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

NCT02761746 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 155

Last updated 2022-08-19

No results posted yet for this study

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.

Conditions

  • Medication Adherence

Interventions

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.

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • Wayne State University

    lead OTHER

Principal Investigators

  • Angulique Y Outlaw, PhD · Wayne State University

  • Sylvie Naar, PhD · University of Florida

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
24 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-22
Primary Completion
2021-04-30
Completion
2021-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02761746 on ClinicalTrials.gov