A Randomized Controlled Clinical Trial of an Internet-based Prevention Intervention to Reduce STI in High-risk HIV Infected MSM
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 181
- 试验地点
- 6
- 主要终点
- STI incidence
研究概览
简要总结
This is a CCTG sponsored trial in collaboration with UCSD-AVRC investigators to get more information about the methods that are used on the internet to provide information on how to reduce the risk of giving or getting infections that are often or usually passed from one person to another during sexual or intimate contact (sexually transmitted infection (STI)). STIs include chlamydia, gonorrhea and syphilis. The purpose of this study is to develop methods that will allow someone who is living with HIV an easy way that they can get information and learn of ways on their own that can decrease their chances of getting sexually transmitted infections and ways that they can reduce the chance that they may transmit HIV to others.
详细描述
Design: CCTG 592 is a randomized, controlled study that will compare the efficacy of web-based intervention to reduce high-risk sexual behavior by persons living with HIV AIDS (PLWH).
Duration: 48 weeks
Sample Size: 200 subjects (100 per arm) that will be randomized
Study Population: HIV-1-infected men who have sex with men (MSM) at least 18 years of age who have a recent history of transmission risk behavior.
Stratification: Subjects will be stratified based upon their baseline antiretroviral use, whether they have a home computer and by site.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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-1 infection, as documented by any licensed screening antibody test, such as ELISA, and confirmed by a second antibody test, such as Western blot, or detectable plasma HIV-1 RNA at any time prior to study entry. If an ELISA or Western Blot are not available, HIV infection may be documented by two HIV RNA values > 2000 copies/mL, drawn at least 24 hours apart. The HIV RNA assays should have been run at a CLIA approved laboratory or equivalent.
- •18 years of age or older.
- •At least one of the following:
- •An HIV negative or unknown status sexual partner in the past three months.
- •A sexually transmitted disease in the past 1 year (other than HIV).
- •More than 2 male partners in past year.
- •Unprotected anal sex in past 3 month.
- •Capable of signing written informed consent.
- •Read and comprehend English
- •Adequate computer skills for study.
排除标准
- •Uncontrolled psychiatric condition.
- •Drug or alcohol users with use that in the opinion of the investigator, would limit follow-up and adequate consent
结局指标
主要结局
STI incidence
时间窗: Baseline and follow-up visits every 3 months
* To compare the composite STI incidence of syphilis or Chlamydia trachomatis (CT) or Neisseria gonorrhea (GC) at any mucosal site among sexually active HIV-infected men during 12 months participation in an Internet risk reduction intervention compared to those that receive a survey instrument alone. * To compare the incidence of nonspecific urethritis by urinalysis and testing for Mycoplasma genitalum and trichomonas sp. among sexually active HIV-infected men during 12 months participation in an Internet risk reduction intervention compared to those that receive a survey instrument alone.
次要结局
- Evaluate risk factors of STIs(Baseline, follow-up visits every 3 months)
研究者
Sheldon Morris
Clinical Professor
University of California, San Diego