NCT00247611

Improving Treatment Adherence in HIV-Infected Individuals

Changing ART Adherence Behavior: The Lifewindows Project

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 594 (actual)
• Sponsor: University of Connecticut · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will develop and evaluate the efficacy of an individualized, interactive, computer software program delivered in conjunction with clinical care in increasing and supporting antiretroviral therapy adherence in HIV-infected individuals.

Detailed description

When antiretroviral therapy (ART) is taken correctly, it can dramatically improve the health and well-being of HIV-infected individuals. However, when the treatment regimen is not followed carefully, the therapy can be ineffective in managing one's HIV, and also can allow for the development of strains of HIV that may be resistant to treatment. Effective ART adherence interventions can help patients to avoid potentially serious individual and public health consequences of suboptimal adherence, but such interventions are often expensive and too intensive for clinics to support offering over time to their patients. This study will develop and evaluate the effectiveness of an individualized, interactive, computer-software intervention program delivered in clinical care in increasing ART adherence in HIV-infected individuals. Because the intervention is a software program, clinic resources required for implementation and sustaining availability over time are minimized. Participants in this \~18-month study were recruited from one of 5 participating clinics that provide HIV care and randomly assigned to control (an assessment only version of the software) or intervention (assessment and tailored intervention software) arm. Participants completed their assigned task in concert with their regularly scheduled HIV medical care visits (but no more frequently than once a month). Primary outcomes were measured at each medical visit. The effect of the adherence intervention was evaluated through comparison of treatment and control arm adherence reports over time and VL.

Conditions

• HIV Antiretroviral Therapy (ART) Adherence
• Health Behavior

Interventions

Type	Name	Description
BEHAVIORAL	LifeWindows Intervention Sessions	At each clinical care visit, intervention arm participants use the full LifeWindows program, which includes welcome and assessment surveys and also includes the active intervention modules. ART adherence promotion intervention activities are tailored to the participant's assessment responses. Participants select which activities he or she wishes to use which culminates in an adherence specific goal.
OTHER	Control	At each clinical care visit, control arm participants use the portion of the LifeWindows software program that provides a welcome from the avatar and collection of assessment items/surveys.

Timeline

• Start date: 2005-10-01
• Primary completion: 2008-03-01
• Completion: 2008-03-01
• First posted: 2005-11-02
• Last updated: 2013-12-20
• Results posted: 2013-12-20

Locations

5 sites across 1 country: United States