Electronic Intervention for HIV Medication Adherence

Study Overview
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Brief Summary
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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.

Official Title
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Randomized Clinical Trial Examining the Efficacy of an Electronic Intervention for HIV Medication Adherence

Conditions
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HIV

Intervention / Treatment
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* Behavioral: Life Steps for Medication Adherence


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lifestyle counseling<br>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<br>* 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.<br>|
| No Intervention: Treatment as Usual<br> | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, Medication adherence, computer-based intervention