iTransition: Pilot Testing a Multilevel Technology Based Intervention to Support Youth Living With HIV From Adolescent to Adult Care
Phase: NA
Conditions: Human Immunodeficiency Virus, HIV Seropositivity
Sponsor: Emory University

Study No.: «ID» 
 
Emory University IRB 
IRB use only 
Document Approved On: «ApproveDate» 
Project Approval Expires On: «ExpireDate» 
 
 
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iTransition: Developing a Multilevel Technology-Based Intervention to Support Youth Living with HIV from 
Adolescent to Adult Care 
 
NCT04383223 
 
Date: August 11, 2019 
 

Study No.: «ID» 
 
Emory University IRB 
IRB use only 
Document Approved On: «ApproveDate» 
Project Approval Expires On: «ExpireDate» 
 
 
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Title Page 
 
 
Study Title 
iTransition: Developing a Multilevel Technology-Based Intervention to Support Youth Living with HIV from Adolescent 
to Adult Care 
 
Short Study Title 
iTransition Development 
 
Principal Investigator: 
Sophia Hussen MD, MPH 
Assistant Professor 
Hubert Department of Global Health & Department of Epidemiology 
Rollins School of Public Health 
Emory University 
shussen@emory.edu 
 
Co-Principal Investigators: 
Andrés Camacho-González 
Associate Professor 
Department of Pediatrics 
Emory University School of Medicine 
Acamac2@emory.edu 
 
Research Study Coordinator: 
Shamia Moore, MPH 
 
 
 
 
 
 
 
 
Hubert Department of Global Health & Department of Epidemiology 
Rollins School of Public Health 
Emory University 
Shamia.jocelyn.moore@emory.edu 
 
Sponsoring Agency 
NIH/NIMH 
 
Date 
August 11, 2019 
 
 
 
 

Study No.: «ID» 
 
Emory University IRB 
IRB use only 
Document Approved On: «ApproveDate» 
Project Approval Expires On: «ExpireDate» 
 
 
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Emory University 
iTransition: Developing a Multilevel Technology-Based Intervention to Support Youth Living with HIV from Adolescent 
to Adult Care 
 
1. STUDY AIMS, BACKGROUND, AND DESIGN 
 
a. Purpose 
 
The goal of this study is to develop a technology-based intervention to help providers and patients 
navigate the transition from pediatric to adult-oriented HIV care.  
 
 
b. Relevant Literature 
 
Healthcare transition (HCT) from pediatric/adolescent to adult-oriented care is a crucial yet often-
neglected disruption to the Care Continuum for youth living with HIV (YLH). YLH fare worse at each Care 
Continuum stage than older adults. About 49% of YLH know their status; of these, 41% are linked to care, 31% 
are retained in care, and only 27% are virally suppressed. Optimizing engagement in care at each stage of the 
continuum is critically important to reduce morbidity/mortality and decrease transmission at the community level. 
HCT from pediatric/adolescent to adult HIV care is 
a particularly high-risk period for disengagement 
from the Care Continuum (Figure 1). In Dr. 
Tanner’s (MPI) recently completed multi-site study, 
only 37% of 135 HCT-eligible youth attended one 
adult clinic visit in a 9-month follow-up period. Dr. 
Hussen’s (MPI) work in Atlanta documented two-
year retention rates < 60% among those initially 
linked to adult care. Addressing barriers to 
continuous engagement through HCT and beyond is 
a critical step in meeting the NIH Office of AIDS 
Research priorities.  
 
There are no evidence-based interventions to 
support HCT for YLH. The few existing HCT 
programs are single-center protocols, and none have been rigorously tested to document post-HCT clinical 
outcomes. These protocols are written exclusively from the pediatric/adolescent clinic perspective, and are 
characterized by a narrow focus on patient preparation; they do not address other YLH barriers, and adult 
provider’s perspectives are largely neglected. No published work examines collaboration and co-planning 
between pediatric/adolescent and adult clinics. Given the individual, clinical and structural barriers to HCT, 
integrated, multi-level interventions that consider YLH, pediatric/adolescent providers, and adult providers are 
needed to ensure that YLH successfully transition to, and remain engaged in, adult care. 
Mobile health (mHealth) interventions are accessible and practical for youth, including YLH. Youth have 
high levels of technology access and usage; nationally, nearly 100% of youth aged 18-29 own a mobile phone, 
and 92% own a smartphone. A recent survey by Dr. Camacho-González (co-I) found that 97% of YLH at 
Atlanta’s Grady Infectious Disease Program (IDP) clinic owned a smartphone and had a monthly plan with 
unlimited data or minutes (unpublished data). Youth commonly use the Internet to access health information and 
are open to mHealth interventions. Other advantages of mHealth interventions for youth include versatility, 
flexibility, and the ability to deliver content that is “targeted, tailored, and personalized,” while also being 

Study No.: «ID» 
 
Emory University IRB 
IRB use only 
Document Approved On: «ApproveDate» 
Project Approval Expires On: «ExpireDate» 
 
 
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standardized to ensure fidelity. Notably, mHealth interventions can also provide real-time intervention 
engagement metrics, or paradata, to researchers.  
 
Healthcare providers use web- and mobile phone-based resources continually in their daily workflow for 
communication, documentation, education, and clinical decision-making. Web-based tools can enhance 
providers’ communication with patients and with each other. An example of patient-provider communication is 
the OncoLink website, in which patients create a tailored cancer survivorship plan (for follow-up after acute 
cancer treatment) to be discussed with their providers. To improve provider-provider communication about 
patient care, web-based platforms have also been developed for: (1) dissemination of standardized tools to ensure 
that important data are always included in communications, and (2) increased legibility, accessibility (including 
remote accessibility), and avoidance of transcription errors. The application of technology to documentation has 
led most U.S. clinics to use an electronic medical record (EMR) system for patient charting, writing orders, and 
interfacing with laboratories. Finally, providers frequently access mobile apps for education and assistance with 
clinical decision-making (e.g., UpToDate™, Epocrates™). An mHealth intervention has a high likelihood of 
uptake and appeal to both YLH and healthcare providers, as both groups are avid utilizers of mobile apps for 
improving their health (YLH) and clinical practice (providers), respectively. 
 
To address the dearth of evidence-based interventions to improve HCT for YLH, we propose to develop 
and pilot test iTransition, a multilevel mHealth intervention designed to support YLH and their 
(pediatric/adolescent and adult) care providers.  
 
c. Brief Overview of Research 
 
This protocol is for Phase I, which comprises the development of the iTransition mobile intervention in conjunction 
with patients (youth living with HIV) and providers (physicians, nurses, and other staff caring for YLH either before 
or after HCT. Of note, this development work (and the subsequent pilot testing which will be outlined in separate 
IRB protocols) will occur at two sites: (1) here in Atlanta at Emory and the Grady IDP clinic, and (2) the Children’s 
Hospital of Philadelphia (CHOP). 
 
Aim: To develop iTransition, an mHealth intervention designed to improve care engagement through HCT by 
targeting YLH, pediatric/adolescent and adult providers’ needs. 
 
d. Anticipated Significance  
 
We will pilot test this  intervention in subsequent phases of this study. It is our hope that ultimately, 
iTransition will be an effective intervention that can be disseminated in clinics across the country to help YLH 
stay engaged in care through the HCT period and beyond. 
 
2. PARTICIPANT POPULATION 
a. Participants 
There are three different types of participants in this study, all of whom will provide input to study 
investigators as they develop the iTransition web app. (1) The youth advisory board (YAB) will be made 
up of YLH either just before or just after the transition from pediatric to adult care. (2) Healthcare 
providers in the Grady IDP and CHOP clinics will be recruited to serve as “Transition Champions” in the 
clinics, and to give provider perspectives on the app being developed. (3) Usability testing participants: 
these youth will do a one-time testing session of preliminary version(s) of the app and give feedback on 
ease of use and content. YAB members may participate, but these can also be different youth. 
b. Inclusion Criteria  
Youth Advisory Board (YAB): 18+ years old, living with HIV (YLH), going through a healthcare 
transition from pediatric/adolescent HIV care to adult HIV care in the next 12 months OR have recently 

Study No.: «ID» 
 
Emory University IRB 
IRB use only 
Document Approved On: «ApproveDate» 
Project Approval Expires On: «ExpireDate» 
 
 
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(within the last 24 months) switched from pediatric/adolescent HIV care to adult HIV care. Recruited 
from CHOP/Grady health systems HIV clinics. 
Providers aka "Champions": Care providers (physicians, nurses, social workers) who care for 
adolescents and adults living with HIV in Philadelphia, PA or Atlanta, GA area. (Providers who 
are adults 18+) 
Usability Testing: 18+ years old, living with HIV (YLH), going through a healthcare transition 
from pediatric/adolescent HIV care to adult HIV care in the next 12 months OR have recently 
(within the last 24 months) switched from pediatric/adolescent HIV care to adult HIV care. 
Recruited from CHOP/Grady health systems HIV clinics. 
 
c. Exclusion Criteria 
i. Aged 17 or younger 
ii. Unwillingness to participate in study activities 
 
d. Recruitment Process 
 
Participants will be recruited from CHOP/Grady Health HIV clinics or partner organizations. 
In Atlanta: The principal investigator, a Grady IDP clinician with established access to this clinic, will 
perform participant selection in the Grady IDP clinic. The investigator will communicate with medical 
providers (colleagues) for their own participation and/or referral of potential participants. Passive 
recruitment using flyers in waiting rooms and other venues may be used. Verbal solicitation in waiting 
rooms or with permission to approach after/before medical visits from medical team will also be used. 
Study team will also review records (password-protected Excel/Redcap databases listing screened or 
enrolled participants and their contact information) collected in other studies where participants gave 
permission to contact for future studies, and contact these potential participants by phone, in-person, or 
email to notify them a new study they may be eligible to participate in. Due to the eligibility requirement 
of upcoming or recent HCT, colleague referral will likely be used first. CHOP will follow similar 
procedures using their research team on site in Philadelphia. 
 
 
e. Recruitment Materials 
 
Recruitment materials will include flyers to be placed in the clinic for self-referral of participants.  
 
3. STUDY PROCEDURES 
a. Procedures  
 
YAB: YAB members will be asked to participate in 60-90-minute meetings/visits twice a month for 6-12 months 
(a total of 12-24 meetings) with other YAB members, the research study and web-app design team either in- 
person or by video conference (using Zoom or other secure video-conference technology) meetings to discuss 
healthcare transition experiences and health web-app preferences. Meetings may be site-specific (Philadelphia- 
only/Atlanta-only) or across sites pending availability of attendees. Video conference meetings will not be 
recorded. 
 
Providers aka "Champions": Participate in approximately 60-minute meetings for 6-12 meetings over 1 year with 
other providers, the research study and web-app design team either in-person or by video conference (using 
Emory's secure video conferencing system or Zoom technology) meetings to discuss healthcare transition from 
provider-prospective and HCT web-app preferences. 
 
Usability Testing: Participate in one 90-120-minute (1.5-2 hours) in-person study visit with up to 0-2 other 
participants, to discuss opinions on web-app features/activities and functionality, YLH- specific HCT content and 
resources, design layout (wireframe) and aesthetics (colors, font, etc) to help research, design, and expert panel 

Study No.: «ID» 
 
Emory University IRB 
IRB use only 
Document Approved On: «ApproveDate» 
Project Approval Expires On: «ExpireDate» 
 
 
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(consultants) further develop iTransition. Participants may be given opportunity to click-through the web-app 
during the session if a test/demonstration version is available during the study visit. Participants may have 
individual or group (3 participants maximum) usability testing study visit. Visit will be audio recorded, 
transcribed, password-protected, and stored on a secure/private drive accessible only to the research team. PHI 
will not be collected or recorded, and a study ID or pseudonym will be used in place of identifiers and established 
prior to recording. If participants disclose identifiers accidentally during a study visit that is audio-recorded, the 
study team will pause the recording and rewind to rerecord over the identifier before continuing the session. All 
audio recordings will be transcribed and password-protected at the earliest convenience of the study and after 
verification the audio recordings will be destroyed.  
 
Information from YAB/Provider meetings will help develop/inform iTransition creation and then will be tested 
for usability. Feedback from usability will further help develop iTransition. Iterative process in design and 
feedback, redesign and feedback until iTransition is developed/completed.  
 
 
 
4. RESEARCH RISKS 
a. Risk and Lessening Risk 
The potential risks to participants are detailed as follows: 
 
• 
Some YAB participants may be uncomfortable answering questions about their past care 
engagement, particularly if it was suboptimal: all information used in enrollment and 
recruitment describing the research activities will include a detailed description of the 
content and expected participation of the respondent, such that the respondent is aware of 
the nature of the questions to be included. Providers may similarly experience discomfort 
when reflecting on their own practices that may not have been helpful to YLH going 
through HCT. However, it will be emphasized that their input does not require personal 
sharing of such experiences. Additionally, participants will have the option to refuse to 
answer or skip any questions on the surveys that they are uncomfortable answering.  
 
• 
For participants who choose to provide their name and address or other personally 
identifying information to study personnel, there is a risk that these data could be 
unintentionally disclosed to someone not authorized to access the data, compromising the 
privacy of the participant. To reduce this risk, all contact information for the study 
participants will be kept in a password protected location, with access restricted to the 
retention officer and PI.  
 
b. Adequacy of Protection against Risks 
 
 
Protections against Risk 
 
To minimize the risk of participants feeling uncomfortable, we will reassure them that they do not 
need to divulge personal stories/anecdotes. We will also ask YAB and Provider Champions to avoid 
discussing details of the app development sessions outside of the group. 
 
To minimize risks to confidentiality, we will provide study data with all appropriate physical and 
operational security protections. Data will be stored in a physically secure environment, and all 
data files will have encryption and strong password protection. Access to data will be on a role-
based standard; only those study staff who require access to identifying data to complete their 
study-related roles will be allowed access, as described above. All study staff will be trained in 

Study No.: «ID» 
 
Emory University IRB 
IRB use only 
Document Approved On: «ApproveDate» 
Project Approval Expires On: «ExpireDate» 
 
 
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security and confidentiality procedures, and will sign a confidentiality agreement before receiving 
access to any participant data. 
 
We will also develop procedures to minimize indirect disclosure that a participant is participating 
in an HIV-related research study. For each mode of recontact information, we will ask specifically 
whether anyone else potentially has access to that mode of communication, and if it is acceptable 
to leave a non-specific message about participation in a health study. The contact information and 
permissions will be updated at each study visit. No study-related messages will ever mention HIV 
or the nature of the research study.  
 
 
c. Certificate of Confidentiality 
 
As this is NIH-funded research, this work will automatically be granted a Certificate of 
Confidentiality. This will help protect the participants’ anonymity with regards to participation in 
our study. 
 
5. CONFIDENTIALITY 
 
a. Data Safety and Monitoring Plan 
 
 
We have formed a Data Safety and Monitoring Plan including: Study investigators will 
dedicate one meeting (either in person or via teleconference call) each quarter to review 
study progress, recruitment, data quality, and participant safety. A report will be 
generated from each of these meetings and shared with the entire study team and NIH 
program officer. 
 
The researchers and project staff will keep personal information (e.g., phone numbers, 
email addresses) confidential. Confidentiality and scientific ethics are of the utmost 
importance to study staff.  
 
Although we will make every effort to protect participants’ privacy, complete privacy 
cannot be absolutely guaranteed because participants will be participating in group 
discussions. We have taken steps to minimize the chance of a breach of confidentiality 
occurring. The consent forms emphasize that information about other participants should 
not be shared outside of the research site, and that participants should not reveal each 
other’s HIV statuses to anyone outside of the study. 
 
 
6. BENEFITS 
 
a. Potential Benefits of the Proposed Research to Human Subjects and Others 
 
Participants will have the opportunity to contribute to a novel intervention designed to 
improve HCT for YLH. Others will benefit because the study will result in an intervention 
(iTransition) that is ready to be tested. 
 
b. Importance of the Knowledge to be gained 
 

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IRB use only 
Document Approved On: «ApproveDate» 
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YLH have high rates of HIV infection and low rates of sustained engagement in care, 
especially during HCT. Developing a theory-based intervention has potential to 
significantly impact public health. 
 
7. PAYMENT 
  
YAB: $25 gift card per visit + roundtrip public transportation for in-person meetings. 
Usability testing: $50 gift card + roundtrip public transportation 
Providers: $50 gift card received quarterly (every three months) throughout 1 year Snacks/Beverages may be provided 
during in-person sessions.  
 
8. COSTS 
 
There will be no costs to the participants to join the study.  
 
9. CONSENT/ASSENT PROCESS AND DOCUMENTATION OF CONSENT/ASSENT 
a. Consent Process, Participant Access to Consent Form  
 
Providers and youth in the YAB will complete written informed consent. Participants will meet with study team 
member in a private location to review the consent form and study procedures and will ask the participant if they 
understand the information reviewed and in the consent form and if they have any questions. The participant will 
be given time to decide to participate during this meeting or may opt to call a study team member at a later date 
when they have opted to participate, or they may deny participation. The participant will be given a paper copy of 
the consent form to keep and the study team will also retain a signed copy when consent has been given. For 
providers, only investigators/study staff who are not the employees' direct supervisors or close colleagues will 
obtain consent for research participation, and that subjects will be informed during the consent process that their 
decision to participate (or not participate) in the research will not affect their performance evaluation or 
employment and that their responses will not be shared with their supervisors. Similarly, for patients, 
investigators who provide care directly to a potential participant will not be involved in the consenting process. 
Of note, youth who participate in the usability testing only (but not the YAB) will complete verbal consent; we 
are requesting a waiver of written consent for these participants. Since they will only have one interaction with 
our team, the consent form would potentially be the only piece of information linking their name to the study (and 
we would like to eliminate this).  
 
10. MULTISITE COORDINATION 
 
a. This is a multi-site study. Web app development activities will occur in both Atlanta (at Emory) and 
Philadelphia (at CHOP – the Children’s Hospital of Philadelphia). Additional investigators at the University 
of North Carolina, Greensboro (UNCG) will also participate in iTransition development, but no participants 
will be enrolled at that site CHOP IRB has already granted exempt status for this portion of our project, and 
UNCG will be applying for the same. For the subsequent phases of the study (i.e. pilot testing, which will 
comprise separate IRB protocols), we are expecting to rely on the CHOP IRB although an official reliance 
agreement has not yet been signed. 
 
           
 
11. FUNDING SOURCES 
 
This study is being funded by the NIH/National Institute of Mental Health 

Study No.: «ID» 
 
Emory University IRB 
IRB use only 
Document Approved On: «ApproveDate» 
Project Approval Expires On: «ExpireDate» 
 
 
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.