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Efficacy of a Brief Intervention and/or Distribution of Free Condoms During Pre-travel Consultation on Sexual Behaviour Abroad

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by University of Lausanne Hospitals.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University of Lausanne Hospitals
ClinicalTrials.gov Identifier:
NCT01056536
First received: January 25, 2010
Last updated: February 3, 2010
Last verified: January 2010
History of Changes
  Purpose

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.


Condition Intervention
Sexually Transmitted Infections
 Behavioral: Structured intervention for the prevention of sexually transmitted infections (STI)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Lausanne Hospitals:

Primary Outcome Measures:
  • Reduction of unprotected casual sex during the trip [ Time Frame: 10 days after returning from abroad ] [ Designated as safety issue: No ]

Enrollment: 1000
Study Start Date: January 2006
Estimated Study Completion Date: July 2010
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Structured intervention + free condoms
The subjects will receive a structured intervention on STI's and will be offered free condoms
 Behavioral: 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.
Active Comparator: Free condoms
Subjects will be offered free condoms at the end of the pre-travel consultation
 Behavioral: 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.
No Intervention: No intervention
The topic of STI's will not be actively discussed during the pretravel consultation
 Behavioral: 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.

Detailed Description:

All persons aged 18 - 45 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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age: 18 - 40 years
  • Travelling without the regular partner

Exclusion Criteria:

  • Refusal of patient to participate
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01056536

Locations
Switzerland
Travel Clinic, Medical Outpatient Department, University of Lausanne
Lausanne, Vaud, Switzerland, 1011
Sponsors and Collaborators
University of Lausanne Hospitals
  More Information

No publications provided by University of Lausanne Hospitals

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: de Valliere Serge,MD, Travel Clinic, Medical Outpatient Department, University Hospital of Lausanne
ClinicalTrials.gov Identifier: NCT01056536     History of Changes
Other Study ID Numbers: MST
Study First Received: January 25, 2010
Last Updated: February 3, 2010
Health Authority: Switzerland: Ethikkommission

Keywords provided by University of Lausanne Hospitals:
Travel
casual sexual relationships
condoms
Structured intervention

Additional relevant MeSH terms:
Sexually Transmitted Diseases
Infection
Virus Diseases
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on May 21, 2013