Positively Connected for Health (PC4H) The Children’s Hospital of Philadelphia, Philadelphia, PA Nadia Dowshen, MD; Susan Lee, MPH Philadelphia FIGHT, Philadelphia, PA Helen Koenig, MD, MPH; Juliet Yates, Ed.M, Ally Richman, PhD

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 Anticipated enrollment: December 2016/January 2017 0 Enrolled to date; awaiting regulatory approval from all sites Monthly enrollment targets: 6-8 youth/per site Regulatory Process Update -Received initial IRB approval (Sept. 2016) -Amendment 1 IRB approval (Oct. 2016) -Amendment 1 is under IRB review (Expected approval Nov. 2016) -IRB application is under IRB review (Expected IRB approval Nov./Dec. 2016)

Implementation Staff Trainings Technology Development Completed REDCap, QDS, web portals (UCLA/CHOP), and institutional network drives trainings Project protocol and recruitment, informed consent, screening, and study visit checklists created and currently training staff on procedures (expected completion Nov. 2016) Currently working with clinical staff from CHOP/FIGHT for patient identification, notification, referrals, etc. Technology Development TYS Android and iOS versions of the app created Working on backend data bug fixes Data Transfers Agreements (CHOP’s Office of Tech Transfer) Business Association Agreement (BAA) with Drexel for app backend Data Transfer Agreement (DTA) with UCLA ETAC to be allowed to upload QDS files to web portal and to later request raw datasets at end of study.

Implementation Challenges Challenges Experienced App glitches and problems with backend data Regulatory for multiple sites Blanket Certificate of Confidentiality (CoC) dependent on all SPNS sites regulatory approval FIGHT challenges coordinating study visits across three clinics Steps for Overcoming Challenges More frequent meetings with app developers CHOP is Philadelphia DCC and attends other site IRB presentation reviews to help address questions/concerns by board members. CHOP requires a CoC in order to start the project locally and may consider getting a CoC specifically for the Philadelphia site if ETAC CoC cannot be obtained in time for Philadelphia project implementation. FIGHT study team is in discussions now with all touch points so we can work out logistics.

Recruitment: Target Population/Settings Target Population Across Sites: 125 HIV-positive, virally unsuppressed youth Age 14-29 Philadelphia FIGHT (195 HIV+ youth between 15-29 years old) Y-HEP Health Center Jonathan Lax Health Center John Bell Health Center The Children’s Hospital of Philadelphia (225 HIV+ youth between 14-24 years old) Adolescent Initiative Special Immunology Philadelphia iknowUshould2 campaign will link any newly diagnosed youth to care with possibility of enrollment into PC4H Connect to Protect (C2P) partner sites FIGHT’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)

Outreach and Recruitment Methods 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 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 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 Procedures Interested in PC4H Participation Approached before or after their clinic visits by a study team member to receive more information about participating in the study Potential participants who may have been lost to care that find out about the study through C2P flyering can contact the number listed on the flyer to learn more about the study from a team member Undecided Potential participants will not be coerced into participating and will be given time to decide if they would like to participate in the study They will be given a copy of the flyer and ICF with contact information to reach a team member when they have made their decision Charts will also be noted to follow up with these potential participants Not Interested in PC4H Participation Patient’s chart will be noted so they are not repeatedly recruited Note – chop is not allowed to collect any PHI/contact information for a study until ICF is given.

Recruitment Challenges Anticipated Challenges with Recruitment: Patient’s desire and ability to commit to 18-month study period Competing demands: housing, employment issues, family responsibilities, etc. Other priorities for clinical care teams at CHOP and FIGHT Potential participants may be excluded from enrolling if participating in another behavioral intervention study that has such a requirement Initial study visit lengthy which can present challenges if at the time of medical appointment Steps for Overcoming Challenges: Work with CHOP/FIGHT clinical care and research teams on prospective participant recruitment for current projects and for PC4H Offer alternative times for youth to complete project visits if they cannot complete after their medical appointment

Contact Information Philadelphia FIGHT Helen Koenig, MD, MPH hkoenig@fight.org Juliet Fink Yates, Ed.M jjfink@fight.org Ally Richman, PhD arichman@fight.org The Children’s Hospital of Philadelphia Nadia Dowshen, MD dowshenn@email.chop.edu Susan Lee, MPH LeeS8@email.chop.edu Discussion