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

HIV Infections Clinical Trial

Official title:

Project Title: A RCT of HIV Adherence Case Management and Modified Directly Observed Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00339092
• Other study ID #: R01MH064388
• Secondary ID: R01MH064388
• Status: Completed
• Phase: N/A
• First received: June 16, 2006
• Last updated: April 17, 2013
• Start date: January 2003
• Est. completion date: April 2008

Study information

• Verified date: April 2013
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• HIV Infections

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	UCSF Market Street Study Site	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CD4 and Viral Load		Measured at baseline and Months 3, 6, and 9	No
Secondary	Adherence		Measured monthly for 9 months	No