Electronic Intervention for HIV Medication Adherence

NCT01291485 | Completed DMC

• 1 other identifier: 2010022
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV

Keywords

HIV; Medication adherence; computer-based intervention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• HIV Treatment Adherence Self-Efficacy

  Baseline, 1-month, 3 months, and 6-months

• Quality of Life

  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

Study Arms (2)

Lifestyle counseling

EXPERIMENTAL

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

Treatment as Usual

NO INTERVENTION

Interventions

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.

Lifestyle counseling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oklahoma State University Center for Health Sciences: lead

Study Sites (1)

Internal Medicine Specialty Services

Tulsa, Oklahoma, 74127, United States

Location

MeSH Terms

Conditions

Medication Adherence

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Thad R Leffingwell, Ph.D.

  Oklahoma State University

  STUDY DIRECTOR

• Kasey R Claborn, M.S.

  Oklahoma State University

  PRINCIPAL INVESTIGATOR

• Johnny Stephens, Pharm.D.

  Oklahoma State University Center for Health Sciences

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctoral Candidate

Study Record Dates

• First Submitted: January 10, 2011
• First Posted: February 8, 2011
• Study Start: January 1, 2011
• Primary Completion: September 1, 2011
• Study Completion: November 1, 2011
• Last Updated: October 10, 2012

Record last verified: 2012-10

Locations

US (1)