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Electronic Intervention for HIV Medication Adherence

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01291485
First Posted: February 8, 2011
Last Update Posted: October 10, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Kasey Claborn, Oklahoma State University Center for Health Sciences
  Purpose
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.

Condition Intervention
HIV Behavioral: Life Steps for Medication Adherence

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Randomized Clinical Trial Examining the Efficacy of an Electronic Intervention for HIV Medication Adherence

Resource links provided by NLM:


Further study details as provided by Kasey Claborn, Oklahoma State University Center for Health Sciences:

Primary Outcome Measures:
  • HIV medication adherence [ Time Frame: up to 6 months ]
    Self-reported adherence to HIV medications will be assessed using the AACTG Medication Adherence Questionnaire (M. A. Chesney, et al., 2000).


Secondary Outcome Measures:
  • HIV Treatment Adherence Self-Efficacy [ Time Frame: Baseline, 1-month, 3 months, and 6-months ]
    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 ]
    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 ]
  • CD4 cell count [ Time Frame: Baseline, 1 month, 3 months, and 6 months ]

Enrollment: 97
Study Start Date: January 2011
Study Completion Date: November 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
No Intervention: Treatment as Usual

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01291485


Locations
United States, Oklahoma
Internal Medicine Specialty Services
Tulsa, Oklahoma, United States, 74127
Sponsors and Collaborators
Oklahoma State University Center for Health Sciences
Investigators
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
  More Information

Responsible Party: Kasey Claborn, Doctoral Candidate, Oklahoma State University Center for Health Sciences
ClinicalTrials.gov Identifier: NCT01291485     History of Changes
Other Study ID Numbers: 2010022
First Submitted: January 10, 2011
First Posted: February 8, 2011
Last Update Posted: October 10, 2012
Last Verified: October 2012

Keywords provided by Kasey Claborn, Oklahoma State University Center for Health Sciences:
HIV
Medication adherence
computer-based intervention