Ignite Creation Date:
2024-05-05 @ 4:52 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00339092
Status:
COMPLETED
Last Update Posted:
2013-04-19
First Post:
2006-06-16
Brief Title:
Modified Directly Observed Therapy for Improving Antiretroviral Therapy Adherence in People With HIV
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Project Title A RCT of HIV Adherence Case Management and Modified Directly Observed Therapy
Status:
COMPLETED
Status Verified Date:
2013-04
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:
None
Brief Summary:
This study will evaluate the effectiveness of a modified directly observed therapy program in increasing antiretroviral therapy adherence in poor HIV-infected residents of urban communities
Detailed Description:
Antiretroviral drug therapy ART is a type of medication treatment for HIV that impairs the viruss ability to multiply When used properly it has been shown to be successful in reducing HIV-related deaths A 95 adherence rate to ART is required to adequately suppress the virus and prevent transmission High rates of mental illness substance use and unstable housing however make adherence to ART particularly problematic in poor urban populations Directly observed therapy DOT in which medication intake is closely monitored improved treatment adherence during the tuberculosis epidemic of the 1990s and is now gaining recognition as a model for improving ART adherence HIV DOT has been successfully delivered to people residing in structured living settings The majority of HIV-infected people however live outside these facilities Therefore there is a need for a modified version of DOT to reach HIV-infected people in community settings This study will evaluate the effectiveness of a MDOT program in increasing ART adherence in poor HIV-infected residents of urban communities
Participants in this open label study will be randomly assigned to either receive standard care or participate in the MDOT program Participants assigned to standard care will report to the study site once a month for 9 months but will not receive any assistance with taking HIV medications Information about medication adherence housing income use of health services drug use sexual practices and mental health services will be collected at each visit Participants in the MDOT program will report to the study site each morning for 3 months Monday through Friday to take their HIV medication and any other medications prescribed by their primary care doctors If an individual does not attend a visit study staff will try to locate the individual in the neighborhood to deliver the medication Medication for the weekend will be prepared by study staff but participants will take it on their own at home At the end of 3 months participants will no longer attend the study site for medication assistance They will however participate in Action Point a county program that helps participants adhere to taking medication for an additional 3 months Participants will also check in with the study staff once a month Following this participants may choose to discontinue the Action Point program for the final 3 months of the study They will continue monthly check-in visits with the study staff At each visit interviews will be conducted and medication adherence will be assessed Blood tests will be performed once every 3 months throughout the study
Participants in this open label study will be randomly assigned to either receive standard care or participate in the MDOT program Participants assigned to standard care will report to the study site once a month for 9 months but will not receive any assistance with taking HIV medications Information about medication adherence housing income use of health services drug use sexual practices and mental health services will be collected at each visit Participants in the MDOT program will report to the study site each morning for 3 months Monday through Friday to take their HIV medication and any other medications prescribed by their primary care doctors If an individual does not attend a visit study staff will try to locate the individual in the neighborhood to deliver the medication Medication for the weekend will be prepared by study staff but participants will take it on their own at home At the end of 3 months participants will no longer attend the study site for medication assistance They will however participate in Action Point a county program that helps participants adhere to taking medication for an additional 3 months Participants will also check in with the study staff once a month Following this participants may choose to discontinue the Action Point program for the final 3 months of the study They will continue monthly check-in visits with the study staff At each visit interviews will be conducted and medication adherence will be assessed Blood tests will be performed once every 3 months throughout the study
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01MH064388 | NIH | None | httpsreporternihgovquickSearchR01MH064388 |