Natural History of HPV Infection in Men: The HIM Study
Summary
Although the natural history of HPV infection in women is currently under investigation in several large cohort studies, no prospective studies of HPV infection in men who may transmit HPV to women are currently in progress. To date, only small cross-sectional studies and small prospective studies in northern Europe have been conducted among heterosexual men. To more fully understand HPV disease in both men and women, there is a need for information regarding the natural history of male HPV infection. Several important questions remain to be answered before prevention strategies, such as implementation of an HPV prevention vaccine, can be fully implemented. These questions include: types of HPV infecting men, incidence of infections, duration and persistence of infections, type-specific antibody response to HPV infections, and factors associated with incidence, persistence and HPV antibody response in men. We are performing a prospective male HPV cohort study to develop a fuller understanding of HPV infection in men. This study would be the first study of the natural history of penile HPV infection in US, Brazilian, and Mexican men.
Description
The study protocol will include a pre-enrollment run-in visit, a baseline visit (enrollment), and 8 additional visits after enrollment scheduled six months apart. Intervals of every six 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.
The HIM Study will examine the natural history of HPV infections in men: the incidence and clearance of type-specific penile HPV infections and humoral immune response to these infections. Adequate evaluation of these events requires the following critical components: 1) experience conducting international research (US, Mexico, and Brazil); 2) experience conducting HPV studies among men; 3) experience conducting prospective studies; 4) analytical experience conducting polymerase chain reaction (PCR) and HPV genotyping; and 5) experience conducting HPV antibody assessment.
Study Design
Observational Model: Ecologic or Community, Time Perspective: Prospective
Conditions
Human Papillomavirus Infection
Intervention
Cohort: 3000 men examined every 6 months for 4 years., Pilot study: 150 men examined every 6 months for 4 years.
Location
H. Lee Moffitt Cancer Center and Research Institute, Inc.
Tampa
Florida
United States
33612
Status
Active, not recruiting
Source
H. Lee Moffitt Cancer Center and Research Institute
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00786760
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Pilot Projects
Small-scale tests of methods and procedures to be used on a larger scale if the pilot study demonstrates that these methods and procedures can work.
Child Behavior
Any observable response or action of a child from 24 months through 12 years of age. For neonates or children younger than 24 months, INFANT BEHAVIOR is available.
Menopause
The last menstrual period. Permanent cessation of menses (MENSTRUATION) is usually defined after 6 to 12 months of AMENORRHEA in a woman over 45 years of age. In the United States, menopause generally occurs in women between 48 and 55 years of age.
Cohort Effect
Variation in health status arising from different causal factors to which each birth cohort in a population is exposed as environment and society change.
Lost To Follow-up
Study subjects in COHORT STUDIES whose outcomes are unknown e.g., because they could not or did not wish to attend follow-up visits.(from Dictionary of Epidemiology, 5th ed.)
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