Motivational Enhancement System for Adherence

HIV Clinical Trial

Official title:

Computer-Delivered Motivational Intervention to Prevent Adherence Problems Among Youth Newly Recommended for HIV Medications: Project MESA (Motivational Enhancement System for Adherence)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01009749
• Other study ID #: ATN 072
• Status: Completed
• Phase: N/A
• First received: November 6, 2009
• Last updated: July 28, 2017
• Start date: August 2009
• Est. completion date: May 2011

Study information

• Verified date: July 2017
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 24 Years

Eligibility

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).

Related Conditions & MeSH terms

• HIV

Intervention

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.
• Motivational Enhancement System for Health (MESH)
Motivational Enhancement System for Health (MESH) is an attentional control providing information on nutrition and exercise.

Locations

Country	Name	City	State
Puerto Rico	University Pediatric Hospital	San Juan
United States	University of Maryland	Baltimore	Maryland
United States	Stoger Hospital of Cook County	Chicago	Illinois
United States	Children's Diagnostic and Treatment Center	Fort Lauderdale	Florida
United States	Children's Hopsital of Los Angeles	Los Angeles	California
United States	St. Jude Childrens Research Hospital	Memphis	Tennessee
United States	University of Miami-Jackson Memorial Medical Center	Miami	Florida
United States	Tulane Medical Center	New Orleans	Louisiana
United States	Mount Sinai Medical Center	New York	New York
United States	Children's Hopsital of Philadelphia	Philadelphia	Pennsylvania
United States	Univ of Califormia at San Francisco	San Francisco	California
United States	University of South Florida	Tampa	Florida
United States	Children's Hospital at Montefiore Medical Center	The Bronx	New York
United States	Children's Hosp Natinal Med Center	Washington, D.C.	District of Columbia

Sponsors (3)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	National Institute of Mental Health (NIMH), National Institute on Drug Abuse (NIDA)

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   ATN Website