Incidence of HPV Infection and HPV-Associated Disease in Screening Indian Men Who Have Sex With HIV-Positive Men
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- HIV Infection
- Human Papillomavirus Infection
- Human Papillomavirus-Related Carcinoma
- Type
- Observational
- Design
- Observational Model: CohortTime Perspective: Prospective
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Only males
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 ...
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.
Tracking Information
- NCT #
- NCT04142398
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: Joel Palefsky AIDS Malignancy Consortium
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