1. 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

2. 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

3. 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)

4. 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.

5. 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.

6. Recruitment: Target Population/Settings
Target Population Across Sites:
125 HIV-positive, virally unsuppressed youth Age 14-29
Philadelphia FIGHT
(195 HIV+ youth between years old)
Y-HEP Health Center
Jonathan Lax Health Center
John Bell Health Center
The Children’s Hospital of Philadelphia
(225 HIV+ youth between 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

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

8. 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

9. 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.

10. 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

11. Contact Information
Philadelphia FIGHT
Helen Koenig, MD, MPH
Juliet Fink Yates, Ed.M
Ally Richman, PhD
The Children’s Hospital of Philadelphia
Nadia Dowshen, MD
Susan Lee, MPH
Discussion