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

Linking Persons With HIV, Discharged From Jail, With Community Care: a Direct Comparison of the Costs and Effects of Three HIV Management Strategies in the District of Columbia Department of Corrections

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.

Study Overview

• Status: Completed
• Conditions: Human Immunodeficiency Virus
• Intervention / Treatment: Diagnostic test: Point-of-Care (POC) Rapid HIV Test; Diagnostic test: Fourth Generation Antigen/antibody (Ag/Ab) HIV Test

Detailed Description

Incarcerated Americans on any given day represent one in 40 (2.5%) Persons Living with HIV (PLWH) in this country, but those ever incarcerated over the course of a year represent 17% of the US epidemic. PLWH are a diverse group in terms of awareness and management of their disease. A portion may be aware of their HIV status and on treatment. This subgroup is at risk of disruption in care if incarcerated. Others may be aware of their status, but untreated, while still others may be unaware of their HIV status. The latter group is of particular importance in terms of the HIV epidemic in criminal justice settings, as a recent meta-analysis indicated that up to 15% of individuals entering jail have undiagnosed infections.

Good management of PLWH during a period of incarceration is critical. Ensuring that care relationships are maintained or newly established will improve health outcomes among PLWH and reduce the risk of transmission once they are discharged. As the median length of stay in jail is short (median < 7 days), rapid HIV testing is critical. Maximizing the yield and speed of HIV testing in a jail environment has the potential to promote rapid entry into care, or rapid re-engagement if persons have fallen out of care. For those testing negative, it can hasten the referral to Pre-Exposure Prophylaxis (PrEP) services.

How correctional facilities offer HIV testing and begin treatment affects long-term outcomes. Because of the rapid churn of jail, point-of-care (POC) rapid testing may lead to a higher percentage of patients receiving test results before leaving jail, compared to conventional assays. Fourth generation laboratory-based antigen/antibody (Ag/Ab) testing can diagnosis more persons with acute HIV infection, who may be in the window period before the POC test turns positive, but has a several hour test turn-around time, and those tested may leave jail before receiving their result. Using both tests for every entrant would permit the jail to experience the benefit of both methods but at greater expense. Collaborating with Washington, DC's city jail, known as DC Department of Corrections (DC DOC), and Unity Healthcare, the network of Federally Qualified Health Centers in Washington DC, which also provides care within the DC DOC, this study has a unique opportunity to measure rapidity of testing, linkage to and commencement of care, and achievement of viral suppression, along with costs of HIV identification.

This study uses a unique, time-sensitive opportunity to compare three separate strategies of universal HIV screening and treating. The strategies of POC testing, 4th generation laboratory-based Ag/Ab testing, and a combination of the two tests will be compared in the DC jail. A rigorous assessment of the three strategies in terms of their feasibility, process measures, and cost-effectiveness on an institutional level will help to guide implementation decisions in jails across the US.

One sub-study will assess the number of persons testing negative who are referred to prevention programs after leaving the jail. A second sub-study will examine antiviral use after jail release, among PLWH.

• Study Type: Observational
• Enrollment (Actual): 122

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20009
      • DC Department of Corrections

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria for Those Testing Negative for HIV:

• 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

Inclusion Criteria for Those Testing Positive for HIV:

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

Exclusion Criteria:

• none

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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 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; 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.; Diagnostic test: Fourth Generation Antigen/antibody (Ag/Ab) HIV 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; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time Until Receipt of Positive Test Result	The time (in hours) from the positive test result in persons not previously diagnosed and receipt of test report.	Up to 5 days
Time Until Receipt of Antiviral Dose	The time (in days) from entry until receipt of first dose of antiviral in the jail, for PLWH.	Up to Jail Discharge
Time Until Viral Suppression	For all PLWH, the time (in days) from entry to achieving viral suppression, if not suppressed at baseline.	6 months after positive HIV intake test
Time Until Meeting with Discharge Planner	For all PLWH, the time (in days) from intake to meeting the discharge planner.	Up to Jail Discharge
Number of Participants Taking PrEP	For those consenting to the first sub-study, the number of high-risk persons who test negative for HIV who successfully link to PrEP within 2 months of jail release and stay on PrEP for at least 6 months will be examined.	2 months after jail release, 6 months after jail release
Number of PLWH who Attend Clinic Visits	For persons living with HIV who consent to the second sub-study, the percentage of persons previously and newly diagnosed who make clinic visits at least once every 6 months will be examined.	1 year
Number of PLWH with Viral Suppression	For persons living with HIV who consent to the second sub-study, the percentage of persons previously and newly diagnosed who are virally suppressed 6 months after sub-study enrollment.	6 months
Cost of Each Testing Strategy	A cost-effectiveness analysis using the intermediate process measures will be conducted. Units of resource items, such as tests and staff time, will be multiplied by their unit costs to calculate total costs. Wage ranges provided by DOC and Unity Healthcare will be used to price staff time; market values will be used for all other items. Costs will then be summed by testing strategy.	6 months

Collaborators and Investigators

• Sponsor: Emory University
• Collaborators: Gilead Sciences
• Investigators: Principal Investigator: Anne Spaulding, MD, MPH, Emory University

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2020
• Primary Completion (Actual): September 3, 2021
• Study Completion (Actual): November 24, 2021

Study Registration Dates

• First Submitted: September 17, 2020
• First Submitted That Met QC Criteria: September 17, 2020
• First Posted (Actual): September 23, 2020

Study Record Updates

• Last Update Posted (Actual): May 23, 2022
• Last Update Submitted That Met QC Criteria: May 20, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: HIV/AIDS; Correctional settings
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases; HIV Infections; Acquired Immunodeficiency Syndrome; Physiological Effects of Drugs; Immunologic Factors; Antibodies
• Other Study ID Numbers: IRB00115929

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified laboratory results, demographics, and survey questions may be made available to other researchers.
• IPD Sharing Time Frame: Individual participant data will available for sharing after publication of the main article from this study.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No