- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00051805
Promoting Adherence to Anti-HIV Drug Regimens
Promoting Adherence to Antiretroviral Regimens
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Poor adherence to complicated antiretroviral (ARV) drug regimens is one of the most pressing behavioral problems in the clinical management of HIV infected persons. Recent medical advances have made it possible to maintain tighter control of viral replication, allowing people with HIV to live longer, healthier lives. However, the complexity of ARV drug regimens and drug side effects make medication adherence problematic. Deviations from the prescribed regimen may allow the virus to resume rapid replication and develop drug resistant mutations that could render the prescribed drugs useless. This study will evaluate the efficacy of a 6-month, theory-based behavioral intervention to enhance adherence to antiretroviral treatment regimens. HIV-related attitudes, depressive symptoms, coping strategies, and social support will also be assessed to examine theoretical assumptions regarding the causal relationship between psychosocial constructs and medication adherence.
Participants in this study will be recruited from UAB Outpatient HIV Clinic patients who are taking ARV medication. Participants will be randomized to a Standard Adherence Promotion Group or an Enhanced Adherence Promotion Group. The Enhanced Adherence Promotion will systematically address specific psychosocial issues associated with medication adherence. Participants will be followed for 6 months, and adherence will be evaluated at monthly study visits. Pill counts, viral loads, self-reported adherence to ARV medication, CD4 count, and genotypic viral resistance will be assessed.
Study Type
Enrollment
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Alabama
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Birmingham, Alabama, United States, 35294
- University of Alabama at Birmingham Outpatient HIV Clinic
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria
- HIV infected
- Receiving services at UAB Outpatient HIV Clinic
- Taking antiretroviral medication
- Able to attend monthly assessment meetings at clinic for 6 months
- Passing score on Mini Mental State Examination
Study Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Pill counts for ARV medications
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Secondary Outcome Measures
Outcome Measure |
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Viral load
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disease progression measures (CD4 count, viral resistance)
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self-reported adherence
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self-reported psychosocial measures
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Collaborators and Investigators
Investigators
- Principal Investigator: Polly Kratt, PhD, MSPH, University of Alabama at Birmingham Outpatient HIV Clinic
Publications and helpful links
General Publications
- Stewart KE,Greene PG,Ross D,Kratt P, Balentine C, Lee P, Wang Y. Sex, drugs, and viral load: Associations in an HIV+ cohort. In: Society of Behavioral Medicine, 27th Annual Meeting & Scientific Sessions; 2006 Mar 23; San Francisco [CA]: Behavioral Medicine Across the Lifespan. Session Abstracts & Program Information Vol. 31, No. suppl. 1, Pages i-I.
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1R01AI045403-01A2 (U.S. NIH Grant/Contract)
- 3R01AI045403-02S1 (U.S. NIH Grant/Contract)
- 5R01AI045403-03 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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