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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: HIV Infection; Human Papillomavirus Infection; Human Papillomavirus-Related Carcinoma
• Intervention / Treatment: Other: Laboratory Biomarker Analysis; Other: Questionnaire Administration; Other: Cytology Specimen Collection Procedure; Procedure: High Resolution Anoscopy with Biopsy; Procedure: Medical Examination; Procedure: Physical Examination

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.

• Study Type: Observational
• Enrollment (Estimated): 246

Contacts and Locations

Study Locations

• India
  • Mumbai, India, 400 012
    • Tata Memorial Hospital
    • Contact: Sharmila A. Pimple; Phone Number: 91-22-24154379; Email: pimplesa@tmc.gov.in
    • Principal Investigator: Sharmila A. Pimple
  • Mumbai, India, 401706
    • Udaan Trust
    • Contact: Vijay Nair; Phone Number: 91-22-3209-4538; Email: airvijaynair@gmail.com
    • Principal Investigator: Vijay Nair
• United States
  • California
    • San Francisco, California, United States, 94143
      • UCSF Medical Center-Parnassus
      • Contact: Joel Palefsky; Phone Number: 877-827-3222; Email: joel.palefsky@ucsf.edu
      • Principal Investigator: Joel Palefsky

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

HIV-seropositive MSM in Mumbai, India

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Screening (health information collection); 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.

Other: Laboratory Biomarker Analysis; Correlative studies; Other: Questionnaire Administration; Ancillary studies; Other: Cytology Specimen Collection Procedure; Undergo penile skin cell and anal swab collection; Other Names: Cytologic Sampling; Procedure: High Resolution Anoscopy with Biopsy; Undergo HRA with biopsy; Other Names: High Resolution Anoscopy-Monitored Biopsy; Procedure: Medical Examination; Undergo anal and penile clinical exam; Other Names: Exam; Examination; Medical Assessment; Medical Exam; Medical Inspection; Procedure: Physical Examination; Undergo targeted physical exam; Other Names: Assessment; Physical; Physical Assessment; Physical Exam

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of HPV-associated high-grade anal intraepithelial neoplasia (HGAIN)	The proportion of men with HPV 6, 11, 16, and/or 18-associated HGAIN will be calculated. HGAIN is determined by biopsy and HPV typing is based on concurrent DNA analysis of anal swabs.	Baseline
Prevalence of premalignant lesions of the penis	Will be calculated using proportions and exact 95% binomial CI.	Baseline
Prevalence and incidence of human papillomavirus (HPV)	Will be estimated for specific types, and for all types combined using the life table approach for incidence. Separate estimates will be made for each anatomical site. Risk factors for site-specific incident infection will be evaluated using regression models for survival events observed in discrete time (e.g. pooled logistic regression), incorporating behavioral and biological predictors measured at baseline, and over time at study visits. Risk factors that will be assessed include behavioral and medical history, CD4+ level, and HIV viral load.	Up to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The proportion of men with HGAIN at baseline according to presence and absence of HPV infection (types 6, 11, 16, and/or 18).	The proportion of men with HGAIN at baseline according to presence and absence of HPV infection (types 6, 11, 16, and/or 18) will be calculated. HGAIN is determined by biopsy and HPV typing is based on concurrent DNA analysis of anal swabs .	Baseline
The proportion of men with premalignant lesions of the penis at baseline according to reported number of sex partners in the last 6 months	The proportion of men with premalignant lesions of the penis at baseline according to number of sex partners in the last 6 months will be calculated. Premalignant lesions of the penis are determined by colposcopic magnification and HPV typing is based on concurrent DNA analysis of penile swabs.	baseline
The proportion of men with HGAIN at baseline according to reported number of sex partners in the last 6 months	The proportion of men with HGAIN at baseline according to number of sex partners in the last 6 months will be calculated. HGAIN is determined by biopsy and HPV typing is based on concurrent DNA analysis of anal swabs.	baseline
The proportion of men with premalignant lesions of the penis at baseline according CD4+ level.	The proportion of men with premalignant lesions of the penis at baseline according to CD4+ level at baseline will be calculated. Premalignant lesions of the penis are determined by colposcopic magnification and HPV typing is based on concurrent DNA analysis of penile swabs .	baseline
The proportion of men with HGAIN at baseline according CD4+ level.	The proportion of men with HGAIN at baseline according to CD4+ level at baseline will be calculated. HGAIN is determined by biopsy and HPV typing is based on concurrent DNA analysis of anal swabs.	baseline
The proportion of men with premalignant lesions of the penis at baseline according to presence and absence of HPV infection (types 6, 11, 16, and/or 18).	The proportion of men with premalignant lesions of the penis at baseline according to presence and absence of HPV infection (types 6, 11, 16, and/or 18) will be calculated. Premalignant lesions of the penis are determined by colposcopic magnification and HPV typing is based on concurrent DNA analysis of penile swabs .	Baseline

Collaborators and Investigators

• Sponsor: AIDS Malignancy Consortium
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Joel Palefsky, AIDS Malignancy Consortium

Study record dates

Study Major Dates

• Study Start (Estimated): April 30, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: August 29, 2019
• First Submitted That Met QC Criteria: October 25, 2019
• First Posted (Actual): October 29, 2019

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 27, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Virus Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Disease Attributes; DNA Virus Infections; Tumor Virus Infections; Urogenital Diseases; Genital Diseases; Infections; Communicable Diseases; Papillomavirus Infections
• Other Study ID Numbers: AMC-094 (Other Identifier: CTEP); UM1CA121947 (U.S. NIH Grant/Contract); NCI-2016-01347 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); R21CA167653 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No