Trial Outcomes & Findings for Human Papillomavirus (HPV) Infection in Young Men Who Have Sex With Men (NCT NCT01422356)
NCT ID: NCT01422356
Last Updated: 2014-02-10
Results Overview
Prevalence of anal HPV of any type at baseline
Recruitment status
COMPLETED
Target enrollment
200 participants
Primary outcome timeframe
Baseline
Results posted on
2014-02-10
Participant Flow
Two hundred males aged 16 to 20 years were recruited into the study. Men were seen at 0, 3, 6 and 12 months.
Participant milestones
| Measure |
12 Month Cohort
16-20 year old males
|
|---|---|
|
Overall Study
STARTED
|
200
|
|
Overall Study
COMPLETED
|
169
|
|
Overall Study
NOT COMPLETED
|
31
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Human Papillomavirus (HPV) Infection in Young Men Who Have Sex With Men
Baseline characteristics by cohort
| Measure |
12 Month Cohort
n=200 Participants
|
|---|---|
|
Age, Continuous
|
19 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
200 Participants
n=93 Participants
|
|
Region of Enrollment
Australia
|
200 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: Number of men at baseline visit
Prevalence of anal HPV of any type at baseline
Outcome measures
| Measure |
Baseline Prevalence
n=200 Participants
|
|---|---|
|
HPV Prevalence
|
61 participants
|
Adverse Events
12 Month Cohort
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
Associate Professor Marcus Chen
Melbourne Sexual Health Centre, Alfred Health
Phone: +61 3 9341 6260
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60