Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
HIV Infection
Type
Observational
Design
Observational Model: CohortTime Perspective: Prospective

Participation Requirements

Age
Between 18 years and 125 years
Gender
Only males

Description

PRIMARY OBJECTIVES: I. To determine the one-year incidence of HIV among high-risk MSM in India. SECONDARY OBJECTIVES: I. 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...

PRIMARY OBJECTIVES: I. To determine the one-year incidence of HIV among high-risk MSM in India. SECONDARY OBJECTIVES: I. 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.

Tracking Information

NCT #
NCT04142385
Collaborators
  • National Cancer Institute (NCI)
  • Tata Memorial Hospital
  • Udaan Trust
  • University of Arkansas
Investigators
Principal Investigator: Joel Palefsky AIDS Malignancy Consortium