Human papillomavirus vaccine effectiveness study among men who have sex with me
- Conditions
- HPV infection, Prevention of HPV infection among healthy participants.Therapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- CTIS2022-502224-49-00
- Lead Sponsor
- Geneeskundige En Gezondheidsdienst Amsterdam
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- 730
(Group 1, recruited at baseline) Being male and reporting sex with other men in preceding 6 months, (Group 2, recruited month 24) Being male and reporting sex with other men in the preceding 6 months, (Group 2, recruited month 24) Age 21-28 years, (Group 2, recruited month 24) Attending the Sexual Health Clinic in Amsterdam, (Group 2, recruited month 24) Accepting hypothetically prophylactic HPV vaccination, (Group 2, recruited month 24) Providing informed consent, (Group 1, recruited at baseline) Age 19-26 years, (Group 1, recruited at baseline) Attending the SHC in Amsterdam, (Group 1, recruited at baseline) Accepting prophylactic HPV vaccination, (Group 1, recruited at baseline) Planning to stay in or around Amsterdam over the next two years, (Group 1, recruited at baseline) Willing and able to return for 1 subsequent visit for vaccination, (Group 1, recruited at baseline) Willing and able to complete an online questionnaire at month 15, (Group 1, recruited at baseline) Willing and able to return for a month 24 final study visit, (Group 1, recruited at baseline) Providing informed consent
(Group 1 & 2) Having been vaccinated with one or more doses of any of the HPV vaccines, (Group 1 & 2) Not able to read/understand Dutch or English, (Group 1 & 2) Previous enrolment in the study, (Group 1 & 2) History of anal cancer or anal intraepithelial neoplasia (AIN), (Group 1 & 2) Unlikely to adhere to the study protocol, (Group 1 & 2) Allergy to one or more components of the vaccine
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method