Spots Global Cancer Trial Database for Incidence of HPV Infection and HPV-Associated Disease in Screening Indian Men Who Have Sex With HIV-Positive Men

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Trial Identification

Brief Title: Incidence of HPV Infection and HPV-Associated Disease in Screening Indian Men Who Have Sex With HIV-Positive Men

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

Study ID: NCT04142398

Conditions

HIV Infection

Human Papillomavirus Infection

Human Papillomavirus-Related Carcinoma

Interventions

Cytology Specimen Collection Procedure

High Resolution Anoscopy with Biopsy

Laboratory Biomarker Analysis

Medical Examination

Physical Examination

Questionnaire Administration

Study Description

Brief 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.

Detailed Description: PRIMARY OBJECTIVES: I. 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: I. 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.