Trial Outcomes & Findings for Brief Intervention and/or Distribution of Free Condoms for Travelers (NCT NCT01056536)
NCT ID: NCT01056536
Last Updated: 2020-03-24
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1681 participants
Primary outcome timeframe
10 days after returning from abroad
Results posted on
2020-03-24
Participant Flow
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.
The study was proposed to 5148 eligible travelers. 1681 travelers accepted to complete the pre-travel questionnaire. 1115 travelers completed the post-travel questionnaire.
Participant milestones
| Measure |
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.
|
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.
|
No Intervention
The topic of STI's will not be actively discussed during the pretravel consultation
|
|---|---|---|---|
|
Overall Study
STARTED
|
596
|
356
|
729
|
|
Overall Study
COMPLETED
|
394
|
240
|
481
|
|
Overall Study
NOT COMPLETED
|
202
|
116
|
248
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
No Intervention
The topic of STI's will not be actively discussed during the pretravel consultation
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
202
|
116
|
248
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Structured Intervention + Free Condoms
n=394 Participants
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.
|
Free Condoms
n=240 Participants
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.
|
No Intervention
n=481 Participants
The topic of STI's will not be actively discussed during the pretravel consultation
|
Total
n=1115 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=394 Participants
|
0 Participants
n=240 Participants
|
0 Participants
n=481 Participants
|
0 Participants
n=1115 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
394 Participants
n=394 Participants
|
240 Participants
n=240 Participants
|
481 Participants
n=481 Participants
|
1115 Participants
n=1115 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=394 Participants
|
0 Participants
n=240 Participants
|
0 Participants
n=481 Participants
|
0 Participants
n=1115 Participants
|
|
Sex: Female, Male
Female
|
210 Participants
n=394 Participants
|
113 Participants
n=240 Participants
|
262 Participants
n=481 Participants
|
585 Participants
n=1115 Participants
|
|
Sex: Female, Male
Male
|
184 Participants
n=394 Participants
|
127 Participants
n=240 Participants
|
219 Participants
n=481 Participants
|
530 Participants
n=1115 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Switzerland
|
394 participants
n=394 Participants
|
240 participants
n=240 Participants
|
481 participants
n=481 Participants
|
1115 participants
n=1115 Participants
|
PRIMARY outcome
Timeframe: 10 days after returning from abroadOutcome measures
| Measure |
Structured Intervention + Free Condoms
n=394 Participants
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.
|
Free Condoms
n=240 Participants
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.
|
No Intervention
n=481 Participants
The topic of STI's will not be actively discussed during the pretravel consultation
|
|---|---|---|---|
|
Number of Subjects Who Had New Sexual Relationships
|
56 Participants
|
37 Participants
|
61 Participants
|
SECONDARY outcome
Timeframe: 10 days after returning from abroadOutcome measures
| Measure |
Structured Intervention + Free Condoms
n=394 Participants
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.
|
Free Condoms
n=240 Participants
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.
|
No Intervention
n=481 Participants
The topic of STI's will not be actively discussed during the pretravel consultation
|
|---|---|---|---|
|
Number of Subjects Who Used Condoms Inconsistently
|
11 Participants
|
10 Participants
|
14 Participants
|
Adverse Events
Structured Intervention + Free Condoms
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Free Condoms
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
No Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr Serge de Vallière
Travel Clinic, Department of Ambulatory Care and Community Medicine, University Hospital of Lausanne
Phone: +41 79 556 43 12
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place