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

This study has been completed.
Information provided by (Responsible Party):
Yale University Identifier:
First received: November 5, 2008
Last updated: August 18, 2014
Last verified: August 2014

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).


  • 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: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 ]

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

Enrollment: 151
Study Start Date: July 2004
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00786396

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
Principal Investigator: Frederick L Altice, MD Yale University
Principal Investigator: Gerald Friedland, M.D. Yale University
  More Information

Responsible Party: Yale University Identifier: NCT00786396     History of Changes
Other Study ID Numbers: R01 DA 0179059
Study First Received: November 5, 2008
Last Updated: August 18, 2014

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

Additional relevant MeSH terms:
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders processed this record on September 21, 2017