Incidence of Human Immunodeficiency Virus (HIV) Among Indian Men Who Have Sex With Men (MSM)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 150
- 试验地点
- 3
- 主要终点
- Incidence of human immunodeficiency virus (HIV)
研究概览
简要总结
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.
详细描述
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.
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 seronegative, as documented by any licensed HIV test according to National Acquired Immunodeficiency 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
- •Participant 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
Incidence of human immunodeficiency virus (HIV)
时间窗: Up to 12 months
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.
次要结局
- Prevalence of anal human papillomavirus (HPV) infection, assessed by polymerase chain reaction (PCR)(Up to 12 months)
- Successful respondent-driven sampling (RDS)(12 months)
- Prevalence of human papillomavirus (HPV)-associated lesions of the penis(Up to 12 months)
- Prevalence of penile human papillomavirus (HPV) infection, assessed by polymerase chain reaction (PCR)(Up to 12 months)
- Prevalence of human papillomavirus (HPV)-associated lesions of the anus(Up to 12 months)