Tick-borne Illness and Clothing Study

Study Overview
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Brief Summary
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The high risk of acquiring tick-borne diseases by outdoor workers is well documented. Workers most at risk include, foresters, park rangers, land surveyors and other outdoor workers have frequent exposure to tick-infested habitats. Many North Carolina state employees with outdoor occupations report multiple tick bites each year, which indicates that existing tick preventive strategies may be ineffective. The principal goal of this study is to assess whether the use of long-lasting permethrin impregnated uniforms can reduce the number of tick bites sustained by North Carolina outdoor workers.

Official Title
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Preventing Exposure to Ticks and Tick-borne Illness in Outdoor Workers

Conditions
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Tick Bites, Tick-borne Illness

Intervention / Treatment
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* Other: Permethrin Impregnated Uniforms


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Being over 18 years of age Employee of NC Division of Forest Resources, the NC Division of Parks and Recreation, NC Wildlife Resources Commission, or NC County and Local Parks and Recreation who work in Central and Eastern North Carolina An average of 10 or more hours of outdoor work per week during tick season Self-reported prior work-related tick bites Exclusion Criteria: Pregnancy Non-English speaking Known allergy to insecticides

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Permethrin Impregnated Uniforms<br>Uniforms (including pants, shorts, shirts, socks, and hats) treated with long-lasting permethrin. | Other: Permethrin Impregnated Uniforms<br>* Uniforms treated with permethrin according to proprietary process used by Insect Shield, Inc.<br>* Other names: Insect Shield;|
| No Intervention: Placebo<br>Uniforms sent to Insect Shield, washed and refolded (no permethrin applied). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Work Related Tick Bites | Tick bites are defined as ticks attached to or embedded in the skin | Weekly for two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seroconversion Against a Tick-borne Illness | We will define seroconversion as one in which there is a 4-fold change in Immunoglobulin G class antibody titer between sera at enrollment, sera obtained after one year and/or sera obtained at study's end or between acute and convalescent sera for participants developing an acute illness. The antigens that will be used in the serologic assays include Ehrlichia chaffeensis (which would also detect antibodies to E. ewingii and Anaplasma phagocytophilum) and Rickettsia rickettsii (which would also detect antibodies to other spotted fever group rickettsiae). | Upon enrollment, after the first year, and after the second year |