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

AIDS Malignancy Consortium

Status: Withdrawn

Conditions: HIV Infection; Human Papillomavirus Infection; Human Papillomavirus-Related Carcinoma

Treatments: Procedure: Medical Examination; Other: Cytology Specimen Collection Procedure; Procedure: High Resolution Anoscopy with Biopsy; Other: Laboratory Biomarker Analysis; Procedure: Physical Examination; Other: Questionnaire Administration

Study type: Observational

Funder types: NETWORK; NIH

Identifiers

NCT04142398

NCI-2016-01347 (Registry Identifier)

AMC-094

UM1CA121947 (U.S. NIH Grant/Contract)

R21CA167653 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• HIV positive, as documented by any licensed HIV test according to the Indian National acquired immune deficiency syndrome (AIDS) Control Organization (NACO) guidelines
• Participants report any sex with a man in the past 6 months
• Participants must speak Hindi, Marathi, or English
• Participants should not have any plans to move out of the area in the next 12 months and commit to attending two additional visits one at 6 months and one at 12 months

Exclusion criteria

• Active drug or alcohol use or dependence, or other impairment that, in the opinion of the site investigator, would interfere with adherence to study requirements

  • Participants with impairments that, in the opinion of the site investigator, are temporary, will be asked to return another day for enrollment

• Inability to provide informed consent

• History of a sex change operation that would preclude collection of penile or scrotal specimens

Trial design

0 participants in 1 patient group

Screening (health information collection)

Description:

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 DNA, and CD4+ T-cell count at months 0 and 6 and HIV viral load testing at months 0 and 12. Participants also undergo HRA and penile clinical exam at month 12.

Treatment:

Other: Questionnaire Administration

Procedure: Physical Examination

Other: Laboratory Biomarker Analysis

Procedure: High Resolution Anoscopy with Biopsy

Other: Cytology Specimen Collection Procedure

Procedure: Medical Examination