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

January 16, 2003
September 17, 2007
August 2002
Not Provided
Pill counts for ARV medications
Same as current
Complete list of historical versions of study NCT00051805 on ClinicalTrials.gov Archive Site
  • Viral load
  • disease progression measures (CD4 count, viral resistance)
  • self-reported adherence
  • self-reported psychosocial measures
Same as current
Not Provided
Not Provided
 
Promoting Adherence to Anti-HIV Drug Regimens
Promoting Adherence to Antiretroviral Regimens

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
HIV Infections
Behavioral: Promotion of adherence to ARV medications
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
119
July 2006
Not Provided

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
Both
19 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00051805
1R01AI45403-01A2, 3R01AI045403-02S1, 5R01AI045403-03
Not Provided
Not Provided
National Institute of Allergy and Infectious Diseases (NIAID)
Not Provided
Principal Investigator: Polly Kratt, PhD, MSPH University of Alabama at Birmingham Outpatient HIV Clinic
National Institute of Allergy and Infectious Diseases (NIAID)
August 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP