Cohort Study of HIV-1 Incidence Among Clients of the Thai Red Cross AIDS Research Center, Bangkok, Thailand
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 992
- 试验地点
- 1
- 主要终点
- Risk behavior by questionnaire
研究概览
简要总结
The purpose of this study is to assess populations in Thailand at high risk for HIV-1 infection for potential efficacy trials of candidate HIV vaccines to include:
- assess incidence of HIV-1 and volunteer retention
- describe early viral load and CD4 counts
- assess participant willingness to participate in HIV vaccine efficacy trials and other HIV prevention trials
- describe volunteer risk behavior
详细描述
Prospective cohort study of HIV-negative participants who will receive voluntary counseling and testing (VCT) for HIV-antibody in conjunction with questionnaires on risk behavior, willingness to participate in HIV vaccine trials and other HIV prevention trials at 4 month intervals for a period of 1 year. This study will follow 1000 HIV-negative volunteers with an expected minimum of 15-20 incident HIV-infections based on a minimum incidence rate of 1.5/100 person-years. Weighted incidence estimates will be calculated with exact 95% confidence intervals.
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Man or woman aged 18-50 years
- •Willing to provide location or contact information and allow contact
- •Thai citizenship as identified by Thai National Identification card
- •Ability and willingness to provide consent
- •Availability for follow-up for the planned study duration
排除标准
- •Persons who have a history of a medical or psychiatric disorder, that in the judgment of the investigator(s), would interfere with or serve as a contraindication to adherence to the study protocol or ability to give informed consent
- •Persons who are known to be HIV-positive
结局指标
主要结局
Risk behavior by questionnaire
时间窗: 5 years
number of HIV-1 infections per 100 person-years
时间窗: 5 years
Lost to follow-up on an annual basis (10% or better)
时间窗: 5 years
Post-infection viral load and CD4 count
时间窗: 5 years
Willingness to participate in HIV vaccine and prevention trials
时间窗: 5 years
次要结局
- HIV-1 prevalence(5 years)
- HIV-1 genotype distribution(5 years)
研究者
Assoc.Prof.Jintanat Ananworanich, M.D.
Jintanat Ananworanich
SEARCH Research Foundation