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临床试验/NCT04296331
NCT04296331已完成不适用

Enhancing a Universal Testing and Treatment Strategy in Jail to Promote Viral Load Suppression Among Justice-involved People Living With HIV

Montefiore Medical Center1 个研究点 分布在 1 个国家目标入组 6,613 人开始时间: 2019年10月14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
6,613
试验地点
1
主要终点
HIV diagnostic test effectiveness

研究概览

简要总结

"Enhancing a universal testing and treatment strategy in jail to promote viral load suppression among justice-involved people living with HIV" is an observational research study led by Dr. Matthew Akiyama, MSc of Albert Einstein College of Medicine and Montefiore Medical Center and Dr. Anne Spaulding, MPH of Emory University's Rollins School of Public Health. Due to the high rates of undiagnosed Human Immunodeficiency Virus (HIV) in the correctional setting and the short length of stay in jails, this study aims to evaluate whether care coordination within the D.C. Central Detention Facility (DC DOC) and upon release, including testing procedures and antiretroviral therapy (ART) initiation, can improve the connection of adults (age 18 and over) living with HIV to care in the community.

The researchers will retrospectively look at the aggregate-level de-identified data of roughly 3,000 individuals admitted to the DC DOC over a 6-month period to determine the most effective HIV diagnostic test for routine opt-out testing in the correctional setting. Over the course of these 6 months, the correctional facility will transition from using POC only to POC + antigen/antibody (Ag/Ab), to solely using Ag/Ab, each for a 2-month duration. Individuals from this time period who are identified by corrections staff as HIV-positive either through testing upon admission, their electronic medical record (EMR) or self-report, and have a known release date will be considered eligible for the follow-up study to assess if care coordination is effective in linking others with HIV leaving the DC DOC to care. This follow-up will enroll 100 of these individuals who have consented to participate following their release from the DC DOC, and will consist of a chart review of their DC DOC EMRs and those from their community healthcare provider for up to two years after their release.

详细描述

This study will be the first to assess the feasibility, process measures, and estimate cost-effectiveness of a rapid Universal Testing and Treatment (rUTT) intervention in a large urban jail located in Washington, DC - 1 of the 50 communities targeted for End the HIV Epidemic (EtHE) efforts. The aim is to determine the most effective HIV diagnostic test to use for routine opt-out testing in the correctional setting.

The investigators hypothesize that the combination of opt-out POC and Ag/Ab tests offered at intake will maximize the yield of PLWH detected, provision of test results, ART initiation, viral suppression, and cost-effectiveness.

The investigators will examine administrative, de-identified, aggregate data for approximately 3000 individuals (based on 500 individuals currently accepting HIV testing per month) over 6 months. For individuals who provide consent to release their jail medical records after incarceration, the investigators will retrieve the mean time from: 1) positive test to receipt of test results, 2) receipt of test results to first dose of ART in jail, 3) receipt of post-test counseling to meeting the discharge planner, and 4) ART initiation to viral suppression defined as a viral load <200 copies/mL. The investigators will calculate the implementation costs of each strategy using observation of staff time, market values for items used in the intervention, and process measure data collected through chart review (for individuals who consent to release their jail medical records after incarceration). Units of resource items, such as staff time and diagnostic tests, will be multiplied by their unit costs to calculate total costs.

This protocol does not constitute research involving prisoners (as outlined by the U.S. Department of Health & Human Services Office for Human Research Protections - https://www.hhs.gov/ohrp/regulations-and-policy/guidance/faq/prisoner-research/index.html) since the investigators will not be:

  1. Obtaining identifiable private data or information about prisoner subjects through intervention or interaction with them while incarcerated.
  2. Seeking the informed consent of prisoners to be subjects in research;
  3. Using, studying or analyzing, for research purposes, identifiable private information about prisoners, or identifiable specimens obtained from prisoners; or
  4. Surveying prisoners for this research study.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

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

  • Admitted to DC DOC between October 14th, 2019 and October 31st, 2020
  • Has initiated ART by time of release
  • Being HIV-positive: confirmed either through HIV testing upon entry, was known to be HIV-positive through the EMR, or self-reported being HIV-positive

排除标准

  • 未提供

结局指标

主要结局

HIV diagnostic test effectiveness

时间窗: 6 months

To determine the most effective HIV diagnostic test for routine opt-out testing in the correctional setting

次要结局

  • Cost-effectiveness(6 months)
  • Linkage to care(6 months)

研究者

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

Matthew Akiyama

Assistant Professor of Medicine

Montefiore Medical Center

研究点 (1)

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