwelling of an eligible household (as defined above and determined at the time of recruitment) are eligible and encouraged to enroll. In addition, persons who move into an enrolled household after the start of the study and plan to live in the household for a minimum of three months are eligible and encouraged to enroll

Inclusion Criteria

  • Willing to grant access to medical records.

  • Intention to live in the household for a minimum of three months.


 
Pilot Study
 
Inclusion Criteria:
  • One adult parent or guardian and one child under age 18 in same household willing to participate
  • Current residents of Salt Lake County
  • Able to read English
  • Willing to have staff come to home to complete study visit

Exclusion Criteria

Main Study

  • Intention of any core household member (i.e., those members that allow the household to meet the number (minimum of 3) and age distribution (at least one person <18 or >64 years of age) inclusion criterion above) to move away from area in <12 months.

  • Intention of any core household member to move away from area for more than 30 days at any one time during the 12 month study period.