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Promoting Adherence to Anti-HIV Drug Regimens

This study has been completed.
Sponsor:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00051805
First received: January 16, 2003
Last updated: September 17, 2007
Last verified: August 2007
History of Changes
  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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:
  • Pill counts for ARV medications

Secondary Outcome Measures:
  • 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
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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

Additional Information:
Click here for more information on adherence  This link exits the ClinicalTrials.gov site
Click here for more information on adhering to a regimen  This link exits the ClinicalTrials.gov site

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: 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

Additional relevant MeSH terms:
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
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013