Directly Observed Therapy for Community-Released HIV+ Prisoners - NCT00786396-06510 (Clinical Trial 251609)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy251609.aspx
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| City: |
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New Haven |
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State:
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CT |
| Zip Code: |
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06510 |
| Conditions: |
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HIV/AIDS - Substance Abuse |
| Purpose: |
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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.
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| Study summary: |
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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. |
| 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 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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November 4, 2009 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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