Electronic Intervention for HIV Medication Adherence

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kasey Claborn, Oklahoma State University Center for Health Sciences
ClinicalTrials.gov Identifier:
NCT01291485
First received: January 10, 2011
Last updated: October 9, 2012
Last verified: October 2012

January 10, 2011
October 9, 2012
January 2011
September 2011   (final data collection date for primary outcome measure)
HIV medication adherence [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]
Self-reported adherence to HIV medications will be assessed using the AACTG Medication Adherence Questionnaire (M. A. Chesney, et al., 2000).
Same as current
Complete list of historical versions of study NCT01291485 on ClinicalTrials.gov Archive Site
  • HIV Treatment Adherence Self-Efficacy [ Time Frame: Baseline, 1-month, 3 months, and 6-months ] [ Designated as safety issue: No ]
    Self-efficacy for adherence to HIV medications will be assessed using the HIV-ASES (Johnson et al., 2007). The HIV-ASES is a 12-item scale of patient confidence in their ability to carry out behaviors related to adhering to medication regimens. Responses range from 1 ("cannot do it at all") to 10 ("completely certain can do it"). Item scores are averaged with higher scores indicating higher adherence self-efficacy.
  • Quality of Life [ Time Frame: Baseline, 1-month, 3-months, and 6-months ] [ Designated as safety issue: No ]
    Quality of life will be assessed using the McGill Quality of Life questionnaire (S. Robin Cohen, Hassan, Lapointe, & Mount, 1996). This instrument is a 16-item scale that assesses quality of life in four domains: physical well-being, psychological well-being, existential well-being, and support; each item is assessed on a 0-10 point scale.
  • Viral Load [ Time Frame: Baseline, 1 month, 3 months, and 6 months ] [ Designated as safety issue: No ]
  • CD4 cell count [ Time Frame: Baseline, 1 month, 3 months, and 6 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Electronic Intervention for HIV Medication Adherence
Randomized Clinical Trial Examining the Efficacy of an Electronic Intervention for HIV Medication Adherence

The purpose of this study is to develop and examine the feasibility and initial efficacy of a computer-based intervention to improve medication adherence among people living with HIV.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
HIV
Behavioral: Life Steps for Medication Adherence
The intervention was adapted into an electronic version of the empirically supported Life Steps intervention for HIV medication adherence. Education about HIV and medication adherence, motivational interviewing, cognitive behavioral techniques, and problem-solving strategies to improve medication adherence and clinical outcomes in people living with HIV were also included in the intervention.
  • Experimental: Lifestyle counseling
    Intervention includes education about HIV and medication adherence, motivational interviewing, cognitive behavioral techniques, and problem-solving strategies to improve HIV medication adherence and clinical outcomes.
    Intervention: Behavioral: Life Steps for Medication Adherence
  • No Intervention: Treatment as Usual
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
97
November 2011
September 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • infected with HIV
  • over age 18
  • currently prescribed a Highly Active Antiretroviral Therapy (HAART) regimen
  • prescribed a regimen for the first time, changing regimens, or report adherence below 95% agree to brief follow-up interviews

Exclusion Criteria:

  • physical impairment that would prevent them from successfully completing the computer-based program (e.g., blind, deaf, severe neuropsychological impairment)
  • Actively psychotic
  • Not fluent in English
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01291485
2010022
Yes
Kasey Claborn, Oklahoma State University Center for Health Sciences
Oklahoma State University Center for Health Sciences
Not Provided
Study Director: Thad R Leffingwell, Ph.D. Oklahoma State University
Principal Investigator: Kasey R Claborn, M.S. Oklahoma State University
Study Chair: Johnny Stephens, Pharm.D. Oklahoma State University Center for Health Sciences
Oklahoma State University Center for Health Sciences
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP