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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by Yale University.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Yale University
ClinicalTrials.gov Identifier:
NCT00786396
First received: November 5, 2008
Last updated: June 30, 2010
Last verified: June 2010

November 5, 2008
June 30, 2010
July 2004
December 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00786396 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Directly Observed Therapy for Community-Released HIV+ Prisoners
Directly Observed Therapy for Community-Released HIV+ Prisoners

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • HIV/AIDS
  • Substance Abuse
Behavioral: Directly administered antiretroviral therapy
Daily observation of subjects taking their HIV medications
  • 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.
    Intervention: Behavioral: Directly administered antiretroviral therapy
  • No Intervention: 2
    SAT (standard of care) group will take their medications as directed by their physicians for the period of one year.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
151
Not Provided
December 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00786396
R01 DA 0179059
No
Professor, Frederick Altice, M.D., Yale University School of Medicine-AIDS Program
Yale University
Not Provided
Principal Investigator: Frederick L Altice, MD Yale University
Principal Investigator: Gerald Friedland, M.D. Yale University
Yale University
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP