Electronic Intervention for HIV Medication Adherence

HIV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01291485
• Other study ID #: 2010022
• Status: Completed
• Phase: N/A
• First received: January 10, 2011
• Last updated: October 9, 2012
• Start date: January 2011
• Est. completion date: November 2011

Study information

• Verified date: October 2012
• Source: Oklahoma State University Center for Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: November 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• HIV

Intervention

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.

Locations

Country	Name	City	State
United States	Internal Medicine Specialty Services	Tulsa	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Oklahoma State University Center for Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Viral Load		Baseline, 1 month, 3 months, and 6 months	No
Secondary	CD4 cell count		Baseline, 1 month, 3 months, and 6 months	No