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Linking Persons With HIV, Discharged From Jail, With Community Care

2022年5月20日 更新者:Anne C Spaulding、Emory University

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

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.

研究概览

详细说明

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.

研究类型

观察性的

注册 (实际的)

122

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • District of Columbia
      • Washington、District of Columbia、美国、20009
        • DC Department of Corrections

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Participants will be enrolled from the study population of NCT04296331, comprised of individuals admitted to D.C. Central Detention Facility (DC DOC) between October 2019 and April 2021.

描述

Inclusion Criteria for Those Testing Negative for HIV:

  • Able to understand and speak English
  • Confirmed HIV negative status
  • Planning to stay in the metropolitan DC area upon jail release
  • Candidate for PrEP using attached screening instrument and interested in taking it

Inclusion Criteria for Those Testing Positive for HIV:

  • Able to understand and speak English
  • Confirmed HIV positive status
  • Planning to stay in the metropolitan DC area upon jail release

Exclusion Criteria:

  • none

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
干预/治疗
POC Testing Alone
POC HIV testing (the current standard of care) will be conducted for persons entering jail during the first two-month period.
Point-of-care (POC) rapid HIV testing provides results within minutes, however, it cannot reliably detect new infections. It can take up to 90 days after exposure for HIV infections to be diagnosed with POC rapid testing.
POC and 4th Generation Testing
POC plus 4th Generation HIV Testing will be conducted for persons entering jail during the second two-month period.
Point-of-care (POC) rapid HIV testing provides results within minutes, however, it cannot reliably detect new infections. It can take up to 90 days after exposure for HIV infections to be diagnosed with POC rapid testing.
Fourth generation laboratory-based antigen/antibody (Ag/Ab) HIV testing can detect acute HIV infections (as early as 18 days after exposure), but it takes several hours to process.
4th Generation Testing Alone
4th Generation HIV Testing will be conducted for persons entering jail during the third two-month period.
Fourth generation laboratory-based antigen/antibody (Ag/Ab) HIV testing can detect acute HIV infections (as early as 18 days after exposure), but it takes several hours to process.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Number of Entrants Tested
大体时间:Up to 24 hours
The number of entrants receiving an HIV test within 24 hours of intake will be examined.
Up to 24 hours
Percentage of PLWH Identified in First 24 Hours
大体时间:Up to 24 hours
The percentage of PLWH identified within the first 24 hours of admission, among all PLWH who enter, will be examined.
Up to 24 hours
Number of New HIV Diagnosed Prior to Discharge
大体时间:Up to Jail Discharge
The number of persons with a new diagnosis of HIV who receive test results before discharge will be examined.
Up to Jail Discharge
Number of Entrants with Acute HIV Infection Identified
大体时间:Up to 5 days
The number of entrants identified having an acute HIV infection will be examined.
Up to 5 days

次要结果测量

结果测量
措施说明
大体时间
Time Until Receipt of Positive Test Result
大体时间:Up to 5 days
The time (in hours) from the positive test result in persons not previously diagnosed and receipt of test report.
Up to 5 days
Time Until Receipt of Antiviral Dose
大体时间:Up to Jail Discharge
The time (in days) from entry until receipt of first dose of antiviral in the jail, for PLWH.
Up to Jail Discharge
Time Until Viral Suppression
大体时间:6 months after positive HIV intake test
For all PLWH, the time (in days) from entry to achieving viral suppression, if not suppressed at baseline.
6 months after positive HIV intake test
Time Until Meeting with Discharge Planner
大体时间:Up to Jail Discharge
For all PLWH, the time (in days) from intake to meeting the discharge planner.
Up to Jail Discharge
Number of Participants Taking PrEP
大体时间:2 months after jail release, 6 months after jail release
For those consenting to the first sub-study, the number of high-risk persons who test negative for HIV who successfully link to PrEP within 2 months of jail release and stay on PrEP for at least 6 months will be examined.
2 months after jail release, 6 months after jail release
Number of PLWH who Attend Clinic Visits
大体时间:1 year
For persons living with HIV who consent to the second sub-study, the percentage of persons previously and newly diagnosed who make clinic visits at least once every 6 months will be examined.
1 year
Number of PLWH with Viral Suppression
大体时间:6 months
For persons living with HIV who consent to the second sub-study, the percentage of persons previously and newly diagnosed who are virally suppressed 6 months after sub-study enrollment.
6 months
Cost of Each Testing Strategy
大体时间:6 months
A cost-effectiveness analysis using the intermediate process measures will be conducted. Units of resource items, such as tests and staff time, will be multiplied by their unit costs to calculate total costs. Wage ranges provided by DOC and Unity Healthcare will be used to price staff time; market values will be used for all other items. Costs will then be summed by testing strategy.
6 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

合作者

调查人员

  • 首席研究员:Anne Spaulding, MD, MPH、Emory University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2020年11月10日

初级完成 (实际的)

2021年9月3日

研究完成 (实际的)

2021年11月24日

研究注册日期

首次提交

2020年9月17日

首先提交符合 QC 标准的

2020年9月17日

首次发布 (实际的)

2020年9月23日

研究记录更新

最后更新发布 (实际的)

2022年5月23日

上次提交的符合 QC 标准的更新

2022年5月20日

最后验证

2022年5月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

IPD 计划说明

De-identified laboratory results, demographics, and survey questions may be made available to other researchers.

IPD 共享时间框架

Individual participant data will available for sharing after publication of the main article from this study.

IPD 共享访问标准

Individual participant data will be available for sharing with fellow researchers who submit a proposal for secondary data analysis. Proposals should be sent to aspauld@emory.edu.

IPD 共享支持信息类型

  • 研究方案
  • 树液

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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