Brief Intervention and/or Distribution of Free Condoms for Travelers

March 23, 2020 updated by: Serge de Valliere, University of Lausanne Hospitals

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1681

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • Vaud
      • Lausanne, Vaud, Switzerland, 1011
        • Travel Clinic, Medical Outpatient Department, University of Lausanne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 44 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age: 18 - 44 years
  • Travelling without the regular partner

Exclusion Criteria:

  • Refusal of patient to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Device: Free condoms
Subjects will be proposed free condoms at the end of the pre-travel consultation.
Active Comparator: Free condoms
Subjects will be offered free condoms at the end of the pre-travel consultation
Device: Free condoms
Subjects will be proposed 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Subjects Who Had New Sexual Relationships
Time Frame: 10 days after returning from abroad
10 days after returning from abroad

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of Subjects Who Used Condoms Inconsistently
Time Frame: 10 days after returning from abroad
10 days after returning from abroad

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Lausanne Hospitals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

November 1, 2011

Study Registration Dates

First Submitted

January 25, 2010

First Submitted That Met QC Criteria

January 25, 2010

First Posted (Estimate)

January 26, 2010

Study Record Updates

Last Update Posted (Actual)

March 24, 2020

Last Update Submitted That Met QC Criteria

March 23, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MST

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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