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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
Sponsor:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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 or disease Intervention/treatment Phase
HIV Infections Behavioral: Promotion of adherence to ARV medications Not Applicable

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 Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions
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Outcome Measures
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Pill counts for ARV medications

Secondary Outcome Measures :
  1. Viral load
  2. disease progression measures (CD4 count, viral resistance)
  3. self-reported adherence
  4. self-reported psychosocial measures

Eligibility Criteria
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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Locations
United States, Alabama
University of Alabama at Birmingham Outpatient HIV Clinic
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Principal Investigator: Polly Kratt, PhD, MSPH University of Alabama at Birmingham Outpatient HIV Clinic
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

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