Expired Study
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Birmingham, Alabama 35294


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.


Study summary:

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.


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


Study is Available At:


Original ID:

1R01AI45403-01A2


NCT ID:

NCT00051805


Secondary ID:

3R01AI045403-02S1


Study Acronym:


Brief Title:

Promoting Adherence to Anti-HIV Drug Regimens


Official Title:

Promoting Adherence to Antiretroviral Regimens


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

19 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Institute of Allergy and Infectious Diseases (NIAID)


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

119


Enrollment Type:


Overall Contact Information

Official Name:Polly Kratt, PhD, MSPH
Principal Investigator
University of Alabama at Birmingham Outpatient HIV Clinic

Study Dates

Start Date:August 2002
Completion Date:July 2006
Completion Type:Actual
Verification Date:August 2007
Last Changed Date:September 17, 2007
First Received Date:January 16, 2003

Study Outcomes

Outcome Type:Primary Outcome
Measure:Pill counts for ARV medications
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Viral load
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:disease progression measures (CD4 count, viral resistance)
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:self-reported adherence
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:self-reported psychosocial measures
Safety Issues:False

Study Interventions

Intervention Type:Behavioral
Name:Promotion of adherence to ARV medications

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:NIH
Agency Type:Lead Sponsor
Agency Name:National Institute of Allergy and Infectious Diseases (NIAID)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation: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.

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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