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.

Study Overview

• Status: Completed
• Conditions: HIV
• Intervention / Treatment: Behavioral: Life Steps for Medication Adherence

• Study Type: Interventional
• Enrollment (Actual): 97
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74127
      • Internal Medicine Specialty Services

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Treatment as Usual
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HIV Treatment Adherence Self-Efficacy	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.	Baseline, 1-month, 3 months, and 6-months
Quality of Life	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.	Baseline, 1-month, 3-months, and 6-months
Viral Load		Baseline, 1 month, 3 months, and 6 months
CD4 cell count		Baseline, 1 month, 3 months, and 6 months

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): September 1, 2011
• Study Completion (Actual): November 1, 2011

Study Registration Dates

• First Submitted: January 10, 2011
• First Submitted That Met QC Criteria: February 7, 2011
• First Posted (Estimate): February 8, 2011

Study Record Updates

• Last Update Posted (Estimate): October 10, 2012
• Last Update Submitted That Met QC Criteria: October 9, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Keywords: HIV; Medication adherence; computer-based intervention
• Other Study ID Numbers: 2010022