HIVNCT01009749

Motivational Enhancement System for Adherence

A study testing Motivational Enhancement System for Adherence (MESA) and Motivational Enhancement System for Health (MESH) in people with HIV, run by University of North Carolina, Chapel Hill at 14 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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… Read more about this study

Who is it for?: Ages 16 to 24 years
Conditions the study is for: HIV
What is being tested?: Motivational Enhancement System for Adherence (MESA) and Motivational Enhancement System for Health (MESH)
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 76 participants
Where: 14 sitesin 2 countries
Study dates: Aug 2009to May 2011
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 16 to 24 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

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;

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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.

Who cannot join

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;

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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).

Trial locations and contacts

14 sites in 2 countries.

Country

City, postcode or hospital

14 sites in 2 countries

United States13 sites

University of Maryland
Baltimore, Maryland, 21201
Stoger Hospital of Cook County
Chicago, Illinois, 60612
Children's Diagnostic and Treatment Center
Fort Lauderdale, Florida, 33316
Children's Hopsital of Los Angeles
Los Angeles, California, 90027
St. Jude Childrens Research Hospital
Memphis, Tennessee, 38105
University of Miami-Jackson Memorial Medical Center
Miami, Florida, 33101
Tulane Medical Center
New Orleans, Louisiana, 70112
Mount Sinai Medical Center
New York, New York, 10128
Children's Hopsital of Philadelphia
Philadelphia, Pennsylvania, 19104
Univ of Califormia at San Francisco
San Francisco, California, 94143
University of South Florida
Tampa, Florida, 33606
Children's Hospital at Montefiore Medical Center
The Bronx, New York, 10467
Children's Hosp Natinal Med Center
Washington D.C., District of Columbia, 20010

Other trials in United States

Puerto Rico1 site

University Pediatric Hospital
San Juan, 00936

Other trials in Puerto Rico

About this study

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

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.

Conditions: HIV
Being tested: Motivational Enhancement System for Adherence (MESA), Motivational Enhancement System for Health (MESH)
Keywords: HAART, HIV, Adherence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT01009749
Study group	Role	What they receive
MESA	Experimental	Not described Receives: Behavioral: Motivational Enhancement System for Adherence (MESA)
MESH	Active comparator	Not described Receives: Behavioral: Motivational Enhancement System for Health (MESH)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 26 months

Secondary outcomes (5)

To compare service utilization rates among youth randomized to MESA plus standard care versus those in an attention control condition plus standard care.
Measured: 26 months
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 26 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2009May 2011

First posted9 Nov 2009 (estimated)
Study startAug 2009
Primary completionMay 2011
Study completionMay 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HIVStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 76 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01009749
Sponsor's protocol ID: ATN 072
Status last verified: Jul 2017
First submitted: 6 Nov 2009
Last updated: 1 Aug 2017
Results posted: No
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 1 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Computer-Delivered Motivational Intervention to Prevent Adherence Problems Among Youth Newly Recommended for HIV Medications: Project MESA (Motivational Enhancement System for Adherence)
ClinicalTrials.gov ID: NCT01009749
Acronym / sponsor ID: ATN 072
Conditions: HIV
Keywords: HAART, HIV, Adherence
Study type: Interventional
Recruitment status: Completed
Enrolment: 76 participants (actual)
Lead sponsor: University of North Carolina, Chapel HillUniversity, hospital or other
Collaborators: National Institute on Drug Abuse (NIDA), National Institute of Mental Health (NIMH)
Study start: Aug 2009
Primary completion: May 2011 (actual)
Study completion: May 2011 (actual)
First posted: 9 Nov 2009 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This is a two-phase study, consisting of the following plan:

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
MESA	Experimental	Behavioral: Motivational Enhancement System for Adherence (MESA)
MESH	Active comparator	Behavioral: Motivational Enhancement System for Health (MESH)

Who may qualify

Ages: 16 to 24 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (11 listed)

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.

Key exclusion criteria (9 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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.	Behavioural	MESA
Motivational Enhancement System for Health (MESH)Motivational Enhancement System for Health (MESH) is an attentional control providing information on nutrition and exercise.	Behavioural	MESH

Primary outcome

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
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

5 secondary outcomes

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
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
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
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
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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2017.
ATN WebsiteLink provided by the sponsor.

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RecruitingObservational study
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RecruitingEarly Phase 1
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Sylvie Naar-King, PhD study chair

Adolescent Trials Network

14 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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. (time frame: 26 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01009749.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2017.