NCT00919997

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 302 (actual)
• Sponsor: AIDS Malignancy Consortium · Network
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Nonneoplastic Condition
• Precancerous Condition

Interventions

Type	Name	Description
GENETIC	DNA analysis	Anal pap smear, penile pap smear, blood collection, and saliva collection at a single study visit for HPV DNA analysis.
GENETIC	polymerase chain reaction	Blood and saliva samples collected at a single study visit will be analyzed for for HPV DNA.
OTHER	fluorescence activated cell sorting	Blood and saliva samples collected at a single study visit will be analyzed for for HPV DNA.
OTHER	questionnaire administration	Describe risk factors for penile, anal and oral HPV infection in Indian HIV-seropositive MSM.
OTHER	study of socioeconomic and demographic variables	Describe risk factors for penile, anal and oral HPV infection in Indian HIV-seropositive MSM.
PROCEDURE	study of high risk factors	Describe risk factors for penile, anal and oral HPV infection in Indian HIV-seropositive MSM.

Timeline

• Start date: 2009-07-01
• Primary completion: 2010-07-01
• Completion: 2010-07-01
• First posted: 2009-06-12
• Last updated: 2015-10-05

Locations

1 site across 1 country: United States