Tick-borne Illness and Clothing Study of Rhode Island
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/16/2017 |
| Start Date: | February 2016 |
| End Date: | August 2019 |
| Contact: | John W Wallace, PhD, MSPH |
| Email: | john.wallace@unc.edu |
| Phone: | 919-962-8870 |
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.
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.
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.
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.
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
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