Human Papilloma Virus Infection in HIV-Positive Indian Men Who Have Sex With Men

Study Overview
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Brief Summary
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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
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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.

Official Title
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HPV Infection in Indian HIV-Seropositive Men Who Have Sex With Men (MSM)

Conditions
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Nonneoplastic Condition, Precancerous Condition

Intervention / Treatment
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* Genetic: DNA analysis
* Genetic: polymerase chain reaction
* Other: fluorescence activated cell sorting
* Other: questionnaire administration
* Other: study of socioeconomic and demographic variables
* Procedure: study of high risk factors


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Specimen collection<br>Single group study. Blood, saliva, anal cytology, and penile cytology samples, and questionnaire responses will be collected from participants at a single study visit. | Genetic: DNA analysis<br>* Anal pap smear, penile pap smear, blood collection, and saliva collection at a single study visit for HPV DNA analysis.<br>Genetic: polymerase chain reaction<br>* Blood and saliva samples collected at a single study visit will be analyzed for for HPV DNA.<br>Other: fluorescence activated cell sorting<br>* Blood and saliva samples collected at a single study visit will be analyzed for for HPV DNA.<br>Other: questionnaire administration<br>* Describe risk factors for penile, anal and oral HPV infection in Indian HIV-seropositive MSM.<br>Other: study of socioeconomic and demographic variables<br>* Describe risk factors for penile, anal and oral HPV infection in Indian HIV-seropositive MSM.<br>Procedure: study of high risk factors<br>* Describe risk factors for penile, anal and oral HPV infection in Indian HIV-seropositive MSM.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detectable human papilloma virus DNA in the penis, anus, or mouth |  | Study entry | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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human papilloma virus infection, HIV infection, HIV Infections