Nonneoplastic Condition, Precancerous Condition
Conditions
Keywords
human papilloma virus infection, HIV infection, HIV Infections
Brief summary
RATIONALE: Gathering information about human papilloma virus (HPV) infection in HIV-positive men who have sex with men may help doctors learn more about the disease. PURPOSE: This clinical trial is studying HPV infection in HIV-positive Indian men who have sex with men.
Detailed description
OBJECTIVES: * Describe the prevalence of penile, anal, and oral human papilloma virus (HPV) infection in HIV-seropositive Indian men who have sex with men. * Determine the spectrum of HPV types at these anatomic sites in these patients. * Determine the distribution of strain variants of HPV 16, 18, and 31 at these anatomic sites in these patients. * Describe risk factors for penile, anal, and oral HPV infection in these patients. OUTLINE: This is a multicenter study. Patients complete interviewer-administered questionnaires on demographics, native place, socioeconomic status, medical history, numbers of sexual partners and sexual practices, circumcision status, and risk factors for oral malignancies and human papilloma virus (HPV), including oral sex, smoking or chewing tobacco, drug use, oral hygiene, and tooth loss. Patients undergo cell sample collection from the penis, scrotum, anus, and mouth, and saliva sample collection for HPV DNA testing by PCR. Patients also undergo blood sample collection to measure CD4+ count and HIV viral load by FACS and PCR.
Interventions
GENETICDNA analysis
Anal pap smear, penile pap smear, blood collection, and saliva collection at a single study visit for HPV DNA analysis.
GENETICpolymerase chain reaction
Blood and saliva samples collected at a single study visit will be analyzed for for HPV DNA.
Blood and saliva samples collected at a single study visit will be analyzed for for HPV DNA.
OTHERquestionnaire administration
Describe risk factors for penile, anal and oral HPV infection in Indian HIV-seropositive MSM.
OTHERstudy of socioeconomic and demographic variables
Describe risk factors for penile, anal and oral HPV infection in Indian HIV-seropositive MSM.
PROCEDUREstudy of high risk factors
Describe risk factors for penile, anal and oral HPV infection in Indian HIV-seropositive MSM.
Sponsors
National Cancer Institute (NCI)
The Emmes Company, LLC
AIDS Malignancy Consortium
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * HIV-1 infection, as documented by ELISA and confirmed by a second testing method (e.g., western blot, HIV-1 culture, HIV-1 antigen, plasma HIV-1 RNA, or a second antibody test by a method other than ELISA) \- If prior documentation and confirmation of HIV-1 infection is not available, two licensed rapid HIV tests are allowed * Must have had receptive or insertive anal intercourse with another man within the past 6 months PATIENT CHARACTERISTICS: * Speaks Hindi (in Mumbai) or Tamil (in Vellore) * No active drug or alcohol use or dependence that, in the opinion of the site Investigator, would interfere with adherence to study requirements * No history of a sex-change operation that would preclude collection of penile or scrotal specimens PRIOR CONCURRENT THERAPY: * Not specified
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Detectable human papilloma virus DNA in the penis, anus, or mouth | Study entry |
Secondary
| Measure | Time frame |
|---|---|
| Distribution of strain variants of HPV 16, 18 and 31 | Study entry |
| Describe risk factors for penile, anal and oral HPV infection in Indian HIV-seropositive MSM | Study entry |
Countries
United States
Outcome results
None listed