NCT01056536

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,681

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

January 25, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 26, 2010

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
8.4 years until next milestone

Results Posted

Study results publicly available

March 24, 2020

Completed
Last Updated

March 24, 2020

Status Verified

March 1, 2020

Enrollment Period

2.9 years

First QC Date

January 25, 2010

Results QC Date

February 18, 2020

Last Update Submit

March 23, 2020

Conditions

Keywords

Travelcasual sexual relationshipscondomsStructured intervention

Outcome Measures

Primary Outcomes (1)

  • Number of Subjects Who Had New Sexual Relationships

    10 days after returning from abroad

Secondary Outcomes (1)

  • Number of Subjects Who Used Condoms Inconsistently

    10 days after returning from abroad

Study Arms (3)

Structured intervention + free condoms

EXPERIMENTAL

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).Device: Free condoms

Free condoms

ACTIVE COMPARATOR

Subjects will be offered free condoms at the end of the pre-travel consultation

Device: Free condoms

No intervention

NO INTERVENTION

The topic of STI's will not be actively discussed during the pretravel consultation

Interventions

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.

Structured intervention + free condoms

Subjects will be proposed free condoms at the end of the pre-travel consultation.

Free condomsStructured intervention + free condoms

Eligibility Criteria

Age18 Years - 44 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Refusal of patient to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Travel Clinic, Medical Outpatient Department, University of Lausanne

Lausanne, Canton of Vaud, 1011, Switzerland

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Sexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Communicable DiseasesInfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Dr Serge de Vallière
Organization
Travel Clinic, Department of Ambulatory Care and Community Medicine, University Hospital of Lausanne

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant

Study Record Dates

First Submitted

January 25, 2010

First Posted

January 26, 2010

Study Start

January 1, 2006

Primary Completion

December 1, 2008

Study Completion

November 1, 2011

Last Updated

March 24, 2020

Results First Posted

March 24, 2020

Record last verified: 2020-03

Locations