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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Serge de Valliere, University of Lausanne Hospitals
ClinicalTrials.gov Identifier:
NCT01056536
First received: January 25, 2010
Last updated: August 20, 2014
Last verified: August 2014

January 25, 2010
August 20, 2014
January 2006
December 2008   (final data collection date for primary outcome measure)
Reduction of unprotected casual sex during the trip [ Time Frame: 10 days after returning from abroad ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01056536 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Efficacy of a Brief Intervention and/or Distribution of Free Condoms During Pre-travel Consultation on Sexual Behaviour Abroad
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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Sexually Transmitted Infections
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.
  • 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
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1000
November 2011
December 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Refusal of patient to participate
Both
18 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT01056536
MST
No
Serge de Valliere, University of Lausanne Hospitals
University of Lausanne Hospitals
Not Provided
Not Provided
University of Lausanne Hospitals
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP