Clinical trial NCT00381992: Risk Assessment of Long-Haul Truck Drivers
Official title: Risk Assessment of Long-Haul Truck Drivers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gonorrhea
Chlamydia Infections
Hepatitis B
Hepatitis C
Diabetes Mellitus
Hypertension
Obesity
HIV Infections
Hyperlipidemia
Keywords: sexual risk behavior
diabetes mellitus
hypertension
obesity
human immunodeficiency virus
hyperlipidemia
chlamydia
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: University of Alabama at Birmingham
First posted: 2006-09-28
Enrollment: 294
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: American long-haul truck drivers affiliated with participating companies or presenting as clients at participating truck stops.

Brief 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.

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: The prevalence of hepatitis B, hepatitis C, hypertension, hyperlipidemia, diabetes and obesity, HIV, N. gonorrhoeae, and C. trachomatis
timeFrame: Cross-sectional
Secondary outcomes:
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Laura H Bachmann, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1080/13691050701582936.