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TerminatedNCT00051766Updated Jun 24, 2005

Computer-Assisted Adherence Program for Patients Taking Anti-HIV Drugs

An interventional study of Computer-based Intervention in Acquired Immunodeficiency Syndrome and HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Terminated at 1 site in United States. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2005-06-24.

Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Not applicable, Interventional, and Educational/counseling/training

Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
16 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Acquired Immunodeficiency Syndrome
  • HIV Infections

Keywords

  • compliance
  • medication
  • antiretroviral
  • adherence
  • intervention
  • treatment experienced
03

In context

HIV Infections

4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.

This study's enrollment of 200 is above the median of 83 across 3,251 interventional studies indexed under HIV Infections.

Browse HIV Infections studies →

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,401 studies on the registry; 179 are open to participants now.

Of its 396 completed or terminated interventional studies of FDA-regulated products, 294 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria

  • Visual impairments that prevent patient from reading text on a computer screen
  • Obvious cognitive impairment
05

Study design

Phase
Not applicable
Primary purpose
Educational/counseling/training
Allocation
Randomized
Intervention model
Factorial assignment
Masking
None (open label)
Enrollment
200 participants

Interventions

  • BehavioralComputer-based Intervention
06

Study locations

1 site
  • San Francisco General Hospital
    San Francisco, California 94110, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 24, 2005, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00051766
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
First posted
Jan 17, 2003
Last update
Jun 24, 2005

Study contacts

Frederick M. Hecht, MD
study chair · San Francisco General Hospital
Amy B. Bronstone, PhD
study director · West Portal Software Corporation
Roger Hofmann, BS
principal investigator · West Portal Software Corporation
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in May 2005. You cannot join it, but the record below documents what was studied.

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