Accidents, TrafficNCT01733537
Improving Motorcycle Taxi Driver Visibility in Tanzania
A study testing Free reflective, fluorescent vest and Education in people with Accidents, Traffic, run by Duke University at 1 site in Tanzania.
Trial summary
The purpose of this study is to determine whether providing motorcycle taxi drivers with a free reflective fluorescent vest will result in increased use of reflective or fluorescent clothing compared to education about wearing reflective or fluorescent clothing alone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Accidents, Traffic
- What is being tested?
- Free reflective, fluorescent vest and Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteTanzania
- Study dates
- Feb 2013to Jun 2013
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- motorcycle riders who identify themselves as motorcycle taxi drivers
- individuals must work at least 2 days a week as a motorcycle taxi driver
- have a telephone number for ride solicitation
- have a license plate that is able to be recorded
- are at least 18 years old
- are willing to have us contact them in the future for repeat surveys
Who cannot join
- motorcycle riders who do not meet the above criteria
- motorcycle riders who do not consent to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improving Motorcycle Taxi Driver Visibility in Tanzania-A Cluster Randomized Controlled Trial
The purpose of this study is to determine whether providing motorcycle taxi drivers with a free reflective fluorescent vest will result in increased use of reflective or fluorescent clothing compared to education about wearing reflective or fluorescent clothing alone.
Read the detailed description
Road traffic injuries are the 4th leading cause of death among individuals in the economically productive age group (age 15 to 59) in low and middle income countries. The Africa region currently has some of the world's highest traffic injury rates, with vulnerable road users, including motorcycle riders, bearing a disproportionate share of the injury burden.
Motorcycles are a rapidly growing form of transport in Africa, both for personal and commercial transportation. Conspicuity measures-factors that increase a motorcycle rider's visibility-for the prevention of motorcycle crash have been previously studied and found to be associated with a decreased risk of crash.
Motorcycle taxi drivers are a particularly high risk population for motorcycle crash as they operate a motorcycle for several hours a day. Reflective, fluorescent safety vests are a common article worn by motorcycle drivers in some locations; however, penetration of such clothing in Moshi is currently low. This study aims to increase use of reflective vests among commercial motorcycle drivers. We will test whether provision of a free reflective, fluorescent vest increases use of reflective, fluorescent clothing compared to education about wearing reflective, fluorescent clothing alone.
- Conditions
- Accidents, Traffic
- Being tested
- Free reflective, fluorescent vest, Education
- Keywords
- traffic accidents, motorcycle, injury, conspicuity
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Free reflective, fluorescent vestOther
Motorcycle taxi drivers in the intervention arm will receive a free reflective, fluorescent vest
EducationBehavioural
Both arms will receive brief, basic education about recommended measures to increase their visibility
| Study group | Role | What they receive |
|---|---|---|
| Vest and Education | Experimental | Motorcycle Taxi Drivers provided with a reflective, fluorescent vest and basic education about recommended measures to increase their visibility Receives: Other: Free reflective, fluorescent vest; Behavioral: Education |
| Education Alone | Other | Motorcycle Taxi Drivers provided with basic education about recommended measures to increase their visibility Receives: Behavioral: Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Use of reflective or fluorescent clothing
The use of reflective or fluorescent clothing will be compared between the intervention and control groups over the observation period
Measured: 3-5 months
Secondary outcomes (2)
Wearing White Helmet
The use of white helmets will be compared between the intervention and control groups over the observation period
Measured: 3-5 months
Daytime Running Headlights
The use of daytime running headlights will be compared between the intervention and control groups over the observation period
Measured: 3-5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2012 (estimated)
- Study startFeb 2013
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Accidents, TrafficStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Kilimanjaro Christian Medical Centre, Tanzania, Fogarty International Center of the National Institute of Health
- Responsible party
- Sponsor
- Investigators
- Nathan M Thielman, MD, MPH, Principal investigator, Duke UniversitySteven A Sumner, MD, Study director, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01733537
- Sponsor's protocol ID
- Pro00034415
- Other IDs
- 1R25TW009337-01
- Status last verified
- Aug 2013
- First submitted
- 21 Nov 2012
- Last updated
- 9 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Motorcycle Taxi Driver Visibility in Tanzania-A Cluster Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01733537
- Acronym / sponsor ID
- Pro00034415
- Conditions
- Accidents, Traffic
- Keywords
- traffic accidents, motorcycle, injury, conspicuity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Kilimanjaro Christian Medical Centre, Tanzania, Fogarty International Center of the National Institute of Health
- Study start
- Feb 2013
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 27 Nov 2012 (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.
The purpose of this study is to determine whether providing motorcycle taxi drivers with a free reflective fluorescent vest will result in increased use of reflective or fluorescent clothing compared to education about wearing reflective or fluorescent clothing alone.
Detailed description
Road traffic injuries are the 4th leading cause of death among individuals in the economically productive age group (age 15 to 59) in low and middle income countries. The Africa region currently has some of the world's highest traffic injury rates, with vulnerable road users, including motorcycle riders, bearing a disproportionate share of the injury burden.
Motorcycles are a rapidly growing form of transport in Africa, both for personal and commercial transportation. Conspicuity measures-factors that increase a motorcycle rider's visibility-for the prevention of motorcycle crash have been previously studied and found to be associated with a decreased risk of crash.
Motorcycle taxi drivers are a particularly high risk population for motorcycle crash as they operate a motorcycle for several hours a day. Reflective, fluorescent safety vests are a common article worn by motorcycle drivers in some locations; however, penetration of such clothing in Moshi is currently low. This study aims to increase use of reflective vests among commercial motorcycle drivers. We will test whether provision of a free reflective, fluorescent vest increases use of reflective, fluorescent clothing compared to education about wearing reflective, fluorescent clothing alone.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vest and Education | Experimental | Other: Free reflective, fluorescent vest, Behavioral: EducationMotorcycle Taxi Drivers provided with a reflective, fluorescent vest and basic education about recommended measures to increase their visibility |
| Education Alone | Other | Behavioral: EducationMotorcycle Taxi Drivers provided with basic education about recommended measures to increase their visibility |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- motorcycle riders who identify themselves as motorcycle taxi drivers
- individuals must work at least 2 days a week as a motorcycle taxi driver
- have a telephone number for ride solicitation
- have a license plate that is able to be recorded
- are at least 18 years old
Key exclusion criteria (2 listed)
- motorcycle riders who do not meet the above criteria
- motorcycle riders who do not consent to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Free reflective, fluorescent vestMotorcycle taxi drivers in the intervention arm will receive a free reflective, fluorescent vest | Other | Vest and Education |
| EducationBoth arms will receive brief, basic education about recommended measures to increase their visibility | Behavioural | Education Alone, Vest and Education |
Primary outcome
Use of reflective or fluorescent clothing
Time frame: 3-5 months
The use of reflective or fluorescent clothing will be compared between the intervention and control groups over the observation period
2 secondary outcomes
Wearing White Helmet
Time frame: 3-5 months
Daytime Running Headlights
Time frame: 3-5 months
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 9 Aug 2013.
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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.
Nathan M Thielman, MD, MPH principal investigator
Duke University
Steven A Sumner, MD study director
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Free reflective, fluorescent vest and Education in people with Accidents, Traffic, run by Duke University at 1 site in Tanzania.
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 6 inclusion and 2 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 9 Aug 2013. 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 Tanzania. 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?
Use of reflective or fluorescent clothing (time frame: 3-5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Aug 2013.