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

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ClinicalTrials.gov Identifier: NCT02761746
Recruitment Status : Recruiting
First Posted : May 4, 2016
Last Update Posted : March 12, 2019
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Angulique Outlaw, Wayne State University

Tracking Information
First Submitted Date  ICMJE February 29, 2016
First Posted Date  ICMJE May 4, 2016
Last Update Posted Date March 12, 2019
Actual Study Start Date  ICMJE February 22, 2016
Estimated Primary Completion Date April 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 9, 2016)
  • Change in Medication Adherence (Visual Analog Scale) [ Time Frame: 12 Months ]
    A change from baseline (1-month) medication adherence (Visual Analog Scale score) at 12 months via Audio-Computer Assisted Self-Interview (ACASI).
  • Change in Medication Adherence (Hair Sample Assay; physiological parameter) [ Time Frame: 6 Months ]
    A change from baseline (6-month) medication adherence (hair sample collected from the head) at 12 months.
  • Change in Viral Load (biomedical measure) [ Time Frame: 12 Months ]
    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).
  • Change in CD4 count (biomedical measure) [ Time Frame: 12 Months ]
    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).
Original Primary Outcome Measures  ICMJE
 (submitted: May 1, 2016)
  • Change in Medication Adherence (Visual Analog Scale) [ Time Frame: 12 Months ]
    A change from baseline (1-month) medication adherence (Visual Analog Scale score) at 12 months via Audio-Computer Assisted Self-Interview (ACASI).
  • Change in medication adherence (hair sample; physiological parameter) [ Time Frame: 6 Months ]
    A change from baseline (6-month) medication adherence (hair sample collected from the head) at 12 months.
  • Change in health outcomes (biomedical measures) [ Time Frame: 12 Months ]
    Viral load and CD4 count 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 health outcomes at 12 months (decrease in viral load, increase undetectable status, and increase in the CD4 count).
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 9, 2016)
  • Information (HIV Treatment Knowledge score) as an intervention treatment effect [ Time Frame: 12 Months ]
    Information, as measured by HIV Treatment Knowledge Score, will be obtained via ACASI at baseline, 1-month, and 3-, 6-, 9-, and 12-months.
  • Motivation (Readiness Ruler Importance score) as a intervention treatment effect [ Time Frame: 12 Months ]
    Motivation, as measured by Rollnick's Readiness Ruler score adapted to focus on the importance of taking HIV medication will be obtained via ACASI at baseline, 1-month, and 3-, 6-, 9-, and 12-months.
  • Motivation (Decisional Balance for Adherence score) as a intervention treatment effect [ Time Frame: 12 Months ]
    Motivation, as measured by the Decisional Balance for Adherence Score will be obtained via ACASI at baseline, 1-month, and 3-, 6-, 9-, and 12-months.
  • Behavioral Skills (Readiness Ruler Confidence score) as a intervention treatment effect [ Time Frame: 12 Months ]
    Behavioral Skills, as measured by Rollnick's Readiness Ruler score adapted to focus on confidence for taking HIV medication, will be obtained via ACASI at baseline, 1-month, and 3-, 6-, 9-, and 12-months.
  • Behavioral Skills (Temptation Adherence score) as a intervention treatment effect [ Time Frame: 12 Months ]
    Behavioral Skills, measured by the Temptation Adherence score, will be obtained via ACASI at baseline, 1-month, and 3-, 6-, 9-, and 12-months.
  • Predicting differential intervention response as measured by substance abuse (questionnaire score) [ Time Frame: 12 Months ]
    Substance use, as measured by the Alcohol, Smoking, and Substance Involvement Screening Test v3.0: (ASSIST), will be obtained via ACASI at baseline, and 3-, 6- 9-, and 12-months.
  • Predicting differential intervention response as measured by executive functioning (questionnaire score) [ Time Frame: 12 Months ]
    Executive functioning, as measured by the Behavior Rating Inventory of Executive Functioning-Adult Version: (BRIEF-A), will be obtained via ACASI at baseline, and 3-, 6- 9-, and 12-months.
  • Predicting differential intervention response as measured by structural barriers (questionnaire score) [ Time Frame: 12 Months ]
    Structural barriers, as measured by the Services and Support score, will be obtained via ACASI at baseline, and 3-, 6- 9-, and 12-months.
  • Predicting differential intervention response as measured by mental health symptoms (questionnaire score) [ Time Frame: 12 Months ]
    Mental health symptoms, as measured by the Brief Symptom Inventory-18: (BSI-18), will be obtained via ACASI at baseline, 1-month, and 3-, 6-, 9-, and 12-months.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 1, 2016)
  • Information (HIV Treatment Knowledge score) as an intervention treatment effect [ Time Frame: 12 Months ]
    Information, as measured by HIV Treatment Knowledge Score, will be obtained via ACASI at baseline, 1-month, and 3-, 6-, 9-, and 12-months.
  • Motivation (questionnaire scores) as a intervention treatment effect [ Time Frame: 12 Months ]
    Motivation, as measured by Rollnick's Readiness Ruler Score adapted to focus on the importance of taking HIV medication and the Decisional Balance for Adherence Score will be obtained via ACASI at baseline, 1-month, and 3-, 6-, 9-, and 12-months.
  • Behavioral skills (questionnaire scores) as a intervention treatment effect [ Time Frame: 12 Months ]
    Behavioral Skills, as measured by Rollnick's Readiness Ruler score adapted to focus on confidence for taking HIV medication and the Temptation Adherence score will be obtained via ACASI at baseline, 1-month, and 3-, 6-, 9-, and 12-months.
  • Predicting differential intervention response as measured by substance abuse, executive functioning, and structural barriers (questionnaire scores) [ Time Frame: 12 Months ]
    Substance use (measured by the Alcohol, Smoking, and Substance Involvement Screening Test v3.0: ASSIST), executive functioning (measured by the Behavior Rating Inventory of Executive Functioning-Adult Version: BRIEF-A), and structural barriers (Services and Support) will be obtained via ACASI at baseline, and 3-, 6- 9-, and 12-months.
  • Predicting differential intervention response as measured by mental health symptoms (questionnaire score) [ Time Frame: 12 Months ]
    Mental health symptoms, as measured by the Brief Symptom Inventory-18: (BSI-18), will be obtained via ACASI at baseline, 1-month, and 3-, 6-, 9-, and 12-months.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Motivational Enhancement System for Adherence (MESA) for Youth Starting ART
Official Title  ICMJE Motivational Enhancement System for Adherence (MESA) for Youth Starting Antiretroviral Therapy (ART)
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.
Detailed 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Medication Adherence
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: Intervention Condition (MESA)
    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.
    Intervention: Behavioral: MESA
  • No Intervention: Control Condition (SH)
    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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 10, 2019)
200
Original Estimated Enrollment  ICMJE
 (submitted: May 1, 2016)
300
Estimated Study Completion Date  ICMJE April 30, 2021
Estimated Primary Completion Date April 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years to 24 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Angulique Y Outlaw, PhD (313) 577-0791 aoutlaw@med.wayne.edu
Contact: Monique Jones, MPH (313) 577-0792 mogreen@med.wayne.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02761746
Other Study ID Numbers  ICMJE 052115B3F
R01MH108442 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Angulique Outlaw, Wayne State University
Study Sponsor  ICMJE Wayne State University
Collaborators  ICMJE National Institute of Mental Health (NIMH)
Investigators  ICMJE
Principal Investigator: Angulique Y Outlaw, PhD Wayne State University
Principal Investigator: Sylvie Naar, PhD University of Florida
PRS Account Wayne State University
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP