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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2016-01347 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| AMC-094 | |||
| AMC-094 | Other Identifier | AIDS Malignancy Consortium | |
| AMC-094 | Other Identifier | CTEP | |
| R21CA167653 | U.S. NIH Grant/Contract | View source | |
| UM1CA121947 | U.S. NIH Grant/Contract | View source |
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Closed due to lack of funding.
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cytology Specimen Collection Procedure | Other | Undergo penile skin cell and anal swab collection |
|
| 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 |
| 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 |
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Inclusion Criteria:
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
Inability to provide informed consent
History of a sex change operation that would preclude collection of penile or scrotal specimens
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HIV-seropositive MSM in Mumbai, India
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| Name | Affiliation | Role |
|---|---|---|
| Joel Palefsky | AIDS Malignancy Consortium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSF Medical Center-Parnassus | San Francisco | California | 94143 | United States | ||
| Tata Memorial Hospital |
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Tissue
| High Resolution Anoscopy with Biopsy | Procedure | Undergo HRA with biopsy |
|
|
| Laboratory Biomarker Analysis | Other | Correlative studies |
|
| Medical Examination | Procedure | Undergo anal and penile clinical exam |
|
|
| Physical Examination | Procedure | Undergo targeted physical exam |
|
|
| Questionnaire Administration | Other | Ancillary studies |
|
| 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 |
| Mumbai |
| 400 012 |
| India |
| Udaan Trust | Mumbai | 401706 | India |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D030361 | Papillomavirus Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D004266 | DNA Virus Infections |
| D014412 | Tumor Virus Infections |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D001706 | Biopsy |
| D000070536 | Independent Medical Evaluation |
| D012149 | Restraint, Physical |
| ID | Term |
|---|---|
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D013048 | Specimen Handling |
| D003949 | Diagnostic Techniques, Surgical |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D032763 | Behavior Control |
| D013812 | Therapeutics |
| D007103 | Immobilization |
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