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

Study Overview
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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.

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.

Official Title
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Investigating Human Papillomavirus (HPV) Infection and HPV-Associated Disease in Indian Men Who Have Sex With Men Who Are HIV-Positive

Conditions
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HIV Infection, Human Papillomavirus Infection, Human Papillomavirus-Related Carcinoma

Intervention / Treatment
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* Other: Cytology Specimen Collection Procedure
* Procedure: High Resolution Anoscopy with Biopsy
* Other: Laboratory Biomarker Analysis
* Procedure: Medical Examination
* Procedure: Physical Examination
* Other: Questionnaire Administration


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Screening (health information collection)<br>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<br>* Undergo penile skin cell and anal swab collection<br>* Other names: Cytologic Sampling;Procedure: High Resolution Anoscopy with Biopsy<br>* Undergo HRA with biopsy<br>* Other names: High Resolution Anoscopy-Monitored Biopsy;Other: Laboratory Biomarker Analysis<br>* Correlative studies<br>Procedure: Medical Examination<br>* Undergo anal and penile clinical exam<br>* Other names: Medical Inspection;Procedure: Physical Examination<br>* Undergo targeted physical exam<br>* Other names: Physical Exam;Other: Questionnaire Administration<br>* Ancillary studies<br>|

What is the study measuring?
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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 |