NCT01454414

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
159

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

October 10, 2011

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 19, 2011

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

June 30, 2014

Completed
Last Updated

March 30, 2021

Status Verified

May 1, 2014

Enrollment Period

2 years

First QC Date

October 10, 2011

Results QC Date

April 25, 2014

Last Update Submit

March 9, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Work Related Tick Bites

    Tick bites are defined as ticks attached to or embedded in the skin

    Weekly for two years

Secondary Outcomes (1)

  • Seroconversion Against a Tick-borne Illness

    Upon enrollment, after the first year, and after the second year

Study Arms (2)

Permethrin Impregnated Uniforms

EXPERIMENTAL

Uniforms (including pants, shorts, shirts, socks, and hats) treated with long-lasting permethrin.

Other: Permethrin Impregnated Uniforms

Placebo

NO INTERVENTION

Uniforms sent to Insect Shield, washed and refolded (no permethrin applied).

Interventions

Uniforms treated with permethrin according to proprietary process used by Insect Shield, Inc.

Also known as: Insect Shield
Permethrin Impregnated Uniforms

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Pregnancy
  • Non-English speaking
  • Known allergy to insecticides

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gillings School of Global Public Health

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Tick Bites

Condition Hierarchy (Ancestors)

Bites and StingsPoisoningChemically-Induced DisordersWounds and Injuries

Results Point of Contact

Title
Dr. Meagan Vaughn
Organization
University of North Carolina at Chapel Hill

Study Officials

  • Steven R Meshnick, MD, PhD

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 10, 2011

First Posted

October 19, 2011

Study Start

October 1, 2010

Primary Completion

October 1, 2012

Study Completion

April 1, 2013

Last Updated

March 30, 2021

Results First Posted

June 30, 2014

Record last verified: 2014-05

Locations