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
  Purpose

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.


Condition Intervention
HIV Infections
Behavioral: Managed problem solving
Behavioral: Standard care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Managed Problem Solving: An HIV Adherence Trial

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Improved adherence [ Time Frame: Measured at Year 4 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 180
Study Start Date: July 2005
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Participants will receive managed problem solving for 12 months
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.
Active Comparator: 2
Participants will receive standard of care for 12 months
Behavioral: Standard care
Participants will receive standard of care for 12 months.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00130273

Locations
United States, Pennsylvania
University of Pennsylvania School of Medicine
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Investigators
Principal Investigator: Robert Gross, MD, MSCE University of Pennsylvania
  More Information

No publications provided by University of Pennsylvania

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Robert Gross, Associate Professor of Medicine and Epidemiology, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00130273     History of Changes
Other Study ID Numbers: R01 MH067498, R01MH067498, DAHBR 9A-ASPG
Study First Received: August 11, 2005
Last Updated: July 12, 2012
Health Authority: United States: Federal Government

Keywords provided by University of Pennsylvania:
HIV
AIDS
Problem Solving
Antiretroviral Therapy, Highly Active
Patient Compliance

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

ClinicalTrials.gov processed this record on August 21, 2014