- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01009749
Motivational Enhancement System for Adherence
Computer-Delivered Motivational Intervention to Prevent Adherence Problems Among Youth Newly Recommended for HIV Medications: Project MESA (Motivational Enhancement System for Adherence)
This is a two-phase study, consisting of the following plan:
Phase I - This is a pre-test of the feasibility and acceptability of the beta version of a computer-delivered intervention, Motivational Enhancement System for Adherence (MESA), as well as the control intervention Motivational Enhancement System for Health (MESH) at three selected AMTUs. Following analysis of the responses in Phase I and further modification of the intervention, Phase II will be initiated.
Phase II - This is a pilot, randomized, controlled trial (RCT) testing a two-session computer-delivered intervention, MESA, designed to increase motivation for adherence to Highly Active Antiretroviral Therapy (HAART) among youth newly recommended to begin medications, as well as an attention control, MESH, matched for dose and delivery format. Phase II is open to all 15 AMTUs.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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San Juan, Puerto Rico, 00936
- University Pediatric Hospital
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California
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Los Angeles, California, United States, 90027
- Children's Hopsital of Los Angeles
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San Francisco, California, United States, 94143
- Univ of Califormia at San Francisco
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District of Columbia
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Washington, D.C., District of Columbia, United States, 20010
- Children's Hosp Natinal Med Center
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Florida
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Fort Lauderdale, Florida, United States, 33316
- Children's Diagnostic and Treatment Center
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Miami, Florida, United States, 33101
- University of Miami-Jackson Memorial Medical Center
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Tampa, Florida, United States, 33606
- University of South Florida
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Illinois
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Chicago, Illinois, United States, 60612
- Stoger Hospital of Cook County
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Louisiana
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New Orleans, Louisiana, United States, 70112
- Tulane Medical Center
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Maryland
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Baltimore, Maryland, United States, 21201
- University of Maryland
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New York
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New York, New York, United States, 10128
- Mount Sinai Medical Center
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The Bronx, New York, United States, 10467
- Children's Hospital at Montefiore Medical Center
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Children's Hopsital of Philadelphia
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Tennessee
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Memphis, Tennessee, United States, 38105
- St. Jude Childrens Research Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Phase I & II, all participants
- Engaged in care at the enrolling AMTU;
- HIV-1 infection documented by a positive result on any of the following licensed tests at any time: any HIV-1 antibody test confirmed by Western blot, HIV-1 culture, HIV-1 DNA PCR, or plasma HIV-1 RNA PCR > 1,000 copies/ml;
- Age 16 to 24 years, inclusive at the time of enrollment;
- Naïve to antiretroviral therapy; NOTE: Females who have received antiretroviral therapy for the sole purpose of preventing maternal to child transmission (MTCT) will be considered antiretroviral naïve.
- Ability to understand written and/or spoken English;
- Willingness to provide signed informed consent/assent in either English or Spanish; and
- Parental or legal guardian permission, if warranted.
Phase I MESA Participants/Phase II All Participants - Recommended by a health care provider to start HAART for treatment of HIV-1 infection within the 12 weeks prior to protocol screening.
Phase I MESH Participants
- Not recommended by a health care provider to start HAART for treatment of HIV-1 infection.
Exclusion Criteria:
Phase I & II, all participants
- 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 protocol requirements and/or interfere with the protocol objectives; and
- Concurrent participation or participation within the previous 4 weeks, in any behavioral intervention study or program, including, but not limited to, ATN 069 and ATN 073. Permission to co-enroll into other behavioral studies or programs must be obtained from the protocol chair or designee.
Phase II, All Participants Prior participation in the Phase I MESA intervention (Phase I MESH control participants are eligible to participate).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: MESA
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MESA is designed to increase motivation for adherence to Highly Active Antiretroviral Therapy (HAART) among youth newly recommended to begin medications.
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Active Comparator: MESH
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Motivational Enhancement System for Health (MESH) is an attentional control providing information on nutrition and exercise.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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To assess the feasibility and acceptability of the Motivational Enhancement System for Adherence (MESA) among HIV-infected youth newly beginning HAART; and in an attention control condition plus standard care.
Time Frame: 26 months
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26 months
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To compare levels of motivation to adhere and adherence and reductions in HIV-1 viral loads at follow-up among youth randomized to MESA plus standard care versus those randomized to MESH plus standard care.
Time Frame: 26 months
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26 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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To compare service utilization rates among youth randomized to MESA plus standard care versus those in an attention control condition plus standard care.
Time Frame: 26 months
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26 months
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To examine self-efficacy for adherence for youth randomized to MESA plus standard care compared to those in an attention control condition plus standard care.
Time Frame: 26 months
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26 months
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To assess HAART medication knowledge among youth randomized to MESA plus standard care versus those in an attention control condition plus standard care.
Time Frame: 26 months
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26 months
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To assess levels of motivation and self-efficacy for healthy eating and exercise among youth randomized to MESH plus standard care compared to those randomized to MESA plus standard care.
Time Frame: 26 months
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26 months
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To examine the levels of nutrition and exercise knowledge among youth randomized to MESH plus standard care compared to those randomized to MESA plus standard care.
Time Frame: 26 months
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26 months
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Collaborators and Investigators
Investigators
- Study Chair: Sylvie Naar-King, PhD, Adolescent Trials Network
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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