NCT04142398

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

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

• Status: Withdrawn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 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.

Conditions

• HIV Infection
• Human Papillomavirus Infection
• Human Papillomavirus-Related Carcinoma

Interventions

Type	Name	Description
OTHER	Cytology Specimen Collection Procedure	Undergo penile skin cell and anal swab collection
PROCEDURE	High Resolution Anoscopy with Biopsy	Undergo HRA with biopsy
OTHER	Laboratory Biomarker Analysis	Correlative studies
PROCEDURE	Medical Examination	Undergo anal and penile clinical exam
PROCEDURE	Physical Examination	Undergo targeted physical exam
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