Clinical trial NCT02613585: Tick-borne Illness and Clothing Study of Rhode Island
Official title: Tick-borne Illness and Clothing Study of Rhode Island
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tick Bites
Tick-borne Diseases
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: University of Rhode Island
name: East Carolina University
name: National Institute for Occupational Safety and Health (NIOSH/CDC)
First posted: 2015-11-24
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Work Related Tick Bites Per Week
timeFrame: Weekly for two years
Secondary outcomes:
measure: Change in permethrin metabolite levels after 3 weeks
timeFrame: Enrollment to 3 weeks after study initiation
measure: Change in permethrin metabolite levels after 1 year
timeFrame: Enrollment to end of study year 1
measure: Change in concentration of permethrin in clothing after 1 year
timeFrame: Enrollment to end of study year 1
measure: Change in concentration of permethrin in clothing after 2 years
timeFrame: Enrollment to 2 years after study initiation
measure: Change in tick repellency after 1 year
timeFrame: Enrollment to 1 year after study initiation
measure: Change in tick repellency after 2 years
timeFrame: Enrollment to 2 years after study initiation
measure: Pathogen seroconversion in study year 1
timeFrame: Enrollment to year 1
measure: Pathogen seroconversion in study year 2
timeFrame: Study year 1 to study year 2
Other outcomes:
Locations:
city: Kingston
country: United States
facility: University of Rhode Island
state: Rhode Island
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Steven R Meshnick, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: