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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
David Bangsberg, MD, National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00339092
First received: June 16, 2006
Last updated: April 17, 2013
Last verified: April 2013

June 16, 2006
April 17, 2013
January 2003
April 2008   (final data collection date for primary outcome measure)
CD4 and Viral Load [ Time Frame: Measured at baseline and Months 3, 6, and 9 ] [ Designated as safety issue: No ]
CD4 and Viral Load (measured at Month 9)
Complete list of historical versions of study NCT00339092 on ClinicalTrials.gov Archive Site
Adherence [ Time Frame: Measured monthly for 9 months ] [ Designated as safety issue: No ]
Adherence (measured at Month 9)
Not Provided
Not Provided
 
Modified Directly Observed Therapy for Improving Antiretroviral Therapy Adherence in People With HIV
Project Title: A RCT of HIV Adherence Case Management and Modified Directly Observed Therapy

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
HIV Infections
  • 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
  • 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.
  • Experimental: Treatment
    Participants who receive storefront modified directly observed therapy (MDOT) of prescribed antiretrovirals
    Intervention: Behavioral: Modified Directly Observed Therapy
  • Active Comparator: Control
    Participants who receive standard care
    Intervention: Behavioral: Standard Care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
April 2008
April 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00339092
R01 MH64388, R01MH064388
No
David Bangsberg, MD, National Institute of Mental Health (NIMH)
Massachusetts General Hospital
National Institute of Mental Health (NIMH)
Principal Investigator: David R. Bangsberg, MD, MPH Massachusetts General Hospital
Massachusetts General Hospital
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP