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

NCT04142398 | Withdrawn DMC

• 4 other identifiers: AMC-094NCI-2016-01347R21CA167653UM1CA121947
• Study Type: observational
• Target: N/A
• Locations: 2 countries
• Sites: 3

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• The proportion of men with HGAIN at baseline according to presence and absence of HPV infection (types 6, 11, 16, and/or 18).

  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

  baseline

• The proportion of men with HGAIN at baseline according to reported number of sex partners in the last 6 months

  baseline

• The proportion of men with premalignant lesions of the penis at baseline according CD4+ level.

  baseline

• The proportion of men with HGAIN at baseline according CD4+ level.

  baseline

Study Arms (1)

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

Interventions

Cytology Specimen Collection Procedure OTHER

Undergo penile skin cell and anal swab collection

Also known as: Cytologic Sampling

Screening (health information collection)

High Resolution Anoscopy with Biopsy PROCEDURE

Undergo HRA with biopsy

Also known as: High Resolution Anoscopy-Monitored Biopsy

Screening (health information collection)

Laboratory Biomarker Analysis OTHER

Correlative studies

Screening (health information collection)

Medical Examination PROCEDURE

Undergo anal and penile clinical exam

Also known as: Exam, Examination, Medical Assessment, Medical Exam, Medical Inspection

Screening (health information collection)

Physical Examination PROCEDURE

Undergo targeted physical exam

Also known as: Assessment, Physical, Physical Assessment, Physical Exam

Screening (health information collection)

Questionnaire Administration OTHER

Ancillary studies

Screening (health information collection)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

HIV-seropositive MSM in Mumbai, India

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AIDS Malignancy Consortium: lead
• National Cancer Institute (NCI): collaborator

Study Sites (3)

UCSF Medical Center-Parnassus

San Francisco, California, 94143, United States

Location

Tata Memorial Hospital

Mumbai, 400 012, India

Location

Udaan Trust

Mumbai, 401706, India

Location

Biospecimen

Retention: SAMPLES WITH DNA

Tissue

MeSH Terms

Conditions

HIV Infections; Papillomavirus Infections

Interventions

Biopsy; Independent Medical Evaluation; Restraint, Physical

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; DNA Virus Infections; Tumor Virus Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Behavior Control; Therapeutics; Immobilization

Study Officials

• Joel Palefsky

  AIDS Malignancy Consortium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2019
• First Posted: October 29, 2019
• Study Start (Estimated): April 30, 2027
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2031
• Last Updated: June 6, 2025

Record last verified: 2025-06

Locations

IN (2); US (1)