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| 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:
| 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 |
| 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.
|
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Christopher Cannon, MPH, CHES | 203 764 9958 | christopher.cannon@yale.edu |
| 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 | |
| Principal Investigator: | Frederick L Altice, MD | Yale University |
| Principal Investigator: | Gerald Friedland, M.D. | Yale University |
More Information
| 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 |
|
HIV AIDS substance abuse |
directly administered antiretroviral therapy adherence Substance Abuse and Dependency |
|
Mental Disorders Substance-Related Disorders Disorders of Environmental Origin |