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临床试验/NCT00624247
NCT00624247已完成早期 1 期

Early Versus Delayed Routine HIV Testing in Connecticut Jails

Yale University4 个研究点 分布在 1 个国家目标入组 621 人开始时间: 2007年8月最近更新:
适应症

试验速览

阶段
早期 1 期
状态
已完成
入组人数
621
试验地点
4
主要终点
The proportion of individuals in each testing group who are orally swabbed and consented to rapid HIV testing.

研究概览

简要总结

The objective of this non-randomized, controlled, trial is to evaluate the optimal time to approach newly incarcerated jail inmates for routine opt-out HIV testing in a manner that maximizes the number of individuals able to demonstrate capacity to consent and willingness to receive HIV testing.

详细描述

Primary outcome: proportion of individuals in each assigned group that agree to be swabbed for HIV testing and are able to consent to the study.

The prevalence of HIV infection in the United States is four times greater in correctional settings compared to the general population. Because prisons and jails house a population facing a disproportionate share of the burden of HIV infection, these facilities serve as important sites for the testing and treatment of HIV. The Center for Disease Control and Prevention's recent recommendations to implement routine opt-out HIV testing in all healthcare settings presents an important challenge and opportunity to correctional institutions. By effectively implementing routine opt-out testing, correctional facilities can expand HIV testing to one of society's most at-risk populations. Subsequently, testing can lead to appropriate access to counseling and treatment both within the correctional setting and upon release into the community.

Although jails interact with a larger number of individuals at risk for HIV infection than do prisons, they also pose unique logistical and health-related constraints in several important ways that impact HIV testing strategies. Jail populations experience short periods of incarceration and high rates of turnover with many-fold greater admissions and discharges. Jails also house individuals with higher rates of acute intoxication from psychoactive drugs, uncontrolled mental illness, and suicidal behavior. The suicide rate in jails is three times that in state prisons; nearly a quarter of these suicides take place within the first 48 hours of admission. Furthermore, the individuals who enter jails have higher recent risk behaviors for HIV than those in prisons.

Given these considerations, a major challenge to implementing routine opt-out HIV testing in jails is choosing the optimal time to conduct testing. The timing of delivering non-emergent, traumatically emotional health information (such as a preliminary positive result in an asymptomatic patient) must be carefully considered. Recently incarcerated inmates might be too intoxicated or psychologically distressed to demonstrate capacity to consent to or opt out of routine testing, and may be unprepared to consider and respond to the consequences of a preliminary positive HIV test result. Likewise, the challenge with postponing testing is that many individuals experience very short stays in jail, with approximately one-third leaving within 48 hours, followed by further attrition daily for the first week and may lose the opportunity for getting life-saving information in a timely manner.

Therefore, the objective of this study is to evaluate the optimal time to approach newly incarcerated jail inmates for routine opt-out HIV testing in a manner that maximizes the number of individuals able to demonstrate capacity to consent and willingness to receive HIV testing.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Screening
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All newly incarcerated inmates will be eligible for this study.

排除标准

  • 未提供

结局指标

主要结局

The proportion of individuals in each testing group who are orally swabbed and consented to rapid HIV testing.

时间窗: Immediately, the following evening, and 7 days post-entry

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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