Tick-borne Illness and Clothing Study (TICS)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
|Official Title:||Preventing Exposure to Ticks and Tick-borne Illness in Outdoor Workers|
- Tick bites [ Time Frame: Weekly for two years ] [ Designated as safety issue: No ]Tick bites are defined as ticks attached to or embedded in the skin
- Seroconversion against a tick-borne illness [ Time Frame: Upon enrollment, after the first year, and after the second year ] [ Designated as safety issue: No ]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).
|Study Start Date:||October 2010|
|Study Completion Date:||April 2013|
|Primary Completion Date:||October 2012 (Final data collection date for primary outcome measure)|
Experimental: Permethrin Impregnated Uniforms
Uniforms (including pants, shorts, shirts, socks, and hats) treated with long-lasting permethrin.
Other: Permethrin Impregnated Uniforms
Uniforms treated with permethrin according to proprietary process used by Insect Shield, Inc.
Other Name: Insect Shield
No Intervention: Placebo
Uniforms sent to Insect Shield, washed and refolded (no permethrin applied).
|United States, North Carolina|
|Gillings School of Global Public Health|
|Chapel Hill, North Carolina, United States, 27599|
|Principal Investigator:||Steven R Meshnick, MD, PhD||University of North Carolina, Chapel Hill|