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

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Emory University

Status

Completed

Conditions

Human Immunodeficiency Virus

Treatments

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

Study type

Observational

Funder types

Other
Industry

Identifiers

NCT04560556
IRB00115929

Details and patient eligibility

About

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.

Full 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.

Enrollment

122 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

122 participants in 3 patient groups

POC Testing Alone
Description:
POC HIV testing (the current standard of care) will be conducted for persons entering jail during the first two-month period.
Treatment:
Diagnostic Test: Point-of-Care (POC) Rapid HIV Test
POC and 4th Generation Testing
Description:
POC plus 4th Generation HIV Testing will be conducted for persons entering jail during the second two-month period.
Treatment:
Diagnostic Test: Point-of-Care (POC) Rapid HIV Test
Diagnostic Test: Fourth Generation Antigen/antibody (Ag/Ab) HIV Test
4th Generation Testing Alone
Description:
4th Generation HIV Testing will be conducted for persons entering jail during the third two-month period.
Treatment:
Diagnostic Test: Fourth Generation Antigen/antibody (Ag/Ab) HIV Test

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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