Sexually Transmitted InfectionsNCT01056536
Brief Intervention and/or Distribution of Free Condoms for Travelers
A study testing Structured intervention for the prevention of sexually transmitted infections (STI). and Free condoms in people with Sexually Transmitted Infections, run by University of Lausanne Hospitals at 1 site in Switzerland.
Trial summary
The objective of this study is to assess the impact of a structured intervention and/or free distribution of condoms during the pre-travel consultation on sexual risk behavior of young persons traveling alone. Read more about this study
- Who is it for?
- Ages 18 to 44 yearsHealthy volunteers can take part
- Conditions the study is for
- Sexually Transmitted Infections
- What is being tested?
- Structured intervention for the prevention of sexually transmitted infections (STI). and Free condoms
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,681 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2006to Nov 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 44 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age: 18 - 44 years
- Travelling without the regular partner
Who cannot join
- Refusal of patient to participate
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Travel Clinic, Medical Outpatient Department, University of Lausanne
Lausanne, Canton of Vaud, 1011
About this study
Official title: Efficacy of a Brief Intervention and/or Distribution of Free Condoms During Pre-travel Consultation on Sexual Behaviour Abroad: a Randomized Controlled Trial
The objective of this study is to assess the impact of a structured intervention and/or free distribution of condoms during the pre-travel consultation on sexual risk behavior of young persons traveling alone.
Read the detailed description
All persons aged 18 - 44 years planning to travel alone and attending the travel clinic of the Medical Outpatient Clinic in Lausanne will be asked to participate. The subjects will be randomized into three groups: 1. no intervention, 2. free condoms without further explanations, 3. a structured intervention of 5 minutes on STI risk reduction plus free condoms. The structured interventions will include information about the number of travelers engaging in new sexual relationships, the different types of STI and their prevalence in different countries and population groups. The subjects will complete a pre-travel questionnaire prior to the medical consultation. A post-travel questionnaire will be sent to them 10 days after their trip. The questionnaires will include questions on demographic characteristics, sexual habits, alcohol/tobacco/marijuana consumption and sexual relationships during the trip.
- Conditions
- Sexually Transmitted Infections
- Being tested
- Structured intervention for the prevention of sexually transmitted infections (STI)., Free condoms
- Keywords
- Travel, casual sexual relationships, condoms, Structured intervention
- Medical subject headings
- Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured intervention for the prevention of sexually transmitted infections (STI).Behavioural
The structured intervention will include information about the number of travelers engaging in new sexual relationships, the different types of STI and their prevalence in different countries and population groups. The intervention will last approximately 5 minutes. At the end of the structured intervention the subjects will be offered free condoms.
Free condomsDevice
Subjects will be proposed free condoms at the end of the pre-travel consultation.
| Study group | Role | What they receive |
|---|---|---|
| Structured intervention + free condoms | Experimental | The subjects will receive a structured intervention on STI's and will be offered free condoms Receives: Behavioral: Structured intervention for the prevention of sexually transmitted infections (STI).; Device: Free condoms |
| Free condoms | Active comparator | Subjects will be offered free condoms at the end of the pre-travel consultation Receives: Device: Free condoms |
| No intervention | No intervention | The topic of STI's will not be actively discussed during the pretravel consultation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects Who Had New Sexual Relationships
Measured: 10 days after returning from abroad
Secondary outcomes (1)
Number of Subjects Who Used Condoms Inconsistently
Measured: 10 days after returning from abroad
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2010 (estimated)
- Study startJan 2006
- Primary completionDec 2008
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sexually Transmitted InfectionsStudies of the same condition, open and under way.
- 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
- 1,681 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lausanne Hospitals
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serge de Valliere, University of Lausanne Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01056536
- Sponsor's protocol ID
- MST
- Status last verified
- Mar 2020
- First submitted
- 25 Jan 2010
- Last updated
- 24 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Senn N, de Valliere S, Berdoz D, Genton B. Motivational brief intervention for the prevention of sexually transmitted infections in travelers: a randomized controlled trial. BMC Infect Dis. 2011 Nov 1;11:300. doi: 10.1186/1471-2334-11-300.
PubMed 22044609
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Brief Intervention and/or Distribution of Free Condoms During Pre-travel Consultation on Sexual Behaviour Abroad: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01056536
- Acronym / sponsor ID
- MST
- Conditions
- Sexually Transmitted Infections
- Keywords
- Travel, casual sexual relationships, condoms, Structured intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,681 participants (actual)
- Lead sponsor
- University of Lausanne HospitalsUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Dec 2008 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 26 Jan 2010 (estimated)
- Results
- Posted 24 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to assess the impact of a structured intervention and/or free distribution of condoms during the pre-travel consultation on sexual risk behavior of young persons traveling alone.
Detailed description
All persons aged 18 - 44 years planning to travel alone and attending the travel clinic of the Medical Outpatient Clinic in Lausanne will be asked to participate. The subjects will be randomized into three groups: 1. no intervention, 2. free condoms without further explanations, 3. a structured intervention of 5 minutes on STI risk reduction plus free condoms. The structured interventions will include information about the number of travelers engaging in new sexual relationships, the different types of STI and their prevalence in different countries and population groups. The subjects will complete a pre-travel questionnaire prior to the medical consultation. A post-travel questionnaire will be sent to them 10 days after their trip. The questionnaires will include questions on demographic characteristics, sexual habits, alcohol/tobacco/marijuana consumption and sexual relationships during the trip.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Structured intervention + free condoms | Experimental | Behavioral: Structured intervention for the prevention of sexually transmitted infections (STI)., Device: Free condomsThe subjects will receive a structured intervention on STI's and will be offered free condoms |
| Free condoms | Active comparator | Device: Free condomsSubjects will be offered free condoms at the end of the pre-travel consultation |
| No intervention | No intervention | –The topic of STI's will not be actively discussed during the pretravel consultation |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age: 18 - 44 years
- Travelling without the regular partner
Key exclusion criteria (1 listed)
- Refusal of patient 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 |
|---|---|---|
| Structured intervention for the prevention of sexually transmitted infections (STI).The structured intervention will include information about the number of travelers engaging in new sexual relationships, the different types of STI and their prevalence in different countries and population groups. The intervention will last approximately 5 minutes. At the end of the structured intervention the subjects will be offered free condoms. | Behavioural | Structured intervention + free condoms |
| Free condomsSubjects will be proposed free condoms at the end of the pre-travel consultation. | Device | Free condoms, Structured intervention + free condoms |
Primary outcome
Number of Subjects Who Had New Sexual Relationships
Time frame: 10 days after returning from abroad
1 secondary outcome
Number of Subjects Who Used Condoms Inconsistently
Time frame: 10 days after returning from abroad
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22044609Senn N, de Valliere S, Berdoz D, Genton B. Motivational brief intervention for the prevention of sexually transmitted infections in travelers: a randomized controlled trial. BMC Infect Dis. 2011 Nov 1;11:300. doi: 10.1186/1471-2334-11-300.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured intervention for the prevention of sexually transmitted infections (STI). and Free condoms in people with Sexually Transmitted Infections, run by University of Lausanne Hospitals at 1 site in Switzerland.
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 2 inclusion and 1 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 24 Mar 2020. 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 Switzerland. 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?
Yes. Results are posted in the registry (first posted 24 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Subjects Who Had New Sexual Relationships (time frame: 10 days after returning from abroad). 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 NCT01056536, 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 24 Mar 2020.