Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

Early Versus Delayed Routine HIV Testing in Connecticut Jails (SWAB)

16 oktober 2014 bijgewerkt door: Yale University
The objective of this non-randomized, controlled, trial is to evaluate the optimal time to approach newly incarcerated jail inmates for routine opt-out HIV testing in a manner that maximizes the number of individuals able to demonstrate capacity to consent and willingness to receive HIV testing.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

Primary outcome: proportion of individuals in each assigned group that agree to be swabbed for HIV testing and are able to consent to the study.

The prevalence of HIV infection in the United States is four times greater in correctional settings compared to the general population. Because prisons and jails house a population facing a disproportionate share of the burden of HIV infection, these facilities serve as important sites for the testing and treatment of HIV. The Center for Disease Control and Prevention's recent recommendations to implement routine opt-out HIV testing in all healthcare settings presents an important challenge and opportunity to correctional institutions. By effectively implementing routine opt-out testing, correctional facilities can expand HIV testing to one of society's most at-risk populations. Subsequently, testing can lead to appropriate access to counseling and treatment both within the correctional setting and upon release into the community.

Although jails interact with a larger number of individuals at risk for HIV infection than do prisons, they also pose unique logistical and health-related constraints in several important ways that impact HIV testing strategies. Jail populations experience short periods of incarceration and high rates of turnover with many-fold greater admissions and discharges. Jails also house individuals with higher rates of acute intoxication from psychoactive drugs, uncontrolled mental illness, and suicidal behavior. The suicide rate in jails is three times that in state prisons; nearly a quarter of these suicides take place within the first 48 hours of admission. Furthermore, the individuals who enter jails have higher recent risk behaviors for HIV than those in prisons.

Given these considerations, a major challenge to implementing routine opt-out HIV testing in jails is choosing the optimal time to conduct testing. The timing of delivering non-emergent, traumatically emotional health information (such as a preliminary positive result in an asymptomatic patient) must be carefully considered. Recently incarcerated inmates might be too intoxicated or psychologically distressed to demonstrate capacity to consent to or opt out of routine testing, and may be unprepared to consider and respond to the consequences of a preliminary positive HIV test result. Likewise, the challenge with postponing testing is that many individuals experience very short stays in jail, with approximately one-third leaving within 48 hours, followed by further attrition daily for the first week and may lose the opportunity for getting life-saving information in a timely manner.

Therefore, the objective of this study is to evaluate the optimal time to approach newly incarcerated jail inmates for routine opt-out HIV testing in a manner that maximizes the number of individuals able to demonstrate capacity to consent and willingness to receive HIV testing.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

621

Fase

  • Vroege fase 1

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

    • Connecticut
      • New Haven, Connecticut, Verenigde Staten, 06511
        • New Haven Community Correctional Center
      • Niantic, Connecticut, Verenigde Staten, 06357
        • York Correctional Institution

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • All newly incarcerated inmates will be eligible for this study.

Exclusion Criteria:

  • None.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Screening
  • Toewijzing: Niet-gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Ander: Immediate
Individuals assigned to be approached for routine HIV testing immediately upon admission to the jail.
Potential subjects are offered swabbing as part of HIV testing by jail medical staff or study staff. All potential subjects are told HIV results can now be made available within a short period of time using an oral swab. Anyone not wanting HIV test results is allowed to refuse at the time of offering the HIV test and not be swabbed. If the inmate agrees to be swabbed and tested, he or she then meets with a member of the research study staff who discusses two separate informed consents - one for study participation and one for HIV testing.
Ander: Following Day
Individuals assigned to be approached for routine HIV testing the day following admission to the jail.
Potential subjects are offered swabbing as part of HIV testing by jail medical staff or study staff. All potential subjects are told HIV results can now be made available within a short period of time using an oral swab. Anyone not wanting HIV test results is allowed to refuse at the time of offering the HIV test and not be swabbed. If the inmate agrees to be swabbed and tested, he or she then meets with a member of the research study staff who discusses two separate informed consents - one for study participation and one for HIV testing.
Ander: Delayed
Individuals assigned to be approached for routine HIV testing several days following admission to the jail.
Potential subjects are offered swabbing as part of HIV testing by jail medical staff or study staff. All potential subjects are told HIV results can now be made available within a short period of time using an oral swab. Anyone not wanting HIV test results is allowed to refuse at the time of offering the HIV test and not be swabbed. If the inmate agrees to be swabbed and tested, he or she then meets with a member of the research study staff who discusses two separate informed consents - one for study participation and one for HIV testing.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
The proportion of individuals in each testing group who are orally swabbed and consented to rapid HIV testing.
Tijdsspanne: Immediately, the following evening, and 7 days post-entry
Immediately, the following evening, and 7 days post-entry

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Onderzoekers

  • Hoofdonderzoeker: Frederick L Altice, MD, Yale University AIDS Program

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 augustus 2007

Primaire voltooiing (Werkelijk)

1 april 2008

Studie voltooiing (Werkelijk)

1 april 2008

Studieregistratiedata

Eerst ingediend

18 februari 2008

Eerst ingediend dat voldeed aan de QC-criteria

26 februari 2008

Eerst geplaatst (Schatting)

27 februari 2008

Updates van studierecords

Laatste update geplaatst (Schatting)

17 oktober 2014

Laatste update ingediend die voldeed aan QC-criteria

16 oktober 2014

Laatst geverifieerd

1 februari 2009

Meer informatie

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren