- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00624247
Early Versus Delayed Routine HIV Testing in Connecticut Jails (SWAB)
Studieoversikt
Detaljert beskrivelse
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
Registrering (Faktiske)
Fase
- Tidlig fase 1
Kontakter og plasseringer
Studiesteder
-
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Connecticut
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New Haven, Connecticut, Forente stater, 06511
- New Haven Community Correctional Center
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Niantic, Connecticut, Forente stater, 06357
- York Correctional Institution
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-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- All newly incarcerated inmates will be eligible for this study.
Exclusion Criteria:
- None.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Screening
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Annen: 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.
|
|
Annen: 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.
|
|
Annen: 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
The proportion of individuals in each testing group who are orally swabbed and consented to rapid HIV testing.
Tidsramme: Immediately, the following evening, and 7 days post-entry
|
Immediately, the following evening, and 7 days post-entry
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Frederick L Altice, MD, Yale University AIDS Program
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Kavasery R, Maru DS, Sylla LN, Smith D, Altice FL. A prospective controlled trial of routine opt-out HIV testing in a men's jail. PLoS One. 2009 Nov 25;4(11):e8056. doi: 10.1371/journal.pone.0008056.
- Kavasery R, Maru DS, Cornman-Homonoff J, Sylla LN, Smith D, Altice FL. Routine opt-out HIV testing strategies in a female jail setting: a prospective controlled trial. PLoS One. 2009 Nov 25;4(11):e7648. doi: 10.1371/journal.pone.0007648.
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 0705002664
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