Clinical trial NCT00051766: Computer-Assisted Adherence Program for Patients Taking Anti-HIV Drugs
Official title: A Computer-Based HIV Medication Adherence Intervention
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Acquired Immunodeficiency Syndrome
HIV Infections
Keywords: compliance
medication
antiretroviral
adherence
intervention
treatment experienced
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
First posted: 2003-01-17
Enrollment: 200
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: ECT

Brief summary: The purpose of this study is to evaluate the effectiveness of a computer-assisted, self-administered adherence program for patients on complicated anti-HIV drug regimens.

Detailed description: Highly active antiretroviral therapy (HAART) for HIV produces dramatic reductions in morbidity and mortality for many patients who maintain a high level of adherence to their medications. However, 20% to 33% of HIV infected patients will miss at least one of their medication doses over a one to three day period. Patient self-report is the most practical method for assessing adherence, but it may produce unreliable and invalid results unless optimally performed. A computer-assisted, self-administered adherence program could improve HIV infected patients' adherence behaviors by accurately and efficiently assessing their medication adherence, delivering an adherence intervention to patients, and producing adherence reports for providers. By providing a neutral and seemingly private interview, computer programs may increase patient disclosure of non-adherence. This study will evaluate the efficacy of a computer-assisted, self-administered adherence program in reducing regimen misunderstandings and enhancing patient adherence.

Participants in this study will be recruited from within the Positive Health Program at San Francisco General Hospital. Patients will be randomly assigned to a Control or Intervention Group. Control Group participants will complete an audio computer-assisted self-interview (A-CASI) assessing their understanding of their medication regimen and adherence. Intervention Group participants will complete the adherence A-CASI and will receive a brief computer-delivered intervention consisting of a graphical depiction of their correct regimen and strategies for improving adherence. Study investigators will forward a computer-generated adherence report, which summarizes their adherence and suggests appropriate interventions, to the Intervention Group's health care providers. All participants will be assessed at least three times over a 6-month period: study entry, Month 3, and Month 6.

Eligibility criteria: Inclusion Criteria

* Receiving HIV care at San Francisco General Hospital's Positive Health Program
* Three or more antiretroviral medications
* HIV-1 viral load \> 500 copies/ml
* At least one previous salvage regimen
* Ability to read English at 8th grade level

Exclusion Criteria

* Visual impairments that prevent patient from reading text on a computer screen
* Obvious cognitive impairment

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco General Hospital
state: California
Study officials:
affiliation: San Francisco General Hospital
name: Frederick M. Hecht, MD
role: STUDY_CHAIR
affiliation: West Portal Software Corporation
name: Amy B. Bronstone, PhD
role: STUDY_DIRECTOR
affiliation: West Portal Software Corporation
name: Roger Hofmann, BS
role: PRINCIPAL_INVESTIGATOR
References: