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)
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.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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California
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San Francisco, California, Estados Unidos, 94115
- UCSF Helen Diller Family Comprehensive Cancer Center
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
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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.
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Anal pap smear, penile pap smear, blood collection, and saliva collection at a single study visit for HPV DNA analysis.
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.
Describe risk factors for penile, anal and oral HPV infection in Indian HIV-seropositive MSM.
Describe risk factors for penile, anal and oral HPV infection in Indian HIV-seropositive MSM.
Describe risk factors for penile, anal and oral HPV infection in Indian HIV-seropositive MSM.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Detectable human papilloma virus DNA in the penis, anus, or mouth
Periodo de tiempo: Study entry
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Study entry
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Distribution of strain variants of HPV 16, 18 and 31
Periodo de tiempo: Study entry
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Study entry
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Describe risk factors for penile, anal and oral HPV infection in Indian HIV-seropositive MSM
Periodo de tiempo: Study entry
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Study entry
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Dilip Mathai, MD, Christian Medical College and Hospital
- Investigador principal: Ashok Row Kavi, Humsafar Trust
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- AMC-060
- U01CA121947 (Subvención/contrato del NIH de EE. UU.)
- CDR0000629624 (Otro identificador: NCI)
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