Clinical trial NCT00786760: Natural History of HPV Infection in Men: The HIM Study
Official title: Natural History of HPV Infection in Men: The HIM Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Human Papillomavirus
Keywords: HPV
Papillomavirus
Infection
Sexually transmitted disease
STD
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2008-11-06
Enrollment: 1431
Sex: MALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 1. Men ages 18-44; a pilot study group, ages 45-70;
2. residents of 3 sites - southern Florida, US, Sao Paulo, Brazil, or state of Morelos, Mexico
3. report no prior diagnosis of penile or anal cancers
4. have never been diagnosed with genital and anal warts
5. have not participated in a HPV vaccine study
6. report no prior diagnosis with acquired immune deficiency syndrome (AIDS) or human immunodeficiency virus (HIV)
7. report no current penile discharge or burning during urination
8. are not currently being treated for a sexually transmitted disease
9. have not been imprisoned or homeless during the last 6 months
10. have not been in drug treatment during the last 6 months
11. no plan to relocate in the next 4 years
12. willing to comply with 10 scheduled visits every 6 months for 4 years

Brief summary: The purpose of this study is to learn about the natural history of Human Papillomavirus (HPV) infection in men. The study will also find out what factors are linked to HPV in men including other sexually transmitted diseases (STDs). If participants test positive for syphilis, gonorrhea or chlamydia, we are required by law to report the results to the Florida Department of Health. Participants will be able to get free medical treatment from the Florida Department of Health for these STDs. Participants will be given a written report of the results of the STD testing.

Detailed description: The study protocol will include a pre-enrollment run-in visit, a baseline visit (enrollment), and 8 additional visits after enrollment scheduled 6 months apart. Intervals of every 6 months were chosen to insure that both acquisition and loss of infections may be assessed, as studies in women indicate that median duration of oncogenic infections ranges between 7-9 months. Informed consent will occur during the run-in visit. The run-in and follow-up visits will include questionnaire administration, visual inspection of the skin and external genitalia, and the collection of urine, blood, oral cells, and penile skin samples If anogenital lesions are present at any of the clinic visits, they will be sampled as well.

Eligibility criteria: Inclusion Criteria:

* Men between 18 and 70 years of age, living in Southern Florida, US; Sao Paulo, Brazil; or state of Morelos, Mexico.
* Participant has never been told that they have penile or anal cancer or genital warts.
* Willing to attend scheduled visits every 6 months in the next 4 years.

Exclusion Criteria:

* Prospective participants with symptoms of any STD (excluding HPV) during screening will not be eligible to participate in the study until the STD (Sexually Transmitted Disease) infection is gone.

Primary outcomes:
measure: Cohort Selection
timeFrame: 3 years, 3 months
Secondary outcomes:
measure: Incidence Rates of Specific HPV Type Infection
timeFrame: 4 years per participant
Other outcomes:
Locations:
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center and Research Institute, Inc.
state: Florida
Study officials:
affiliation: H. Lee Moffitt Cancer Center and Research Institute, Inc.
name: Anna Giuliano, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: