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

This study has been completed.
Sponsor:
Collaborators:
The EMMES Corporation
Information provided by (Responsible Party):
AIDS Malignancy Clinical Trials Consortium
ClinicalTrials.gov Identifier:
NCT00919997
First received: June 11, 2009
Last updated: August 27, 2014
Last verified: August 2014

June 11, 2009
August 27, 2014
July 2009
July 2010   (final data collection date for primary outcome measure)
Detectable human papilloma virus DNA in the penis, anus, or mouth [ Time Frame: Study entry ] [ Designated as safety issue: No ]
Detectable human papilloma virus DNA in the penis, anus, or mouth [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00919997 on ClinicalTrials.gov Archive Site
  • Distribution of strain variants of HPV 16, 18 and 31 [ Time Frame: Study entry ] [ Designated as safety issue: No ]
  • Describe risk factors for penile, anal and oral HPV infection in Indian HIV-seropositive MSM [ Time Frame: Study entry ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Anal cytology Penile cytology Saliva Blood

Non-Probability Sample

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

  • Nonneoplastic Condition
  • Precancerous Condition
  • 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.
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.
Interventions:
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
302
July 2010
July 2010   (final data collection date for primary outcome measure)

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
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00919997
AMC-060, U01CA121947, CDR0000629624
No
AIDS Malignancy Clinical Trials Consortium
AIDS Malignancy Clinical Trials Consortium
  • National Cancer Institute (NCI)
  • The EMMES Corporation
Study Chair: Joel Palefsky, MD University of California, San Francisco
Principal Investigator: Dilip Mathai, MD Christian Medical College and Hospital
Principal Investigator: Ashok Row Kavi Humsafar Trust
AIDS Malignancy Clinical Trials Consortium
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP