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Human Immunodeficiency VirusNCT04560556

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

An observational study of Human Immunodeficiency Virus, run by Emory University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Human Immunodeficiency Virus
What is being tested?
Point-of-Care (POC) Rapid HIV Test and Fourth Generation Antigen/antibody (Ag/Ab) HIV Test
How many people
122 participants
Where
1 siteUnited States
Study dates
10 Nov 2020to 24 Nov 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • none

Trial locations and contacts

1 site in 1 country.

United States1 site
  • DC Department of Corrections

    Washington D.C., District of Columbia, 20009

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Point-of-Care (POC) Rapid HIV Test, Fourth Generation Antigen/antibody (Ag/Ab) HIV Test
Keywords
Correctional settings, HIV/AIDS
Medical subject headings
Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Point-of-Care (POC) Rapid HIV TestDiagnostic 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.

  • Fourth Generation Antigen/antibody (Ag/Ab) HIV TestDiagnostic 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.

Study groups in NCT04560556
Study groupRoleWhat they receive
POC Testing AlonePOC HIV testing (the current standard of care) will be conducted for persons entering jail during the first two-month period.
Receives: Diagnostic Test: Point-of-Care (POC) Rapid HIV Test
POC and 4th Generation TestingPOC plus 4th Generation HIV Testing will be conducted for persons entering jail during the second two-month period.
Receives: Diagnostic Test: Point-of-Care (POC) Rapid HIV Test; Diagnostic Test: Fourth Generation Antigen/antibody (Ag/Ab) HIV Test
4th Generation Testing Alone4th Generation HIV Testing will be conducted for persons entering jail during the third two-month period.
Receives: Diagnostic Test: Fourth Generation Antigen/antibody (Ag/Ab) HIV Test

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Entrants Tested

    The number of entrants receiving an HIV test within 24 hours of intake will be examined.

    Measured: Up to 24 hours

  2. 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.

    Measured: Up to 24 hours

  3. 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.

    Measured: Up to Jail Discharge

  4. Number of Entrants with Acute HIV Infection Identified

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

    Measured: Up to 5 days

Secondary outcomes (8)
  1. 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.

    Measured: Up to 5 days

  2. Time Until Receipt of Antiviral Dose

    The time (in days) from entry until receipt of first dose of antiviral in the jail, for PLWH.

    Measured: Up to Jail Discharge

  3. Time Until Viral Suppression

    For all PLWH, the time (in days) from entry to achieving viral suppression, if not suppressed at baseline.

    Measured: 6 months after positive HIV intake test

  4. Time Until Meeting with Discharge Planner

    For all PLWH, the time (in days) from intake to meeting the discharge planner.

    Measured: Up to Jail Discharge

  5. 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.

    Measured: 2 months after jail release, 6 months after jail release

  6. 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.

    Measured: 1 year

  7. 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.

    Measured: 6 months

  8. 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.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Sep 2020
  2. Study start10 Nov 2020
  3. Primary completion3 Sep 2021
  4. Study completion24 Nov 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
122 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04560556
Sponsor's protocol ID
IRB00115929
Status last verified
May 2022
First submitted
17 Sep 2020
Last updated
23 May 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified laboratory results, demographics, and survey questions may be made available to other researchers.

Questions about this trial

What is this clinical trial studying?

An observational study of Human Immunodeficiency Virus, run by Emory University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Entrants Tested (time frame: Up to 24 hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2022.

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