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

Medication Adherence Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Medication Adherence

• NCT number: NCT02761746
• Study type: Interventional
• Source: Wayne State University
• Status: Completed
• Phase: N/A
• Start date: February 22, 2016
• Completion date: April 30, 2021