NCT04142385

Incidence of HIV Infection in Screening Indian Men Who Have Sex With Men

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

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: AIDS Malignancy Consortium · Network
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• HIV Infection

Interventions

Type	Name	Description
OTHER	Cytology Specimen Collection Procedure	Undergo blood, urethral swab, penile skin cell, and anal swab collection
OTHER	Laboratory Biomarker Analysis	Correlative studies
PROCEDURE	Medical Examination	Undergo anal and penile clinical exam
PROCEDURE	Physical Examination	Undergo targeted physical exam
PROCEDURE	Proctoscopy with Biopsy	Undergo HRA
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2027-04-30
• Primary completion: 2029-12-31
• Completion: 2031-12-31
• First posted: 2019-10-29
• Last updated: 2025-06-06

Locations

3 sites across 2 countries: United States, India