HPV Infection in Indian HIV-Seropositive Men Who Have Sex With Men (MSM)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 302
- 试验地点
- 1
- 主要终点
- Detectable human papilloma virus DNA in the penis, anus, or mouth
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Detectable human papilloma virus DNA in the penis, anus, or mouth
时间窗: Study entry
次要结局
- Distribution of strain variants of HPV 16, 18 and 31(Study entry)
- Describe risk factors for penile, anal and oral HPV infection in Indian HIV-seropositive MSM(Study entry)