Managed Problem Solving to Increase Treatment Adherence in Individuals With HIV - Full Text View

Sponsored by:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00130273

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

MedlinePlus related topics: AIDS AIDS Medicines

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Managed Problem Solving: An HIV Adherence Trial

Further study details as provided by National Institute of Mental Health (NIMH):

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 ]

Estimated Enrollment:	200
Study Start Date:	July 2005
Estimated Study Completion Date:	July 2010
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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.
2: Active Comparator Participants will receive standard of care for 12 months	Behavioral: Standard care Participants will receive standard of care for 12 months.

Arms

Assigned Interventions

1: Experimental

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.

2: Active Comparator

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

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

Contacts

Contact: Jennifer C. Chapman, MPH

215-573-0835

jchapman@cceb.med.upenn.edu

Locations

United States, Pennsylvania
University of Pennsylvania School of Medicine	Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Jennifer C. Chapman, MPH 215-573-0835 jchapman@cceb.med.upenn.edu
Contact: Robert Gross, MD, MSCE 215-898-2437 rgross@cceb.med.upenn.edu
Principal Investigator: Robert Gross, MD, MSCE
Sub-Investigator: Brian Strom, MD, MPH
Sub-Investigator: James C. Coyne, PhD
Sub-Investigator: Steven C. Palmer, PhD
Sub-Investigator: Dean G. Cruess, PhD
Sub-Investigator: Peter S. Houts, PhD

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:

Robert Gross, MD, MSCE

University of Pennsylvania

More Information

Responsible Party:	Center for Clinicial Epidemiology & Biostatistics ( Robert Gross, MD, MSCE, Principal Investigator )
Study ID Numbers:	R01 MH67498, DAHBR 9A-ASPG
Study First Received:	August 11, 2005
Last Updated:	September 19, 2008
ClinicalTrials.gov Identifier:	NCT00130273
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):

HIV
AIDS
Problem Solving
Antiretroviral Therapy, Highly Active
Patient Compliance

Study placed in the following topic categories:

Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on January 16, 2009