Managed Problem Solving to Increase Treatment Adherence in Individuals With HIV (MAPS)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Robert Gross, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00130273
First received: August 11, 2005
Last updated: July 12, 2012
Last verified: July 2012

August 11, 2005
July 12, 2012
July 2005
February 2011   (final data collection date for primary outcome measure)
Improved adherence [ Time Frame: Measured at Year 4 ] [ Designated as safety issue: No ]
Improved adherence
Complete list of historical versions of study NCT00130273 on ClinicalTrials.gov Archive Site
  • Decrease in viral load [ Time Frame: Measured at Year 4 ] [ Designated as safety issue: No ]
  • Increase in CD4 count [ Time Frame: Measured at Year 4 ] [ Designated as safety issue: No ]
  • Decrease in viral load
  • increase in CD4 count
Not Provided
Not Provided
 
Managed Problem Solving to Increase Treatment Adherence in Individuals With HIV
Managed Problem Solving: An HIV Adherence Trial

This study will determine whether a managed problem solving intervention can help patients with HIV better follow their anti-HIV drug regimen and can control HIV better than the standard of care.

HAART is considered to be the most effective treatment for HIV. However, sustained and consistent adherence to HAART is necessary for long-term success. Issues such as memory problems, lack of social support, medication side effects, depression, and substance abuse can significantly reduce patient adherence to HAART. This study will evaluate the effectiveness of a managed problem solving strategy to increase HAART adherence in patients with HIV. Both treatment-naive and treatment-experienced participants will be recruited for this study.

The treatment part of this study will last 12 months. Participants will be randomly assigned to receive the managed problem solving intervention or standard of care for 12 months. Participants in the managed problem solving group will have 4 study visits and will receive 3 phone calls for the first 3 months of the study, and 1 phone call every month for the following 9 months. At each study visit, participants will identify barriers to adherence. During the phone calls, participants will be asked about any steps they have taken to improve their adherence. A medication event monitoring system (MEMS) will be used to assess participants' treatment adherence. MEMS uses microelectronic monitors on the caps of medication bottles to record the timing and frequency of bottle openings. Participants whose adherence has decreased or remained the same at the end of 12 months will be evaluated for regimen changes. Blood collection at the beginning and end of the study will be used to measure viral load and CD4 count. Follow-up phone interviews will be conducted every year for 3 years after the end of treatment.

Study hypothesis: Managed problem solving will result in better adherence to highly active antiretroviral therapy (HAART) and better virologic control and immunological outcomes at the end of 1 year compared with a control group receiving standard or care.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
HIV Infections
  • Behavioral: Managed problem solving
    Participants in the managed problem solving group will have four study visits and will receive three phone calls for the first 3 months of the study, and one phone call every month for the following 9 months. At each study visit, participants will identify barriers to adherence. During the phone calls, participants will be asked about any steps they have taken to improve their adherence. A medication event monitoring system (MEMS) will be used to assess participants' treatment adherence. MEMS uses microelectronic monitors on the caps of medication bottles to record the timing and frequency of bottle openings. Participants whose adherence has decreased or remained the same at the end of 12 months will be evaluated for regimen changes. Blood collection at the beginning and end of the study will be used to measure viral load and CD4 count.
  • Behavioral: Standard care
    Participants will receive standard of care for 12 months.
  • Experimental: 1
    Participants will receive managed problem solving for 12 months
    Intervention: Behavioral: Managed problem solving
  • Active Comparator: 2
    Participants will receive standard of care for 12 months
    Intervention: Behavioral: Standard care
Gross R, Bellamy SL, Chapman J, Han X, O'Duor J, Palmer SC, Houts PS, Coyne JC, Strom BL. Managed problem solving for antiretroviral therapy adherence: a randomized trial. JAMA Intern Med. 2013 Feb 25;173(4):300-6. doi: 10.1001/jamainternmed.2013.2152.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
180
February 2011
February 2011   (final data collection date for primary outcome measure)

Inclusion Criteria for All Participants:

  • HIV infected
  • Infection likely to be susceptible to a specific treatment regimen
  • Have access to a telephone
  • Willing and able to comply with all study requirements

Exclusion Criteria for All Participants:

  • Live in a care facility that provides medications on schedule

Inclusion Criteria for Treatment-Experienced Participants:

  • Restarting HAART after a treatment interruption of at least 3 months OR after virologic failure with a viral load greater than 1,000 copies/ml
  • On a treatment regimen for less than 2 weeks prior to study entry
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00130273
R01 MH067498, R01MH067498, DAHBR 9A-ASPG
Not Provided
Robert Gross, University of Pennsylvania
University of Pennsylvania
National Institute of Mental Health (NIMH)
Principal Investigator: Robert Gross, MD, MSCE University of Pennsylvania
University of Pennsylvania
July 2012

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