Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
135 participants
INTERVENTIONAL
2016-02-29
2020-12-31
Brief Summary
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Detailed Description
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Participants: The investigators will recruit 250 outdoor workers. The investigators anticipate recruiting 80, 80, 40,30, and 20 participants from NationalGrid, the RI Department of Environmental Management, the Massachusetts Department of Conservation \& Recreation, the National Park Service, and the US Fish \& Wildlife Service.
Procedures (methods): This will be a randomized controlled trial. All study subjects will fill out weekly tick logs, collect attached ticks for later speciation and pathogen detection, and submit annual serum samples to test for exposure to tick-borne pathogens. A randomly selected subset of 60 subjects also will be asked to submit urine samples for permethrin metabolite analysis at several time points during follow-up. An additional randomly selected subset (n=30) will be asked to submit worn items of clothing for tick knockdown testing and permethrin content analysis at the end of the first and second years of field testing.
The results of this study could help protect hundreds of thousands of outdoor workers with exposure to ticks and tick-borne pathogens.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Permethrin Impregnated Clothing
Uniforms and work clothing (including pants, shorts, shirts, socks, and hats) treated with long-lasting permethrin by Insect Shield.
Permethrin Impregnated Clothing
Uniforms and work clothing treated with permethrin according to proprietary process used by Insect Shield, Inc.
Untreated Clothing
Uniforms and work clothing sent to Insect Shield, washed and refolded (no permethrin applied).
No interventions assigned to this group
Interventions
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Permethrin Impregnated Clothing
Uniforms and work clothing treated with permethrin according to proprietary process used by Insect Shield, Inc.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* spending an average of 10 or more hours of outdoor work per week during peak tick season, and
* completion of written informed consent.
Exclusion Criteria
* non-English speakers, or
* having a known allergy or sensitivity to insecticides
18 Years
ALL
Yes
Sponsors
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University of Rhode Island
OTHER
East Carolina University
OTHER
National Institute for Occupational Safety and Health (NIOSH/CDC)
FED
University of North Carolina, Chapel Hill
OTHER
Responsible Party
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Principal Investigators
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Steven R Meshnick, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of North Carolina, Chapel Hill
Locations
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University of Rhode Island
Kingston, Rhode Island, United States
Countries
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Related Links
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A prior study, Tick-borne Illness and Clothing Study (TICS), was conducted in North Carolina by UNC. The current study uses similar methodology as described in the NC study, as it applies to outdoor workers and ticks in the Rhode Island area.
Other Identifiers
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15-1770
Identifier Type: -
Identifier Source: org_study_id
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