GonorrheaNCT00381992
Risk Assessment of Long-Haul Truck Drivers
An observational study of Gonorrhea and Chlamydia Infections, run by Wake Forest University Health Sciences at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gonorrhea, Chlamydia Infections, Hepatitis B
- How many people
- 294 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2005to Mar 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: American long-haul truck drivers affiliated with participating companies or presenting as clients at participating truck stops.
Who may be able to join
- Long-haul truck driver as defined as a driver, part-time or full-time, who drives a truck across state lines (interstate)
- English speaking
- Age 21 or greater
- Willing to participate
- Able to provide written informed consent
Who cannot join
- Does not fit definition of truck driver in inclusion criteria #1
- Unwilling to participate
- Unwilling or unable to provide informed consent
- Unable to understand or speak English
- Age < 21 years
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
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.
Read the 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
- Conditions
- Gonorrhea, Chlamydia Infections, Hepatitis B, Hepatitis C, Diabetes Mellitus, Hypertension
- Keywords
- sexual risk behavior, diabetes mellitus, hypertension, obesity, human immunodeficiency virus, hyperlipidemia, chlamydia
- Medical subject headings
- Gonorrhea, Chlamydia Infections, Hepatitis B, Hepatitis C, Diabetes Mellitus, Hypertension, Obesity, HIV Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
The prevalence of hepatitis B, hepatitis C, hypertension, hyperlipidemia, diabetes and obesity, HIV, N. gonorrhoeae, and C. trachomatis
Measured: Cross-sectional
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2006 (estimated)
- Study startSep 2005
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GonorrheaStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 294 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laura H Bachmann, MD, MPH, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00381992
- Sponsor's protocol ID
- F060815005
- Other IDs
- 5R34MH073411-03
- Status last verified
- Dec 2014
- First submitted
- 26 Sep 2006
- Last updated
- 7 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 18038280
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Assessment of Long-Haul Truck Drivers
- ClinicalTrials.gov ID
- NCT00381992
- Acronym / sponsor ID
- F060815005
- Conditions
- Gonorrhea, Chlamydia Infections, Hepatitis B, Hepatitis C, Diabetes Mellitus, Hypertension
- Keywords
- sexual risk behavior, diabetes mellitus, hypertension, obesity, human immunodeficiency virus, hyperlipidemia, chlamydia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 294 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), University of Alabama at Birmingham
- Study start
- Sep 2005
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 28 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- American long-haul truck drivers affiliated with participating companies or presenting as clients at participating truck stops.
Key inclusion criteria (5 listed)
- Long-haul truck driver as defined as a driver, part-time or full-time, who drives a truck across state lines (interstate)
- English speaking
- Age 21 or greater
- Willing to participate
- Able to provide written informed consent
Key exclusion criteria (5 listed)
- Does not fit definition of truck driver in inclusion criteria #1
- Unwilling to participate
- Unwilling or unable to provide informed consent
- Unable to understand or speak English
- Age < 21 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The prevalence of hepatitis B, hepatitis C, hypertension, hyperlipidemia, diabetes and obesity, HIV, N. gonorrhoeae, and C. trachomatis
Time frame: Cross-sectional
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2017.
- Results publication: PubMed 18038280Lichtenstein 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura H Bachmann, MD, MPH principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gonorrhea and Chlamydia Infections, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The prevalence of hepatitis B, hepatitis C, hypertension, hyperlipidemia, diabetes and obesity, HIV, N. gonorrhoeae, and C. trachomatis (time frame: Cross-sectional). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00381992, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2017.