Sexually Transmitted Infections
Conditions
Keywords
Travel, casual sexual relationships, condoms, Structured intervention
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.
Interventions
BEHAVIORALStructured 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.
DEVICEFree condoms
Subjects will be proposed free condoms at the end of the pre-travel consultation.
Sponsors
University of Lausanne Hospitals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 44 Years
Healthy volunteers
Yes
Inclusion criteria
* Age: 18 - 44 years * Travelling without the regular partner
Exclusion criteria
* Refusal of patient to participate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Subjects Who Had New Sexual Relationships | 10 days after returning from abroad |
Secondary
| Measure | Time frame |
|---|---|
| Number of Subjects Who Used Condoms Inconsistently | 10 days after returning from abroad |
Countries
Switzerland
Participant flow
Recruitment details
Study participants were recruited between January 2006 and December 2008.The study was proposed by the administrative staff in the waiting room of the travel clinic.
Pre-assignment details
The study was proposed to 5148 eligible travelers. 1681 travelers accepted to complete the pre-travel questionnaire. 1115 travelers completed the post-travel questionnaire.
Participants by arm
| Arm | Count |
|---|---|
| Structured Intervention + Free Condoms The subjects will receive a structured intervention on STI's and will be offered free condoms
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. | 394 |
| Free Condoms Subjects will be offered free condoms at the end of the pre-travel consultation
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. | 240 |
| No Intervention The topic of STI's will not be actively discussed during the pretravel consultation | 481 |
| Total | 1,115 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 202 | 116 | 248 |
Baseline characteristics
| Characteristic | Total | Free Condoms | No Intervention | Structured Intervention + Free Condoms |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1115 Participants | 240 Participants | 481 Participants | 394 Participants |
| Race and Ethnicity Not Collected | 0 Participants | — | — | — |
| Region of Enrollment Switzerland | 1115 participants | 240 participants | 481 participants | 394 participants |
| Sex: Female, Male Female | 585 Participants | 113 Participants | 262 Participants | 210 Participants |
| Sex: Female, Male Male | 530 Participants | 127 Participants | 219 Participants | 184 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 394 | 0 / 240 | 0 / 481 |
| serious Total, serious adverse events | 0 / 394 | 0 / 240 | 0 / 481 |
Outcome results
Primary
Number of Subjects Who Had New Sexual Relationships
Time frame: 10 days after returning from abroad
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Structured Intervention + Free Condoms | Number of Subjects Who Had New Sexual Relationships | 56 Participants |
| Free Condoms | Number of Subjects Who Had New Sexual Relationships | 37 Participants |
| No Intervention | Number of Subjects Who Had New Sexual Relationships | 61 Participants |
Secondary
Number of Subjects Who Used Condoms Inconsistently
Time frame: 10 days after returning from abroad
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Structured Intervention + Free Condoms | Number of Subjects Who Used Condoms Inconsistently | 11 Participants |
| Free Condoms | Number of Subjects Who Used Condoms Inconsistently | 10 Participants |
| No Intervention | Number of Subjects Who Used Condoms Inconsistently | 14 Participants |