Promoting Adherence to Anti-HIV Drug Regimens
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Purpose
One of the main causes of treatment failure in HIV infected individuals is lack of adherence to complicated drug regimens. The purpose of this study is to evaluate the effectiveness of a behavioral intervention program designed to improve adherence to anti-HIV drug regimens. Participants in this study will be recruited from the University of Alabama at Birmingham (UAB) Outpatient HIV Clinic.
| Condition | Intervention |
|---|---|
|
HIV Infections |
Behavioral: Promotion of adherence to ARV medications |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment |
| Official Title: | Promoting Adherence to Antiretroviral Regimens |
- Pill counts for ARV medications
- Viral load
- disease progression measures (CD4 count, viral resistance)
- self-reported adherence
- self-reported psychosocial measures
| Estimated Enrollment: | 119 |
| Study Start Date: | August 2002 |
| Study Completion Date: | July 2006 |
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.
Eligibility| Ages Eligible for Study: | 19 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00051805
| United States, Alabama | |
| University of Alabama at Birmingham Outpatient HIV Clinic | |
| Birmingham, Alabama, United States, 35294 | |
| Principal Investigator: | Polly Kratt, PhD, MSPH | University of Alabama at Birmingham Outpatient HIV Clinic |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00051805 History of Changes |
| Obsolete Identifiers: | NCT00078780 |
| Other Study ID Numbers: | 1R01AI45403-01A2, 3R01AI045403-02S1, 5R01AI045403-03 |
| Study First Received: | January 16, 2003 |
| Last Updated: | September 17, 2007 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
|
Patient Compliance Adherence Treatment Experienced |
ClinicalTrials.gov processed this record on February 27, 2015