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| Sponsor: | 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 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Managed Problem Solving: An HIV Adherence Trial |
| Estimated Enrollment: | 200 |
| Study Start Date: | July 2005 |
| Estimated Study Completion Date: | July 2010 |
| Estimated Primary Completion Date: | July 2010 (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.
|
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 |
Inclusion Criteria for All Participants:
Exclusion Criteria for All Participants:
Inclusion Criteria for Treatment-Experienced Participants:
Contacts and Locations| Contact: Jennifer C. Chapman, MPH | 215-573-0835 | jchapman@cceb.med.upenn.edu |
| 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 | |
| Principal Investigator: | Robert Gross, MD, MSCE | University of Pennsylvania |
More Information
| Responsible Party: | Robert Gross, MD, MSCE, Principal Investigator, Center for Clinicial Epidemiology & Biostatistics |
| ClinicalTrials.gov Identifier: | NCT00130273 History of Changes |
| Other Study ID Numbers: | R01 MH067498, DAHBR 9A-ASPG |
| Study First Received: | August 11, 2005 |
| Last Updated: | March 23, 2009 |
| Health Authority: | United States: Federal Government |
|
HIV AIDS Problem Solving Antiretroviral Therapy, Highly Active Patient Compliance |
|
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 |
