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Completed

NCT Number: NCT00051805

Promoting Adherence to Anti-HIV Drug 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.

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Key information

Conditions

HIV Infections Behavior Blood-Borne Infections Communicable Diseases Genital Diseases Health Behavior Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Patient Acceptance of Health Care Patient Compliance RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Treatment Adherence and Compliance Urogenital Diseases Virus Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham Outpatient HIV Clinic

Birmingham, Alabama, 35294, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Promotion of adherence to ARV medications

Behavioral

Primary outcomes

  1. Pill counts for ARV medications

Secondary outcomes

  1. Viral load

  2. disease progression measures (CD4 count, viral resistance)

  3. self-reported adherence

  4. self-reported psychosocial measures

Sponsors and collaborators

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Nih

Registry information

Official study title

Promoting Adherence to Antiretroviral Regimens

Important dates

Study start
2002
Study completion
2006
First posted
Jan 17, 2003
Registry last updated
Sep 18, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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