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 immunodeficiency virus (HIV) infection in screening Indian men who have sex with men (MSM). Gathering health information over time from Indian MSM may help doctors determine how many Indian MSM develop new cases of HIV infection.

Official Title

Incidence of Human Immunodeficiency Virus (HIV) Among Indian Men Who Have Sex With Men (MSM)

Details

PRIMARY OBJECTIVES:

  1. To determine the one-year incidence of HIV among high-risk MSM in India.

SECONDARY OBJECTIVES:

  1. To test the feasibility and acceptability of recruiting a sample of 150 high-risk HIV-uninfected MSM using respondent-driven sampling (RDS) and following them every six months for one year.

II. To produce preliminary descriptive data on the prevalence and incidence of human papillomavirus (HPV) infection and HPV-associated disease and sexually transmitted infections (STIs) other than HPV in HIV-seronegative MSM in India.

III. To produce preliminary descriptive data on sexual risk behaviors with men and women, as well as data on other potential confounders.

OUTLINE:

Participants receive a questionnaire, undergo a targeted physical and anal clinical exam, undergo blood collection and urethral swab for STIs, and a penile skin cell and anal swab for cytology and HPV deoxyribonucleic acid (DNA) at months 0, 6, and 12. Participants also undergo high-resolution anoscopy (HRA) and penile clinical exam at month 12.

Keywords

HIV Infection Infection HIV Infections Acquired Immunodeficiency Syndrome Cytology Specimen Collection Procedure Laboratory Biomarker Analysis Medical Examination Physical Examination Proctoscopy with Biopsy

Eligibility

You can join if…

Open to males ages 18 years and up

  • HIV seronegative, as documented by any licensed HIV test according to National Acquired Immunodeficiency 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
  • Participant 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
NCT04142385
Study Type
Observational
Last Updated