Managed Problem Solving to Increase Treatment Adherence in Individuals With HIV

Not Applicable

Completed

• Conditions: HIV Infections
• Interventions: Behavioral: Standard care; Behavioral: Managed problem solving

• Registration Number: NCT00130273
• Lead Sponsor: University of Pennsylvania

Brief Summary

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.

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.

Study Timeline

• Study Start: 2005-07
• Study First Submitted: 2005-08-11
• Study First Submitted QC: 2005-08-11
• Study First Posted: 2005-08-15
• Primary Completion: 2011-02
• Study Completion: 2011-02
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-12
• Last Update Posted: 2012-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Standard care	Participants will receive standard of care for 12 months
1	Managed problem solving	Participants will receive managed problem solving for 12 months

Primary Outcome Measures

Name	Time	Method
Improved adherence	Measured at Year 4

Secondary Outcome Measures

Name	Time	Method
Increase in CD4 count	Measured at Year 4
Decrease in viral load	Measured at Year 4

Trial Locations

Locations (1)

University of Pennsylvania School of Medicine; 🇺🇸 Philadelphia, Pennsylvania, United States