Summary

for males ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion
Joel Palefsky

Description

Summary

This research trial studies the incidence of human papilloma virus (HPV) infection and HPV-associated disease in screening Indian men who have sex with human immunodeficiency virus (HIV)-positive men. Gathering health information over time from Indian men who have sex with men (MSM) may help doctors determine how many HIV -positive MSM develop new HPV infections and how many HIV-positive MSM have HPV related disease.

Official Title

Investigating Human Papillomavirus (HPV) Infection and HPV-Associated Disease in Indian Men Who Have Sex With Men Who Are HIV-Positive

Details

PRIMARY OBJECTIVES:

  1. Determine the prevalence of HPV-associated premalignant lesions in the anus and penis in Indian HIV-seropositive men who have sex with men (MSM).

SECONDARY OBJECTIVES:

  1. Describe risk factors for prevalent premalignant lesions in the anus and penis in Indian HIV-seropositive MSM.

II. Describe the prevalence and incidence of penile and anal HPV infection in Indian HIV-seropositive MSM.

OUTLINE:

Participants receive a questionnaire and undergo a targeted physical and anal clinical exam at months 0, 6, and 12. Participants also undergo a penile skin cell and anal swab at months 0, 6, and 12 for cytology, HPV deoxyribonucleic acid (DNA), and CD4+ T-cell count at months 0 and 6 and HIV viral load testing at months 0 and 12. Participants also undergo high-resolution anoscopy (HRA) and penile clinical exam at month 12.

Keywords

HIV Infection Human Papillomavirus Infection Human Papillomavirus-Related Carcinoma Infection Communicable Diseases Papillomavirus Infections Cytology Specimen Collection Procedure High Resolution Anoscopy with Biopsy Laboratory Biomarker Analysis Medical Examination Physical Examination

Eligibility

You can join if…

Open to males ages 18 years and up

  • HIV positive, as documented by any licensed HIV test according to the Indian National acquired immune deficiency syndrome (AIDS) Control Organization (NACO) guidelines
  • Participants report any sex with a man in the past 6 months
  • Participants must speak Hindi, Marathi, or English
  • Participants should not have any plans to move out of the area in the next 12 months and commit to attending two additional visits one at 6 months and one at 12 months

You CAN'T join if...

  • Active drug or alcohol use or dependence, or other impairment that, in the opinion of the site investigator, would interfere with adherence to study requirements
  • Participants with impairments that, in the opinion of the site investigator, are temporary, will be asked to return another day for enrollment
  • Inability to provide informed consent
  • History of a sex change operation that would preclude collection of penile or scrotal specimens

Locations

  • UCSF Medical Center-Parnassus not yet accepting patients
    San Francisco California 94143 United States
  • Tata Memorial Hospital not yet accepting patients
    Mumbai 400 012 India
  • Udaan Trust not yet accepting patients
    Mumbai 401706 India

Lead Scientist

  • Joel Palefsky
    Joel Palefsky, M.D. Infectious Disease Specialist, Professor of Medicine and Laboratory Medicine Dr. Joel Palefsky is the Chair of the HPV Working Group of the AMC and is the head of the AMC HPV Virology Core Lab.

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
AIDS Malignancy Consortium
ID
NCT04142398
Study Type
Observational
Last Updated