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Electronic Intervention for HIV Medication Adherence

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01291485
Enrollment
97
Registered
2011-02-08
Start date
2011-01-31
Completion date
2011-11-30
Last updated
2012-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV

Keywords

HIV, Medication adherence, computer-based intervention

Brief summary

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.

Interventions

BEHAVIORALLife 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.

Sponsors

Oklahoma State University Center for Health Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
HIV medication adherenceup to 6 monthsSelf-reported adherence to HIV medications will be assessed using the AACTG Medication Adherence Questionnaire (M. A. Chesney, et al., 2000).

Secondary

MeasureTime frameDescription
HIV Treatment Adherence Self-EfficacyBaseline, 1-month, 3 months, and 6-monthsSelf-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 LifeBaseline, 1-month, 3-months, and 6-monthsQuality 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 LoadBaseline, 1 month, 3 months, and 6 months
CD4 cell countBaseline, 1 month, 3 months, and 6 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026