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

Tracking Information
First Received Date ^ICMJE	January 25, 2010
Last Updated Date	February 3, 2010
Start Date ^ICMJE	January 2006
Primary Completion Date	December 2008 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: January 25, 2010)	Reduction of unprotected casual sex during the trip [ Time Frame: 10 days after returning from abroad ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01056536 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Efficacy of a Brief Intervention and/or Distribution of Free Condoms During Pre-travel Consultation on Sexual Behaviour Abroad
Official Title ^ICMJE	Efficacy of a Brief Intervention and/or Distribution of Free Condoms During Pre-travel Consultation on Sexual Behaviour Abroad: a Randomized Controlled Trial
Brief 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.
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.
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Condition ^ICMJE	Sexually Transmitted Infections
Intervention ^ICMJE	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.
Study Arm (s)	Experimental: Structured intervention + free condoms The subjects will receive a structured intervention on STI's and will be offered free condoms Intervention: Behavioral: Structured intervention for the prevention of sexually transmitted infections (STI) Active Comparator: Free condoms Subjects will be offered free condoms at the end of the pre-travel consultation Intervention: Behavioral: Structured intervention for the prevention of sexually transmitted infections (STI) No Intervention: No intervention The topic of STI's will not be actively discussed during the pretravel consultation Intervention: Behavioral: Structured intervention for the prevention of sexually transmitted infections (STI)
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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Enrollment ^ICMJE	1000
Estimated Completion Date	July 2010
Primary Completion Date	December 2008 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Age: 18 - 40 years Travelling without the regular partner Exclusion Criteria: Refusal of patient to participate
Gender	Both
Ages	18 Years to 40 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Switzerland

Administrative Information
NCT Number ^ICMJE	NCT01056536
Other Study ID Numbers ^ICMJE	MST
Has Data Monitoring Committee	No
Responsible Party	de Valliere Serge,MD, Travel Clinic, Medical Outpatient Department, University Hospital of Lausanne
Study Sponsor ^ICMJE	University of Lausanne Hospitals
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	University of Lausanne Hospitals
Verification Date	January 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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