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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Structured intervention + free condoms | Experimental | The subjects will receive a structured intervention on STI's and will be offered free condoms |
|
| Free condoms | Active Comparator | Subjects 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Structured intervention for the prevention of sexually transmitted infections (STI). | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Who Had New Sexual Relationships | 10 days after returning from abroad |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Who Used Condoms Inconsistently | 10 days after returning from abroad |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Travel Clinic, Medical Outpatient Department, University of Lausanne | Lausanne | Canton of Vaud | 1011 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22044609 | Derived | 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. |
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The study was proposed to 5148 eligible travelers. 1681 travelers accepted to complete the pre-travel questionnaire. 1115 travelers completed the post-travel questionnaire.
Study participants were recruited between January 2006 and December 2008.The study was proposed by the administrative staff in the waiting room of the travel clinic.
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| ID | Title | Description |
|---|---|---|
| FG000 | Structured Intervention + Free Condoms | The subjects will receive a structured intervention on STI's and will be offered free condoms 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. |
| FG001 | Free Condoms | Subjects will be offered free condoms at the end of the pre-travel consultation 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. |
| FG002 | No Intervention | The topic of STI's will not be actively discussed during the pretravel consultation |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Structured Intervention + Free Condoms | The subjects will receive a structured intervention on STI's and will be offered free condoms 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Subjects Who Had New Sexual Relationships | Posted | Count of Participants | Participants | 10 days after returning from abroad |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Structured Intervention + Free Condoms | The subjects will receive a structured intervention on STI's and will be offered free condoms 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Serge de Vallière | Travel Clinic, Department of Ambulatory Care and Community Medicine, University Hospital of Lausanne | +41 79 556 43 12 | serge.de-valliere@unisante.ch |
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| ID | Term |
|---|---|
| D012749 | Sexually Transmitted Diseases |
| ID | Term |
|---|---|
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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|
| Free condoms | Device | Subjects will be proposed free condoms at the end of the pre-travel consultation. |
|
| BG001 | Free Condoms | Subjects will be offered free condoms at the end of the pre-travel consultation 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. |
| BG002 | No Intervention | The topic of STI's will not be actively discussed during the pretravel consultation |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | No Intervention | The topic of STI's will not be actively discussed during the pretravel consultation |
|
|
| Secondary | Number of Subjects Who Used Condoms Inconsistently | Posted | Count of Participants | Participants | 10 days after returning from abroad |
|
|
|
| 0 |
| 394 |
| 0 |
| 394 |
| EG001 | Free Condoms | Subjects will be offered free condoms at the end of the pre-travel consultation 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. | 0 | 240 | 0 | 240 |
| EG002 | No Intervention | The topic of STI's will not be actively discussed during the pretravel consultation | 0 | 481 | 0 | 481 |
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| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|