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

October 1, 2015 updated by: AIDS Malignancy Consortium

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.

Study Overview

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.

Study Type

Observational

Enrollment (Actual)

302

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • San Francisco, California, United States, 94115
        • UCSF Helen Diller Family Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

HIV-1 infected men who have sex with men from Mumbai and Vellore, India, who are age 18 or older.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Distribution of strain variants of HPV 16, 18 and 31
Time Frame: Study entry
Study entry
Describe risk factors for penile, anal and oral HPV infection in Indian HIV-seropositive MSM
Time Frame: Study entry
Study entry

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Dilip Mathai, MD, Christian Medical College and Hospital
  • Principal Investigator: Ashok Row Kavi, Humsafar Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

June 11, 2009

First Submitted That Met QC Criteria

June 11, 2009

First Posted (Estimate)

June 12, 2009

Study Record Updates

Last Update Posted (Estimate)

October 5, 2015

Last Update Submitted That Met QC Criteria

October 1, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • AMC-060
  • U01CA121947 (U.S. NIH Grant/Contract)
  • CDR0000629624 (Other Identifier: NCI)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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