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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2016-01358 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| AMC-093 | |||
| AMC-093 | Other Identifier | AIDS Malignancy Consortium | |
| AMC-093 | Other Identifier | CTEP | |
| R21CA167652 | 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 |
| Tata Memorial Hospital | OTHER_GOV |
| Udaan Trust | UNKNOWN |
| University of Arkansas |
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This research trial studies the incidence of human immunodeficiency virus (HIV) infection in screening Indian men who have sex with men (MSM). Gathering health information over time from Indian MSM may help doctors determine how many Indian MSM develop new cases of HIV infection.
PRIMARY OBJECTIVES:
I. To determine the one-year incidence of HIV among high-risk MSM in India.
SECONDARY OBJECTIVES:
I. To test the feasibility and acceptability of recruiting a sample of 150 high-risk HIV-uninfected MSM using respondent-driven sampling (RDS) and following them every six months for one year.
II. To produce preliminary descriptive data on the prevalence and incidence of human papillomavirus (HPV) infection and HPV-associated disease and sexually transmitted infections (STIs) other than HPV in HIV-seronegative MSM in India.
III. To produce preliminary descriptive data on sexual risk behaviors with men and women, as well as data on other potential confounders.
OUTLINE:
Participants receive a questionnaire, undergo a targeted physical and anal clinical exam, undergo blood collection and urethral swab for STIs, and a penile skin cell and anal swab for cytology and HPV deoxyribonucleic acid (DNA) at months 0, 6, 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 |
|---|---|---|---|
| Observational (health information collection) | Participants receive a questionnaire, undergo a targeted physical and anal clinical exam, undergo blood collection and urethral swab for STIs, and a penile skin cell and anal swab for cytology and HPV DNA at months 0, 6, 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 blood, urethral swab, penile skin cell, and anal swab collection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of human immunodeficiency virus (HIV) | The total number of participants with incident HIV divided by the total follow-up will be used to calculate the incidence per 100 person years. HIV status is determined by HIV rapid test and a confirmatory Western blot test. | Up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Successful respondent-driven sampling (RDS) | Defined as half of the study sample enrolled and at least 50% of the responses to the questions of RDS acceptability are answered "Not at all embarrassed or burdened by RDS". | 3 months |
| Successful respondent-driven sampling (RDS) |
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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-seronegative 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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| OTHER |
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Blood, tissue
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| Laboratory Biomarker Analysis | Other | Correlative studies |
|
| Medical Examination | Procedure | Undergo anal and penile clinical exam |
|
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| Physical Examination | Procedure | Undergo targeted physical exam |
|
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| Proctoscopy with Biopsy | Procedure | Undergo HRA |
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| Questionnaire Administration | Other | Ancillary studies |
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Defined as more than 80% of participants recruited through RDS. |
| 12 months |
| Prevalence of penile human papillomavirus (HPV) infection, assessed by polymerase chain reaction (PCR) | Summarized using proportions and exact 95% binomial confidence interval (CI). Will be estimated for specific types and for all combined. | Up to 12 months |
| Prevalence of human papillomavirus (HPV)-associated lesions of the penis | Summarized using proportions and exact 95% binomial CI. Will be estimated for specific types and for all combined. | Up to 12 months |
| Prevalence of human papillomavirus (HPV)-associated lesions of the anus | Summarized using proportions and exact 95% binomial CI. Will be estimated for specific types and for all combined. | Up to 12 months |
| Prevalence of anal human papillomavirus (HPV) infection, assessed by polymerase chain reaction (PCR) | Summarized using proportions and exact 95% binomial confidence interval (CI). Will be estimated for specific types and for all combined. | Up to 12 months |
| Mumbai |
| 400 012 |
| India |
| Udaan Trust | Mumbai | 401706 | India |
| ID | Term |
|---|---|
| D015658 | HIV 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 |
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| ID | Term |
|---|---|
| D000070536 | Independent Medical Evaluation |
| D012149 | Restraint, Physical |
| D011351 | Proctoscopy |
| D001706 | Biopsy |
| ID | Term |
|---|---|
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D032763 | Behavior Control |
| D013812 | Therapeutics |
| D007103 | Immobilization |
| D008919 | Investigative Techniques |
| D016099 | Endoscopy, Gastrointestinal |
| D016145 | Endoscopy, Digestive System |
| D003938 | Diagnostic Techniques, Digestive System |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D013048 | Specimen Handling |
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