Electronic Intervention for HIV Medication Adherence
Oklahoma State University Center for Health Sciences
Information provided by (Responsible Party)
Kasey Claborn, Oklahoma State University Center for Health Sciences
First received: January 10, 2011
Last updated: October 9, 2012
Last Verified: October 2012
History of Changes
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.
Behavioral : Life Steps for Medication Adherence
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|
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).
- 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 ]
|Study Start Date:||January 2011|
|Study Completion Date:||November 2011|
|Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
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.
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.
Treatment as Usual
|Ages Eligible for Study:||18 Years and older|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- 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 LocationsChoosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01291485
Locations Show More
|United States, Oklahoma|
|Internal Medicine Specialty Services|
|Tulsa, Oklahoma, United States, 74127|
Sponsors and CollaboratorsOklahoma State University Center for Health Sciences
|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|
|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|
|Study First Received:||January 10, 2011|
|Last Updated:||October 9, 2012|
Keywords provided by Kasey Claborn, Oklahoma State University Center for Health Sciences:HIV
ClinicalTrials.gov processed this data on October 16, 2017
This information is provided by ClinicalTrials.gov.