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Clinical Trial 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.


Clinical Trial 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 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04142385
Study type Observational
Source AIDS Malignancy Consortium
Contact
Status Not yet recruiting
Phase
Start date April 30, 2025
Completion date December 31, 2029

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