Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Risk Assessment of Long-Haul Truck Drivers

This study has been completed.
Sponsor:
Collaborators:
University of Alabama at Birmingham
Information provided by (Responsible Party):
Laura H. Bachmann, Wake Forest School of Medicine
ClinicalTrials.gov Identifier:
NCT00381992
First received: September 26, 2006
Last updated: December 8, 2014
Last verified: December 2014
  Purpose

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.


Condition
Gonorrhea
Chlamydia Infections
Hepatitis B
Hepatitis C
Diabetes Mellitus
Hypertension
Obesity
HIV Infections
Hyperlipidemia

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Risk Assessment of Long-Haul Truck Drivers

Resource links provided by NLM:


Further study details as provided by Wake Forest School of Medicine:

Primary Outcome Measures:
  • The prevalence of hepatitis B, hepatitis C, hypertension, hyperlipidemia, diabetes and obesity, HIV, N. gonorrhoeae, and C. trachomatis [ Time Frame: Cross-sectional ] [ Designated as safety issue: No ]

Enrollment: 294
Study Start Date: September 2005
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

American long-haul truck drivers affiliated with participating companies or presenting as clients at participating truck stops.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00381992

Locations
United States, North Carolina
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest School of Medicine
University of Alabama at Birmingham
Investigators
Principal Investigator: Laura H Bachmann, MD, MPH Wake Forest School of Medicine
  More Information

Publications:
Responsible Party: Laura H. Bachmann, Professor of Medicine, Wake Forest School of Medicine
ClinicalTrials.gov Identifier: NCT00381992     History of Changes
Other Study ID Numbers: F060815005, 5R34MH073411-03
Study First Received: September 26, 2006
Last Updated: December 8, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Wake Forest School of Medicine:
sexual risk behavior
diabetes mellitus
hypertension
obesity
human immunodeficiency virus
hyperlipidemia
chlamydia

Additional relevant MeSH terms:
Chlamydia Infections
Diabetes Mellitus
Hepatitis
Hyperlipidemias
Hypertension
Bacterial Infections
Cardiovascular Diseases
Chlamydiaceae Infections
Digestive System Diseases
Dyslipidemias
Endocrine System Diseases
Genital Diseases, Female
Genital Diseases, Male
Glucose Metabolism Disorders
Gram-Negative Bacterial Infections
Infection
Lipid Metabolism Disorders
Liver Diseases
Metabolic Diseases
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Bacterial
Vascular Diseases

ClinicalTrials.gov processed this record on March 02, 2015