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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.

調査の概要

詳細な説明

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.

研究の種類

観察的

入学 (実際)

122

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

    • District of Columbia
      • Washington、District of Columbia、アメリカ、20009
        • DC Department of Corrections

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

サンプリング方法

非確率サンプル

調査対象母集団

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.

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

コホートと介入

グループ/コホート
介入・治療
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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Number of Entrants Tested
時間枠: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
時間枠: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
時間枠: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
時間枠:Up to 5 days
The number of entrants identified having an acute HIV infection will be examined.
Up to 5 days

二次結果の測定

結果測定
メジャーの説明
時間枠
Time Until Receipt of Positive Test Result
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

協力者

捜査官

  • 主任研究者:Anne Spaulding, MD, MPH、Emory University

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2020年11月10日

一次修了 (実際)

2021年9月3日

研究の完了 (実際)

2021年11月24日

試験登録日

最初に提出

2020年9月17日

QC基準を満たした最初の提出物

2020年9月17日

最初の投稿 (実際)

2020年9月23日

学習記録の更新

投稿された最後の更新 (実際)

2022年5月23日

QC基準を満たした最後の更新が送信されました

2022年5月20日

最終確認日

2022年5月1日

詳しくは

本研究に関する用語

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

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

IPD 共有時間枠

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

IPD 共有アクセス基準

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 共有サポート情報タイプ

  • STUDY_PROTOCOL
  • SAP

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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