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Motivational Enhancement System for Adherence

This study has been completed.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT01009749
First received: November 6, 2009
Last updated: May 8, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
HIV
Behavioral: Motivational Enhancement System for Adherence (MESA)
Behavioral: Motivational Enhancement System for Health (MESH)
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Computer-Delivered Motivational Intervention to Prevent Adherence Problems Among Youth Newly Recommended for HIV Medications: Project MESA (Motivational Enhancement System for Adherence)

Resource links provided by NLM:


Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 76
Study Start Date: August 2009
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MESA Behavioral: 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.
Active Comparator: MESH Behavioral: Motivational Enhancement System for Health (MESH)
Motivational Enhancement System for Health (MESH) is an attentional control providing information on nutrition and exercise.

  Eligibility

Ages Eligible for Study:   16 Years to 24 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01009749

Locations
United States, California
Children's Hopsital of Los Angeles
Los Angeles, California, United States, 90027
Univ of Califormia at San Francisco
San Francisco, California, United States, 94143
United States, District of Columbia
Children's Hosp Natinal Med Center
Washington, District of Columbia, United States, 20010
United States, Florida
Children's Diagnostic and Treatment Center
Fort Lauderdale, Florida, United States, 33316
University of Miami-Jackson Memorial Medical Center
Miami, Florida, United States, 33101
University of South Florida
Tampa, Florida, United States, 33606
United States, Illinois
Stoger Hospital of Cook County
Chicago, Illinois, United States, 60612
United States, Louisiana
Tulane Medical Center
New Orleans, Louisiana, United States, 70112
United States, Maryland
University of Maryland
Baltimore, Maryland, United States, 21201
United States, New York
Children's Hospital at Montefiore Medical Center
Bronx, New York, United States, 10467
Mount Sinai Medical Center
New York, New York, United States, 10128
United States, Pennsylvania
Children's Hopsital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
United States, Tennessee
St. Jude Childrens Research Hospital
Memphis, Tennessee, United States, 38105
Puerto Rico
University Pediatric Hospital
San Juan, Puerto Rico, 00936
Sponsors and Collaborators
Investigators
Study Chair: Sylvie Naar-King, PhD Adolescent Trials Network
  More Information

Additional Information:
No publications provided

Responsible Party: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier: NCT01009749     History of Changes
Other Study ID Numbers: ATN 072
Study First Received: November 6, 2009
Last Updated: May 8, 2014
Health Authority: United States: Federal Government

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
HAART
HIV
Adherence

ClinicalTrials.gov processed this record on November 25, 2014