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.
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
Undergo penile skin cell and anal swab collection
Undergo HRA with biopsy
Correlative studies
UCSF Medical Center-Parnassus
San Francisco, California, United States
Tata Memorial Hospital
Mumbai, India
Udaan Trust
Mumbai, India
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.
Time frame: Baseline
Prevalence of premalignant lesions of the penis
Will be calculated using proportions and exact 95% binomial CI.
Time frame: 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.
Time frame: Up to 12 months
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 .
Time frame: 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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Undergo anal and penile clinical exam
Undergo targeted physical exam
Ancillary studies
Time frame: 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.
Time frame: 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 .
Time frame: 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.
Time frame: 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 .
Time frame: Baseline