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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 2 | No Intervention | SAT (standard of care) group will take their medications as directed by their physicians for the period of one year. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Directly administered antiretroviral therapy | Behavioral | Daily observation of subjects taking their HIV medications |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| DAART subjects will be more likely to make primary HIV care visits than those receiving SAT. | 12 | |
| Lower rate of recidivism and to illicit drug use | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frederick L Altice, MD | Yale University | Principal Investigator |
| Gerald Friedland, M.D. | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University-Yale Clinical Research | Hartford | Connecticut | 06106 | United States | ||
| Yale University School of Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22101218 | Background | Saber-Tehrani AS, Springer SA, Qiu J, Herme M, Wickersham J, Altice FL. Rationale, study design and sample characteristics of a randomized controlled trial of directly administered antiretroviral therapy for HIV-infected prisoners transitioning to the community - a potential conduit to improved HIV treatment outcomes. Contemp Clin Trials. 2012 Mar;33(2):436-44. doi: 10.1016/j.cct.2011.11.002. Epub 2011 Nov 12. | |
| 20024753 |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| New Haven |
| Connecticut |
| 06510 |
| United States |
| Background |
| Springer SA, Chen S, Altice F. Depression and symptomatic response among HIV-infected drug users enrolled in a randomized controlled trial of directly administered antiretroviral therapy. AIDS Care. 2009 Aug;21(8):976-83. doi: 10.1080/09540120802657555. |
| 20177974 | Background | Springer SA, Chen S, Altice FL. Improved HIV and substance abuse treatment outcomes for released HIV-infected prisoners: the impact of buprenorphine treatment. J Urban Health. 2010 Jul;87(4):592-602. doi: 10.1007/s11524-010-9438-4. |
| 22879972 | Background | Meyer JP, Qiu J, Chen NE, Larkin GL, Altice FL. Emergency department use by released prisoners with HIV: an observational longitudinal study. PLoS One. 2012;7(8):e42416. doi: 10.1371/journal.pone.0042416. Epub 2012 Aug 3. |
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |