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Completed

NCT Number: NCT01291485

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.

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Key information

Conditions

HIV Behavior Health Behavior Medication Adherence Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Internal Medicine Specialty Services

Tulsa, Oklahoma, 74127, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Life Steps for Medication Adherence

Behavioral

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.

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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.

  2. 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.

  3. Viral Load

    Time frame: Baseline, 1 month, 3 months, and 6 months

  4. CD4 cell count

    Time frame: Baseline, 1 month, 3 months, and 6 months

Sponsors and collaborators

Lead sponsor

Oklahoma State University Center for Health Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Feb 8, 2011
Registry last updated
Oct 10, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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