A Randomized Controlled Trial of HIV Testing and Linkage to Care at Community Corrections
14. august 2019 oppdatert av: Friends Research Institute, Inc.
A Randomized Controlled Trial and Cohort Study of HIV Testing and Linkage to Care Corrections
The investigators propose to conduct both a randomized trial of HIV testing in community corrections, and a randomized trial of linkage to HIV care for people with HIV recruited through community corrections (probation and parole).
Studieoversikt
Detaljert beskrivelse
The first study is a two-group randomized controlled trial in which 6,000 male and female probationers and parolees in Baltimore City, Maryland and Providence, Rhode Island will be randomly assigned to one of two treatment conditions: 1) On-site rapid testing conducted by research staff co-located for the purposes of this study at the probation/parole office; or 2) Off-site referral for rapid HIV testing at a community health center or HIV testing clinic.
Inclusion criteria will be: 1) Adult probationer/parolee; 2) not known to be HIV positive, and 3) resident of greater Baltimore or Providence throughout the study period.
Exclusion criteria will be: 1) unable to give informed consent.
The second study is a randomized trial, whereby all individuals identified at community corrections with HIV will be offered enrollment in a one-year intervention study to examine the ability to improve linkage into HIV care.
Participants will be randomized to receive one of two conditions: 1) Project Bridge for one year, or 2) Treatment as Usual-referral to standard level of care.
Moreover, those randomized to TAU will be given an opportunity to "crossover" to PB if they have failed to engage in treatment during the first three months.
The rationale for choosing the two cities of Baltimore, MD and Providence, RI is due to the historically high rates of heroin addiction that is associated with multiple HIV-related risk behaviors in these two cities and a high likelihood of being on probation and/or parole.
Furthermore, Maryland ranks 10th and Rhode Island ranks 4th in the nation in the number of probationers per 100,000 adult residents.
Studietype
Intervensjonell
Registrering (Faktiske)
797
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Maryland
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Baltimore, Maryland, Forente stater
- Maryland Department of Public Safety and Correctional Services (DPSCS), Division of Parole and Probation
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Probation or Parole;
- Resident of Baltimore, MD or Providence, RI; 3) Willing to be tested for HIV
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Screening
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: On-site Rapid HIV Testing
On-site rapid testing conducted by research staff co-located for the purposes of this study at the probation/parole office.
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Project Bridge provides intensive case management for individuals with HIV as they transition back into the community from incarceration.
The primary goal of the program is to increase continuity of medical care through social stabilization.
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Ingen inngripen: Off-site Referral for HIV Testing
Off-site referral for rapid HIV testing at a community health center or HIV testing clinic
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Eksperimentell: Project Bridge
Project Bridge provides intensive case management for individuals with HIV as they transition back into the community from incarceration.
The primary goal of the program is to increase continuity of medical care through social stabilization.
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Project Bridge provides intensive case management for individuals with HIV as they transition back into the community from incarceration.
The primary goal of the program is to increase continuity of medical care through social stabilization.
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Ingen inngripen: Treatment as Usual
Passive referral to HIV community treatment provider.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Number of Participants Willing to Undergo Rapid HIV Testing
Tidsramme: Baseline
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Aim 1: To determine the willingness of the community corrections population to undergo HIV testing (Seek). Aim 1a: To compare a strategy of rapid HIV testing on site in community corrections (probation and parole offices) to referral to an off site community HIV testing location with a randomized control study (Test). |
Baseline
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Number of Participants That Entered Community HIV Treatment
Tidsramme: 3-months
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Number of Participants That Entered Community HIV Treatment (yes versus no) at the 3-month post baseline follow-up period.
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3-months
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Retention in Community HIV Treatment
Tidsramme: 18 months
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Number of Days with Retention in Community HIV Treatment
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18 months
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Proportion of Those Prescribed Highly Active Antiretroviral Therapy (HAART) Who Are Undetectable
Tidsramme: 6,12,18-months
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To determine if a promising, theory driven, case management based strategy (Project Bridge), will be utilized by individuals with HIV recruited through community corrections.
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6,12,18-months
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Michael S Gordon, D.P.A., Friends Research Institute, Inc.
- Hovedetterforsker: Josiah D Rich, M.D., Brown University
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Crable EL, Blue TR, McKenzie M, Rich JD, Gordon MS. Effect of Case Management on HIV Outcomes for Community Corrections Population: Results of an 18-Month Randomized Controlled Trial. J Acquir Immune Defic Syndr. 2021 May 1;87(1):755-762. doi: 10.1097/QAI.0000000000002624.
- Gordon MS, Kinlock TW, McKenzie M, Wilson ME, Rich JD. Rapid HIV testing for individuals on probation/parole: outcomes of an intervention trial. AIDS Behav. 2013 Jul;17(6):2022-30. doi: 10.1007/s10461-013-0456-6.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. april 2011
Primær fullføring (Faktiske)
1. august 2016
Studiet fullført (Faktiske)
1. august 2016
Datoer for studieregistrering
Først innsendt
1. juni 2011
Først innsendt som oppfylte QC-kriteriene
2. juni 2011
Først lagt ut (Anslag)
6. juni 2011
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
21. august 2019
Siste oppdatering sendt inn som oppfylte QC-kriteriene
14. august 2019
Sist bekreftet
1. august 2019
Mer informasjon
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .