Electronic Intervention for HIV Medication Adherence
|ClinicalTrials.gov Identifier: NCT01291485|
Recruitment Status : Completed
First Posted : February 8, 2011
Last Update Posted : October 10, 2012
|Condition or disease||Intervention/treatment||Phase|
|HIV||Behavioral: Life Steps for Medication Adherence||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||97 participants|
|Intervention Model:||Parallel Assignment|
|Primary Purpose:||Supportive Care|
|Official Title:||Randomized Clinical Trial Examining the Efficacy of an Electronic Intervention for HIV Medication Adherence|
|Study Start Date :||January 2011|
|Actual Primary Completion Date :||September 2011|
|Actual Study Completion Date :||November 2011|
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|
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01291485
|United States, Oklahoma|
|Internal Medicine Specialty Services|
|Tulsa, Oklahoma, United States, 74127|
|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|