- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01366495
A Randomized Controlled Trial of HIV Testing and Linkage to Care at Community Corrections
14 augusti 2019 uppdaterad 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).
Studieöversikt
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
797
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Maryland
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Baltimore, Maryland, Förenta staterna
- Maryland Department of Public Safety and Correctional Services (DPSCS), Division of Parole and Probation
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-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- Probation or Parole;
- Resident of Baltimore, MD or Providence, RI; 3) Willing to be tested for HIV
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Undersökning
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
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.
|
|
Inget ingripande: 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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Experimentell: 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.
|
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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Inget ingripande: Treatment as Usual
Passive referral to HIV community treatment provider.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Number of Participants Willing to Undergo Rapid HIV Testing
Tidsram: Baseline
|
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
Tidsram: 3-months
|
Number of Participants That Entered Community HIV Treatment (yes versus no) at the 3-month post baseline follow-up period.
|
3-months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Retention in Community HIV Treatment
Tidsram: 18 months
|
Number of Days with Retention in Community HIV Treatment
|
18 months
|
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Proportion of Those Prescribed Highly Active Antiretroviral Therapy (HAART) Who Are Undetectable
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Michael S Gordon, D.P.A., Friends Research Institute, Inc.
- Huvudutredare: Josiah D Rich, M.D., Brown University
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- 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.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 april 2011
Primärt slutförande (Faktisk)
1 augusti 2016
Avslutad studie (Faktisk)
1 augusti 2016
Studieregistreringsdatum
Först inskickad
1 juni 2011
Först inskickad som uppfyllde QC-kriterierna
2 juni 2011
Första postat (Uppskatta)
6 juni 2011
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
21 augusti 2019
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
14 augusti 2019
Senast verifierad
1 augusti 2019
Mer information
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .