Tick Bites, Tick-borne Diseases
Conditions
Brief summary
Lyme and other tick-borne diseases pose a significant health threat to outdoor workers. This study is a double-blind randomized controlled trial of outdoor workers in Rhode Island and the surrounding area that will address the following study aims: 1) Evaluate the effectiveness of LLPI clothing in preventing tick bites among outdoor workers in Lyme endemic areas; 2) Measure the urine levels of permethrin metabolites in study subjects; and 3) Measure the loss over time of knockdown activity against ticks and of permethrin in LLPI clothing.
Detailed description
Lyme and other tick-borne diseases pose a significant health threat to outdoor workers. In a double-blind randomized controlled trial (RCT) in North Carolina outdoor workers, the investigators previously showed that long-lasting permethrin-impregnated (LLPI) clothing provided \>80% protection for one year against Lone Star tick bites among outdoor workers in North Carolina. But there are three issues that need to be addressed before this finding can be translated into policy: 1) Do LLPI clothing protect against black legged ticks, the vector for Lyme disease, babesiosis and anaplasmosis? 2) What levels of permethrin and its metabolites are absorbed, and are they potentially toxic? 3) Why did the LLPI clothing in our previous study lose efficacy after a year? 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.
Interventions
OTHERPermethrin Impregnated Clothing
Uniforms and work clothing treated with permethrin according to proprietary process used by Insect Shield, Inc.
Sponsors
University of Rhode Island
East Carolina University
National Institute for Occupational Safety and Health (NIOSH/CDC)
University of North Carolina, Chapel Hill
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* over 18 years of age, * 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
* pregnancy or a planned pregnancy during the follow-up period (since exposure to an insecticide is involved), * non-English speakers, or * having a known allergy or sensitivity to insecticides
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Work Related Tick Bites Per Week | Weekly for two years | Reported tick bites, defined as ticks attached to or embedded in the skin. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in permethrin metabolite levels after 1 year | Enrollment to end of study year 1 | Metabolites measured in urine, compared to baseline prior to wearing clothing. |
| Change in concentration of permethrin in clothing after 1 year | Enrollment to end of study year 1 | Measurement of the chemical concentration of clothing samples after study year 1, compared against concentration of a newly treated clothing sample. |
| Change in concentration of permethrin in clothing after 2 years | Enrollment to 2 years after study initiation | Measurement of the chemical concentration of clothing samples after study year 2, compared against concentration of a newly treated clothing sample. |
| Change in permethrin metabolite levels after 3 weeks | Enrollment to 3 weeks after study initiation | Permethrin metabolites measured in urine, compared to baseline prior to wearing clothing. |
| Change in tick repellency after 2 years | Enrollment to 2 years after study initiation | Measurement of the tick repellency (knockdown activity) of clothing samples after study year 2, compared against concentration of a newly treated piece of clothing sample. |
| Pathogen seroconversion in study year 1 | Enrollment to year 1 | Seroconversion in year 1 is defined as a fourfold rise in antibody titers against pathogens of tick-borne disease when comparing titers between baseline and after year 1. |
| Pathogen seroconversion in study year 2 | Study year 1 to study year 2 | Seroconversion in year 2 is defined as a fourfold rise in antibody titers against pathogens of tick-borne disease when comparing titers between baseline and after year 2. |
| Change in tick repellency after 1 year | Enrollment to 1 year after study initiation | Measurement of the tick repellency (knockdown activity) of clothing samples after study year 1, compared against concentration of a newly treated piece of clothing sample. |
Countries
United States
Outcome results
None listed