Tick-borne Illness and Clothing Study (TICS)
Primary Purpose
Tick Bites, Tick-borne Illness
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Permethrin Impregnated Uniforms
Sponsored by
About this trial
This is an interventional prevention trial for Tick Bites
Eligibility Criteria
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
Sites / Locations
- Gillings School of Global Public Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Permethrin Impregnated Uniforms
Placebo
Arm Description
Uniforms (including pants, shorts, shirts, socks, and hats) treated with long-lasting permethrin.
Uniforms sent to Insect Shield, washed and refolded (no permethrin applied).
Outcomes
Primary Outcome Measures
Work Related Tick Bites
Tick bites are defined as ticks attached to or embedded in the skin
Secondary Outcome Measures
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).
Full Information
NCT ID
NCT01454414
First Posted
October 10, 2011
Last Updated
March 9, 2021
Sponsor
University of North Carolina, Chapel Hill
Collaborators
North Carolina State University
1. Study Identification
Unique Protocol Identification Number
NCT01454414
Brief Title
Tick-borne Illness and Clothing Study
Acronym
TICS
Official Title
Preventing Exposure to Ticks and Tick-borne Illness in Outdoor Workers
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
April 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
North Carolina State University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tick Bites, Tick-borne Illness
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
159 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Permethrin Impregnated Uniforms
Arm Type
Experimental
Arm Description
Uniforms (including pants, shorts, shirts, socks, and hats) treated with long-lasting permethrin.
Arm Title
Placebo
Arm Type
No Intervention
Arm Description
Uniforms sent to Insect Shield, washed and refolded (no permethrin applied).
Intervention Type
Other
Intervention Name(s)
Permethrin Impregnated Uniforms
Other Intervention Name(s)
Insect Shield
Intervention Description
Uniforms treated with permethrin according to proprietary process used by Insect Shield, Inc.
Primary Outcome Measure Information:
Title
Work Related Tick Bites
Description
Tick bites are defined as ticks attached to or embedded in the skin
Time Frame
Weekly for two years
Secondary Outcome Measure Information:
Title
Seroconversion Against a Tick-borne Illness
Description
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).
Time Frame
Upon enrollment, after the first year, and after the second year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven R Meshnick, MD, PhD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gillings School of Global Public Health
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
24745637
Citation
Vaughn MF, Funkhouser SW, Lin FC, Fine J, Juliano JJ, Apperson CS, Meshnick SR. Long-lasting permethrin impregnated uniforms: A randomized-controlled trial for tick bite prevention. Am J Prev Med. 2014 May;46(5):473-80. doi: 10.1016/j.amepre.2014.01.008.
Results Reference
result
Learn more about this trial
Tick-borne Illness and Clothing Study
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