Back to resultsBrief Intervention and/or Distribution of Free Condoms for Travelers
Primary Purpose
Sexually Transmitted Infections
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Structured intervention for the prevention of sexually transmitted infections (STI).
Free condoms
Sponsored by
About this trial
This is an interventional prevention trial for Sexually Transmitted Infections focused on measuring Travel, casual sexual relationships, condoms, Structured intervention
Eligibility Criteria
Inclusion Criteria:
- Age: 18 - 44 years
- Travelling without the regular partner
Exclusion Criteria:
- Refusal of patient to participate
Sites / Locations
- Travel Clinic, Medical Outpatient Department, University of Lausanne
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
No Intervention
Arm Label
Structured intervention + free condoms
Free condoms
No intervention
Arm Description
The subjects will receive a structured intervention on STI's and will be offered free condoms
Subjects will be offered free condoms at the end of the pre-travel consultation
The topic of STI's will not be actively discussed during the pretravel consultation
Outcomes
Primary Outcome Measures
Number of Subjects Who Had New Sexual Relationships
Secondary Outcome Measures
Number of Subjects Who Used Condoms Inconsistently
Full Information
NCT ID
NCT01056536
First Posted
January 25, 2010
Last Updated
March 23, 2020
Sponsor
University of Lausanne Hospitals
1. Study Identification
Unique Protocol Identification Number
NCT01056536
Brief Title
Brief Intervention and/or Distribution of Free Condoms for Travelers
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
November 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Lausanne Hospitals
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 - 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sexually Transmitted Infections
Keywords
Travel, casual sexual relationships, condoms, Structured intervention
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1681 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Structured intervention + free condoms
Arm Type
Experimental
Arm Description
The subjects will receive a structured intervention on STI's and will be offered free condoms
Arm Title
Free condoms
Arm Type
Active Comparator
Arm Description
Subjects will be offered free condoms at the end of the pre-travel consultation
Arm Title
No intervention
Arm Type
No Intervention
Arm Description
The topic of STI's will not be actively discussed during the pretravel consultation
Intervention Type
Behavioral
Intervention Name(s)
Structured intervention for the prevention of sexually transmitted infections (STI).
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Free condoms
Intervention Description
Subjects will be proposed free condoms at the end of the pre-travel consultation.
Primary Outcome Measure Information:
Title
Number of Subjects Who Had New Sexual Relationships
Time Frame
10 days after returning from abroad
Secondary Outcome Measure Information:
Title
Number of Subjects Who Used Condoms Inconsistently
Time Frame
10 days after returning from abroad
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
44 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age: 18 - 44 years
Travelling without the regular partner
Exclusion Criteria:
Refusal of patient to participate
Facility Information:
Facility Name
Travel Clinic, Medical Outpatient Department, University of Lausanne
City
Lausanne
State/Province
Vaud
ZIP/Postal Code
1011
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
22044609
Citation
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.
Results Reference
derived
Learn more about this trial
Brief Intervention and/or Distribution of Free Condoms for Travelers
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