Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
76 participants
INTERVENTIONAL
2009-08-31
2011-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Motivational Enhancement System for Adherence (MESA) for Youth Starting ART
NCT02761746
Healthy Choices to Promote Health and Reduce Risk in HIV-Infected Youth
NCT00103532
Incentives to Promote Medication Adherence Among HIV-Infected Youth
NCT02206906
Effectiveness of Enhanced Counseling and Observed Therapy on Antiretroviral Adherence in People With HIV
NCT00602758
Intervention Targeting Medication Adherence and Methamphetamine Use in HIV Positive Men (ACE)
NCT01122186
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
MESA
Motivational Enhancement System for Adherence (MESA)
MESA is designed to increase motivation for adherence to Highly Active Antiretroviral Therapy (HAART) among youth newly recommended to begin medications.
MESH
Motivational Enhancement System for Health (MESH)
Motivational Enhancement System for Health (MESH) is an attentional control providing information on nutrition and exercise.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Motivational Enhancement System for Adherence (MESA)
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)
Motivational Enhancement System for Health (MESH) is an attentional control providing information on nutrition and exercise.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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).
16 Years
24 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institute on Drug Abuse (NIDA)
NIH
National Institute of Mental Health (NIMH)
NIH
University of North Carolina, Chapel Hill
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Sylvie Naar-King, PhD
Role: STUDY_CHAIR
Adolescent Trials Network
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Children's Hopsital of Los Angeles
Los Angeles, California, United States
Univ of Califormia at San Francisco
San Francisco, California, United States
Children's Hosp Natinal Med Center
Washington D.C., District of Columbia, United States
Children's Diagnostic and Treatment Center
Fort Lauderdale, Florida, United States
University of Miami-Jackson Memorial Medical Center
Miami, Florida, United States
University of South Florida
Tampa, Florida, United States
Stoger Hospital of Cook County
Chicago, Illinois, United States
Tulane Medical Center
New Orleans, Louisiana, United States
University of Maryland
Baltimore, Maryland, United States
Mount Sinai Medical Center
New York, New York, United States
Children's Hospital at Montefiore Medical Center
The Bronx, New York, United States
Children's Hopsital of Philadelphia
Philadelphia, Pennsylvania, United States
St. Jude Childrens Research Hospital
Memphis, Tennessee, United States
University Pediatric Hospital
San Juan, , Puerto Rico
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
ATN Website
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ATN 072
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.