Neurobehavioral Model of HIV in Injection Drug Users
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 836
- 试验地点
- 1
- 主要终点
- HIV-Risk Behavior Outcomes
研究概览
简要总结
The purpose of this R01 study is to evaluate the association between neuropsychological executive dysfunction and HIV infection among young injection and non-injection drug users. A longitudinal study will be conducted in which the cohort of seronegative drug users completing a baseline neuropsychological battery are re-assessed on three subsequent occasions, roughly six months apart. The primary aim of the longitudinal study is to estimate the magnitude of the suspected causal relationship between executive dysfunction and HIV-risk behaviors while adjusting for time-invariant (e.g. sex, ethnicity) and time-varying (e.g. degree of drug abuse) covariates. We also seek to evaluate: (1) the degree to which specific executive dysfunctions predispose heroin and cocaine users to high-risk injection practices or sex behaviors, and (2) whether observed relationship between executive dysfunction and HIV-risk behaviors can be understood independent of levels of drug -taking frequency, or whether the observed data are more consistent with complex patterns of interdependency between executive dysfunction, drug-taking frequency, and HIV-risk-behaviors. If successful, this project will shed new light on significant and potentially malleable HIV-risk factors in injection and non-injection drug users. This will be important evidence because injection drug abuse continues to account for a large proportion of HIV seroconversions particularly among young women and minorities. As such, this RO1 research project serves as an important initial step in a line of innovative investigations about suspected causal associations between neuropsychological deficits and HIV-risk behaviors in drug users. Ultimately, this line of investigation should lead to changes in public and clinical practices designed to prevent HIV infection.
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
- 15 Years 至 50 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Drug users aged 15 to 50 years old.
排除标准
- •Acute psychotic, suicidal, homicidal ideation.
结局指标
主要结局
HIV-Risk Behavior Outcomes
时间窗: Outcome measure will be assessed at 6, 12 , and up to 18 months after enrollment.
Among the drug-related HIV-risk behaviors are drug use cessation and relapse, risky injection practices, including direct and indirect syringe sharing, disinfection practices, and injection in high risk contexts (e.g. shooting galleries). Sexual practices include number and types of partners (gender), type(s) of sexual acts (oral, vaginal and anal intercourse), condom use, survival sex (sex for money, drugs, shelter, food and protection), and incident sexually transmitted diseases.
次要结局
- Serologic Outcomes(Outcome measure will be assessed at 6, 12 , and up to 18 months after enrollment.)
- Executive Functions(Outcome measure will be assessed at 6, 12 , and up to 18 months after enrollment.)
研究者
Dr. William Latimer
Professor and Dean
The City College of New York
