CTRI/2022/09/045982尚未招募不适用
Incidence of Human Immunodeficiency Virus (HIV) among Indian Men who have Sex with Men
Department of Health Research1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2023年1月3日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- To determine the one-year incidence of HIV among high-risk MSM in India.
研究概览
简要总结
It is well established that men who have sex with men (MSM) have a higher risk of acquiring HIV than othermen.This has been demonstrated through studies of both prevalence and incidence in the US, Africa andAsia. It is likely that MSM in India would have a similarly higher risk for infection. Prevalence studies havedemonstrated that the proportion of Indian MSM infected with HIV is high.The objective of the study is to evaluate the prevalence of anal and penile HPV infection and prevalence of HPV-associated lesions of the anus andpenis amongst men in India having high risk MSM.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- Male
入选标准
- •1.Men age 18 or older 2.HIV sero-negative, as documented by any licensed HIV test according to NACO guidelines.
- •3.Participants report any sex with a man in the past 6 months.
- •4.Participants must speak Hindi, Marathi, or English.
- •5.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
- •1.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.
- •2.Participants with impairments that, in the opinion of the site Investigator, are temporary will be asked to return another day for enrollment.
- •3.Inability to provide informed consent.
- •4.History of a sex change operation that would preclude collection of penile or scrotal specimens.
结局指标
主要结局
To determine the one-year incidence of HIV among high-risk MSM in India.
时间窗: 52 weeks
次要结局
- 1.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.)
研究者
研究点 (1)
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