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临床试验/NCT04560556
NCT04560556已完成不适用

Linking Persons With HIV, Discharged From Jail, With Community Care: a Direct Comparison of the Costs and Effects of Three HIV Management Strategies in the District of Columbia Department of Corrections

Emory University1 个研究点 分布在 1 个国家目标入组 122 人开始时间: 2020年11月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
122
试验地点
1
主要终点
Number of Entrants Tested

研究概览

简要总结

This is a prospective cohort study of outcomes of individuals who entered jail during a period during which one of three serial HIV testing strategies is implemented. This study involves two sub-studies. One sub-study will examine referrals to HIV prevention programs for persons testing negative for HIV while in jail. The second sub-study will monitor antiviral use among those testing positive for HIV.

详细描述

Incarcerated Americans on any given day represent one in 40 (2.5%) Persons Living with HIV (PLWH) in this country, but those ever incarcerated over the course of a year represent 17% of the US epidemic. PLWH are a diverse group in terms of awareness and management of their disease. A portion may be aware of their HIV status and on treatment. This subgroup is at risk of disruption in care if incarcerated. Others may be aware of their status, but untreated, while still others may be unaware of their HIV status. The latter group is of particular importance in terms of the HIV epidemic in criminal justice settings, as a recent meta-analysis indicated that up to 15% of individuals entering jail have undiagnosed infections.

Good management of PLWH during a period of incarceration is critical. Ensuring that care relationships are maintained or newly established will improve health outcomes among PLWH and reduce the risk of transmission once they are discharged. As the median length of stay in jail is short (median < 7 days), rapid HIV testing is critical. Maximizing the yield and speed of HIV testing in a jail environment has the potential to promote rapid entry into care, or rapid re-engagement if persons have fallen out of care. For those testing negative, it can hasten the referral to Pre-Exposure Prophylaxis (PrEP) services.

How correctional facilities offer HIV testing and begin treatment affects long-term outcomes. Because of the rapid churn of jail, point-of-care (POC) rapid testing may lead to a higher percentage of patients receiving test results before leaving jail, compared to conventional assays. Fourth generation laboratory-based antigen/antibody (Ag/Ab) testing can diagnosis more persons with acute HIV infection, who may be in the window period before the POC test turns positive, but has a several hour test turn-around time, and those tested may leave jail before receiving their result. Using both tests for every entrant would permit the jail to experience the benefit of both methods but at greater expense. Collaborating with Washington, DC's city jail, known as DC Department of Corrections (DC DOC), and Unity Healthcare, the network of Federally Qualified Health Centers in Washington DC, which also provides care within the DC DOC, this study has a unique opportunity to measure rapidity of testing, linkage to and commencement of care, and achievement of viral suppression, along with costs of HIV identification.

This study uses a unique, time-sensitive opportunity to compare three separate strategies of universal HIV screening and treating. The strategies of POC testing, 4th generation laboratory-based Ag/Ab testing, and a combination of the two tests will be compared in the DC jail. A rigorous assessment of the three strategies in terms of their feasibility, process measures, and cost-effectiveness on an institutional level will help to guide implementation decisions in jails across the US.

One sub-study will assess the number of persons testing negative who are referred to prevention programs after leaving the jail. A second sub-study will examine antiviral use after jail release, among PLWH.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Number of Entrants Tested

时间窗: Up to 24 hours

The number of entrants receiving an HIV test within 24 hours of intake will be examined.

Number of Entrants with Acute HIV Infection Identified

时间窗: Up to 5 days

The number of entrants identified having an acute HIV infection will be examined.

Percentage of PLWH Identified in First 24 Hours

时间窗: Up to 24 hours

The percentage of PLWH identified within the first 24 hours of admission, among all PLWH who enter, will be examined.

Number of New HIV Diagnosed Prior to Discharge

时间窗: Up to Jail Discharge

The number of persons with a new diagnosis of HIV who receive test results before discharge will be examined.

次要结局

  • Time Until Receipt of Antiviral Dose(Up to Jail Discharge)
  • Time Until Receipt of Positive Test Result(Up to 5 days)
  • Time Until Viral Suppression(6 months after positive HIV intake test)
  • Time Until Meeting with Discharge Planner(Up to Jail Discharge)
  • Number of Participants Taking PrEP(2 months after jail release, 6 months after jail release)
  • Number of PLWH with Viral Suppression(6 months)
  • Number of PLWH who Attend Clinic Visits(1 year)
  • Cost of Each Testing Strategy(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Anne C Spaulding

Associate Professor

Emory University

研究点 (1)

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