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
1 other identifier
observational
6,613
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2019
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 14, 2019
CompletedFirst Submitted
Initial submission to the registry
March 3, 2020
CompletedFirst Posted
Study publicly available on registry
March 5, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 3, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2023
CompletedMay 22, 2023
May 1, 2023
1.9 years
March 3, 2020
May 18, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
HIV diagnostic test effectiveness
To determine the most effective HIV diagnostic test for routine opt-out testing in the correctional setting
6 months
Secondary Outcomes (2)
Linkage to care
6 months
Cost-effectiveness
6 months
Study Arms (3)
POC only
Participants who enter the DC Department of Corrections within the first 2 months of the study will be offered opt-out Point-of-Care (POC) rapid testing
POC + Ag/Ab
Participants who enter the DC Department of Corrections within the third and fourth months of the study will be offered opt-out POC and 4th generation laboratory-based antigen/antibody testing (Ag/Ab)
Ag/Ab only
Participants who enter the DC Department of Corrections within the fifth and sixth months of the study will be offered Ag/Ab testing.
Interventions
DC DOC's current testing practice offers opt-out POC testing with the INSTI® finger stick test at entry
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.
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
Eligibility Criteria
Individuals admitted to DC DOC between October 14th, 2019 and October 31st, 2020
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Montefiore Medical Centerlead
- Emory Universitycollaborator
- Unity Health Care, Inc.collaborator
- National Institutes of Health (NIH)collaborator
Study Sites (1)
Emory University
Atlanta, Georgia, 30322, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Matthew J Akiyama, MD, MSc
Montefiore Medical Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Medicine
Study Record Dates
First Submitted
March 3, 2020
First Posted
March 5, 2020
Study Start
October 14, 2019
Primary Completion
September 3, 2021
Study Completion
April 30, 2023
Last Updated
May 22, 2023
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will not share