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Home > "P" Clinical Trials Conditions > Promoting Adherence to Anti-HIV Drug Regimens  Promoting Adherence to Anti-HIV Drug Regimens
Promoting Adherence to Anti-HIV Drug Regimens
For Condition: HIV Infections
Status: Recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: 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.
Details: 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 six 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:
Study Type: Interventional, Educational/Counseling/Training, Randomized, Active Control, Parallel Assignment, Efficacy Study
Minimum Age/Maximum Age: 19 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria - HIV infected - Receiving services at UAB Outpatient HIV Clinic - Taking antiretroviral medication - Able to attend monthly assessment meetings at clinic for six months - Passing score on Mini Mental State Examination
Total Enrollment: 216
Location and Contact Information:
University of Alabama at Birmingham Outpatient HIV Clinic *Recruiting*
Birmingham, Alabama, 35294
United States
Recruiting Dana Ross
Additional Information:
Study ID Numbers: 1R01AI45403-01A2; 5R01AI045403-03,3R01AI045403-02S1
Study Start Date: August 2002
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00051805
Other Hiv Infections Studies:
1. A Study of Nevirapine to Prevent HIV Transmission from Mothers to Their Babies
2. A Comparison of Fluconazole and Amphotericin B in the Treatment of Cryptococcal Meningitis
3. Safety and Effectiveness of Ritonavir Plus Lamivudine Plus Zidovudine in HIV-Infected Pregnant Women and Their Babies
4. A Phase I Study to Evaluate the Pharmacokinetics, Safety and Antiviral Effects of Concurrent Administration of Zidovudine (AZT) and 2'3'-Dideoxyinosine (ddI) in Patients With Human Immunodeficiency Virus (HIV)
5. A Comparison of Valganciclovir and Ganciclovir in the Treatment of Cytomegalovirus (CMV) of the Eyes
Related Studies:
Other HIV Infections Clinical Trials
Other Alabama Clinical Trials
Other Birmingham Clinical Trials
Promoting Adherence to Anti-HIV Drug Regimens
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