Motivational Enhancement System for Adherence

Not Applicable

Completed

• Conditions: HIV
• Interventions: Behavioral: Motivational Enhancement System for Adherence (MESA); Behavioral: Motivational Enhancement System for Health (MESH)

• Registration Number: NCT01009749
• Lead Sponsor: University of North Carolina, Chapel Hill

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2009-11-06
• Study First Submitted QC: 2009-11-06
• Study First Posted: 2009-11-09
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-28
• Last Update Posted: 2017-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

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.

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MESA	Motivational Enhancement System for Adherence (MESA)	-
MESH	Motivational Enhancement System for Health (MESH)	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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
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 compare service utilization rates among youth randomized to MESA plus standard care versus those in an attention control condition plus standard care.	26 months

Trial Locations

Locations (14)

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

University of South Florida; 🇺🇸 Tampa, Florida, United States

Tulane Medical Center; 🇺🇸 New Orleans, Louisiana, 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

University Pediatric Hospital; 🇵🇷 San Juan, Puerto Rico

St. Jude Childrens Research Hospital; 🇺🇸 Memphis, Tennessee, United States

Children's Hopsital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States

Children's Hopsital of Los Angeles; 🇺🇸 Los Angeles, California, United States

Children's Diagnostic and Treatment Center; 🇺🇸 Fort Lauderdale, Florida, United States

Stoger Hospital of Cook County; 🇺🇸 Chicago, Illinois, United States

University of Maryland; 🇺🇸 Baltimore, Maryland, United States

University of Miami-Jackson Memorial Medical Center; 🇺🇸 Miami, Florida, United States