Ignite Creation Date:
2024-05-05 @ 8:00 PM
Last Modification Date:
2024-10-26 @ 9:57 AM
Study NCT ID:
NCT00786396
Status:
COMPLETED
Last Update Posted:
2014-08-20
First Post:
2008-11-05
Brief Title:
Directly Observed Therapy for Community-Released HIV Prisoners
Sponsor:
Yale University
Organization:
Yale University
Study Overview
Official Title:
Directly Observed Therapy for Community-Released HIV Prisoners
Status:
COMPLETED
Status Verified Date:
2014-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Connect
Brief Summary:
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 DAARTDOT 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 jailprison 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
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 jailprison 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:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None