Investigating Human Papillomavirus (HPV) Infection and HPV-Associated Disease in Indian Men Who Have Sex With Men Who Are HIV-Positive
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 246
- 试验地点
- 3
- 主要终点
- Prevalence of HPV-associated high-grade anal intraepithelial neoplasia (HGAIN)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •HIV positive, as documented by any licensed HIV test according to the Indian National acquired immune deficiency syndrome (AIDS) Control Organization (NACO) guidelines
- •Participants report any sex with a man in the past 6 months
- •Participants must speak Hindi, Marathi, or English
- •Participants should not have any plans to move out of the area in the next 12 months and commit to attending two additional visits one at 6 months and one at 12 months
排除标准
- •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
- •Participants with impairments that, in the opinion of the site investigator, are temporary, will be asked to return another day for enrollment
- •Inability to provide informed consent
- •History of a sex change operation that would preclude collection of penile or scrotal specimens
结局指标
主要结局
Prevalence of HPV-associated high-grade anal intraepithelial neoplasia (HGAIN)
时间窗: Baseline
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.
Prevalence and incidence of human papillomavirus (HPV)
时间窗: Up to 12 months
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.
Prevalence of premalignant lesions of the penis
时间窗: Baseline
Will be calculated using proportions and exact 95% binomial CI.
次要结局
- The proportion of men with premalignant lesions of the penis at baseline according to reported number of sex partners in the last 6 months(baseline)
- The proportion of men with HGAIN at baseline according CD4+ level.(baseline)
- The proportion of men with HGAIN at baseline according to presence and absence of HPV infection (types 6, 11, 16, and/or 18).(Baseline)
- The proportion of men with premalignant lesions of the penis at baseline according CD4+ level.(baseline)
- The proportion of men with HGAIN at baseline according to reported number of sex partners in the last 6 months(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).(Baseline)