Medication AdherenceMESANCT02761746
Motivational Enhancement System for Adherence (MESA) for Youth Starting ART
A study testing MESA in people with Medication Adherence, run by Wayne State University at 7 sites in United States.
Trial summary
This study is a multi-site (Detroit, MI; Los Angeles, CA; Philadelphia, PA, Washington, DC; Aurora, CO; Miami, FL; and Baltimore, MD), two-group randomized controlled trial testing a two-session intervention designed to increase motivation for adherence to antiretroviral treatment (ART) among youth living with HIV… Read more about this study
- Who is it for?
- Ages 16 to 24 years
- Conditions the study is for
- Medication Adherence
- What is being tested?
- MESA
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 155 participants
- Where
- 7 sitesUnited States
- Study dates
- 22 Feb 2016to 30 Apr 2021
- 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
- Youth living with HIV, ages 16 to 24 years 11 months, who are current patients at the 4 participating sites in Detroit, MI; Washington, DC; Los Angeles, CA; Philadelphia, PA; Aurora, CO; Miami, FL; and Baltimore, MD.
- Understands written and/or verbal English.
- Youth must have been verbally recommended to begin ART within the previous 12 weeks (recommendation could have first been made at an earlier time, but the youth must have been notified again by a health care provider in the previous 12 weeks), but has not been on ART for more than 30 days or verbally recommended to restart ART after being off ART for at least 6 months. Females who have received ART for the sole purpose of preventing maternal to child transmission in the past will be considered antiretroviral naïve.
Who cannot join
- 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 study requirements and/or interfere with the study objectives.
- Concurrent participation or participation within the previous 4 weeks, in any behavioral adherence intervention study or program.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
University of Colorado School of Medicine
Aurora, Colorado, 80045
Johns Hopkins School of Medicine
Baltimore, Maryland, 21287
Wayne State University
Detroit, Michigan, 48201
Children's Hospital of Los Angeles
Los Angeles, California, 90027
Univeristy of Miami School of Medicine
Miami, Florida, 33101
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Children's National Medical Center
Washington D.C., District of Columbia, 20010
About this study
Official title: Motivational Enhancement System for Adherence (MESA) for Youth Starting Antiretroviral Therapy (ART)
This study is a multi-site (Detroit, MI; Los Angeles, CA; Philadelphia, PA, Washington, DC; Aurora, CO; Miami, FL; and Baltimore, MD), two-group randomized controlled trial testing a two-session intervention designed to increase motivation for adherence to antiretroviral treatment (ART) among youth living with HIV (YLH) newly recommended to begin medications. Participants are randomized to receive the intervention, Motivational Enhancement System for Adherence (MESA), or the control condition, System for Health (SH: healthy eating and physical activity information). Both groups receive the standard of care regarding the initiation of ART. ART adherence (visual analog scale and hair sample assay) and health outcomes (viral load results, and CD4 counts) are assessed. Additionally, potential mediators (HIV knowledge, motivation for adherence, and self-efficacy for adherence) and predictors of intervention response (substance abuse, mental health symptoms, executive functioning, and stressful life events) are assessed.
Read the detailed description
Medication adherence rates among youth living with HIV (YLH) are inadequate to effectively manage the disease. Very few adherence interventions have been tested with youth, and those that have are difficult to implement in real-world settings due to high intensity of sessions or low attendance rates. Thus, there is a demand for innovative, feasible, and engaging behavioral interventions targeting adherence, especially among YLH, the largest initiators of antiretroviral treatment (ART). A universal primary prevention program is a novel approach to target adherence problems before they begin by providing a prevention intervention to all youth newly initiating ART. This study plans to test a brief, two-session, computer-delivered motivational intervention to prevent adherence difficulties among youth newly prescribed ART. All elements of the study (assessment, intervention, control condition) were piloted in a small multi-site randomized controlled trial (NIH-funded Adolescent Medicine Trials Medicine Network for HIV/AIDS Interventions: ATN). Results suggested feasibility and acceptability, as well as trends for improved adherence when comparing the intervention to an active control condition. For the proposed multi-site randomized clinical trial, youth newly beginning or restarting ART (N=200 from 7 ATN sites in the United States) will be randomize to the Motivational Enhancement System for Adherence (MESA) or to the control condition (System for Health: SH; nutrition and exercise information delivered by the same platform matched for dose). ART adherence (visual analog scale and hair specimen assays) and health outcomes (viral load results and CD4 counts) is the primary outcome. Potential mediators (HIV knowledge, motivation for adherence, and self-efficacy for adherence) on the treatment effects of MESA and moderators (substance abuse, mental health symptoms, executive functioning, and stressful life events) as predictors of differential intervention response will be assessed. It is hypothesized that participants randomized to MESA will show significantly greater adherence and health outcomes than participants randomized to SH over one year of follow-up.
- Conditions
- Medication Adherence
- Being tested
- MESA
- Keywords
- HIV, Adherence, Health Outcomes
- Medical subject headings
- Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MESABehavioural
MESA is tailored based on how important and how confident the participant feels about taking medications as prescribed. If the participant does not believe taking medications is important, they engage in a decisional balance exercise. If the participant believes taking medications is important, they move directly to confidence modules and goal setting. If the participant does not feel confident about taking medications, they engage in activities to boost self-efficacy. Participants are also offered personalized feedback regarding immune status and HIV knowledge with actual adherence feedback provided in the second session. Finally, goal setting is an option, and feedback regarding adherence behavior over the previous month.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Condition (MESA) | Experimental | MESA involves two sessions (ACASI assessment and intervention), one at study entry (prior to beginning ART) and one a month later. Then, participants will complete ACASI assessments only at 3, 6, 9, and 12 months. The first MESA session is tailored based on how important and how confident the person feels about taking medications as prescribed. The participant is also offered personalized feedback regarding immune status and HIV knowledge with actual adherence feedback provided in the second session. Finally, the participant may engage in goal setting. The second MESA session focuses on adherence behavior over the previous month and the consequences (good or bad) of that behavior. Receives: Behavioral: MESA |
| Control Condition (SH) | No intervention | The SH control condition involves two sessions (ACASI assessment and control condition), one at study entry (prior to beginning ART) and one a month later. Then, participants will complete ACASI assessments only at 3, 6, 9, and 12 months. The first SH session targets healthy eating and physical activity and is matched for dose and length of time of the intervention session. Feedback and education are provided, if desired. Finally, the participants may engage in goal setting for healthy eating and physical activity. The second SH session focuses on the goals set during the first session and behavior over the previous month. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Medication Adherence (Visual Analog Scale)
A change from baseline (1-month) medication adherence (Visual Analog Scale score) at 12 months via Audio-Computer Assisted Self-Interview (ACASI).
Measured: 12 Months
Change in Medication Adherence (Hair Sample Assay; physiological parameter)
A change from baseline (6-month) medication adherence (hair sample collected from the head) at 12 months.
Measured: 6 Months
Change in Viral Load (biomedical measure)
Viral load laboratory tests (biomedical measures of health status) will be collected, via a blood sample or obtained from medical record review, at baseline (6 weeks prior to enrollment) and 12-months. A change from baseline viral load at 12 months (decrease in viral load, increase undetectable status).
Measured: 12 Months
Change in CD4 count (biomedical measure)
CD4 count laboratory tests (biomedical measures of health status) will be obtained from medical record review at baseline (6 weeks prior to enrollment) and 12-months. A change from baseline CD4 at 12 months (increase in the CD4 count).
Measured: 12 Months
Secondary outcomes (9)
Information (HIV Treatment Knowledge score) as an intervention treatment effect
Information, as measured by HIV Treatment Knowledge Score, will be obtained via ACASI at baseline, 1-month, and 3-, 6-, 9-, and 12-months.
Measured: 12 Months
Motivation (Readiness Ruler Importance score) as a intervention treatment effect
Motivation, as measured by Rollnick's Readiness Ruler score adapted to focus on the importance of taking HIV medication will be obtained via ACASI at baseline, 1-month, and 3-, 6-, 9-, and 12-months.
Measured: 12 Months
Motivation (Decisional Balance for Adherence score) as a intervention treatment effect
Motivation, as measured by the Decisional Balance for Adherence Score will be obtained via ACASI at baseline, 1-month, and 3-, 6-, 9-, and 12-months.
Measured: 12 Months
Behavioral Skills (Readiness Ruler Confidence score) as a intervention treatment effect
Behavioral Skills, as measured by Rollnick's Readiness Ruler score adapted to focus on confidence for taking HIV medication, will be obtained via ACASI at baseline, 1-month, and 3-, 6-, 9-, and 12-months.
Measured: 12 Months
Behavioral Skills (Temptation Adherence score) as a intervention treatment effect
Behavioral Skills, measured by the Temptation Adherence score, will be obtained via ACASI at baseline, 1-month, and 3-, 6-, 9-, and 12-months.
Measured: 12 Months
Predicting differential intervention response as measured by substance abuse (questionnaire score)
Substance use, as measured by the Alcohol, Smoking, and Substance Involvement Screening Test v3.0: (ASSIST), will be obtained via ACASI at baseline, and 3-, 6- 9-, and 12-months.
Measured: 12 Months
Predicting differential intervention response as measured by executive functioning (questionnaire score)
Executive functioning, as measured by the Behavior Rating Inventory of Executive Functioning-Adult Version: (BRIEF-A), will be obtained via ACASI at baseline, and 3-, 6- 9-, and 12-months.
Measured: 12 Months
Predicting differential intervention response as measured by structural barriers (questionnaire score)
Structural barriers, as measured by the Services and Support score, will be obtained via ACASI at baseline, and 3-, 6- 9-, and 12-months.
Measured: 12 Months
Predicting differential intervention response as measured by mental health symptoms (questionnaire score)
Mental health symptoms, as measured by the Brief Symptom Inventory-18: (BSI-18), will be obtained via ACASI at baseline, 1-month, and 3-, 6-, 9-, and 12-months.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2016 (estimated)
- Study start22 Feb 2016
- Primary completion30 Apr 2021
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Medication AdherenceStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wayne State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Angulique Outlaw, Wayne State University
- Investigators
- Angulique Y Outlaw, PhD, Principal investigator, Wayne State UniversitySylvie Naar, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02761746
- Sponsor's protocol ID
- 052115B3F
- Other IDs
- R01MH108442
- Acronym
- MESA
- Status last verified
- Aug 2022
- First submitted
- 29 Feb 2016
- Last updated
- 19 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Outlaw AY, Templin T, MacDonell K, Jones M, Secord E, Naar S. Motivational Enhancement System for Adherence for Adolescents and Young Adults Newly Recommended to Start Antiretroviral Therapy. J Acquir Immune Defic Syndr. 2025 Jan 1;98(1):49-56. doi: 10.1097/QAI.0000000000003530.
PubMed 39288943
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motivational Enhancement System for Adherence (MESA) for Youth Starting Antiretroviral Therapy (ART)
- ClinicalTrials.gov ID
- NCT02761746
- Acronym / sponsor ID
- MESA / 052115B3F
- Conditions
- Medication Adherence
- Keywords
- HIV, Adherence, Health Outcomes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Wayne State UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 22 Feb 2016 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 4 May 2016 (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 study is a multi-site (Detroit, MI; Los Angeles, CA; Philadelphia, PA, Washington, DC; Aurora, CO; Miami, FL; and Baltimore, MD), two-group randomized controlled trial testing a two-session intervention designed to increase motivation for adherence to antiretroviral treatment (ART) among youth living with HIV (YLH) newly recommended to begin medications. Participants are randomized to receive the intervention, Motivational Enhancement System for Adherence (MESA), or the control condition, System for Health (SH: healthy eating and physical activity information). Both groups receive the standard of care regarding the initiation of ART. ART adherence (visual analog scale and hair sample assay) and health outcomes (viral load results, and CD4 counts) are assessed. Additionally, potential mediators (HIV knowledge, motivation for adherence, and self-efficacy for adherence) and predictors of intervention response (substance abuse, mental health symptoms, executive functioning, and stressful life events) are assessed.
Detailed description
Medication adherence rates among youth living with HIV (YLH) are inadequate to effectively manage the disease. Very few adherence interventions have been tested with youth, and those that have are difficult to implement in real-world settings due to high intensity of sessions or low attendance rates. Thus, there is a demand for innovative, feasible, and engaging behavioral interventions targeting adherence, especially among YLH, the largest initiators of antiretroviral treatment (ART). A universal primary prevention program is a novel approach to target adherence problems before they begin by providing a prevention intervention to all youth newly initiating ART. This study plans to test a brief, two-session, computer-delivered motivational intervention to prevent adherence difficulties among youth newly prescribed ART. All elements of the study (assessment, intervention, control condition) were piloted in a small multi-site randomized controlled trial (NIH-funded Adolescent Medicine Trials Medicine Network for HIV/AIDS Interventions: ATN). Results suggested feasibility and acceptability, as well as trends for improved adherence when comparing the intervention to an active control condition. For the proposed multi-site randomized clinical trial, youth newly beginning or restarting ART (N=200 from 7 ATN sites in the United States) will be randomize to the Motivational Enhancement System for Adherence (MESA) or to the control condition (System for Health: SH; nutrition and exercise information delivered by the same platform matched for dose). ART adherence (visual analog scale and hair specimen assays) and health outcomes (viral load results and CD4 counts) is the primary outcome. Potential mediators (HIV knowledge, motivation for adherence, and self-efficacy for adherence) on the treatment effects of MESA and moderators (substance abuse, mental health symptoms, executive functioning, and stressful life events) as predictors of differential intervention response will be assessed. It is hypothesized that participants randomized to MESA will show significantly greater adherence and health outcomes than participants randomized to SH over one year of follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Condition (MESA) | Experimental | Behavioral: MESAMESA involves two sessions (ACASI assessment and intervention), one at study entry (prior to beginning ART) and one a month later. Then, participants will complete ACASI assessments only at 3, 6, 9, and 12 months. The first MESA session is tailored based on how important and how confident the person feels about taking medications as prescribed. The participant is also offered personalized feedback regarding immune status and HIV knowledge with actual adherence feedback provided in the second session. Finally, the participant may engage in goal setting. The second MESA session focuses on adherence behavior over the previous month and the consequences (good or bad) of that behavior. |
| Control Condition (SH) | No intervention | –The SH control condition involves two sessions (ACASI assessment and control condition), one at study entry (prior to beginning ART) and one a month later. Then, participants will complete ACASI assessments only at 3, 6, 9, and 12 months. The first SH session targets healthy eating and physical activity and is matched for dose and length of time of the intervention session. Feedback and education are provided, if desired. Finally, the participants may engage in goal setting for healthy eating and physical activity. The second SH session focuses on the goals set during the first session and behavior over the previous month. |
Who may qualify
- Ages
- 16 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Youth living with HIV, ages 16 to 24 years 11 months, who are current patients at the 4 participating sites in Detroit, MI; Washington, DC; Los Angeles, CA; Philadelphia, PA; Aurora, CO; Miami, FL; and Baltimore, MD.
- Understands written and/or verbal English.
- Youth must have been verbally recommended to begin ART within the previous 12 weeks (recommendation could have first been made at an earlier time, but the youth must have been notified again by a health care provider in the previous 12 weeks), but has not been on ART for more than 30 days or verbally recommended to restart ART after being off ART for at least 6 months. Females who have received ART for the sole purpose of preventing maternal to child transmission in the past will be considered antiretroviral naïve.
Key exclusion criteria (7 listed)
- 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.
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 |
|---|---|---|
| MESAMESA is tailored based on how important and how confident the participant feels about taking medications as prescribed. If the participant does not believe taking medications is important, they engage in a decisional balance exercise. If the participant believes taking medications is important, they move directly to confidence modules and goal setting. If the participant does not feel confident about taking medications, they engage in activities to boost self-efficacy. Participants are also offered personalized feedback regarding immune status and HIV knowledge with actual adherence feedback provided in the second session. Finally, goal setting is an option, and feedback regarding adherence behavior over the previous month. | Behavioural | Intervention Condition (MESA) |
Primary outcome
Change in Medication Adherence (Visual Analog Scale)
Time frame: 12 Months
A change from baseline (1-month) medication adherence (Visual Analog Scale score) at 12 months via Audio-Computer Assisted Self-Interview (ACASI).
Change in Medication Adherence (Hair Sample Assay; physiological parameter)
Time frame: 6 Months
A change from baseline (6-month) medication adherence (hair sample collected from the head) at 12 months.
Change in Viral Load (biomedical measure)
Time frame: 12 Months
Viral load laboratory tests (biomedical measures of health status) will be collected, via a blood sample or obtained from medical record review, at baseline (6 weeks prior to enrollment) and 12-months. A change from baseline viral load at 12 months (decrease in viral load, increase undetectable status).
Change in CD4 count (biomedical measure)
Time frame: 12 Months
CD4 count laboratory tests (biomedical measures of health status) will be obtained from medical record review at baseline (6 weeks prior to enrollment) and 12-months. A change from baseline CD4 at 12 months (increase in the CD4 count).
9 secondary outcomes
Information (HIV Treatment Knowledge score) as an intervention treatment effect
Time frame: 12 Months
Motivation (Readiness Ruler Importance score) as a intervention treatment effect
Time frame: 12 Months
Motivation (Decisional Balance for Adherence score) as a intervention treatment effect
Time frame: 12 Months
Behavioral Skills (Readiness Ruler Confidence score) as a intervention treatment effect
Time frame: 12 Months
Behavioral Skills (Temptation Adherence score) as a intervention treatment effect
Time frame: 12 Months
Predicting differential intervention response as measured by substance abuse (questionnaire score)
Time frame: 12 Months
Predicting differential intervention response as measured by executive functioning (questionnaire score)
Time frame: 12 Months
Predicting differential intervention response as measured by structural barriers (questionnaire score)
Time frame: 12 Months
Predicting differential intervention response as measured by mental health symptoms (questionnaire score)
Time frame: 12 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 19 Aug 2022.
- Derived from this study: PubMed 39288943Outlaw AY, Templin T, MacDonell K, Jones M, Secord E, Naar S. Motivational Enhancement System for Adherence for Adolescents and Young Adults Newly Recommended to Start Antiretroviral Therapy. J Acquir Immune Defic Syndr. 2025 Jan 1;98(1):49-56. doi: 10.1097/QAI.0000000000003530.
- Individual participant dataSharing planned: No
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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.
Angulique Y Outlaw, PhD principal investigator
Wayne State University
Sylvie Naar, PhD principal investigator
University of Florida
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MESA in people with Medication Adherence, run by Wayne State University at 7 sites in United States.
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 3 inclusion and 7 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 19 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. 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?
Change in Medication Adherence (Visual Analog Scale) (time frame: 12 Months). The study lists 4 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 NCT02761746, which also lists 1 linked publication.
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 19 Aug 2022.