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Modified Directly Observed Therapy for Improving Antiretroviral Therapy Adherence in People With HIV

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00339092
First Posted: June 20, 2006
Last Update Posted: April 19, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
David Bangsberg, MD, National Institute of Mental Health (NIMH)
  Purpose
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.

Condition Intervention
HIV Infections Behavioral: Modified Directly Observed Therapy Behavioral: Standard Care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Project Title: A RCT of HIV Adherence Case Management and Modified Directly Observed Therapy

Resource links provided by NLM:


Further study details as provided by David Bangsberg, MD, National Institute of Mental Health (NIMH):

Primary Outcome Measures:
  • CD4 and Viral Load [ Time Frame: Measured at baseline and Months 3, 6, and 9 ]

Secondary Outcome Measures:
  • Adherence [ Time Frame: Measured monthly for 9 months ]

Enrollment: 150
Study Start Date: January 2003
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment
Participants who receive storefront modified directly observed therapy (MDOT) of prescribed antiretrovirals
Behavioral: Modified Directly Observed Therapy
Treatment includes storefront modified directly observed therapy (MDOT) of prescribed antiretrovirals. 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. At the end of 3 months, participants will no longer attend the study site for medication assistance. Participants will then attend Action Point, a county program that helps participants adhere to taking medication, for an additional 3 months.
Other Name: MDOT
Active Comparator: Control
Participants who receive standard care
Behavioral: Standard Care
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.

Detailed Description:

Antiretroviral drug therapy (ART) is a type of medication treatment for HIV that impairs the virus's 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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • HIV infected
  • Severely immunosuppressed (HIV viral load of greater than 400 copies/ml)
  • Does not consistently take prescribed ARV
  • Currently prescribed HIV medications or prescribed to start taking HIV medications

Exclusion Criteria:

  • Currently participating in any other adherence program or intervention study
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00339092


Locations
United States, California
UCSF Market Street Study Site
San Francisco, California, United States, 94102
Sponsors and Collaborators
Massachusetts General Hospital
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: David R. Bangsberg, MD, MPH Massachusetts General Hospital
  More Information

Responsible Party: David Bangsberg, MD, Principal Investigator, National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00339092     History of Changes
Other Study ID Numbers: R01MH064388 ( U.S. NIH Grant/Contract )
First Submitted: June 16, 2006
First Posted: June 20, 2006
Last Update Posted: April 19, 2013
Last Verified: April 2013

Keywords provided by David Bangsberg, MD, National Institute of Mental Health (NIMH):
HIV
ART

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases