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.
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
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.
- Conditions
- Human Immunodeficiency Virus
- 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 group | Role | What they receive |
|---|---|---|
| POC Testing Alone | POC 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 Testing | POC 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 Alone | 4th 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.
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
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
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
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)
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
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
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
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
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
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
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
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.
- First posted23 Sep 2020
- Study start10 Nov 2020
- Primary completion3 Sep 2021
- Study completion24 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Immunodeficiency VirusStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences
- Responsible party
- Principal investigator, Anne C Spaulding, Emory University
- Investigators
- Anne Spaulding, MD, MPH, Principal investigator, Emory University
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.
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04560556
- Acronym / sponsor ID
- IRB00115929
- Conditions
- Human Immunodeficiency Virus
- Keywords
- Correctional settings, HIV/AIDS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Gilead Sciences
- Study start
- 10 Nov 2020 (actual)
- Primary completion
- 3 Sep 2021 (actual)
- Study completion
- 24 Nov 2021 (actual)
- First posted
- 23 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| POC Testing Alone | – | Diagnostic Test: Point-of-Care (POC) Rapid HIV TestPOC HIV testing (the current standard of care) will be conducted for persons entering jail during the first two-month period. |
| POC and 4th Generation Testing | – | Diagnostic Test: Point-of-Care (POC) Rapid HIV Test, Diagnostic Test: Fourth Generation Antigen/antibody (Ag/Ab) HIV TestPOC plus 4th Generation HIV Testing will be conducted for persons entering jail during the second two-month period. |
| 4th Generation Testing Alone | – | Diagnostic Test: Fourth Generation Antigen/antibody (Ag/Ab) HIV Test4th Generation HIV Testing will be conducted for persons entering jail during the third two-month period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Point-of-Care (POC) Rapid HIV TestPoint-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 | POC Testing Alone, POC and 4th Generation Testing |
| Fourth Generation Antigen/antibody (Ag/Ab) HIV TestFourth 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. | Diagnostic test | 4th Generation Testing Alone, POC and 4th Generation Testing |
Primary outcome
Number of Entrants Tested
Time frame: Up to 24 hours
The number of entrants receiving an HIV test within 24 hours of intake will be examined.
Percentage of PLWH Identified in First 24 Hours
Time frame: Up to 24 hours
The percentage of PLWH identified within the first 24 hours of admission, among all PLWH who enter, will be examined.
Number of New HIV Diagnosed Prior to Discharge
Time frame: Up to Jail Discharge
The number of persons with a new diagnosis of HIV who receive test results before discharge will be examined.
Number of Entrants with Acute HIV Infection Identified
Time frame: Up to 5 days
The number of entrants identified having an acute HIV infection will be examined.
8 secondary outcomes
Time Until Receipt of Positive Test Result
Time frame: Up to 5 days
Time Until Receipt of Antiviral Dose
Time frame: Up to Jail Discharge
Time Until Viral Suppression
Time frame: 6 months after positive HIV intake test
Time Until Meeting with Discharge Planner
Time frame: Up to Jail Discharge
Number of Participants Taking PrEP
Time frame: 2 months after jail release, 6 months after jail release
Number of PLWH who Attend Clinic Visits
Time frame: 1 year
Number of PLWH with Viral Suppression
Time frame: 6 months
Cost of Each Testing Strategy
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2022.
- Individual participant dataSharing planned: Yes. De-identified laboratory results, demographics, and survey questions may be made available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne Spaulding, MD, MPH principal investigator
Emory University
1 site in 1 country: see every site and its status.
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.