Human Papilloma Virus Infection in HIV-Positive Indian Men Who Have Sex With Men
NCT ID: NCT00919997
Last Updated: 2015-10-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
302 participants
OBSERVATIONAL
2009-07-31
2010-07-31
Brief Summary
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PURPOSE: This clinical trial is studying HPV infection in HIV-positive Indian men who have sex with men.
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Detailed Description
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* 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.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Specimen collection
Single group study. Blood, saliva, anal cytology, and penile cytology samples, and questionnaire responses will be collected from participants at a single study visit.
DNA analysis
Anal pap smear, penile pap smear, blood collection, and saliva collection at a single study visit for HPV DNA analysis.
polymerase chain reaction
Blood and saliva samples collected at a single study visit will be analyzed for for HPV DNA.
fluorescence activated cell sorting
Blood and saliva samples collected at a single study visit will be analyzed for for HPV DNA.
questionnaire administration
Describe risk factors for penile, anal and oral HPV infection in Indian HIV-seropositive MSM.
study of socioeconomic and demographic variables
Describe risk factors for penile, anal and oral HPV infection in Indian HIV-seropositive MSM.
study of high risk factors
Describe risk factors for penile, anal and oral HPV infection in Indian HIV-seropositive MSM.
Interventions
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DNA analysis
Anal pap smear, penile pap smear, blood collection, and saliva collection at a single study visit for HPV DNA analysis.
polymerase chain reaction
Blood and saliva samples collected at a single study visit will be analyzed for for HPV DNA.
fluorescence activated cell sorting
Blood and saliva samples collected at a single study visit will be analyzed for for HPV DNA.
questionnaire administration
Describe risk factors for penile, anal and oral HPV infection in Indian HIV-seropositive MSM.
study of socioeconomic and demographic variables
Describe risk factors for penile, anal and oral HPV infection in Indian HIV-seropositive MSM.
study of high risk factors
Describe risk factors for penile, anal and oral HPV infection in Indian HIV-seropositive MSM.
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
MALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
The Emmes Company, LLC
INDUSTRY
AIDS Malignancy Consortium
NETWORK
Responsible Party
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Principal Investigators
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Joel Palefsky, MD
Role: STUDY_CHAIR
University of California, San Francisco
Dilip Mathai, MD
Role: PRINCIPAL_INVESTIGATOR
Christian Medical College and Hospital
Ashok Row Kavi
Role: PRINCIPAL_INVESTIGATOR
Humsafar Trust
Locations
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UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States
Countries
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Other Identifiers
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CDR0000629624
Identifier Type: OTHER
Identifier Source: secondary_id
AMC-060
Identifier Type: -
Identifier Source: org_study_id
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