Linking Persons With HIV, Discharged From Jail, With Community Care

NCT04560556 | Completed

• 1 other identifier: IRB00115929
• Study Type: observational
• Target: 122
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Human Immunodeficiency Virus

Keywords

Correctional settings; HIV/AIDS

Outcome Measures

Primary Outcomes (4)

• Number of Entrants Tested

  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

  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

  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

  The number of entrants identified having an acute HIV infection will be examined.

  Up to 5 days

Secondary Outcomes (8)

• Time Until Receipt of Positive Test Result

  Up to 5 days

• Time Until Receipt of Antiviral Dose

  Up to Jail Discharge

• Time Until Viral Suppression

  6 months after positive HIV intake test

• Time Until Meeting with Discharge Planner

  Up to Jail Discharge

• Number of Participants Taking PrEP

  2 months after jail release, 6 months after jail release

Study Arms (3)

POC Testing Alone

POC HIV testing (the current standard of care) will be conducted for persons entering jail during the first two-month period.

Diagnostic Test: Point-of-Care (POC) Rapid HIV Test

POC and 4th Generation Testing

POC plus 4th Generation HIV Testing will be conducted for persons entering jail during the second two-month period.

Diagnostic Test: Point-of-Care (POC) Rapid HIV Test; Diagnostic Test: Fourth Generation Antigen/antibody (Ag/Ab) HIV Test

4th Generation Testing Alone

4th Generation HIV Testing will be conducted for persons entering jail during the third two-month period.

Diagnostic Test: Fourth Generation Antigen/antibody (Ag/Ab) HIV Test

Interventions

Point-of-Care (POC) Rapid HIV Test DIAGNOSTIC_TEST

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 Testing Alone; POC and 4th Generation Testing

Fourth Generation Antigen/antibody (Ag/Ab) HIV Test DIAGNOSTIC_TEST

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; POC and 4th Generation Testing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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
• Able to understand and speak English
• Confirmed HIV positive status
• Planning to stay in the metropolitan DC area upon jail release

You may not qualify if:

• none

Sponsors & Collaborators

• Emory University: lead
• Gilead Sciences: collaborator

Study Sites (1)

DC Department of Corrections

Washington D.C., District of Columbia, 20009, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

HIV Testing

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Microbiological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Anne Spaulding, MD, MPH

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 17, 2020
• First Posted: September 23, 2020
• Study Start: November 10, 2020
• Primary Completion: September 3, 2021
• Study Completion: November 24, 2021
• Last Updated: May 23, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Individual participant data will available for sharing after publication of the main article from this study.
• Access Criteria: 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.

Locations

US (1)