Clinical trial NCT01009749: Motivational Enhancement System for Adherence
Official title: Computer-Delivered Motivational Intervention to Prevent Adherence Problems Among Youth Newly Recommended for HIV Medications: Project MESA (Motivational Enhancement System for Adherence)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Keywords: HAART
HIV
Adherence
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: National Institute of Mental Health (NIMH)
First posted: 2009-11-09
Enrollment: 76
Sex: ALL
Minimum age (years): 16
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility 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).

Primary outcomes:
measure: 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.
timeFrame: 26 months
measure: 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.
timeFrame: 26 months
Secondary outcomes:
measure: To compare service utilization rates among youth randomized to MESA plus standard care versus those in an attention control condition plus standard care.
timeFrame: 26 months
measure: 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.
timeFrame: 26 months
measure: To assess HAART medication knowledge among youth randomized to MESA plus standard care versus those in an attention control condition plus standard care.
timeFrame: 26 months
measure: 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.
timeFrame: 26 months
measure: 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.
timeFrame: 26 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Children's Hopsital of Los Angeles
state: California
city: San Francisco
country: United States
facility: Univ of Califormia at San Francisco
state: California
city: Washington, D.C.
country: United States
facility: Children's Hosp Natinal Med Center
state: District of Columbia
city: Fort Lauderdale
country: United States
facility: Children's Diagnostic and Treatment Center
state: Florida
city: Miami
country: United States
facility: University of Miami-Jackson Memorial Medical Center
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Chicago
country: United States
facility: Stoger Hospital of Cook County
state: Illinois
city: New Orleans
country: United States
facility: Tulane Medical Center
state: Louisiana
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: New York
country: United States
facility: Mount Sinai Medical Center
state: New York
city: The Bronx
country: United States
facility: Children's Hospital at Montefiore Medical Center
state: New York
city: Philadelphia
country: United States
facility: Children's Hopsital of Philadelphia
state: Pennsylvania
city: Memphis
country: United States
facility: St. Jude Childrens Research Hospital
state: Tennessee
city: San Juan
country: Puerto Rico
facility: University Pediatric Hospital
Study officials:
affiliation: Adolescent Trials Network
name: Sylvie Naar-King, PhD
role: STUDY_CHAIR
References: