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Directly Observed Therapy for Community-Released HIV+ Prisoners (Connect)

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ClinicalTrials.gov Identifier: NCT00786396
Recruitment Status : Completed
First Posted : November 6, 2008
Last Update Posted : August 20, 2014
Sponsor:
Information provided by (Responsible Party):
Yale University

Brief Summary:

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:

  • At the end of six months those receiving DAART will have a higher level of adherence to HAART as compared to the SAT group.
  • The DAART Intervention will result in subjects having lower viral loads and higher CD4 counts as compared to the SAT group.
  • At the end of six months, the DAART group will have a lower rate of recidivism to jail/prison as compared to the SAT group.
  • Over the year, the DAART group will be more likely to make repeated primary HIV care visits than the SAT group.

Condition or disease Intervention/treatment Phase
HIV/AIDS Substance Abuse Behavioral: Directly administered antiretroviral therapy Not Applicable

Detailed Description:

Any individual that is HIV positive and incarcerated for at least a period of 90 days and on antiretroviral medications would be referred to the study by the medical staff of the incarceration facilities prior to release or within 30 days of release an individual would be able to self refer.

Subjects would be screened and consented and interviewed prior to their release from incarceration, on their day of release, and monthly for a period of one year. At the time of their day of release interview, subjects are randomized to either the intervention DAART group or the standard of care SAT group. All subjects would be assessed and offered opiate substitution therapy if there was a prior history of opiate dependency as a means of relapse prevention.

Subjects in DAART would be seen everyday for a period of six months by a team of research assistants who observe the subjects taking their medications, and their last six months would be done as standard of care. Standard of care SAT subjects would continue to take their medications on their own as prescribed. All subjects would be interviewed monthly and quarterly would have laboratory blood tests completed.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 151 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Directly Observed Therapy for Community-Released HIV+ Prisoners
Study Start Date : July 2004
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arm Intervention/treatment
Experimental: DAART
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.
Behavioral: Directly administered antiretroviral therapy
Daily observation of subjects taking their HIV medications
No Intervention: 2
SAT (standard of care) group will take their medications as directed by their physicians for the period of one year.



Primary Outcome Measures :
  1. 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. [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. DAART subjects will be more likely to make primary HIV care visits than those receiving SAT. [ Time Frame: 12 ]
  2. Lower rate of recidivism and to illicit drug use [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • HIV seropositive
  • 18 years of age or older
  • incarcerated for a minimum of 90days
  • living in New Haven or Hartford
  • currently on HAART or willing to begin HAART medications

Exclusion Criteria:

  • Not meeting inclusion criteria

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00786396


Locations
United States, Connecticut
Yale University-Yale Clinical Research
Hartford, Connecticut, United States, 06106
Yale University School of Medicine
New Haven, Connecticut, United States, 06510
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Frederick L Altice, MD Yale University
Principal Investigator: Gerald Friedland, M.D. Yale University

Publications:
Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT00786396     History of Changes
Other Study ID Numbers: R01 DA 0179059
First Posted: November 6, 2008    Key Record Dates
Last Update Posted: August 20, 2014
Last Verified: August 2014

Keywords provided by Yale University:
HIV
AIDS
substance abuse
directly administered antiretroviral therapy
adherence
Substance Abuse and Dependency

Additional relevant MeSH terms:
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders