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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2027-04-30

Study Completion Date

2031-12-31

Brief Summary

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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.

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Detailed Description

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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

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HIV Infection Human Papillomavirus Infection Human Papillomavirus-Related Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Cytology Specimen Collection Procedure

Intervention Type OTHER

Undergo penile skin cell and anal swab collection

High Resolution Anoscopy with Biopsy

Intervention Type PROCEDURE

Undergo HRA with biopsy

Laboratory Biomarker Analysis

Intervention Type OTHER

Correlative studies

Medical Examination

Intervention Type PROCEDURE

Undergo anal and penile clinical exam

Physical Examination

Intervention Type PROCEDURE

Undergo targeted physical exam

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Cytology Specimen Collection Procedure

Undergo penile skin cell and anal swab collection

Intervention Type OTHER

High Resolution Anoscopy with Biopsy

Undergo HRA with biopsy

Intervention Type PROCEDURE

Laboratory Biomarker Analysis

Correlative studies

Intervention Type OTHER

Medical Examination

Undergo anal and penile clinical exam

Intervention Type PROCEDURE

Physical Examination

Undergo targeted physical exam

Intervention Type PROCEDURE

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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Cytologic Sampling High Resolution Anoscopy-Monitored Biopsy Exam Examination Medical Assessment Medical Exam Medical Inspection Assessment Physical Physical Assessment Physical Exam

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No