Promoting Adherence to Anti-HIV Drug Regimens
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ClinicalTrials.gov Identifier: NCT00051805 |
Recruitment Status
:
Completed
First Posted
: January 17, 2003
Last Update Posted
: September 18, 2007
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections | Behavioral: Promotion of adherence to ARV medications | Not Applicable |
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 : | Interventional (Clinical Trial) |
Enrollment : | 119 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Official Title: | Promoting Adherence to Antiretroviral Regimens |
Study Start Date : | August 2002 |
Actual Study Completion Date : | July 2006 |

- Pill counts for ARV medications
- Viral load
- disease progression measures (CD4 count, viral resistance)
- self-reported adherence
- self-reported psychosocial measures

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 19 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 |
Publications:
ClinicalTrials.gov Identifier: | NCT00051805 History of Changes |
Obsolete Identifiers: | NCT00078780 |
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 ) |
First Posted: | January 17, 2003 Key Record Dates |
Last Update Posted: | September 18, 2007 |
Last Verified: | August 2007 |
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Patient Compliance Adherence Treatment Experienced |
Additional relevant MeSH terms:
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |