NCT02761746

Motivational Enhancement System for Adherence (MESA) for Youth Starting ART

Motivational Enhancement System for Adherence (MESA) for Youth Starting Antiretroviral Therapy (ART)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 155 (actual)
• Sponsor: Wayne State University · Academic / Other
• Sex: All
• Age: 16 Years – 24 Years
• Healthy volunteers: Not accepted

Summary

This study is a multi-site (Detroit, MI; Los Angeles, CA; Philadelphia, PA, Washington, DC; Aurora, CO; Miami, FL; and Baltimore, MD), two-group randomized controlled trial testing a two-session intervention designed to increase motivation for adherence to antiretroviral treatment (ART) among youth living with HIV (YLH) newly recommended to begin medications. Participants are randomized to receive the intervention, Motivational Enhancement System for Adherence (MESA), or the control condition, System for Health (SH: healthy eating and physical activity information). Both groups receive the standard of care regarding the initiation of ART. ART adherence (visual analog scale and hair sample assay) and health outcomes (viral load results, and CD4 counts) are assessed. Additionally, potential mediators (HIV knowledge, motivation for adherence, and self-efficacy for adherence) and predictors of intervention response (substance abuse, mental health symptoms, executive functioning, and stressful life events) are assessed.

Detailed description

Medication adherence rates among youth living with HIV (YLH) are inadequate to effectively manage the disease. Very few adherence interventions have been tested with youth, and those that have are difficult to implement in real-world settings due to high intensity of sessions or low attendance rates. Thus, there is a demand for innovative, feasible, and engaging behavioral interventions targeting adherence, especially among YLH, the largest initiators of antiretroviral treatment (ART). A universal primary prevention program is a novel approach to target adherence problems before they begin by providing a prevention intervention to all youth newly initiating ART. This study plans to test a brief, two-session, computer-delivered motivational intervention to prevent adherence difficulties among youth newly prescribed ART. All elements of the study (assessment, intervention, control condition) were piloted in a small multi-site randomized controlled trial (NIH-funded Adolescent Medicine Trials Medicine Network for HIV/AIDS Interventions: ATN). Results suggested feasibility and acceptability, as well as trends for improved adherence when comparing the intervention to an active control condition. For the proposed multi-site randomized clinical trial, youth newly beginning or restarting ART (N=200 from 7 ATN sites in the United States) will be randomize to the Motivational Enhancement System for Adherence (MESA) or to the control condition (System for Health: SH; nutrition and exercise information delivered by the same platform matched for dose). ART adherence (visual analog scale and hair specimen assays) and health outcomes (viral load results and CD4 counts) is the primary outcome. Potential mediators (HIV knowledge, motivation for adherence, and self-efficacy for adherence) on the treatment effects of MESA and moderators (substance abuse, mental health symptoms, executive functioning, and stressful life events) as predictors of differential intervention response will be assessed. It is hypothesized that participants randomized to MESA will show significantly greater adherence and health outcomes than participants randomized to SH over one year of follow-up.

Conditions

• Medication Adherence

Interventions

Type	Name	Description
BEHAVIORAL	MESA	MESA is tailored based on how important and how confident the participant feels about taking medications as prescribed. If the participant does not believe taking medications is important, they engage in a decisional balance exercise. If the participant believes taking medications is important, they move directly to confidence modules and goal setting. If the participant does not feel confident about taking medications, they engage in activities to boost self-efficacy. Participants are also offered personalized feedback regarding immune status and HIV knowledge with actual adherence feedback provided in the second session. Finally, goal setting is an option, and feedback regarding adherence behavior over the previous month.

Timeline

• Start date: 2016-02-22
• Primary completion: 2021-04-30
• Completion: 2021-04-30
• First posted: 2016-05-04
• Last updated: 2022-08-19

Locations

7 sites across 1 country: United States