Human Papilloma Virus Infection in HIV-Positive Indian Men Who Have Sex With Men
HPV Infection in Indian HIV-Seropositive Men Who Have Sex With Men (MSM)
RATIONALE: Gathering information about human papilloma virus (HPV) infection in HIV-positive men who have sex with men may help doctors learn more about the disease.
PURPOSE: This clinical trial is studying HPV infection in HIV-positive Indian men who have sex with men.
調査の概要
状態
詳細な説明
OBJECTIVES:
- Describe the prevalence of penile, anal, and oral human papilloma virus (HPV) infection in HIV-seropositive Indian men who have sex with men.
- Determine the spectrum of HPV types at these anatomic sites in these patients.
- Determine the distribution of strain variants of HPV 16, 18, and 31 at these anatomic sites in these patients.
- Describe risk factors for penile, anal, and oral HPV infection in these patients.
OUTLINE: This is a multicenter study.
Patients complete interviewer-administered questionnaires on demographics, native place, socioeconomic status, medical history, numbers of sexual partners and sexual practices, circumcision status, and risk factors for oral malignancies and human papilloma virus (HPV), including oral sex, smoking or chewing tobacco, drug use, oral hygiene, and tooth loss.
Patients undergo cell sample collection from the penis, scrotum, anus, and mouth, and saliva sample collection for HPV DNA testing by PCR. Patients also undergo blood sample collection to measure CD4+ count and HIV viral load by FACS and PCR.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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California
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San Francisco、California、アメリカ、94115
- UCSF Helen Diller Family Comprehensive Cancer Center
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
DISEASE CHARACTERISTICS:
HIV-1 infection, as documented by ELISA and confirmed by a second testing method (e.g., western blot, HIV-1 culture, HIV-1 antigen, plasma HIV-1 RNA, or a second antibody test by a method other than ELISA)
- If prior documentation and confirmation of HIV-1 infection is not available, two licensed rapid HIV tests are allowed
- Must have had receptive or insertive anal intercourse with another man within the past 6 months
PATIENT CHARACTERISTICS:
- Speaks Hindi (in Mumbai) or Tamil (in Vellore)
- No active drug or alcohol use or dependence that, in the opinion of the site Investigator, would interfere with adherence to study requirements
- No history of a sex-change operation that would preclude collection of penile or scrotal specimens
PRIOR CONCURRENT THERAPY:
- Not specified
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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Specimen collection
Single group study.
Blood, saliva, anal cytology, and penile cytology samples, and questionnaire responses will be collected from participants at a single study visit.
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Anal pap smear, penile pap smear, blood collection, and saliva collection at a single study visit for HPV DNA analysis.
Blood and saliva samples collected at a single study visit will be analyzed for for HPV DNA.
Blood and saliva samples collected at a single study visit will be analyzed for for HPV DNA.
Describe risk factors for penile, anal and oral HPV infection in Indian HIV-seropositive MSM.
Describe risk factors for penile, anal and oral HPV infection in Indian HIV-seropositive MSM.
Describe risk factors for penile, anal and oral HPV infection in Indian HIV-seropositive MSM.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
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Detectable human papilloma virus DNA in the penis, anus, or mouth
時間枠：Study entry
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Study entry
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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Distribution of strain variants of HPV 16, 18 and 31
時間枠：Study entry
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Study entry
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Describe risk factors for penile, anal and oral HPV infection in Indian HIV-seropositive MSM
時間枠：Study entry
|
Study entry
|
協力者と研究者
捜査官
- 主任研究者：Dilip Mathai, MD、Christian Medical College and Hospital
- 主任研究者：Ashok Row Kavi、Humsafar Trust
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- AMC-060
- U01CA121947 (米国 NIH グラント/契約)
- CDR0000629624 (その他の識別子：NCI)
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