Tailored Motivational Interviewing Implementation-Effectiveness Trial in Multidisciplinary Adolescent HIV Care Settings
Conditions: HIV Infections, Adolescent Development, Care Eliciting Behavior, Patient Non-Compliance, Patient Refusal of Treatment
Sponsor: Florida State University

PROTOCOL TITLE: TMI
Page 1 of 13
Revised: December 1, 2018
PROTOCOL TITLE: Scale it up: Effectiveness-implementation research to enhance HIV-related 
self-management among adolescents and young adults: Tailored Motivational Interviewing 
Implementation Intervention (TMI)
PRINCIPAL INVESTIGATOR:
Sylvie Naar, Ph.D.
College of Medicine, Behavioral Sciences and Social medicine
Center for Translational Behavioral Science
248-207-2903
Sylvie.naar@med.fsu.edu
VERSION NUMBER/DATE:
12.1.2018– Coincides with existing, approved HSC#: 2018.21813 & 2018.26613 
REVISION HISTORY
Revision 
#
Version Date
Summary of Changes
Consent 
Change?
1
8/9/19
Adding 2 key personnel, a release of information 
form, and clarifying protocol on coding lab
No
2
12/8/21
Updating language related to data for future use 
(section 7.0 – Data and specimen banking) to 
comply with NIH data sharing policies
No

PROTOCOL TITLE: TMI
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Revised: December 1, 2018
Table of Contents
1.0
Study Summary....................................................................................................................3
2.0
Objectives* ..........................................................................................................................4
3.0
Background*........................................................................................................................4
4.0
Study Endpoints*.................................................................................................................4
5.0
Study Intervention/Investigational Agent ...........................................................................4
6.0
Procedures Involved* ..........................................................................................................5
7.0
Data and Specimen Banking* ..............................................................................................5
8.0
Sharing of Results with Subjects*........................................................................................6
9.0
Study Timelines*..................................................................................................................6
10.0
Inclusion and Exclusion Criteria*.........................................................................................6
11.0
Vulnerable Populations*......................................................................................................6
12.0
Local Number of Subjects....................................................................................................7
13.0
Recruitment Methods..........................................................................................................7
14.0
Withdrawal of Subjects*......................................................................................................7
15.0
Risks to Subjects* ................................................................................................................7
16.0
Potential Benefits to Subjects*............................................................................................8
17.0
Data Management* and Confidentiality .............................................................................8
18.0
Provisions to Monitor the Data to Ensure the Safety of Subjects* .....................................8
19.0
Provisions to Protect the Privacy Interests of Subjects .......................................................9
20.0
Compensation for Research-Related Injury.........................................................................9
21.0
Economic Burden to Subjects..............................................................................................9
22.0
Consent Process...................................................................................................................9
23.0
Process to Document Consent in Writing..........................................................................12
24.0
Setting................................................................................................................................13
25.0
Resources Available...........................................................................................................13
26.0
Multi-Site Research*..........................................................................................................13

PROTOCOL TITLE: TMI
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1.0
Study Summary
Study Title
Scale it up: Effectiveness-implementation research to enhance 
HIV-related self-management among adolescents and young 
adults: Tailored Motivational Interviewing Implementation 
Intervention (TMI)
Study Design
Multi-site clinical intervention targeting health care providers
Primary Objective
Test a multi-faceted Tailored Motivational Interviewing 
Implementation intervention (TMI), based on the DAP to scale up 
an EBP in multidisciplinary adolescent HIV care settings while 
balancing flexibility and fidelity
Secondary Objective(s)
Sustainment through communities of practice (CoP)
Research Intervention(s) 
multi-faceted Tailored Motivational Interviewing Implementation 
intervention
Study Population
10 Adolescent HIV sites in the US
Sample Size
Average of 15 providers per site (current N=139)
Study Duration for 
individual participants
3 years
Study Specific 
Abbreviations/ 
Definitions 
Tailored Motivational Interviewing Implementation intervention 
(TMI); Dynamic Adaptation Process (DAP); implementation 
science (IS); youth living with HIV (YLH); Motivational 
Interviewing (MI); evidence-based practice (EBPs); exploration, 
preparation, implementation, and sustainment phases (EPIS); 
Communities of Practice (CoP); Implementation team (iTeam)

PROTOCOL TITLE: TMI
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Revised: December 1, 2018
2.0
Objectives*
The goal of this proposal is to test a multi-faceted Tailored Motivational Interviewing 
Implementation intervention (TMI), based on the Dynamic Adaptation Process (DAP) to 
scale up an EBP in multidisciplinary adolescent HIV care settings, while balancing 
flexibility and fidelity. 
To address this goal, we are using a dynamic wait-listed design to determine the impact 
of TMI on the integration of MI with fidelity in 10 adolescent HIV sites in the United 
States with an average of 15 providers and 100 patients each. At the start of TMI, clinics 
were randomly assigned in 5 blocks of (2 sites each) sites 3 months apart. Role play 
completion is considered consent to participate. Provider competence ratings (primary 
outcome) are collected quarterly during pre-implementation, implementation, and 
sustainment. Across sites, providers preceding the implementation intervention form a 
control or comparison group, and the providers following the start of the 
implementation intervention form the intervention group. As each block completes a 
year of implementation, those sites are re-randomized to internal facilitation (a person 
from each site will be chosen to be an MI supervisor to be available for ongoing 
coaching) plus Communities of Practice (CoP), or CoP only. For the CoP, the site will 
decide how to meet as a group to continue MI practice.
3.0
Background*
The NIH Office of AIDS Research called for implementation science (IS) to address the 
behavioral research-practice gap. Motivational Interviewing (MI) is the only behavioral 
intervention to date shown to be effective to improve self-management for youth living 
with HIV (YLH). MI was also the only intervention to demonstrate success across the 
youth HIV care cascade. MI interventions can target multiple behaviors and be delivered 
by multiple provider-types as is common in adolescent HIV care settings. Finally, MI is 
already embedded in the clinical guidelines for HIV care and HIV risk reduction. 
Implementation Science is the scientific study of methods to promote the uptake of 
research findings and evidence-based practice (EBPs) to improve the quality of behavior 
change approaches in health care settings. A primary challenge of scaling up EBPs is the 
balance of flexibility (adaptation to context) and fidelity (provider adherence and 
competence). The Dynamic Adaptation Process (DAP) guides tailoring of MI 
implementation at the exploration, preparation, implementation, and sustainment 
phases (EPIS) of scale up. The goal of this project is to test a multi-faceted Tailored 
Motivational Interviewing Implementation intervention (TMI), based on the DAP to scale 
up an EBP in multidisciplinary adolescent HIV care settings while balancing flexibility and 
fidelity. 
4.0
Study Endpoints*
One of the primary goals of this study is to help participants hone and develop new MI 
skills to increase medication and treatment adherence among the youth that they serve 
in HIV clinics. Thus, the primary outcome is improving MI skills among the health care 
provider participants in the study, with secondary goals of improving health outcomes 
for youth living with HIV and risk reduction among youth at risk for contracting HIV. 
5.0
Study Intervention

PROTOCOL TITLE: TMI
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Revised: December 1, 2018
TMI Implementation Intervention Strategies: 
Pre-Implementation: Key stakeholders were identified for the Implementation team (iTeam). 
The iTeam have conference calls during the baseline period to discuss barriers and facilitators 
and iteratively draft locally-customized implementation strategies until iTeam members and 
experts "approve" the strategies. The first iTeam call is initiated 6 months prior to the start of 
the Implementation phase at each site and monthly iTeam calls start 3 months prior to the start 
of the Implementation phase at each site. In addition, the iTeams have the option of 
implementing an anonymous consumer satisfaction of clinic environment survey, which will be 
provided via a Qualtrics survey link and anonymous data is shared with the study team. This 
survey is administered 1-month prior to the workshop, 1 month after the workshop, and 1 year 
after the workshop. 
Implementation. Adapted training begins in this phase. The iTeam continues to meet monthly to 
review adherence to program requirements and external MINT facilitator reports and 
recommends further adaptations as necessary while maintaining fidelity to minimum 
requirements detailed below. 
Initial Workshop. Ten hours of group workshop training were delivered by members of MINT 
(Todd, Hartlieb, Cockern), adapted from findings of sequential analysis in our pilot work and 
interactions with the local iTeams. MI training relies on experiential activities developed by the 
network while minimizing didactic presentations. Cooperative learning methods allow staff 
members to coach each other in small groups to promote experiential learning and group 
cohesion. Group MI methods are included to increase intrinsic motivation for implementation 
strategies. Non-TMI participants to attend the workshop if desired. Attendance was capped at 
25 so that sufficient individualized attention could be given to attendees, and TMI participants 
were prioritized for attendance. TMI participants were only eligible to continue beyond baseline 
participation if they attended at least 50% of the workshop.
Fidelity Monitoring. Provider MI competency will be measured with the MI Coach Rating 
Scale (see Measures below) during the baseline, implementation, and sustainment 
periods. Individual coaching following each quarterly assessment will be triggered by a 
provider falling below the competency threshold on the standardized patient interaction 
for the quarterly assessments during the implementation period only. To define this 
threshold, during the project start-up phase, Dr. Chapman will lead an IRT-based 
standard setting process. To accomplish this, there are several steps: (1) Enlist a sample 
of approximately 8 - 10 MI experts. (2) Obtain each expert’s (independently rated) pool 
of “essential” MI items. This will be achieved using a survey format that is similar to 
traditional “bookmark” standard setting procedures, with the expert indicating whether 
or not each item is essential for acceptable TMI competence. (3) Compute the average 
“difficulty” of the selected items for each expert based on the item difficulty calibrations 
from the NHLBI-funded center grant, and compute the average difficulty across experts. 
(4) Compute confidence bounds for the mastery level using the standard error of the 
Rasch measure. (5) Construct the competence threshold score (i.e., the standard) as the 
criterion score + mastery level ± confidence level. (6) Apply the competence standard to 
data from the previous projects with scale (NHLBI-funded center grant and ATN 128), 
and, as a source of validity evidence, test whether key outcomes differ for providers 
above and below the competency threshold. 

PROTOCOL TITLE: TMI
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Coaching Feedback. Providers receive written feedback regarding their competency 
scores based on the RA coding of recordings of standard patient interactions. All 
participants will receive two, 1-hour coaching sessions by a MINT trainer following the 
workshop, but before the next quarterly assessment. Participants may receive a 45-
minute coaching session by a MINT trainer following each quarterly assessment during 
the implementation period only. This coaching is required if scores fall below 
competency and optional if scores are above competency. The standardized coaching 
includes a brief interaction to elicit change talk around MI implementation, feedback on 
two highest and two lowest ratings, review of the role play audio recording and 
interactive coaching activities (e.g., role plays) targeting the lowest ratings. 
Organizational Supports. While many aspects of this implementation strategy are 
adaptable, organizational leadership will review data on completion of the role play and 
coaching sessions and will determine corrective action for suboptimal adherence. Each 
site will receive the same incentive budget (equivalent of $50 per staff member) and will 
determine whether incentives will be provided episodically or after program 
completion. The iTeam will decide how to deliver incentives (i.e., directly to individuals 
for completion of program requirements, utilize a lottery system, or provide a group 
reward when all site participants adhere to program requirements); however, beginning 
in cycle 8, participants must be provided at least a $10 incentive for completing role 
plays. 
Sustainment. The iTeam will guide the site(s) to develop a community of practice (CoP). 
CoPs are based on a view of learning as an individual and social phenomenon rather 
than a one-way transfer of formal knowledge between groups or individuals. By having 
providers participate in the implementation phase, a CoP is already beginning to 
develop at the sites. The iTeam will guide the continued development of the CoP as 
needed by assisting with scheduling and setting meeting agendas to encourage MI 
practice, peer coaching and potentially fidelity monitoring, and prevent drift. In addition 
to CoP, half the sites will be randomized to receive 0.1 FTE of funding during the 
sustainment period for an internal facilitator who will be trained to continue quarterly 
fidelity monitoring and coaching feedback when scores fall below competency. The 
funding may be split among two facilitators to account for staff turnover. The iTeam will 
choose the facilitator(s) based on participant competency, provider interest and 
motivation, and the participant’s role within the organization. The chosen internal 
facilitator will be given the option of declining this position for any reason. If they 
choose to accept the appointment, they will be asked to sign a release of information to 
help the study team and site ensure their ability to act in the role of internal facilitator. 
The internal facilitator will be able to choose how much information is shared and with 
whom the information will be shared. 
6.0
Procedures Involved*
Participants will be part of a multi-phase motivational interviewing (MI) implementation 
program through the sites where they are employed. MI training will be conducted at 
sites as part of ongoing professional development. 
Participation in the study includes: 

PROTOCOL TITLE: TMI
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Revised: December 1, 2018
(1) Fidelity Assessments: Quarterly for three years, participants will complete audio
recorded standardized patient interactions (a total of 13) over the phone (approximately
30 minutes each) with a study staff member. The study staff member will role play as a
patient with HIV and record the session, which will be rated using the MI Coach Rating
Scale. This is being done to conduct assessments of their MI skills.
(2) MI training. An MI training workshop will be conducted as part of professional
development at the sites. The timing of the training will depend on randomization (two
sites are randomized to receive MI training every three months for up to 15 months).
Prior to a participant’s site’s MI training, they will complete standard patient
interactions quarterly. While the total number of interactions does not change, the
number of interactions they do prior to training depends on their sites randomization
and will vary from 2 to a maximum of 6. In the period following initial training, but
before the next fidelity assessment, participants will complete two 1-hour coaching
sessions over the phone. Following this period, participants may receive additional
coaching quarterly for one year following the fidelity assessments described above.
After one year, sites will be randomized to internal facilitation (a person from each site 
will be chosen to be an MI supervisor to be available for ongoing fidelity monitoring and 
coaching) plus CoP (the site will decide how to meet as a group to continue MI practice), 
or to CoP only. 
Implementation Teams (iTeams): There will also be an opportunity for some participants 
to be part of the iTeam at each site. The iTeam will meet monthly to review study 
progress and make recommendations for how best to implement and sustain MI at each 
Tailored Motivational Interviewing (TMI) Implementation Intervention site.
Data is formative, longitudinal, qualitative, and quantitative in nature. 
7.0
Data and Specimen Banking*
The database will be password protected and stored on a password protected computer and 
cloud server. 
At the end of the study data collected will be made available, in accordance with the NIH Data 
Sharing Policy (http://grants.nih.gov/grants/policy/data_sharing). These data will be saved for 
future use and may be shared with other researchers. The data stored and shared cannot be 
linked to participants (i.e., deidentified data will not link information to PHI, site, date, and city).
8.0
Sharing of Results with Subjects*
Participant providers are part of the Adolescent treatment network (ATN) and may access the 
findings of the study once published through this network. 
9.0
Study Timelines*
At this time all participants are enrolled and all sites have either begun or completed the 
implementation phase. All sites are projected to complete participation by November 
2020.

PROTOCOL TITLE: TMI
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Revised: December 1, 2018
10.0
Subject Population*
The table below provides a breakdown of the current participant pool and participation in the 
beginning of cycle 8. Participants are affiliated with clinical sites within the ATN. 
PROGRESS BY SITE
      Site 1 
17
Total Consented
6
Discontinued TMI participation
11
Active (current participants)
0
Completed this cycle
11
Not completed 
       Site 2
19
Total Consented
6
Discontinued TMI participation
13
Active (current participants)
2
Completed this cycle
11
Not completed 
    Site 3
18
Total Consented
8
Discontinued TMI participation
10
Active (current participants)
0
Completed this cycle
10
Not completed 
Site 6
29
Total Consented
9
Discontinued TMI participation
20
Active (current participants)
3
Completed this cycle
17
Not completed 
Site 7
18
Total Consented
3
Discontinued TMI participation
15
Active (current participants)
1
Completed this cycle
14
Not completed 
Site 8
16
Total Consented
4
Discontinued TMI participation
12
Active (current participants)
0
Completed this cycle
12
Not completed 
Site 10
11
Total Consented
1
Discontinued TMI participation
10
Active (current participants)
0
Completed this cycle
10
Not completed
    Site 11
15
Total Consented
4
Discontinued TMI participation
11
Active (current participants)
0
Completed this cycle
11
Not completed
 Site 12
24
Total Consented
5
Discontinued TMI participation
19
Active (current participants)

PROTOCOL TITLE: TMI
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Revised: December 1, 2018
0
Completed this cycle
0
Not completed
      Site 13
23
Total Consented
5
Discontinued TMI participation
18
Active (current participants)
2
Completed this cycle
16
Not completed 
TOTAL
190
Total Consented
51
Discontinued TMI Participation
139
Active (current participants)
8
Completed this cycle
112
Not completed this cycle 
11.0
Vulnerable Populations*
N/A
12.0
Local Number of Subjects
N/A – all participants are at external sites.
13.0
Recruitment Methods
N/A – the study is no longer recruiting participants. Participants were recruited using the 
following protocol: “The site Co-PI or his/her designated research staff will complete the TMI 
Potential Participants form (attached) to refer potential staff to the TMI research staff for 
potential participation in TMI. The site Co-PI's and site designated research staff will have to 
option to provide referred staff at their site with an initial introduction to TMI. This introduction 
will include a review of the TMI information sheet, along with a description the basic procedure 
and time commitment for the training and implementation of the study. Staff will be informed 
that participation is voluntary and they will be provided with an opportunity to ask questions. 
TMI research staff will be available to attend the introductory meeting by telephone or Skype if 
the site Co-PI so desires. Alternatively, TMI research staff will conduct the introductory meeting 
by telephone or Skype with referred staff as a group or individually. Referred staff will be 
encouraged to follow up with TMI research staff individually with additional questions or to 
decline participation. Referred staff may also decline participation at any time through their site 
Co-PI or designated representative if they so desire. Once the Co-PI or designated 
representative has confirmed that the referred staff have received an initial introduction to the 
TMI study, TMI research staff will contact each referred staff member by email to invite them to 
participate in TMI by completing a TMI role play. The procedures for scheduling a role play will 
be described and staff will be reminded that their completion of a TMI role play is their consent 
to participate in the study (this is described in the information sheet as well). The information 
sheet will be included in this recruitment contact and staff will be encouraged to review it if they 
have not already done so and to contact the TMI research staff by phone or email with 
questions or concerns (recruitment email content is included in the Email Templates document). 
Interested staff members will initiate scheduling an appointment for a TMI role play. At the time 
of the TMI role play appointment, the study staff member conducting the role play will verbally 
confirm with the staff member that s/he understands that completion of the role play is his/her 
consent to participate in the TMI study. If the staff member confirms, then the TMI role play is 
completed. If the staff member does not confirm, or has additional questions, the actor will 

PROTOCOL TITLE: TMI
Page 10 of 13
Revised: December 1, 2018
refer him/her to the TMI project coordinator or TMI senior project assistant for follow-up. The 
staff member can choose to complete the role play at that time (enrolling in the TMI study), 
delay a completion decision until after s/he has contacted the TMI project coordinator or senior 
project assistant, or decline participation in TMI.”
14.0
Withdrawal of Subjects*
Participants may choose to leave the study at any point. Participants may be removed 
from the study based on changes in their clinical role and if they have less than 4 hours 
of client contact per week on average. Participant data will be included, unless a 
participant requests that their data is removed. In such cases, the participant’s data will 
be deleted. 
15.0
Risks to Subjects*
This study carries no known risks to participants, because it is a study of motivational 
interviewing (MI) training for staff and implementation of MI in HIV ATN network clinical sites. 
16.0
Potential Benefits to Subjects*
Participants will hone new skills expected to be beneficial to increasing the adherence of 
the youth they serve in their HIV clinics. Motivational interviewing (MI) is a set of skills 
to expand the capacity of people working with youth living with HIV to provide culturally 
competent care services and increase successful care outcomes. Participants in this 
study will receive intensive training and support in MI to improve communication with 
youth living with HIV during HIV care visits, to improve outreach, as well as prevention 
programs.
17.0
Data Management* and Confidentiality
Data will be analyzed using formative, longitudinal, qualitative, and quantitative methods. 
Participants are identified in the research records only by a codename or number. Site staff do 
not have access to individual participant competency scores, but the iTeam is aware of the 
extent of participation and aggregated competency. Percentages of site participants above or 
below competency are shared with the iTeam only after the end of each cycle to avoid 
inadvertently compromising participant privacy. All staff involved on the project have 
completed the necessary CITI human subjects training. 
In regard to data management, the TMI coding lab functions as a forum to train coders in 
use of the Motivational Interviewing Coach Rating Scale (MI-CRS), to improve the 
utility of the MI-CRS, and to coordinate and monitor the ongoing inter-rater reliability 
(IRR) of coders. Coders use recorded roleplays as practice for coding to maintain the 
reliability of the data.
18.0
Provisions to Monitor the Data to Ensure the Safety of Subjects*
N/A
19.0
Provisions to Protect the Privacy Interests of Subjects
Participants are identified in the research records only by a codename or number. Site 
staff do not have access to individual participant competency scores, but the iTeam is 

Page 11 of 13
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PROTOCOL TITLE: TMI
aware of the extent of participation and aggregated competency. Percentages of site 
participants above or below competency are shared with the iTeam only after the end 
of each cycle to avoid inadvertently compromising participant privacy. Participants 
complete some group trainings (i.e., MI workshop), but may choose to end 
participation or withdraw from the study at any time. Participants may choose not to 
answer questions that cause them discomfort. Only approved staff will have access to 
participant data. 
20.0 Compensation for Research-Related Injury
N/A
21.0 Economic Burden to Subjects
N/A
22.0 Consent Process
A waiver of documentation of consent was previously approved for the current study; however, 
the TMI information sheet was provided to all participants at the time of the initial introduction 
to TMI or emailed to them ahead of time. It was provided by email again when the recruitment 
email was sent. Consent was discussed verbally immediately prior to completion of the first TMI 
role play. Documentation of consent was not obtained as completion of a role play is considered 
consent to participate.
23.0 Process to Document Consent in Writing
N/A – a waiver of documentation of consent was previously approved for this study. 
24.0 Setting
This is a sub-study associated with the larger SIU study, in which we use the same sites 
for other associated studies. These sites are a part of the Adolescent Medicine Trials 
Network for HIV/AIDS Intervention (ATN); please reference protocol number 
2017.21748. Research has been ongoing at these sites since 2017.  
25.0 Resources Available
Participants have already been recruited and are involved in ongoing research at the 
sites listed above and below. The CTBScience and FSU College of Medicine are providing 
other resources not described in site reliance agreements. Multiple study personnel are clinical 
psychologists and health professionals in the case of an unexpected adverse 
event.  
26.0 Multi-Site Research* (Delete this section if this is not a Multi-Site Research Study.) 
Below, presented in the table, are the number of participants active in the study by clinical site 
for the beginning of cycle 8. All recruitment is complete at this phase of the study. All sites have 

PROTOCOL TITLE: TMI
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Revised: December 1, 2018
existing reliance agreements with the FSU IRB. See attached for the communications worksheet 
between sites. Communication is open and ongoing between the study team, Site co-PIs, and 
Study Coordinators. Our team has a designated communication liaison who completes a 
majority of communication between the team and sites in order to reduce possible confusion. 
PROGRESS BY SITE
     Site 1
17
Total Consented
6
Discontinued TMI participation
11
Active (current participants)
0
Completed this cycle
11
Not completed 
        Site 2
19
Total Consented
6
Discontinued TMI participation
13
Active (current participants)
2
Completed this cycle
11
Not completed 
    Site 3
18
Total Consented
8
Discontinued TMI participation
10
Active (current participants)
0
Completed this cycle
10
Not completed 
      Site 6
29
Total Consented
9
Discontinued TMI participation
20
Active (current participants)
3
Completed this cycle
17
Not completed 
    Site 7
18
Total Consented
3
Discontinued TMI participation
15
Active (current participants)
1
Completed this cycle
14
Not completed 
Site 8
16
Total Consented
4
Discontinued TMI participation
12
Active (current participants)
0
Completed this cycle
12
Not completed 
      Site 10
11
Total Consented
1
Discontinued TMI participation
10
Active (current participants)
0
Completed this cycle
10
Not completed
     Site 11
15
Total Consented
4
Discontinued TMI participation
11
Active (current participants)
0
Completed this cycle
11
Not completed
Site 12
24
Total Consented
5
Discontinued TMI participation

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Revised: December 1, 2018
19
Active (current participants)
0
Completed this cycle
0
Not completed
      Site 13
23
Total Consented
5
Discontinued TMI participation
18
Active (current participants)
2
Completed this cycle
16
Not completed 
TOTAL
190
Total Consented
51
Discontinued TMI Participation
139
Active (current participants)
8
Completed this cycle
112
Not completed this cycle