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

NCT02761746 | Completed DMC

• 2 other identifiers: 052115B3FR01MH108442
• Study Type: interventional
• Target: 155
• Locations: 1 country
• Sites: 7

Brief 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

Keywords

HIV; Adherence; Health Outcomes

Outcome Measures

Primary Outcomes (4)

• Change in Medication Adherence (Visual Analog Scale)

  A change from baseline (1-month) medication adherence (Visual Analog Scale score) at 12 months via Audio-Computer Assisted Self-Interview (ACASI).

  12 Months

• Change in Medication Adherence (Hair Sample Assay; physiological parameter)

  A change from baseline (6-month) medication adherence (hair sample collected from the head) at 12 months.

  6 Months

• Change in Viral Load (biomedical measure)

  Viral load laboratory tests (biomedical measures of health status) will be collected, via a blood sample or obtained from medical record review, at baseline (6 weeks prior to enrollment) and 12-months. A change from baseline viral load at 12 months (decrease in viral load, increase undetectable status).

  12 Months

• Change in CD4 count (biomedical measure)

  CD4 count laboratory tests (biomedical measures of health status) will be obtained from medical record review at baseline (6 weeks prior to enrollment) and 12-months. A change from baseline CD4 at 12 months (increase in the CD4 count).

  12 Months

Secondary Outcomes (9)

• Information (HIV Treatment Knowledge score) as an intervention treatment effect

  12 Months

• Motivation (Readiness Ruler Importance score) as a intervention treatment effect

  12 Months

• Motivation (Decisional Balance for Adherence score) as a intervention treatment effect

  12 Months

• Behavioral Skills (Readiness Ruler Confidence score) as a intervention treatment effect

  12 Months

• Behavioral Skills (Temptation Adherence score) as a intervention treatment effect

  12 Months

Study Arms (2)

Intervention Condition (MESA)

EXPERIMENTAL

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.

Behavioral: MESA

Control Condition (SH)

NO INTERVENTION

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.

Interventions

MESA BEHAVIORAL

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.

Intervention Condition (MESA)

Eligibility Criteria

• Age: 16 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wayne State University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (7)

Children's Hospital of Los Angeles

Los Angeles, California, 90027, United States

Location

University of Colorado School of Medicine

Aurora, Colorado, 80045, United States

Location

Children's National Medical Center

Washington D.C., District of Columbia, 20010, United States

Location

Univeristy of Miami School of Medicine

Miami, Florida, 33101, United States

Location

Johns Hopkins School of Medicine

Baltimore, Maryland, 21287, United States

Location

Wayne State University

Detroit, Michigan, 48201, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• Outlaw AY, Templin T, MacDonell K, Jones M, Secord E, Naar S. Motivational Enhancement System for Adherence for Adolescents and Young Adults Newly Recommended to Start Antiretroviral Therapy. J Acquir Immune Defic Syndr. 2025 Jan 1;98(1):49-56. doi: 10.1097/QAI.0000000000003530.

  PMID: 39288943 DERIVED

MeSH Terms

Conditions

Medication Adherence

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Angulique Y Outlaw, PhD

  Wayne State University

  PRINCIPAL INVESTIGATOR

• Sylvie Naar, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 29, 2016
• First Posted: May 4, 2016
• Study Start: February 22, 2016
• Primary Completion: April 30, 2021
• Study Completion: April 30, 2021
• Last Updated: August 19, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)