Tick-borne Illness and Clothing Study (TICS)

March 9, 2021 updated by: University of North Carolina, Chapel Hill

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

159

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Gillings School of Global Public Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Insect Shield
No Intervention: Placebo
Uniforms sent to Insect Shield, washed and refolded (no permethrin applied).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Work Related Tick Bites
Time Frame: Weekly for two years
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
Time Frame: Upon enrollment, after the first year, and after the second year
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Carolina, Chapel Hill

Collaborators

North Carolina State University

Investigators

  • Principal Investigator: Steven R Meshnick, MD, PhD, University of North Carolina, Chapel Hill

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

October 10, 2011

First Submitted That Met QC Criteria

October 15, 2011

First Posted (Estimate)

October 19, 2011

Study Record Updates

Last Update Posted (Actual)

March 30, 2021

Last Update Submitted That Met QC Criteria

March 9, 2021

Last Verified

May 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10-1027

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Tick Bites

Clinical Trials on Permethrin Impregnated Uniforms

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Congo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe