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Directly Observed Therapy for Community-Released HIV+ Prisoners (Connect)
This study is currently recruiting participants.
Verified by Yale University, August 2009
First Received: November 5, 2008   Last Updated: August 3, 2009   History of Changes
Sponsor: Yale University
Information provided by: Yale University
ClinicalTrials.gov Identifier: NCT00786396
  Purpose

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 Intervention
HIV/AIDS
Substance Abuse
Behavioral: Directly administered antiretroviral therapy

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment, Efficacy Study
Official Title: Directly Observed Therapy for Community-Released HIV+ Prisoners

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • DAART subjects will be more likely to make primary HIV care visits than those receiving SAT. [ Time Frame: 12 ] [ Designated as safety issue: No ]
  • Lower rate of recidivism and to illicit drug use [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: July 2004
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
DAART: Experimental
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
2: No Intervention
SAT (standard of care) group will take their medications as directed by their physicians for the period of one year.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00786396

Contacts
Contact: Christopher Cannon, MPH, CHES 203 764 9958 christopher.cannon@yale.edu

Locations
United States, Connecticut
Yale University School of Medicine Recruiting
New Haven, Connecticut, United States, 06510
Contact: Christopher Cannon, BA     203-764-9958     christopher.cannon@yale.edu    
Yale University-Yale Clinical Research Recruiting
Hartford, Connecticut, United States, 06106
Contact: Sandra Wise     860-293-0777        
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Frederick L Altice, MD Yale University
Principal Investigator: Gerald Friedland, M.D. Yale University
  More Information

No publications provided

Responsible Party: Yale University School of Medicine-AIDS Program ( Professor, Frederick Altice, M.D. )
Study ID Numbers: R01 DA 0179059
Study First Received: November 5, 2008
Last Updated: August 3, 2009
ClinicalTrials.gov Identifier: NCT00786396     History of Changes
Health Authority: United States: Federal Government;   United States: Institutional Review Board

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

Additional relevant MeSH terms:
Mental Disorders
Substance-Related Disorders
Disorders of Environmental Origin

ClinicalTrials.gov processed this record on February 08, 2010