HIV Jail POC-AgAB Testings

NCT04296331 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 6613

Last updated 2023-05-22

No results posted yet for this 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

Interventions

DIAGNOSTIC_TEST

POC

DC DOC's current testing practice offers opt-out POC testing with the INSTI® finger stick test at entry

DIAGNOSTIC_TEST

Ag/Ab

The DC DOC will transition from offering their current POC testing upon entry to offering opt-out HIV testing with Ag/Ab: ARCHITECT® laboratory-based test.

DIAGNOSTIC_TEST

POC + Ag/Ab

As the DC DOC transitions to utilizing the Ag/Ab: ARCHITECT® laboratory-based test from their current POC testing, jail nurses will offer new entrants op-out testing with the two methods

Sponsors & Collaborators

  • Emory University

    collaborator OTHER
  • Unity Health Care, Inc.

    collaborator INDUSTRY
  • National Institutes of Health (NIH)

    collaborator NIH
  • Montefiore Medical Center

    lead OTHER

Principal Investigators

  • Matthew J Akiyama, MD, MSc · Montefiore Medical Center

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-14
Primary Completion
2021-09-03
Completion
2023-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04296331 on ClinicalTrials.gov