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Promoting Adherence to Anti-HIV Drug Regimens

NCT ID: NCT00051805

Last Updated: 2007-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

119 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-08-31

Study Completion Date

2006-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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HIV Infections

Keywords

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Patient Compliance Adherence Treatment Experienced

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Interventions

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Promotion of adherence to ARV medications

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role lead

Principal Investigators

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Polly Kratt, PhD, MSPH

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham Outpatient HIV Clinic

Locations

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University of Alabama at Birmingham Outpatient HIV Clinic

Birmingham, Alabama, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND

Other Identifiers

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3R01AI045403-02S1

Identifier Type: NIH

Identifier Source: secondary_id

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5R01AI045403-03

Identifier Type: NIH

Identifier Source: secondary_id

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1R01AI045403-01A2

Identifier Type: NIH

Identifier Source: org_study_id

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NCT00078780

Identifier Type: -

Identifier Source: nct_alias