NCT00786396|Completed
Directly Observed Therapy for Community-Released HIV+ Prisoners
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Sponsor study identifier
interventional
151
1 country
2
Study Start
July 2004
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2010
Actual (reported)Study Completion
December 2010
Actual (reported)The aim of this study is to develop effective interventions for HIV-infected prisoners who are released to the community. The intervention that we will study will be directly observed therapy (DAART/DOT) and we will compare this to the current standard of care that involves self-administered therapy (SAT). All subjects will get transitional case management and all subjects with a prior history of opiate dependence will be offered opiate substitution therapy (buprenorphine or methadone). Hypotheses:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2010
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 2004
Date type not reportedThis date has not been verified as actual or estimated.
November 5, 2008
Actual (reported)November 6, 2008
Actual (reported)December 2010
Actual (reported)December 2010
Actual (reported)Virological success, defined as greater than 1 log HIV-1 copies/mL reduction or Viral load less than 400 copies/mL at the end of six months on the intervention.
12 months
DAART subjects will be more likely to make primary HIV care visits than those receiving SAT.
12
Lower rate of recidivism and to illicit drug use
12 months
Group that will be observed daily taking their medications for a period of six months. Followed by the remaining six months of the intervention in which the subject will take medications on their own.
SAT (standard of care) group will take their medications as directed by their physicians for the period of one year.
Daily observation of subjects taking their HIV medications
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Yale University-Yale Clinical Research
Hartford, Connecticut, 06106, United States
Yale University School of Medicine
New Haven, Connecticut, 06510, United States
Saber-Tehrani AS, Springer SA, Qiu J, Herme M, Wickersham J, Altice FL. Rationale, study design and sample characteristics of a randomized controlled trial of directly administered antiretroviral therapy for HIV-infected prisoners transitioning to the community - a potential conduit to improved HIV treatment outcomes. Contemp Clin Trials. 2012 Mar;33(2):436-44. doi: 10.1016/j.cct.2011.11.002. Epub 2011 Nov 12.
Springer SA, Chen S, Altice F. Depression and symptomatic response among HIV-infected drug users enrolled in a randomized controlled trial of directly administered antiretroviral therapy. AIDS Care. 2009 Aug;21(8):976-83. doi: 10.1080/09540120802657555.
Frederick L Altice, MD
Yale University
Gerald Friedland, M.D.
Yale University
151 participants (actual enrollment reported by the registry).
First Submitted
November 5, 2008
First Posted
November 6, 2008
Study Start
July 2004
Date type not reportedThis date has not been verified as actual or estimated.
Therapists to Administer Contingency Management-Therapist Phase - 1
Contact the study team to confirm eligibility.
Springer SA, Chen S, Altice FL. Improved HIV and substance abuse treatment outcomes for released HIV-infected prisoners: the impact of buprenorphine treatment. J Urban Health. 2010 Jul;87(4):592-602. doi: 10.1007/s11524-010-9438-4.
Meyer JP, Qiu J, Chen NE, Larkin GL, Altice FL. Emergency department use by released prisoners with HIV: an observational longitudinal study. PLoS One. 2012;7(8):e42416. doi: 10.1371/journal.pone.0042416. Epub 2012 Aug 3.
Primary Completion
December 2010
Actual (reported)Study Completion
December 2010
Actual (reported)Last Updated
August 20, 2014
Record last verified: 2014-08
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Source: ClinicalTrials.gov.
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