Clinical trial NCT02761746: Motivational Enhancement System for Adherence (MESA) for Youth Starting ART
Official title: Motivational Enhancement System for Adherence (MESA) for Youth Starting Antiretroviral Therapy (ART)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Medication Adherence
Keywords: HIV
Adherence
Health Outcomes
Lead sponsor: Wayne State University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2016-05-04
Enrollment: 155
Sex: ALL
Minimum age (years): 16
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Medication Adherence (Visual Analog Scale)
timeFrame: 12 Months
measure: Change in Medication Adherence (Hair Sample Assay; physiological parameter)
timeFrame: 6 Months
measure: Change in Viral Load (biomedical measure)
timeFrame: 12 Months
measure: Change in CD4 count (biomedical measure)
timeFrame: 12 Months
Secondary outcomes:
measure: Information (HIV Treatment Knowledge score) as an intervention treatment effect
timeFrame: 12 Months
measure: Motivation (Readiness Ruler Importance score) as a intervention treatment effect
timeFrame: 12 Months
measure: Motivation (Decisional Balance for Adherence score) as a intervention treatment effect
timeFrame: 12 Months
measure: Behavioral Skills (Readiness Ruler Confidence score) as a intervention treatment effect
timeFrame: 12 Months
measure: Behavioral Skills (Temptation Adherence score) as a intervention treatment effect
timeFrame: 12 Months
measure: Predicting differential intervention response as measured by substance abuse (questionnaire score)
timeFrame: 12 Months
measure: Predicting differential intervention response as measured by executive functioning (questionnaire score)
timeFrame: 12 Months
measure: Predicting differential intervention response as measured by structural barriers (questionnaire score)
timeFrame: 12 Months
measure: Predicting differential intervention response as measured by mental health symptoms (questionnaire score)
timeFrame: 12 Months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Children's Hospital of Los Angeles
state: California
city: Aurora
country: United States
facility: University of Colorado School of Medicine
state: Colorado
city: Washington
country: United States
facility: Children's National Medical Center
state: District of Columbia
city: Miami
country: United States
facility: Univeristy of Miami School of Medicine
state: Florida
city: Baltimore
country: United States
facility: Johns Hopkins School of Medicine
state: Maryland
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Wayne State University
name: Angulique Y Outlaw, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Florida
name: Sylvie Naar, PhD
role: PRINCIPAL_INVESTIGATOR
References: