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NCT04296331 · ClinicalTrials.gov registry record

HIV Jail POC-AgAB Testings

A clinical trial of HIV/AIDS, sponsored by Montefiore Medical Center.

Completed
Registry status
6,613
Enrollment target
1
Study location

NCT04296331 is a study of HIV/AIDS that has completed, run by Montefiore Medical Center. The registered enrollment target is 6,613 participants, below the 33,072-participant average among 61 other HIV/AIDS trials with a reported enrollment target (80% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT04296331, a study of HIV/AIDS, has completed, sponsored by Montefiore Medical Center.

COMPLETED
Registry status
6,613 participants
Enrollment target
1
Study location

Study Summary

"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.

Conditions Studied

HIV/AIDS

Interventions

  • DIAGNOSTIC_TEST POC
  • DIAGNOSTIC_TEST Ag/Ab
  • DIAGNOSTIC_TEST POC + Ag/Ab

Study Locations (1)

Georgia

  • Emory University - Atlanta

Trial Details

FieldValue
Enrollment Target 6,613 participants
Start Date 2019-10-14
Est. Completion 2023-04-30

Sponsor

Montefiore Medical Center

345 total trials

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What the Registry Record Tells You About NCT04296331

The ClinicalTrials.gov registry entry for NCT04296331 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 6,613 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 33,072-participant average among 61 other HIV/AIDS trials with a reported enrollment target (80% lower). The listed sponsor is Montefiore Medical Center, which has 345 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with HIV/AIDS appearing as the primary indexed condition, and to 3 interventions - of which POC is the first listed.

NCT04296331 reports 1 study location spanning 1 distinct geographic area - top geographies include Georgia.

Frequently Asked Questions

What is clinical trial NCT04296331 about?

NCT04296331 is a clinical study titled "HIV Jail POC-AgAB Testings". "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 Spauldin...

What is the current status of trial NCT04296331?

This trial is currently completed. The enrollment target is 6,613 participants. The study started on 2019-10-14. Estimated completion is 2023-04-30.

What conditions does trial NCT04296331 study?

This clinical trial studies the following conditions: HIV/AIDS.

What interventions are being tested in trial NCT04296331?

The interventions under investigation include: POC (DIAGNOSTIC_TEST), Ag/Ab (DIAGNOSTIC_TEST), POC + Ag/Ab (DIAGNOSTIC_TEST).

Who is sponsoring clinical trial NCT04296331?

This trial is sponsored by Montefiore Medical Center, which has 345 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04296331 being conducted?

This trial has 1 study location across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.