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

20 maja 2022 zaktualizowane przez: Anne C Spaulding, Emory University

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.

Przegląd badań

Szczegółowy opis

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.

Typ studiów

Obserwacyjny

Zapisy (Rzeczywisty)

122

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

    • District of Columbia
      • Washington, District of Columbia, Stany Zjednoczone, 20009
        • DC Department of Corrections

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Metoda próbkowania

Próbka bez prawdopodobieństwa

Badana populacja

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.

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Kohorty i interwencje

Grupa / Kohorta
Interwencja / Leczenie
POC Testing Alone
POC HIV testing (the current standard of care) will be conducted for persons entering jail during the first two-month period.
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.
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 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.
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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Number of Entrants Tested
Ramy czasowe: Up to 24 hours
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
Ramy czasowe: Up to 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
Ramy czasowe: Up to Jail 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
Ramy czasowe: Up to 5 days
The number of entrants identified having an acute HIV infection will be examined.
Up to 5 days

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Time Until Receipt of Positive Test Result
Ramy czasowe: Up to 5 days
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
Ramy czasowe: Up to Jail Discharge
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
Ramy czasowe: 6 months after positive HIV intake test
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
Ramy czasowe: Up to Jail Discharge
For all PLWH, the time (in days) from intake to meeting the discharge planner.
Up to Jail Discharge
Number of Participants Taking PrEP
Ramy czasowe: 2 months after jail release, 6 months after jail release
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
Ramy czasowe: 1 year
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
Ramy czasowe: 6 months
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
Ramy czasowe: 6 months
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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Współpracownicy

Śledczy

  • Główny śledczy: Anne Spaulding, MD, MPH, Emory University

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

10 listopada 2020

Zakończenie podstawowe (Rzeczywisty)

3 września 2021

Ukończenie studiów (Rzeczywisty)

24 listopada 2021

Daty rejestracji na studia

Pierwszy przesłany

17 września 2020

Pierwszy przesłany, który spełnia kryteria kontroli jakości

17 września 2020

Pierwszy wysłany (Rzeczywisty)

23 września 2020

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

23 maja 2022

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

20 maja 2022

Ostatnia weryfikacja

1 maja 2022

Więcej informacji

Terminy związane z tym badaniem

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu IPD

De-identified laboratory results, demographics, and survey questions may be made available to other researchers.

Ramy czasowe udostępniania IPD

Individual participant data will available for sharing after publication of the main article from this study.

Kryteria dostępu do udostępniania IPD

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.

Typ informacji pomocniczych dotyczących udostępniania IPD

  • PROTOKÓŁ BADANIA
  • SOK ROŚLINNY

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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Badania kliniczne na Point-of-Care (POC) Rapid HIV Test

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