Positively Connected for Health (PC4H) The Children’s Hospital of Philadelphia, Philadelphia, PA Nadia Dowshen, MD; Susan Lee, MPH; Siobhan Gruschow, MPH, MEd Philadelphia FIGHT, Philadelphia, PA Helen Koenig, MD, MPH; Ally Richman, PhD; Graham Beckley

PC4H Overview iknowUshould2 Positively Connected for Health (PC4H) will work with HIV+ and at-risk youth in Philadelphia through three distinct social media interventions: APPlify Your Health A digital health literacy workshop that uses pop-up iPad and smartphone labs to support youth who will be engaged in our two social media interventions iknowUshould2 An existing CHOP web-based social media campaign that encourages HIV testing and linkage to care for status unknown youth TreatYourSelf A mobile app designed for and with input from HIV+ youth to improve adherence to antiretroviral therapy and engagement in care

Implementation Enrollment: May 2017 Regulatory Process Update 1 Enrolled to date CHOP: 4 consented participants FIGHT: 6 consented participants Monthly enrollment targets: 6-8 youth/site Regulatory Process Update Expanded eligibility criteria Removed Drexel as backend app data manager -Amendment 5 IRB approval (May 2017) - Amendment 5 is under IRB review (Expected approval June 2017 ) -Need to submit Amendment re hosting (Expected IRB approval TBD)

Implementation Technology Development TYS Android version of the app in final stages of development Drexel will no longer host backend data; CHOP will host CHOP & Drexel modifying backend for deployment Hold on iOS version Data Transfers Agreements (CHOP’s Office of Tech Transfer) Business Association Agreement (BAA) with Drexel not needed Data Transfer Agreement (DTA) between CHOP and UCLA ETAC is complete; FIGHT still needs to complete a DTA Regulatory Received Blanket Certificate of Confidentiality (CoC) on March 6th

Implementation Challenges & Successes Privacy concerns with management of backend data Delays in app development due to limited resources and experience of development team No longer able to develop iOS version of app due to time constraints and complexity of iOS app store Steps for Overcoming Challenges Meetings with leadership at CHOP, FIGHT, and Drexel CHOP Department of Biomedical Informatics (DBHi) will host backend Drexel’s College of Computing and Informatics has made additional investments, including support from more senior developers to work on app and hosting Purchasing Android phones and plans for iOS participants Successes Developers created minimum viable product for Android app Backend data view and maintenance streamlined for research team

Recruitment: Target Population/Settings Target Population Across Sites: 125 HIV-positive youth age 14-29 who are virally unsuppressed and/or have been out of for at least 6 months in the last 2 years Philadelphia FIGHT (195 HIV+ youth between 15-29 years old) Y-HEP Health Center Jonathan Lax Health Center John Bell Health Center Children’s Hospital of Philadelphia (225 HIV+ youth between 14-24 years old) Adolescent Initiative Special Immunology Philadelphia Philadelphia FIGHT’s AIDS Education Month (AEM) Events: CHOP had a table at the HIV Prevention and Outreach Summit with study materials iknowUshould2 campaign will link any newly diagnosed youth to care with possibility of enrollment into PC4H Connect to Protect (C2P) partner sites FIGHT and CHOP’s counseling, testing, referral, and navigation team will link newly diagnosed youth each year to PC4H

PC4H Flyer CHOP FIGHT Created with input from IRB, clinical providers, researchers, and CHOP’s Youth Community Advisory Board (YCAB)

Participant Recruitment Potential Participants (N=22) Approached (n=15) Consented & Screened (n=4) Needed more time (n=6) Not good fit (n=5) Not interested (n=7) Potential Participants (n=35) Recruited (n=17) Couldn’t meet, but interested (n=5) Not Interested (n=1) Consented (n=6) Enrolled (n=1) No show (n=5) Missed (n=18) As of June 12, 2017

Outreach and Recruitment Methods CHOP HIV multidisciplinary care team weekly case review referrals Manual medical chart review of CHOP medical records by physician Word of mouth solicitation Flyers in CHOP exam and consult rooms and C2P partner sites Distribution of flyers and ICF forms to potential participants at clinic visits Philadelphia FIGHT faculty/staff weekly forum provider referrals EMR medical chart review of scheduled patients Flagged charts so providers know to ask potential participants if they are interested Flyers in FIGHT waiting areas Staff at Health centers, case managers, treatment education staff, CTRN staff Word of mouth solicitation Philadelphia FIGHT Provider referral: All currently-enrolling studies will be discussed in a weekly forum where all Philadelphia FIGHT staff who are capable of referring patients will be present Chart review: Research coordinators will review charts of scheduled patients as often as possible. Every attempt will be made to perform daily chart reviews. Post-it notes  will be used to mark the charts of potential research candidates and to help remind clinicians that a particular patient may be eligible for a particular study Database query: Queries will be conducted on all available and useful databases when deemed appropriate Flyers in waiting rooms, clinics, education sites The Children’s Hospital of Philadelphia Provider referral Weekly case review-The Children’s Hospital of Philadelphia Adolescent Initiative (CHOP AI) holds a weekly case review on Tuesday mornings with all AI physicians, nurse practitioners, social workers, and research staff and will be able to discuss the past week’s patients and the upcoming week’s scheduled patients to identify potential participants for study recruitment. Flyers Word of mouth solicitation

Recruitment Successes & Challenges Adolescent Initiative and Special Immunology clinical teams identifying & referring clinic patients Reviewing and flagging potential patient charts Research team collaborates with Social Workers to get notified of possible participants Challenges FIGHT medical providers want different communication for recruitment (e.g., email each day, email list of total provider patients) Approaching walk-ins at FIGHT Steps for Overcoming Challenges FIGHT recruiter meeting individually with medical providers to develop individualized recruitment strategies Messaging with Front Desk Staff to approach walk-ins: will have access to clinical chat accounts SW notes not always in EPIC schedule for research view

Additional App Updates Minimum Viable Product Simplified avatar Backend data temporarily stored locally Updates to participants Avatar will be silhouette  stock images created by research team  customizable Backend data will be stored locally on participant phones until CHOP backend set up is complete Current version of the app to final version of the home page

Contact Information Philadelphia FIGHT Helen Koenig, MD, MPH hkoenig@fight.org Ally Richman, PhD arichman@fight.org Graham Beckley gbeckley@fight.org The Children’s Hospital of Philadelphia Nadia Dowshen, MD dowshenn@email.chop.edu Susan Lee, MPH LeeS8@email.chop.edu Siobhan Gruschow, MPH, MEd GruschowS@email.chop.edu Discussion