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

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.

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.