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

Wayne State University

Status: Completed

Conditions: Medication Adherence

Treatments: Behavioral: MESA

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02761746

R01MH108442 (U.S. NIH Grant/Contract)

052115B3F

Details and patient eligibility

About

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.

Full 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.

Enrollment: 155 patients

Sex: All

Ages: 16 to 24 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Youth living with HIV, ages 16 to 24 years 11 months, who are current patients at the 4 participating sites in Detroit, MI; Washington, DC; Los Angeles, CA; Philadelphia, PA; Aurora, CO; Miami, FL; and Baltimore, MD.
• Understands written and/or verbal English.
• Youth must have been verbally recommended to begin ART within the previous 12 weeks (recommendation could have first been made at an earlier time, but the youth must have been notified again by a health care provider in the previous 12 weeks), but has not been on ART for more than 30 days or verbally recommended to restart ART after being off ART for at least 6 months. Females who have received ART for the sole purpose of preventing maternal to child transmission in the past will be considered antiretroviral naïve.

Exclusion criteria

• Known pregnancy (pregnancy testing is not required).
• Inability to understand spoken or written English.
• Visibly distraught and/or visibly emotionally unstable (e.g., exhibiting suicidal, homicidal, manic or violent behavior).
• Active drug or alcohol use or dependence that, in the opinion of the site personnel, would interfere with ability to give true informed consent and to adhere to the study requirements.
• Active psychiatric condition that in the opinion of the site personnel, would interfere with the ability to give true informed consent and to adhere to the study requirements.
• Acute illness that, in the opinion of the treating clinician, would interfere with the participant's ability to adhere to the study requirements and/or interfere with the study objectives.
• Concurrent participation or participation within the previous 4 weeks, in any behavioral adherence intervention study or program.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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155 participants in 2 patient groups

Intervention Condition (MESA)

Experimental group

Description:

MESA involves two sessions (ACASI assessment and intervention), one at study entry (prior to beginning ART) and one a month later. Then, participants will complete ACASI assessments only at 3, 6, 9, and 12 months. The first MESA session is tailored based on how important and how confident the person feels about taking medications as prescribed. The participant is also offered personalized feedback regarding immune status and HIV knowledge with actual adherence feedback provided in the second session. Finally, the participant may engage in goal setting. The second MESA session focuses on adherence behavior over the previous month and the consequences (good or bad) of that behavior.

Treatment:

Behavioral: MESA

Control Condition (SH)

No Intervention group

Description:

The SH control condition involves two sessions (ACASI assessment and control condition), one at study entry (prior to beginning ART) and one a month later. Then, participants will complete ACASI assessments only at 3, 6, 9, and 12 months. The first SH session targets healthy eating and physical activity and is matched for dose and length of time of the intervention session. Feedback and education are provided, if desired. Finally, the participants may engage in goal setting for healthy eating and physical activity. The second SH session focuses on the goals set during the first session and behavior over the previous month.