Modified Directly Observed Therapy for Improving Antiretroviral Therapy Adherence in People With HIV
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ClinicalTrials.gov Identifier: NCT00339092 |
Recruitment Status
:
Completed
First Posted
: June 20, 2006
Last Update Posted
: April 19, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections | Behavioral: Modified Directly Observed Therapy Behavioral: Standard Care | Not Applicable |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 150 participants |
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 |
Study Start Date : | January 2003 |
Actual Primary Completion Date : | April 2008 |
Actual Study Completion Date : | April 2008 |

Arm | Intervention/treatment |
---|---|
Experimental: Treatment
Participants who receive storefront modified directly observed therapy (MDOT) of prescribed antiretrovirals
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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
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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.
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- CD4 and Viral Load [ Time Frame: Measured at baseline and Months 3, 6, and 9 ]
- Adherence [ Time Frame: Measured monthly for 9 months ]

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

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
United States, California | |
UCSF Market Street Study Site | |
San Francisco, California, United States, 94102 |
Principal Investigator: | David R. Bangsberg, MD, MPH | Massachusetts General Hospital |
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 Posted: | June 20, 2006 Key Record Dates |
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 |