Directly Observed Therapy for Community-Released HIV+ Prisoners

Study Overview
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Brief Summary
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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: 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.

Detailed Description
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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.

Official Title
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Directly Observed Therapy for Community-Released HIV+ Prisoners

Conditions
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HIV/AIDS, Substance Abuse

Intervention / Treatment
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* Behavioral: Directly administered antiretroviral therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DAART<br>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<br>* Daily observation of subjects taking their HIV medications<br>|
| No Intervention: 2<br>SAT (standard of care) group will take their medications as directed by their physicians for the period of one year. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AIDS, substance abuse, directly administered antiretroviral therapy, adherence, Substance Abuse and Dependency, HIV