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)
1 other identifier
interventional
76
2 countries
14
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable hiv
Started Aug 2009
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2009
CompletedFirst Submitted
Initial submission to the registry
November 6, 2009
CompletedFirst Posted
Study publicly available on registry
November 9, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedAugust 1, 2017
July 1, 2017
1.7 years
November 6, 2009
July 28, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
26 months
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.
26 months
Secondary Outcomes (5)
To compare service utilization rates among youth randomized to MESA plus standard care versus those in an attention control condition plus standard care.
26 months
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.
26 months
To assess HAART medication knowledge among youth randomized to MESA plus standard care versus those in an attention control condition plus standard care.
26 months
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.
26 months
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.
26 months
Study Arms (2)
MESA
EXPERIMENTALMESH
ACTIVE COMPARATORInterventions
MESA is designed to increase motivation for adherence to Highly Active Antiretroviral Therapy (HAART) among youth newly recommended to begin medications.
Motivational Enhancement System for Health (MESH) is an attentional control providing information on nutrition and exercise.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
Children's Hopsital of Los Angeles
Los Angeles, California, 90027, United States
Univ of Califormia at San Francisco
San Francisco, California, 94143, United States
Children's Hosp Natinal Med Center
Washington D.C., District of Columbia, 20010, United States
Children's Diagnostic and Treatment Center
Fort Lauderdale, Florida, 33316, United States
University of Miami-Jackson Memorial Medical Center
Miami, Florida, 33101, United States
University of South Florida
Tampa, Florida, 33606, United States
Stoger Hospital of Cook County
Chicago, Illinois, 60612, United States
Tulane Medical Center
New Orleans, Louisiana, 70112, United States
University of Maryland
Baltimore, Maryland, 21201, United States
Mount Sinai Medical Center
New York, New York, 10128, United States
Children's Hospital at Montefiore Medical Center
The Bronx, New York, 10467, United States
Children's Hopsital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
St. Jude Childrens Research Hospital
Memphis, Tennessee, 38105, United States
University Pediatric Hospital
San Juan, 00936, Puerto Rico
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Sylvie Naar-King, PhD
Adolescent Trials Network
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 6, 2009
First Posted
November 9, 2009
Study Start
August 1, 2009
Primary Completion
May 1, 2011
Study Completion
May 1, 2011
Last Updated
August 1, 2017
Record last verified: 2017-07