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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00381992
Other study ID # F060815005
Secondary ID 5R34MH073411-03
Status Completed
Phase N/A
First received September 26, 2006
Last updated November 3, 2017
Start date September 2005
Est. completion date March 2010

Study information

Verified date December 2014
Source Wake Forest University Health Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

International studies have repeatedly documented a substantial prevalence of sexual risk behaviors and high rates of human immunodeficiency virus (HIV) and other sexually transmitted infections (STI) ranging from 5%-56% amongst long-distance truck drivers ("truckers") living in diverse international settings including India, Bangladesh, South Africa, China, Laos and Thailand. The prevalence of sexual risk factors and STI/HIV in US drivers is unknown. This proposal will provide both qualitative and quantitative data on HIV risk behaviors by interviewing and testing truckers working for established long-distance trucking firms, the sector which accounts for most of the jobs in the trucking and warehousing industry in the United States. The data obtained from this study will be used to inform the development of an HIV prevention intervention for long-haul truck drivers.


Description:

The study proposed in this R34 application will address the following specific aims:

Specific Aim 1. To perform focus groups and in-depth interviews with long-haul truck drivers to guide development of both a behavioral risk assessment instrument and an acceptable HIV/STI screening protocol for long-haul truckers.

Specific Aim 2. To perform in-depth interviews with trucking industry executives to determine barriers to routine HIV/STI assessment and screening of their employees.

Specific Aim 3. To perform a pilot phase with a subsample of long-haul truck drivers characterized by the following steps: TTM-based "cognitive interviews" (N=5); pilot testing of the survey and biomedical screening protocol (N=15); and a follow-up focus group (N=8)

Specific Aim 4. To assess a sample of (N=300) truck drivers for general health and sexual risk behaviors using the adapted theory-based survey and to determine the prevalence of hepatitis B, hepatitis C, hypertension, hyperlipidemia, diabetes and obesity, HIV, N. gonorrhoeae, and C. trachomatis


Recruitment information / eligibility

Status Completed
Enrollment 294
Est. completion date March 2010
Est. primary completion date March 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years and older
Eligibility Inclusion Criteria:

1. Long-haul truck driver as defined as a driver, part-time or full-time, who drives a truck across state lines (interstate)

2. English speaking

3. Age 21 or greater

4. Willing to participate

5. Able to provide written informed consent

Exclusion Criteria:

1. Does not fit definition of truck driver in inclusion criteria #1

2. Unwilling to participate

3. Unwilling or unable to provide informed consent

4. Unable to understand or speak English

5. Age < 21 years

Study Design


Locations

Country Name City State
United States Wake Forest University Health Sciences Winston-Salem North Carolina

Sponsors (3)

Lead Sponsor Collaborator
Wake Forest University Health Sciences National Institute of Mental Health (NIMH), University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

References & Publications (1)

Lichtenstein B, Hook EW 3rd, Grimley DM, St Lawrence JS, Bachmann LH. HIV risk among long-haul truckers in the USA. Cult Health Sex. 2008 Jan;10(1):43-56. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary The prevalence of hepatitis B, hepatitis C, hypertension, hyperlipidemia, diabetes and obesity, HIV, N. gonorrhoeae, and C. trachomatis Cross-sectional
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