TAKE Steps: Motivational Interviewing to Improve Comprehensive HIV and Sexually Transmitted Infection Prevention in Adolescent Primary Care
Phase: NA
Conditions: Self Efficacy, HIV Prevention, STI Prevention
Sponsor: Children's Hospital of Philadelphia

 
Template version: May 28, 2014 
 
 
 
NCT05215262 - TAKE Steps: Motivational Interviewing to Prevent STIs 
 
Children’s Hospital of Philadelphia ID: 19-016708 
Protocol Title: Health Coaching to Improve Comprehensive HIV and Sexually Transmitted 
Infection Prevention in Adolescent Primary Care 
Protocol Date: 7/3/2024 
 
 

 
 
 
 
 
 
 
 
ii
 
Title: 
Health Coaching to Improve Comprehensive HIV and Sexually 
Transmitted Infection Prevention in Adolescent Primary Care 
Short Title 
STI Health Coaching 
Regulatory Sponsor: 
 
eIRB Number 
19-016708 
Protocol Date:  
4/21/2020 
Amendment 1 Date: 1/31/2020 
Amendment 2 Date: 4/21/2020  
Amendment 3 Date: 7/13/2020 
Amendment 4 Date: 9/16/2020 
Amendment 6 Date: 5/10/2021 
Amendment 12 Date: 12/20/2021 
Amendment 16 Date: 3/28/2022 
Amendment 17 Date: 7/27/2022 
Amendment 19 Date: 11/2/2022 
Amendment 21 Date: 3/16/2023 
Amendment 22 Date: 5/11/2023 
Amendment 24 Date: 6/13/2023 
Amendment 25 Date: 7/26/2023 
Amendment 30 Date: 7/3/2024 
Site Principal Investigator 
Nadia Dowshen, MD, MSHP 
The Children’s Hospital of Philadelphia  
Roberts Center for Pediatric Research 
2716 South Street 
Philadelphia, PA, 19104  
Phone 267-426-2591  
Email: dowshenn@email.chop.edu 
 

 
 
 
 
 
 
 
 
 
 
iii
TABLE OF CONTENTS 
Table of Contents .................................................................................................................. iii 
Abbreviations and Definitions of Terms.............................................................................. v 
Abstract ................................................................................................................................. vi 
Table 1: Schedule of Study Procedures for aim 3 rct ...................................................... viii 
1 
BACKGROUND INFORMATION AND RATIONALE ....................................................................... 1 
1.1 
INTRODUCTION ..................................................................................................................................... 1 
1.2 
NAME AND DESCRIPTION OF INTERVENTION ........................................................................................ 1 
1.3 
RELEVANT LITERATURE AND DATA ..................................................................................................... 1 
1.4 
COMPLIANCE STATEMENT .................................................................................................................... 3 
2 
STUDY OBJECTIVES .............................................................................................................................. 3 
2.1 
PRIMARY OBJECTIVE (OR AIM) ............................................................................................................ 3 
3 
INVESTIGATIONAL PLAN .................................................................................................................... 4 
3.1 
GENERAL SCHEMA OF STUDY DESIGN ................................................................................................. 4 
3.1.1 
Screening Phase .............................................................................................................................. 5 
3.1.2 
Study Treatment Phase .................................................................................................................... 5 
3.1.3 
Follow-up Phase ............................................................................................................................. 6 
3.2 
ALLOCATION TO TREATMENT GROUPS AND BLINDING ........................................................................ 6 
3.3 
STUDY DURATION, ENROLLMENT AND NUMBER OF SITES ................................................................... 6 
3.3.1 
Duration of Study Participation ...................................................................................................... 6 
3.3.2 
Total Number of Study Sites/Total Number of Subjects Projected .................................................. 7 
3.4 
STUDY POPULATION ............................................................................................................................. 7 
3.4.1 
Inclusion Criteria ............................................................................................................................ 7 
3.4.2 
Exclusion Criteria ........................................................................................................................... 8 
4 
STUDY PROCEDURES ............................................................................................................................ 9 
4.1 
SCREENING/BASELINE VISIT ................................................................................................................ 9 
4.2 
STUDY INTERVENTION PHASE .............................................................................................................. 9 
4.2.1 
Follow up Visit 1 ........................................................................................................................... 10 
4.3 
UNSCHEDULED VISITS ........................................................................................................................ 10 
4.4 
SUBJECT COMPLETION/WITHDRAWAL ............................................................................................... 10 
4.4.1 
Early Termination Study Visit ....................................................................................................... 11 
5 
STUDY EVALUATIONS AND MEASUREMENTS ............................................................................ 11 
5.1 
SCREENING AND MONITORING EVALUATIONS AND MEASUREMENTS ................................................ 11 
5.1.1 
Aim 1 ............................................................................................................................................. 11 
5.1.2 
Aim 2 ............................................................................................................................................. 12 
5.1.3 
Aim 3 ............................................................................................................................................. 13 
5.2 
EFFICACY EVALUATIONS ................................................................................................................... 14 
5.2.1 
Diagnostic Tests, Scales, Measures, etc. ....................................................................................... 14 
5.3 
SAFETY EVALUATION ......................................................................................................................... 14 
6 
STATISTICAL CONSIDERATIONS .................................................................................................... 16 
6.1 
PRIMARY ENDPOINT ........................................................................................................................... 16 
6.2 
SECONDARY ENDPOINTS .................................................................................................................... 17 
6.3 
STATISTICAL METHODS...................................................................................................................... 17 
6.3.1 
Baseline Data ................................................................................................................................ 17 
6.3.2 
Analysis ......................................................................................................................................... 18 
6.3.3 
Safety Analysis .............................................................................................................................. 20 
6.4 
SAMPLE SIZE AND POWER .................................................................................................................. 20 

 
 
 
 
 
 
 
 
 
 
iv
7 
STUDY MEDICATION (AIM 3 STUDY INTERVENTION) ............................................................. 21 
7.1 
DESCRIPTION ...................................................................................................................................... 21 
8 
SAFETY MANAGEMENT ..................................................................................................................... 23 
8.1 
CLINICAL ADVERSE EVENTS .............................................................................................................. 23 
8.2 
ADVERSE EVENT REPORTING ............................................................................................................. 23 
9 
STUDY ADMINISTRATION ................................................................................................................. 24 
9.1 
TREATMENT ASSIGNMENT METHODS................................................................................................. 24 
9.1.1 
Randomization............................................................................................................................... 24 
9.1.2 
Blinding ......................................................................................................................................... 24 
9.1.3 
Unblinding .................................................................................................................................... 24 
9.2 
DATA COLLECTION AND MANAGEMENT ............................................................................................ 24 
9.3 
CONFIDENTIALITY .............................................................................................................................. 25 
9.4 
REGULATORY AND ETHICAL CONSIDERATIONS.................................................................................. 26 
9.4.1 
Data and Safety Monitoring Plan ................................................................................................. 26 
9.4.2 
Risk Assessment ............................................................................................................................. 27 
9.4.3 
Potential Benefits of Trial Participation ....................................................................................... 28 
9.4.4 
Risk-Benefit Assessment ................................................................................................................ 28 
9.5 
RECRUITMENT STRATEGY .................................................................................................................. 28 
9.6 
INFORMED CONSENT/ASSENT AND HIPAA AUTHORIZATION ............................................................ 30 
9.7 
PAYMENT TO SUBJECTS/FAMILIES...................................................................................................... 31 
10 
PUBLICATION ............................................................................................................................... 32 
References ............................................................................................................................. 33 
 

 
 
 
 
 
 
 
 
 
 
v
ABBREVIATIONS AND DEFINITIONS OF TERMS 
ACES 
 
Adverse Childhood Experiences Survey 
AIM 
 
Acceptability of the Intervention Measure  
ATN 
 
Adolescent Trials Network 
AYA 
 
Adolescents and young adults 
ACT 
 
Acceptance and Commitment Therapy 
AE 
 
Adverse event 
ASC 
 
Adolescent Specially Care Clinic 
CFIR 
 
Consolidated Framework for Implementation Research 
CHOP 
 
Children’s Hospital of Philadelphia  
CRAFFT 
 
Car, Relax, Alone, Forget, Friends. Trouble-Screening Tool 
CSR 
 
Chart-simulated recall 
EHR 
 
Electronic health record 
FIM 
 
Feasibility of Intervention Measure 
GSES 
 
Generalized Self-Efficacy Scale 
HIV 
 
Human Immunodeficiency Virus  
HC 
 
Health Coaching 
IAM 
 
Intervention Appropriateness Measure 
IRB 
 
Institutional Review Board 
MI 
 
Motivational interviewing 
NAAT 
 
Nucleic acid amplification test  
NIH 
 
National Institute of Health  
NIMH 
 
National Institute of Mental Health  
PAM 
 
Patient Activation Measure 
PCP 
 
Primary care providers 
PHI 
 
Private Health Information 
PHQ 
 
Patient Health Questionnaire 
PrEP 
 
Pre-exposure prophylaxis 
RCT 
 
Randomized Control Trial 
REDCap 
 
Research Electronic Data Capture 
RPR 
 
Rapid Plasmin Reagin 
SOC 
 
Standard of Care 
STD 
 
Sexually transmitted disease  
STI 
 
Sexually transmitted infection 

 
 
 
 
 
 
 
 
 
 
vi
ABSTRACT 
Context: (Background) 
Pediatric primary care systems are uniquely positioned to reduce HIV and STI incidence in 
adolescents, despite substantial challenges to sexual health service delivery. Health coaching 
is a developmentally appropriate and effective method of targeting motivation and behavior 
change in adolescents.  
Objectives: (primary and important secondary objectives) 
Primary Aim 1: To adapt a health coaching intervention to provide comprehensive, PrEP-
inclusive, HIV and STI prevention for adolescents at elevated risk of HIV in pediatric 
primary care 
Primary Aim 2: To identify contextual barriers and facilitators to implementation of the 
adapted health coaching intervention in pediatric primary care 
Primary Aim 3: To conduct a randomized controlled trial (RCT) to test for the intervention’s 
effect on HIV prevention self-efficacy, as well as feasibility and acceptability among 
adolescents at high risk of STI and HIV acquisition 
Study Design:  
Aim 1: Observational cross-sectional study  
Aim 2: Observational cross-sectional study  
Aim 3: Randomized control trial  
Setting/Participants: 
All aims: Participants will be recruited in-person or via telephone or email from CHOP 
Primary Care Clinics. Research activities will also be conducted at the Roberts Center for 
Pediatric Research, as well as primary care clinics, and on a virtual platform capable of 
video conferencing using a HIPAA compliant CHOP approved vendor. 
In addition, for Aim 1, participants will also be recruited from the Adolescent Specialty 
Clinic (ASC) at 3550 Market. In addition, participants can be referred by word-of-mouth 
from other study participants. 
Key eligibility criteria 
Aim 1: n= 50 male and female participants ages 13-19, with a history of one or more STIs, 
and can speak and understand written English, and has access to internet, a mobile device or 
computer, and video conferencing using a HIPAA compliant CHOP approved vendor. 
Aim 2: n= 25 clinicians, clinic staff, and administrators who have provided clinical care to 
patients with STI diagnosis in the past 6 months and can speak and understand written 
English. 

 
 
 
 
 
 
 
 
 
 
vii
Aim 3: n=150 participants, 75 for each arm (with the chance of more participants in the 
RCT’s intervention arm than control arm if there are changes to the randomization scheme). 
HIV-negative youth ages 13-19 within 30 days of treatment for an STI diagnosis of incident 
gonorrhea, chlamydia, trichomonas, or syphilis at the aforementioned clinics, and can speak 
and understand written English. 
Study Interventions and Measures:  
Aim 1: Observational study identifying barriers and facilitators to HIV/STI prevention 
strategies through surveys, virtual or in-person in-depth interviews and focus groups.  
Aim 2: Observational study identifying acceptability, feasibility, and appropriateness of the 
coaching intervention through survey individual semi-structured interviews and chart-
simulated recall.  
Aim 3: Randomized controlled trial of the health coaching intervention designed to increase 
perceived self-efficacy in STI and HIV prevention, using survey measures, interviews, and 
chart abstraction for outcome measurement.  
 

 
viii  
 
 
 
 
 
 
 
 
TABLE 1: SCHEDULE OF STUDY PROCEDURES FOR AIM 3 RCT 
 
Study procedures, by treatment group for the Aim 3 randomized controlled trial. 
 
Screening 
and 
Enrollment 
Baseline 
1 Week  
+ 7/- 5 days 
1 Month 
+ 30/- 14 
days 
3 Months 
+ 30/- 14 
days 
6 Months 
+/- 30 days 
Study procedure 
 
HC1 
SOC2 
HC 
SOC 
HC 
SOC 
HC 
SOC 
HC 
SOC 
Review of 
Inclusion / 
Exclusion Criteria 
X 
-- 
-- 
-- 
-- 
-- 
-- 
-- 
-- 
-- 
-- 
Informed Consent  
X 
-- 
-- 
-- 
-- 
-- 
-- 
-- 
-- 
-- 
-- 
Randomization 
-- 
X 
X 
-- 
-- 
-- 
-- 
-- 
-- 
-- 
-- 
CASIs3 
-- 
X 
X 
X 
-- 
-- 
-- 
X 
X 
X 
X 
Health Coaching 
-- 
X 
-- 
X 
-- 
X 
-- 
X 
-- 
-- 
-- 
Feedback Interview 
-- 
-- 
-- 
-- 
-- 
-- 
-- 
X 
-- 
-- 
-- 
Chart Abstraction 
-- 
X 
X 
-- 
-- 
-- 
-- 
X 
X 
X 
X 
‘ 
1HC: Health coaching arm  
2SOC: Standard of care arm  
3Computer assisted survey instruments  
.

 
  
 
 
 
1
1 
BACKGROUND INFORMATION AND RATIONALE 
1.1 Introduction 
The proposed research seeks to: 1) adapt an existing Health Coaching intervention to focus 
on comprehensive adolescent biobehavioral HIV/STI prevention; 2) identify barriers and 
facilitators to intervention implementation in pediatric primary care; and 3) test the 
intervention in two high STI-incidence pediatric primary care clinics. If successful in 
accomplishing my aims, I will generate an intervention and dissemination strategy that are 
feasible to implement in primary care and poised to test whether it improves HIV prevention 
outcomes while simultaneously launching an independent career in HIV/STI prevention 
research.  
1.2 Name and Description of Intervention 
The third aim of this cluster of studies will consist of a randomized controlled trial of a 
health coaching intervention for adolescents with diagnosed sexually transmitted infections 
(STIs). The coaching sessions will provide HIV/STI prevention education and teach 
motivational interviewing (MI) and Acceptance and Commitment Therapy (ACT)-informed 
behavior change strategies using didactics, role plays, and patient encounter observations. 
1.3 Relevant Literature and Data 
Pre-exposure prophylaxis (PrEP) is the newest evidence-based practice for HIV 
prevention in adolescents. PrEP has arrived in the context of disproportionate rates of HIV 
infection and rising sexually transmitted infections (STIs) in adolescents. While 13-24 years 
olds comprise ~13% of the U.S. population, they represent 21% of incident HIV cases. STIs 
in the U.S. are rising dramatically,1 with ~50% of incident STIs occurring in youth aged 15-
24.2 These statistics highlight the need for new strategies to reduce adolescent HIV and STI 
incidence. In adult clinical trials, oral tenofovir-emtricitabine (TDF-FTC)-based PrEP has 
been >90% effective in preventing HIV in highly adherent users.3,4 The Adolescent Trials 
Network (ATN) 110/113 trials recently demonstrated PrEP safety in adolescents, leading to 
expanded Food and Drug Administration (FDA) approval in 2018.5,6 The Centers for 
Disease Control and Prevention (CDC) now recommends PrEP for HIV negative individuals 
who are sexually active and not in a relationship with a recently tested HIV negative partner 
and have a recent STI, infrequent condom use with partners of unknown or high-risk HIV 
status, or are men who have sex with men (MSM) with recent condomless anal sex.7 As 
prevention options expand, there is a critical need for behavioral HIV prevention 
interventions to keep pace to ensure that PrEP reaches youth at highest risk of HIV 
infection.  
    CDC guidelines situate PrEP within comprehensive HIV/STI prevention care.7 Patients 
must be monitored every three months for risk reduction counseling, HIV, and STI testing. 
Given the dramatic recent rise in adolescent STIs and potential STI increases in PrEP users, 
PrEP must also be paired with STI prevention approaches.8 Unfortunately, while PrEP is 
known to be effective and safe for adolescents, <2% of PrEP prescriptions are for 
adolescents <18 years. To move PrEP to scale, research is needed to determine who should 
be involved in PrEP delivery, what the behavioral targets are for risk reduction, which 

 
  
 
 
 
2
factors may serve as barriers to uptake, when the optimal time is for linkage to PrEP, and 
how to best intervene to increase HIV and STI prevention behavior in adolescents.  
    Pediatric primary care systems are uniquely positioned to reduce HIV and STI incidence 
in adolescents, despite substantial challenges to sexual health service delivery. While most 
youth will be in the care of a pediatrician when their STI or HIV infection occurs, currently, 
there is no evidence-based comprehensive biobehavioral HIV prevention framework for 
integrating PrEP in pediatric primary care. The U.S. Preventative Services Task Force 
(USPSTF), CDC, and American Academy of Pediatrics (AAP) all recommend routine 
HIV/STI screening and counseling at primary care visits, and the USPSTF recently gave 
PrEP a Grade A recommendation for individuals at high risk of HIV infection.,9-13 However, 
there are significant discrepancies between guidelines and current practice. A survey of U.S. 
pediatric primary care providers (PCPs) found that <50% recommended routine STI and 
HIV testing to their adolescent patients.14 The most common barriers to sexual health 
delivery are lack of time and provider self-efficacy.15 Addressing all currently recommended 
prevention topics AND delivering PrEP to high-risk youth would require a substantial 
increase in the time currently allotted for pediatric visits. Since ‘buying’ providers additional 
time to provide comprehensive prevention is infeasible, this research will adapt a theory-
driven health coaching intervention to increase HIV/STI prevention behavior in adolescents, 
paired with clinician delivery of PrEP.  
     Health coaching is a developmentally appropriate and effective method of targeting 
motivation and behavior change in adolescents. Coaches utilize motivational interviewing 
(MI) to facilitate behavior change, and strategies grounded in Acceptance and Commitment 
Therapy (ACT),16 a mindfulness-informed cognitive behavioral therapy, to educate, create 
prevention social norms, and nurture self-efficacy to adopt and sustain target behaviors. 
Coaches are typically allied health professionals who complete manualized and certified 
training.17 Coaching interventions are generally intensive programs that involve weekly-
monthly 30-60 minute sessions over 1-6 months. Although time-intensive, a USPSTF 
systematic review found that only high-intensity risk reduction interventions (>2 hours total) 
significantly reduce STIs in adolescents.18,19 While PCPs are essential for PrEP delivery, the 
counseling time needed to create effective behavior change is infeasible in the routine office 
setting. Instead, this counseling can be delivered by coaches who can meet repeatedly with 
patients to develop and enact tailored risk reduction plans and then partner with PCPs who 
can prescribe PrEP. Cost-benefit analyses demonstrate that health coaching can lead to 
significant savings in expenditures for >20 chronic health conditions, making it a promising 
option for high-value care delivery.20  
   To create an effective AND scalable intervention, we aim to develop and test an 
intervention that has the capacity to be implemented in pediatric primary care. Most HIV 
and STI prevention interventions have focused on key sub-populations of adolescents such 
as young men and transgender women who have sex with men (YMSM/TW) who comprise 
the vast majority of incident HIV infections, or young women who carry the 
disproportionate burden of morbidity associated with STIs but are overlooked in PrEP 
interventions.21-23 However, in primary care, there is a need for interventions such as health 
coaching which can be broadly applied to adolescents, but tailored to the needs of specific 

 
  
 
 
 
3
demographic populations. Lastly, while coaches may be essential in moving youth toward 
PrEP uptake, PCPs will be necessary for prescription and medical management. 
Unfortunately, even among Adolescent Medicine specialized pediatricians, only 35% have 
prescribed PrEP and the odds of prescription are double in those who feel confident in their 
PrEP knowledge.24 Therefore, for this research, we will involve multi-level stakeholders in 
implementation research addressing the integration of coaching and, in tandem, PrEP 
delivery in primary care.  
1.4 Compliance Statement 
This study will be conducted in full accordance all applicable Children’s Hospital of 
Philadelphia Research Policies and Procedures and all applicable Federal and state laws and 
regulations including 45 CFR 46. All episodes of noncompliance will be documented. 
The investigators will perform the study in accordance with this protocol, will obtain 
consent and assent, and will report unanticipated problems involving risks to subjects or 
others in accordance with The Children’s Hospital of Philadelphia IRB Policies and 
Procedures and all federal requirements. Collection, recording, and reporting of data will be 
accurate and will ensure the privacy, health, and welfare of research subjects during and 
after the study.  
2 
STUDY OBJECTIVES 
The overarching purpose of this study is to optimize HIV and STI prevention delivery in 
primary care by adapting, optimizing, and testing a youth-focused, health coaching 
intervention to deliver comprehensive HIV/STI prevention, including PrEP, to high-risk 
adolescents. 
2.1 Primary Objective (or Aim) 
There are three primary aims to this study: 
Primary Aim 1: To adapt a health coaching intervention to provide comprehensive, PrEP-
inclusive, HIV and STI prevention for adolescents at elevated risk of HIV in pediatric 
primary care 
Primary Aim 2: To identify contextual barriers and facilitators to implementation of the 
adapted health coaching intervention in pediatric primary care 
Primary Aim 3: To conduct a randomized controlled trial (RCT) to test for the 
intervention’s effect on HIV prevention self-efficacy, as well as feasibility and acceptability 
among adolescents at high risk of STI and HIV acquisition. 
 

 
  
 
 
 
4
3 
INVESTIGATIONAL PLAN 
3.1 General Schema of Study Design 
The project will be conducted as part of a K23 career development award with three aims. 
Each aim represents a sub-study of the overarching study to achieve the overall goal. Aims 1 
and 2 will occur sequentially and each should take approximately a year to complete. The 
results of Aim 1 and 2 will go to inform the randomized control trial (RCT) in Aim 3. 
However, Aim 3 enrollment can occur even if there is no enrollment in Aim 2. Aim 3 will 
occur over a 12-18-month period. 
Aim 1: Observational, qualitative, cross-sectional study (n~50). Youth with complete one of 
five focus groups (~5-8 youth per group) or an in-depth interview to identify barriers and 
facilitators to HIV/STI prevention behavior to be addressed in the intervention and 
determine preferences for intervention format and delivery strategy. Participants will also 
complete a brief CASI at the time of study enrollment after informed consent. At the end of 
each focus group and in-depth interview, we will remind participants of where they can 
access sexual health and preventative care services and we will share the clinics’ contact 
information. It is of note that Aim 1 focus groups might not occur if any conditions prohibit 
the gathering of focus groups within the primary care setting. 
Aim 2: Observational, mixed methods using chart stimulated recall (CSR), in-depth 
interviews, and quantitative measurement of acceptability, feasibility and appropriateness of 
the PrEP-inclusive coaching intervention in pediatric primary care. Participants will 
complete a single study visit with completion of CSR, semi-structured audio-recorded 
interviews, and a computer assisted survey instrument (CASI) delivered on a secure tablet or 
laptop with acceptability, feasibility, and appropriateness measures. 
Aim 3: We will conduct 1) an iterative pilot phase followed by 2) a small RCT assessing 
intervention effect on the intermediate target of prevention self-efficacy. Pilot testing will 
occur over a 3-month period to prime intervention for implementation, with the aim of 
recruiting n=10 pilot participants. Pilot phase participants will follow the same study 
procedure timeline as participants randomized to the coaching intervention arm of the RCT, 
excluding the 6-month follow-up visit. Pilot participants will not be followed in the RCT or 
contribute outcome data. At the end of every health coaching visit (the baseline, 1-week, 1-
month and 3-month visits), pilot phase participants will complete a brief feedback interview 
to ensure face validity and identify areas needing refinement. Feedback will be incorporated 
into the study design, with amendments submitted to the IRB as needed. The RCT will 
randomize youth with recent STI 1:1 to the coaching intervention vs a standard of care 
(SOC) control. If difficulty retaining coaching participants during the RCT generates a 
disparity in evaluable participants per arm, the RCT’s randomization scheme will be 
changed to 2:1, intervention vs SOC, to balance numbers of evaluable participants per arm. 
Both arms (intervention and SOC) will have data collection visits at the baseline, the 3-
month, and the 6-month-follow-up time points. In addition, the intervention group will have 
health coaching sessions at baseline, 1 week, 1 month and 3 months. At the end of the 3-
month health coaching visit, a sample of RCT phase participants assigned to the intervention 
arm will complete a brief feedback interview to ensure face validity and identify areas 
needing refinement for future studies. 

 
  
 
 
 
5
3.1.1 Screening Phase 
Aim 1: Participants for the virtual or in-person in-depth interviews and focus groups will be 
identified through the CHOP STI testing database, a data platform with >20,000 HIV/STI 
testing encounters (2014-present) which updates in near-real time using a business 
intelligence application (Qlik, Radnor, PA). The password-protected dataset application is 
only accessible to the principal investigator (PI) and the study team. Potential subjects will 
be identified using the protocol inclusion and exclusion criteria. Study staff be provided a 
list of potential participants via the Pediatrics Research Consortium (PeRC) and will confirm 
participant eligibility criteria in the electronic health record (EHR), based on age and prior 
STI status. Participants can also be recruited in-person by the research team from the CHOP 
Adolescent Specialty Clinic and referred into the study by word-of-mouth from existing 
study participants. For all participants, consent for the study will occur via a Research 
Electronic Data Capture (REDCap) form and can occur in-person or via a secure online 
form emailed from the REDCap platform. Participants will not be told on the consent form 
that they are being recruited because they are diagnosed with an STI. This is because 
knowing this information would inform the participants of the health information of the 
others in the focus group. Given the sensitive nature of the data and enrollment of minor 
adolescents, per the guidance of the CHOP REDCap team, participant’s personal email 
addresses will be collected via the consent form to mitigate the use of any potential auto-
default parent/guardian email addresses via MyCHOP, and to ensure participants receive a 
copy of their signed/e-signed consent form. 
Aim 2:  Clinical provider participants will be identified through assistance by PeRC. We 
will solicit a list of names and emails of those who are in the clinical practices meeting the 
inclusion criteria at CHOP Karabots and Cobbs Creek clinics. All potential participants will 
be sent an email through the secure CHOP system asking if they are interested in 
participating in a research study and detailing brief study information. From an email survey 
link, potential participants can access the secure REDCap screening survey to determine 
eligibility.  
Aim 3: Potential clinical trial participants will be identified and referred for recruitment by 
any of three strategies: 1) when nurses or clinical providers call with positive STI results, 
they will provide adolescent patients with information about the study; 2) the STI database 
will be checked daily by the study team to identify new STI diagnoses and obtain the 
confidential contact information for potential participants to contact them directly by phone; 
and 3) potential participants will be approached in-person at the time of STI testing or 
treatment. Screening for the study will occur via a REDCap form and can occur in person or 
by phone.  
3.1.2 Study Treatment Phase  
Aim 1: No intervention 
Aim 2: No intervention  
Aim 3: The study treatment phase for the RCT will consist of data collection and health 
coaching visits over a 6-month period (see Table 1: Schedule of Study Procedures for Aim 3 

 
  
 
 
 
6
RCT). The health coaching sessions will consist of HIV and STI prevention education, 
motivational interviewing, and acceptance and commitment therapy. 
3.1.3 Follow-up Phase 
Aim 1: No intervention  
Aim 2: No intervention  
Aim 3: All RCT participants will have a 6-month follow-up visit. Participants in the 
intervention arm will be able to attend the follow-up visit if they attend at least one of the 
health coaching visits. For both arms, the follow up visit will consist of the same data 
collection (CASIs and chart abstraction) as the 3-month visit. 
3.2 Allocation to Treatment Groups and Blinding 
Aim 1: N/A  
Aim 2: N/A 
Aim 3: Non-stratified 1:1 randomization will occur at baseline using the REDCap 
randomization tool based on randomization tables. The study team will not be able to change 
study groups for participants once randomization has taken place. The randomization will 
not be blinded to the participants or the study team because of the nature of the intervention. 
As mentioned in Section 3, if difficulty retaining coaching participants during the RCT 
generates a disparity in evaluable participants per arm, the RCT’s randomization scheme 
will be changed to 2:1, intervention vs SOC, to balance numbers of evaluable participants 
per arm. 
3.3 Study Duration, Enrollment and Number of Sites 
3.3.1 Duration of Study Participation 
Aim 1: Study duration for Aim 1 will be two days, as the first day participants will complete 
the CASI at time of consent, and the second day (scheduled based on participant availability, 
they will complete the virtual or in-person focus group or in-depth interview.  
Aim 2: Study duration for Aim 2 will be one day for completing all the activities. 
Aim 3:  
Pilot phase: We will use pilot testing over a projected 3-month period to ensure that 
intervention critical steps are primed for implementation. Over one month, we aim to recruit 
n=10 participants. Pilot phase participants will follow the same study procedure timeline as 
participants randomized to the coaching intervention arm of the RCT, excluding the 6-month 
follow-up visit, and will not be followed in the RCT or contribute outcome data.  At the end 
of every health coaching visit (the baseline, 1-week, 1-month and 3-month visits), pilot 
phase participants will complete a brief feedback interview to ensure face validity and 
identify areas needing refinement. Following this phase, we will systematically review 

 
  
 
 
 
7
feedback and adapt the study design and strategy as needed prior to the RCT, with 
amendments submitted to the IRB as needed for modifications to study design. 
Intervention phase: Study duration for Aim 3 will consist of data collection and health 
coaching visits over a 6-month period (see Table 1: Schedule of Study Procedures for Aim 3 
RCT), with the baseline visit as the study’s start. Visit windows, as described in Table 1, 
show that the 1 week visit window is +7/-5 days, the 1 month visit window is + 30/- 14 
days, the 3-month visit window is + 30/- 14 days, and 6-month visit window is +/- 30 days. 
 
3.3.2 Total Number of Study Sites/Total Number of Subjects Projected 
The study, including all three aims, will be conducted at investigative sites in the United 
States. For Aim 1, participants will be recruited from two clinics affiliated with the 
Children’s Hospital of Philadelphia (CHOP) that house Title X adolescent family planning 
clinics, Karabots Care Network and Cobbs Creek Care Network, from the Adolescent 
Specialty Clinic, and by word-of-mouth referral from existing participants. For Aim 2, 
participants will be recruited from two clinics affiliated with the Children’s Hospital of 
Philadelphia (CHOP) that house Title X adolescent family planning clinics, Karabots Care 
Network and Cobbs Creek Care Network. For Aim 3, participants will be recruited from 
Children’s Hospital of Philadelphia (CHOP) primary care clinics.  
Analysis and study coordination will occur at the Roberts Center for Pediatric Research of 
the Children’s Hospital of Philadelphia. 
Aim 1: Recruitment goal for Aim 1 is 50 participants, recruited in groups of 5-8 for virtual 
or in-person focus groups or in-depth interviews. Once this number is reached, recruitment 
will stop.  
Aim 2: Recruitment goal for Aim 2 is 25 clinicians, clinic staff, and administrators are 
recruited from the primary care clinics. Once this number is reached, no more providers will 
be recruited. 
Aim 3: Recruitment goal for the pilot phase is 10 participants.  Recruitment goal for the 
RCT is 150 participants, 75 for each arm (with the chance of more participants in the RCT’s 
intervention arm than control arm if there are changes to the randomization scheme).  
3.4 Study Population 
3.4.1 Inclusion Criteria 
Aim 1 
1) Males or females age 13 to 19 years.   
2) History of ≥1 STI 
3) Able to speak and understand written English 

 
  
 
 
 
8
4) Able to access internet, a mobile device or computer, and video conferencing using a 
HIPAA compliant CHOP approved vendor. During the COVID-19 Pandemic, study 
procedures must be conducted remotely to protect participant safety; this is only 
applicable to Aim 1 and will not apply to the remainder of the study.  
Aim 2 
1) Clinical providers (physicians, certified nurse practitioners, physician assistants, and 
registered nurses) who provide clinic care to ≥1 adolescent patient diagnosed with an 
STI in the past year.  
 
2) Able to speak and understand written English 
Aim 3 
1) Males or females aged 13 to 19 years.  
 
2) Seeking STI-related testing, treatment, prevention counseling, or follow-up care 
 
3) History of ≥1 STI in the 30 days prior to recruitment 
 
4) Confirmed treatment for a laboratory-confirmed diagnosis of Trichomonas vaginalis (via 
microscopy or nucleic acid amplification test [NAAT]), Neisseria gonorrhea (NAAT), 
Chlamydia trachomatis (NAAT), or Treponema pallidum (via new positive rapid 
plasmin reagin [RPR] assay) within the prior 30 days 
 
5) Self-reported HIV negative status and/or HIV negative status as per medical record 
review 
 
6) Able to speak and understand written English 
 
7) If participating in remote visits, must be able to access internet, a mobile device or 
computer, and video conferencing using a HIPAA compliant CHOP approved vendor.  If 
attending in-person visits, must be able to access a phone for scheduling in-person visits. 
3.4.2 Exclusion Criteria 
All aims  
1) Unable to provide informed consent due to intoxication or severe psychological distress. 
Subjects that do not meet all of the enrollment criteria may not be enrolled. Any violations 
of these criteria must be reported in accordance with IRB Policies and Procedures.  
 

 
  
 
 
 
9
4 
STUDY PROCEDURES 
4.1 Screening/Baseline Visit 
Aim 1 
 Informed Consent  
 Survey questionnaire 
 Virtual or in-person focus group or in-depth interview: Given the sensitive nature of 
the topic, we recognize that some youth may not be comfortable in the group setting. 
At the time of informed consent, participants will have the ability to opt-out of the 
focus group and instead conduct an individual, audio or video recorded, in-depth 
interview. In addition, if participants who have opted for focus group participation 
are unable to attend the group at the scheduled time or no-show for the focus group, 
they will be offered the option of conducting an in-person, or if necessary, a 
telephone or video conferencing interview using a HIPAA compliant CHOP 
approved vendor. 
 At the end of each focus group and in-depth interview, we will remind participants of 
where they can access sexual health and preventative care services and we will share 
the clinics’ contact information. 
Aim 2 
 Informed consent  
 Chart simulated recall  
 In-depth interview  
 CASIs measuring demographics acceptability, feasibility, and appropriateness of 
PrEP in pediatric care  
Aim 3 
 Informed Consent 
 Randomization 
 Computer assisted survey instruments (See Section 5.1.3.1) 
 Health coaching 
 Electronic medical record review 
4.2 Study Intervention Phase 
Aim 1: No intervention  
Aim 2: No intervention 
Aim 3: The discussion of the intervention phase is strictly for Aim 3 of the study project.  
For the Aim 3 RCT phase, the participants randomized to the standard of care group will not 
undergo the health coaching intervention. The participants randomized to the health 
coaching group will attend health coaching sessions at the baseline, 1-week, 1-month and 3-
month visits. 

 
  
 
 
 
10
4.2.1 Follow up Visit 1 
Aim 1: N/A  
Aim 2: N/A  
Aim 3: Both the health coaching group and the standard of care group will complete follow-
up surveys at the 6-month follow-up visit. 
 
4.3 Unscheduled Visits 
Aim 1: There will be no unscheduled visits for the virtual or in-person focus groups or in-
depth interviews. 
Aim 2: There will be no unscheduled visits for the provider interviews. 
Aim 3: Research staff will attempt to be flexible with unscheduled visits and conduct a study 
visit if the participant is within the time frame for their next visit. If the participant is not 
within the time frame for their next visit, the study staff will reschedule the participant for 
another time.  
4.4 Subject Completion/Withdrawal 
Aims 1, 2, 3: Participant completion of the study will be closely monitored in both treatment 
arms. Our criteria for defining study completion, withdrawal, drop out, and attrition is 
defined below. 
Multiple attempts will be made to retain participants in the study. Participants in either 
treatment group who do not attend a visit after 3 unsuccessful contact attempts will be 
considered a no-show for that visit.  
Subjects may withdraw from the study at any time without prejudice to their care. They may 
also be discontinued from the study at the discretion of the Investigator for lack of adherence 
to visit schedules. The Investigator may also withdraw subjects who violate the study plan, 
or to protect the subject for reasons of safety or for administrative reasons. It will be 
documented whether or not each subject completes the study. If the Investigator becomes 
aware of any serious, related adverse events after the subject completes or withdraws from 
the study, they will be recorded on the CRF.  
Participants will be asked to provide at least three forms of secure contact information (e.g., 
cell phone, email, social media). In addition, participants will be asked about preferred 
method of contact, and will be asked for consent to text message. At the end of each study 
visit, participants will be scheduled for their next visit. We will use flexible visit windows 
for each coaching visit. Before the window opens, participants will be contacted via their 
preferred method to confirm their next appointment. If a participant does not respond after 
2--3 attempts using one strategy (i.e., texting, emailing, calling) then a new outreach strategy 
will be used to diversify the approach. If a participant does not respond after five 
unanswered attempts, we will stop trying. Study staff will provide reminder contact (text, 
call or email) prior to each visit based on the participants preferred method. To facilitate 
follow up, the coaching sessions will not be restricted to the clinic, and instead coaches will 

 
  
 
 
 
11
be able to meet youth in the community or over a CHOP-approved HIPAA compliant 
platform. 
4.4.1 Early Termination Study Visit 
Aims 1, 2, 3: If a visit is interrupted due to external factors, attempts will be made to resume 
at the earliest possible time, and resultant data will be handled in the same fashion as survey 
collection and interviews completed in one sitting. Participants who withdraw from the 
survey or interview prior to completion will be offered the option of having their earlier 
responses redacted from the record.  If they choose to do so, any data collected for that 
participant will be excluded from all analyses. If participants elect to end an interview early 
but allow use of data already collected or if interviews are truncated due to external factors 
and unable to be completed, responses will be collected and handled according to standard 
study procedures. Analysis of data from partial interviews will be included in the study for 
the questions or portions of the survey and/or interview which were completed.  
 
5 
STUDY EVALUATIONS AND MEASUREMENTS 
5.1 Screening and Monitoring Evaluations and Measurements 
5.1.1 Aim 1  
5.1.1.1 Focus groups or In-depth interviews 
Five audio recorded in-person, or video recorded virtual focus groups will be conducted ~50 
participants, 5-8 per group.  
Focus groups and in-depth interviews will identify HIV/STI prevention barriers and 
facilitators and preferences for an intervention format across different demographic 
populations of adolescents. We will conduct separate focus groups for the following 
populations: cisgender females, heterosexual males and YMSM/TW, and a mixed sex/sexual 
orientation group of adolescents with identified depression on their annual primary care 
screening. Participants will have the option to complete an in-depth interview if they wish to 
not participate in the focus group, as described in section 4.1.  Identifying key content 
themes and delivery preferences among different demographic groups and youth with 
mental health conditions will allow for enhanced tailoring of content for different adolescent 
user groups. For example, if youth with depression are more likely to identify medication 
self-efficacy as a barrier to PrEP uptake, intervention content can be tailored for this 
population to emphasize PrEP adherence strategies.  
Focus groups will occur in-person, or if necessary, via virtual video conferencing using a 
HIPAA compliant CHOP approved vendor. Focus groups will start with an informational 
session on HIV/STI prevention strategies (PrEP, condoms, HIV/STI testing, and partner 
notification). We will then facilitate the focus group to identify the most salient barriers/ 
facilitators for each prevention strategy within each focus group.  In the second half of the 
focus groups, we will focus on adolescent preferences for the delivery of sexual health care, 
and delivery of the proposed intervention. Youth will then share their preferences. Focus 
groups will last 1-2 hours. The individual in-depth interviews will occur in-person, via 

 
  
 
 
 
12
phone, or video conferencing using a HIPAA compliant CHOP approved vendor.  These 
interviews will focus on youth preferences for sexual health care in primary care, using the 
participant’s own prior sexual health encounters in primary care as the framework for the 
interview. Given the sensitive nature of the topic, youth have the option to opt out of any of 
the interview questions (see appendix). In-depth interviews will last 30-45 minutes.  
5.1.1.2 Survey Questionnaire 
Prior to focus group participation, participants will complete a brief survey in-person, or via 
an emailed REDCap link, which will take approximately 15 minutes and will be used to 
assess demographics and sexual health measures. This will include questions of hearing of, 
accessing, and plans to start PrEP. We will measure knowledge of prevention strategies like 
PrEP and targets, including demographics and sexual behavior via CASI in REDCap. For 
participants who consented in-person, they will have the option to complete the survey in-
person at the time of informed consent. For those participants recruited via phone or email, 
they will complete the survey via a REDCap link emailed to them before the virtual or in-
person focus group or interview. 
5.1.1.3 Electronic Medical Record Review 
As part of the study, the study team will review the CHOP medical record of the participants 
for particular variables:  
 STI diagnoses (gonorrhea, chlamydia, syphilis, trichomonas)  
 Mental health diagnoses: derived from the problem list in the general EPIC chart.  
No data will be accessed from protected mental health encounters.   
This information will be taken through the CHOP EPIC system as well as our team’s 
QlikView database. The QlikView data visualization platform contains STI diagnosis data 
that is derived from EPIC and relayed from the CHOP data warehouse. These data will be 
used to confirm STI and mental health diagnosis from screening.  
5.1.2 Aim 2 
5.1.2.1 Chart simulated recall 
Prior to the CSR, providers will receive a brief educational session about health coaching 
and PrEP. The CSR will then provide data on clinician decision making around PrEP and 
comprehensive HIV prevention delivery. Chart-simulated recall is a well-validated method 
in which providers review charts of their own patient encounters to understand clinical 
decision making and rationale for clinical behavior. Study staff will randomly select 3-4 
charts of visits where an STI diagnosis was made. Clinicians will be asked to give a 1-2 
sentence summary of the encounter including the patient’s age, sex, chief complaint, and 
mental health comorbidities. With the EHR available for reference, we will ask participants 
what factors facilitated or hindered delivery of HIV and STI prevention care, including PrEP 
counseling or initiation, HIV testing, discussion of partner notification. We will ask if and 
how mental health co-morbidities affected with delivery of prevention care. These data will 
be used to understand how and when clinicians may best refer to the coaching intervention.  

 
  
 
 
 
13
5.1.2.2 In-depth interview 
Additional interview questions will be grounded in the Consolidated Framework for 
Implementation Research (CFIR) which includes five core constructs associated with 
effective implementation: 1) characteristics of the intervention: acceptability of PrEP and 
coaching, and advantages to current care; 2) outer setting: perception of patient needs and 
impact of mental health comorbidities; 3) inner setting: characteristics of the primary care 
system and implementation climate for PrEP and coaching; 4) characteristics of individual 
provider: knowledge, beliefs, and self-efficacy for HIV/STI prevention care, including PrEP 
prescription; and 5) implementation process: attitudes toward integrating comprehensive 
HIV and STI prevention in primary care. 
5.1.2.3 Computer Assisted Survey Instruments 
Acceptability of the proposed coaching intervention in primary care will be measured via the 
Acceptability of the Intervention Measure (AIM). Feasibility, the extent to which the 
intervention could be successfully implemented within the setting, will be measured by the 
Feasibility of Intervention Measure (FIM). Appropriateness, the perceived fit of the 
intervention and relevance for the practice setting, will be measured with the Intervention 
Appropriateness Measure (IAM). 
5.1.3 Aim 3 
5.1.3.1 Computer Assisted Survey Instruments (baseline, 3-month and 6-month visit)  
The CASI will take approximately 40 minutes. These data will be entered directly into the 
secure REDCap platform by participants, with the option of having the survey read aloud 
and entered by study staff if the participant prefers. We will measure theorized intervention 
predictors and targets including demographics, sexual behavior, health activation, stigma, 
and self-efficacy. Surveys are: 
Background/Demographics 
Current Prevention Practices 
Intentions Questions 
Self-Efficacy 
Knowledge and Attitudes Survey  
Confidence in Safer Sex Scale  
CRAFFT  
General Self Efficacy Scale (GSES)  
HIV Knowledge and Attitude  
Modified ACES Inventory  
Modified Partner Communication  
Parent Adolescent Communication  
Sexual Self Efficacy Scale  
Youth Pediatric Symptom Checklist  

 
  
 
 
 
14
Interpersonal Reactivity Index (IRI) 
Inventory of Parent and Peer Attachment (IPPA) 
Coaching Satisfaction Survey 
 
5.1.3.2 Health Coaching Session 
Coaches will review the interview output with participants to collaboratively create a 
coaching plan prioritizing educational and skills-building topics for coaching sessions. At 
each coaching session, coaches will reassess barriers and facilitators of HIV/STI prevention 
and deliver indicated risk-reduction counseling. Coaching sessions will focus on generating 
skills to move participants toward prevention goal attainment by using MI to elicit 
participant perspectives on prevention needs (such as PrEP initiation) and challenges, and 
then using ACT to reframe barriers as recognizable dilemmas for which there are effective 
solutions. Each coaching session will include a brief psycho-educational module about an 
HIV/STI prevention topic according to the individualized educational plan. The Aim 2 data 
will determine the optimal method for coaches to communicate prevention goals to the PCP 
after each session, to ensure appropriate linkage to clinical care. 
5.1.3.3 Electronic Medical Record Review 
As part of the study, the study team will review the CHOP medical record of the participants 
for particular variables:  
 STI test dates 
 STI diagnoses  
 STI medications including PrEP 
 Mental health diagnoses: derived from the problem list in the general EPIC chart.  
No data will be accessed from protected mental health encounters.   
5.2 Efficacy Evaluations 
These are the measures that will be used to assess the efficacy of the study intervention  
Aim 1: N/A 
Aim 2: N/A 
Aim 3: The primary efficacy outcome is the difference in change in self-efficacy between 
baseline and six-month visits for the intervention group versus control, as measured by the 
modified Generalized Self-Efficacy Scale.  
5.2.1 Diagnostic Tests, Scales, Measures, etc. 
See the list of CASIs in section 5.1.3.1 above.  
5.3 Safety Evaluation 
Subject safety will be monitored by adverse events surveillance, reporting and attention to 
continuous quality improvement to reduce the occurrence of adverse events. 

 
  
 
 
 
15
Although the study is minimal risk, it still requires a high level of scrutiny and vigilance 
with respect to participant safety and data management, particularly given the sensitive 
nature of the data and enrollment of minor adolescents. At least once every three months, we 
will review data storage and integrity. We will jointly review and report any unanticipated or 
adverse events (i.e., breach of privacy) to the CHOP IRB and National Institute of Mental 
Health (NIMH) in accordance with the NIMH reportable events policy.  
For Aim 1, the focus groups and individual interviews contain questions that may make 
some participants uncomfortable or contain sensitive information. At the beginning of the 
focus group, we will outline the rules of the group (see appendix), including a statement that 
participants can opt out of answering any question, that confidentiality will be upheld, and 
that all opinions will be respected, and that we will use pseudonyms (e.g. favorite superhero, 
cartoon character, or color) to refer to each other in the group. For the Aim 1 individual 
interviews, participants will be allowed to opt out of any questions, and the script has been 
designed to still glean important information about sexual health in primary care, even if a 
participant does not want to share their own testing experience. In addition, the study team 
will take additional precautions for those participants completing focus groups or in-depth 
interviews on a phone or via video conferencing using a HIPAA compliant CHOP approved 
vendor. We will have two research team members moderating each focus group. The virtual 
conference rooms will be password protected, and a study team member must admit each 
participant into the group. Before admitting them to the larger group, a study team member 
will individually and confidentially confirm the physical location of each participant and 
their best contact information. Participants will also choose a pseudonym (e.g. favorite 
superhero, cartoon character, or color) prior to entering the virtual focus group and the 
moderator will change their screen name to that pseudonym prior to entry. 
For Aim 3, all participants will be patients of CHOP primary care clinics, and thus can be 
rapidly referred to clinicians and social workers in case there is a need to intervene for an 
identified mental health issue. Our mood rating instrument, the PSC-17, does not include 
any assessment of suicidal ideation. However, if a participant discloses suicidal ideation, 
homicidal ideation, or abuse during an intervention session, the PI will be notified 
immediately, as well as the clinic social worker.  Based on clinician assessment, participants 
who report suicidal ideation will be referred to the local Emergency Department or 
psychiatric crisis center, as needed. Any reports of child abuse will be reported to the clinic 
social worker and reported to ChildLine in accordance with Pennsylvania State Law.  All 
participants will be provided mental health resources at the end of the first session, 
irrespective of their score on the PSC-17. 
Participants will complete a modified version of the Adverse Childhood Experiences survey. 
To minimize the risk to participants that may arise regarding fear of disclosing a specific 
form of adversity, the study will utilize a modified version of the ACES questionnaire that 
has been validated in middle and high school students. The modified inventory is presented 
in 7 items. Within each item, participants are presented with a diagram including 2-4 circles. 
Each circle contains the description of an ACE, with language adapted from the cited 
inventories. The wording has been modified to be appropriate for the reading and 
comprehension abilities of 14 to 18-year-olds. Participants are instructed to read the ACE 
description contained in each circle, to think back on their entire life, and to decide if the 

 
  
 
 
 
16
ACE described within the circle applies to them. Youth respond to each item on the 
inventory by indicating how many circles (0- 4) in that item apply to them. The modified 
ACE inventory allows the investigators to calculate a conventional ACE score (in keeping 
with the extant literature). Because this is a validated scale, we must include all questions to 
come up with a composite score. However, participants do not have to answer any question 
they feel uncomfortable with. There is a great deal of literature about the connection 
between ACES and STI diagnoses.25-29 The data from the ACES questionnaire will be used 
to determine whether the final health coaching intervention needs to be modified to contain 
trauma-focused elements. Lastly, substance abuse will be measured by the CRAFFT which 
contains opening questions frequency of substance use, followed by questions regarding 
specific negative consequences of substance abuse. A score >4 on the CRAFFT is suggests 
substance dependence. Participants with CRAFFT scores >4 will be given a list of resources 
for substance treatment and referred back to their PCP. 
ACES questionnaire 
There are some questions included in the ACES questionnaire that probe about sensitive 
information related to prior childhood trauma. While participants are informed that they may 
refuse to answer any questions at any time, responses or reactions to certain questions may 
indicate potential distress on the part of the participants. If at any time during the assessment 
or completion of the questionnaires, a participant divulges to any study staff that he or she is 
at risk for harm, including but not limited to being abused or experiencing violence, if harm 
is suspected or likely, or if the participant indicates he or she is suicidal/homicidal, a 
member of the subject’s primary care team or a study physician will be notified. This 
primary care team member or study physician will come speak directly in-person or over the 
phone with the subject at that time. They will determine clinical risk and follow up, which 
may include referral to one of the onsite primary care social workers or a local crisis center. 
6 
STATISTICAL CONSIDERATIONS 
6.1 Primary Endpoint 
Aim1: Identification of barriers and facilitators to HIV/STI prevention behavior to be 
addressed in the intervention and determine preferences for intervention format and delivery 
strategy. 
Aim 2:  
o Acceptability of PrEP in primary care will be measured with the Acceptability of the 
Intervention Measure (AIM).  
o Feasibility, the extent to which the intervention could be successfully implemented 
within the setting, will be measured by the Feasibility of Intervention Measure 
(FIM).  
o Appropriateness, the perceived fit of the intervention and relevance for the practice 
setting, will be measured with the Intervention Appropriateness Measure (IAM) 
Aim 3: Prevention self-efficacy, an intermediate behavioral target in our theoretical model. 
This construct will be measured at baseline, intermediate, and final follow up visit using a 

 
  
 
 
 
17
modified Generalized Self-Efficacy Scale (GSES) assessing HIV and STI prevention self-
efficacy. 
6.2 Secondary Endpoints 
Aim 1: None 
Aim 2: None 
Aim 3: 
 Referral feasibility: # potential participants referred/# eligible.  
 Recruitment feasibility: # enrolled/# patients referred.  
 Retention feasibility: # completing all sessions/# enrolled.  
 Acceptability: Assessed at the final visit by a Coaching Satisfaction Survey 
 Secondary outcomes:  
o a) Repeat STI test results at three-months and six-months. 
o b) Prevention behavior, including uptake of PrEP, condom use, HIV testing, and 
partner notification of positive STI results 
 
6.3 Statistical Methods 
6.3.1 Baseline Data  
Aim 1: Study information will be gathered through focus group and in-depth interview data. 
Themes from the focus groups and in-depth interviews will be reported and will be used to 
inform aims 2 and 3. Data from the baseline CASI summarized by standard descriptive 
summaries (e.g. means and standard deviations for continuous variables such as age and 
percentages for categorical variables such as gender). These data will be used to help 
identify whether different themes emerge from different populations of youth by sex, 
gender, and sexual orientation.  
Aim 2: Baseline and demographic characteristics will be summarized by standard 
descriptive summaries (e.g. means and standard deviations for continuous variables such as 
age and percentages for categorical variables such as gender). Themes from the individual 
interviews and results from the chart simulated recall will be reported and be used to inform 
aim 3. 
Aim 3: Baseline and demographic characteristics will be summarized by standard 
descriptive summaries (e.g. means and standard deviations for continuous variables such as 
age and percentages for categorical variables such as gender). We will also report baseline 
data from the multiple scale instruments, such as sexual behavior, substance use, risk 
perception and stigma scales, etc. (See section 5.1.3.1 for list of instruments.) 

 
  
 
 
 
18
6.3.2 Analysis 
Aim 1: We will conduct a deductive qualitative analysis of focus group transcripts and in-
depth interview transcripts with our theoretical model guiding the coding process. Codes 
related to model constructs will be assigned to interview segments to organize the data, 
using the software NVivo, with two study team members separately reviewing the first 10 
transcripts line by line, assigning codes as concepts become apparent. We will compare text 
segments to those that have been previously assigned the same code, and to segments coded 
separately by each analyst, to decide whether they reflect the same concept. We will use this 
process to generate a coding scheme, then apply it to all transcripts. Once coding is 
complete, we will review the data to document emerging themes-general insights gleaned 
from the entirety of the data- which may inform intervention content. 
Aim 2: Survey data will be summarized via descriptive statistics. We will set a >80% 
threshold for high acceptability, feasibility and appropriateness. The interview coding 
process will parallel that described in Aim 1. We will use an integrated deductive and 
inductive coding approach. Transcripts will be reviewed using deductive methodology, 
where CFIR determinants will be used as the coding framework. After completion, the 
transcripts will be re-reviewed using inductive methodology where codes identifying novel 
barriers and facilitators of implementation that do not map onto the CFIR will be identified 
and used to develop a coding framework that is then applied to all transcripts. We will 
integrate the qualitative and quantitative data by merging findings through a comparative 
coding analysis. The AIM and FIM scores will be dichotomized (completely 
disagree/disagree vs completely agree/agree). We will compare the distribution of content 
themes between providers with high vs low acceptability and, separately, high vs low 
feasibility ratings. Data will then be used as a starting point in which to build an optimized 
PrEP-inclusive coaching implementation strategy to be tested in the subsequent RCT.  
Aim 3: The primary analysis will be based on an intention to treat approach and will include 
all subjects randomized at Visit 1.   
The primary outcome for the RCT is the change in prevention self-efficacy between 
intervention and control conditions between the baseline and six-month (final) visits. We 
will compare the exposure variable of treatment group with the outcome variable of 
continuous score on the modified Generalized Self-Efficacy Scale at baseline, intermediate 
(e.g. three month), and six-month visits using mixed effects logistic regression models with 
a random intercept for patient and a random slope for time. In exploratory analyses, to 
determine if the mental health predictors impact the self--efficacy outcome, we will create 
separate mixed effects regression models to compare self-efficacy score for those with and 
without mood ratings consistent with depression on the PSC-17, high trauma (Adverse 
Childhood Experiences Scale score >4 vs not), and substance abuse (CRAFFT score >4) 
adjusting for treatment group and demographic characteristics including sex. In order to 
assess the impact of STI timing on the primary outcome of prevention self--efficacy, we will 
use linear regression models and days between STI diagnosis and the first coaching visit in 
the intervention group, adjusting for demographic covariates including sex and sexual 
orientation. Finally, we will assess if coaching may have a significant effect on other 
domains in the self--efficacy pathway of our model, by repeating the primary analysis above 
with scores for the Patient Activation Measure [PAM], and Confidence in Safer Sex Scale. 

 
  
 
 
 
19
There will be no adjustment of p value for multiple comparisons given the exploratory 
nature of these analyses. 
Secondary outcome analyses: 
o Referral feasibility: Calculated as the number of potential participants referred to 
study staff over the number of patients with bacterial STI at the clinics during the 
study period. This denominator will be identified using the CHOP STI dataset. 
 
o Recruitment feasibility: Calculated as the number of patients enrolled over the 
number of patients referred. 
 
o Retention feasibility: Calculated as the proportion of participants who completed 
each follow--up coaching session over the total number of scheduled coaching visits. 
To determine if the mental health is associated with retention, I will use logistic 
regression to compare proportions of subjects retained between the following 
participant groups: high depressive symptoms, high trauma score, and substance 
abuse (see definitions in exploratory analysis section above), adjusting for 
demographic characteristics such as race and sex. 
 
Fidelity will be assessed by reviewing baseline visit transcripts for the first ten participants 
and reviewing a random sample of 2 visits per week for ongoing supervision 
 
o We will use the Motivational Interviewing Assessment-Supervisory Tools for 
Enhancing Proficiency (MIA-STEP) cut offs for fidelity: interventionist will have to 
demonstrate in the first ten sessions the use of at least half of the MI consistent items 
three to four times, namely, receive a “Somewhat” (4) frequency and extensiveness 
rating and at least an “Adequate” (4) skill level rating. In other words, the 
interventionist has to show capacity to use a moderate amount of MI strategies and 
skills and show an adequate level of performance when implementing them. 
 
o On random sample, if three successive sessions occur in which they fall below 
proficiency standards, the interventionist will receive additional training, feedback, 
and coaching until he or she demonstrated again the minimal MI proficiency 
standards. Supervisors may elect to use the protocol’s MI proficiency standards as a 
supervisory benchmark for their clinicians. The MIA-Step MI rating worksheet tool 
(see below) will be used to assist in this task 
(https://motivationalinterviewing.org/sites/default/files/mia-step.pdf) 
 
o In addition, the interventionist will complete the content checklist after each visit to 
assure each psychoeducation content domain (e.g. condoms, partner notification) 
was addressed in the session. 
 
o Acceptability: I will calculate the proportion of participants who endorse each item 
on the Coaching Satisfaction Survey in the "agree" or "strongly agree" range. 

 
  
 
 
 
20
Exploratory outcome analyses: Utilization of prevention behavior at the six-month time 
point. I will calculate the proportion of participants who: 
o Initiate PrEP 
o Do not develop repeat sexually transmitted infection (STI) 
o Report 100% condom use 
o Receive HIV testing 
o Report partner notification of their initial STI 
6.3.3 Safety Analysis 
At least once every three months, we will review data storage and integrity. We will jointly 
review and report any unanticipated or adverse events (i.e. breach of privacy) to the CHOP 
IRB and NIMH in accordance with the NIMH reportable events policy. The frequencies of 
AEs will be summarized, although because this study is minimal risk, few are expected. 
6.4 Sample Size and Power 
Aim 1: The individual focus group size of 5-8 is informed by consensus methods literature. 
The goal of the pooled focus group size of ~50 is thematic saturation.  The goal of the in-
depth interviews is thematic saturation, which could be reach at ~15 participants. If we do 
not reach saturation at this sample size, or if key themes emerge among subgroups of 
participants which we wish to further explore, we will continue focus groups and in-depth 
interviews until saturation is met. 
Aim 2: Previous studies demonstrate that 3-6 charts per clinician are sufficient for reliable 
and valid assessment in CSRs. We propose to interview 25 clinicians and nurses with the 
goal of achieving saturation of themes, for which this sample size should be sufficient, and 
will continue if saturation is not met. 
Aim 3: We propose a sample size of 150 participants (75 intervention, 75 control – with the 
possibility of a greater number of intervention than control if we shift to 2:1 randomization) 
based on the aim of detecting a moderate effect size score difference in the change in 
modified GSES scores between intervention and control. Given this sample size, and 
assuming a range of intra--subject correlations across subjects ranging from (0.01 to 0.3), we 
will have 80% power and a two--sided alpha of 0.05 to detect a 0.7-0.9 standard deviation 
difference change in GSES scores from baseline and six months by treatment group. And be 
protected from and up to 10% lost-to-follow-up rate. 
 
 

 
  
 
 
 
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7 
STUDY MEDICATION (AIM 3 STUDY INTERVENTION) 
7.1 Description 
Interventionist training: The health coach will be a masters level interventionist with 
expertise in HIV/STI prevention. The interventionist will complete a 2-day MI training. The 
Coach training will be reinforced in monthly meetings with the PI throughout the RCT to 
review session recordings for fidelity and boost MI skills. 
 
Iterative pilot phase: Pilot testing will occur over a 3-month period to ensure that 
intervention critical steps are primed for implementation, with the aim of recruiting n=10 
pilot participants. Pilot phase participants will follow the same study procedure timeline as 
participants randomized to the coaching intervention arm of the RCT, excluding the 6-month 
follow-up visit. Pilot participants will not be followed in the RCT or contribute outcome 
data. At the end of every health coaching visit (the baseline, 1-week, 1-month and 3-month 
visits), pilot phase participants will complete a brief feedback interview to ensure face 
validity and identify areas needing refinement. Feedback will be incorporated into the study 
design, with amendments submitted to the IRB as needed.  
Intervention:  
The intervention focuses on improving three specific domains related to STI and HIV risk: 
1) knowledge, 2) activation (the motivation to manage one’s own health) and 3) self-
efficacy (the belief that a person can successfully carry out behavior change. With respect to 
health behaviors, the intervention aims to improve uptake of specific prevention practices 
based on the participants’ preferences. 
The format of the intervention is designed to have an intensive first session encompassing 1) 
psychoeducation about STI and HIV prevention; 2) motivational interviewing (MI-based) 
counseling to identify top prevention problems and goals, enhance commitment to behavior 
change, and develop an individualized prevention plan; and 3) Referral to the evidence-
based components of their prevention plan: for example, connecting to a PrEP navigator to 
facilitate PrEP start, getting an HIV test, (which may include health management steps like 
learning how to message their provider to ask for test orders), or learning evidence-based 
skills to improve interpersonal communication that can be applied to condom negotiation or 
partner notification. Much of the format for the intervention draws on the MI literature, and 
many of the skills are adapted from Interpersonal Psychotherapy-Adolescent Skills Training 
(IPT-AST), an evidence-based depression prevention program.  The interventionist has been 
trained in MI through a two-day intensive online training through the Motivational 
Interviewing Network of Trainers.  
After the first session, the interventionist will follow up with the participant in one week to 
review the goals and prevention plan, and then in one month to check on progress and use 
MI to troubleshoot roadblocks. Participants in both the intervention and in the standard of 
care arm will follow up again in 3 months at clinic for repeat STI testing, as indicated by 
CDC. Participants in the intervention arm will have a final wrap up MI session at that time, 
however they will be able to reach out to the interventionist for an additional 3 months until 
the end of the study with questions or to access support around their prevention goals. At the 

 
  
 
 
 
22
end of the 3-month health coaching visit, a sample of RCT phase participants assigned to the 
intervention arm will complete a brief feedback interview to ensure face validity and 
identify areas needing refinement for future studies. 
The SOC group will receive treatment as usual. After their baseline visit, they will be 
referred to their PCP for management of any clinical issues that arise. Their clinic visit 
schedule will follow their clinical needs and recommendations of their provider. They will 
complete the 3-month and 6-month research visits. After completing the study, SOC 
participants will be offered one coaching session. 
 

 
  
 
 
 
23
8 
 SAFETY MANAGEMENT 
8.1 Clinical Adverse Events 
Clinical adverse events (AEs) will be monitored throughout the study.  
8.2 Adverse Event Reporting 
Since the study procedures are not greater than minimal risk, SAEs are not expected. If any 
unanticipated problems related to the research involving risks to subjects or others happen 
during the course of this study (including SAEs) they will be reported to the IRB in 
accordance with CHOP IRB SOP 408: Unanticipated Problems Involving Risks to Subjects. 
AEs that are not serious but that are notable and could involve risks to subjects will be 
summarized in narrative or other format and submitted to the IRB at the time of continuing 
review.  
If a participant volunteers information that she or another minor is experiencing abuse or 
that she has thoughts of harming herself or others, we will notify CHOP social work and the 
appropriate authorities as needed. In addition, if the participant discloses potentially harmful 
side effects of the birth control method, we may make a clinical referral to the CHOP 
emergency department, ASC, and/or their primary care provider, depending on the severity 
of the side effect. We will track any referrals and/or mandatory reports that are made in 
REDCap.  
 

 
  
 
 
 
24
9 
 STUDY ADMINISTRATION 
9.1 Treatment Assignment Methods 
9.1.1 Randomization 
Aim 3: Simple 1:1 randomization will occur at baseline using the REDCap randomization 
tool. The randomization tables will be created by a statistician that is not a part of the study 
team. The study team will not take part in randomization. Participants will complete the 
baseline CASI before being randomized. The study team will not be able to change 
randomization after it is applied in REDCap. 
As mentioned in Section 3, if difficulty retaining coaching participants during the RCT 
generates a disparity in evaluable participants per arm, the RCT’s randomization scheme 
will be changed to 2:1, intervention vs SOC, to balance numbers of evaluable participants 
per arm. 
9.1.2 Blinding 
There will be no patient or study team blinding. Due to the nature of the intervention, there 
could not be blinding to which study arm the participants are in.  
9.1.3 Unblinding 
N/A  
9.2 Data Collection and Management 
All study data will be kept in compliance with CHOP procedures. Electronic data will be 
stored on CHOP supported REDCap platforms, databases created will be password-
protected and stored on a CHOP SAN research drive and coded or de-identified at the 
earliest convenience of the study. Interview audio and focus group audio or video files and 
paper copies of surveys will be kept in a locked file cabinet in a locked office until 
recordings can be transcribed into electronic files and stored in the CHOP SAN network 
drive. Paper survey forms will be entered into REDCap as soon as possible. Paper survey 
forms will only be used if there are problems connecting to the internet for survey 
completion on a tablet or laptop computer since REDCap is web-based. 
1. 
Confidentiality. Participants will be given unique study IDs to ensure that data cannot 
be linked to PHI. The study data will be recorded in REDCap whenever possible. 
Paper copy forms will be recorded in REDCap at the earliest possible convenience by 
study staff. All efforts will be made to enter paper form information into REDCap 
immediately following the participant visit completion, but if the paper copy cannot 
be entered into REDCap immediately due to internet connection errors, the paper 
copies will be stored in a locked file cabinet in the PI’s locked office until a study 
team member can record the information in REDCap at the earliest possible moment. 
Paper surveys will be eliminated per CHOP’s policy once information is entered and 
confirmed in REDCap. Data downloaded from REDCap will be password-protected, 
stored on a CHOP SAN network drive, and stored in a folder that only study staff 
have access to. Participants will use pseudonyms (favorite superhero, cartoon 

 
  
 
 
 
25
character, or color) to refer to each other during the focus groups. The interview files 
will also be kept in a locked file cabinet in the PI’s office. The audio or video 
recordings of focus groups and interviews will be transcribed, and electronic files will 
be kept on a CHOP SAN network drive in a folder that only study staff has access to. 
Once the files are transcribed, the original recording files will be destroyed. The audio 
or video recordings will be sent to a CHOP-approved audio or video transcription 
agency specializing in health-related research. They will be anonymized and not 
include the participant’s name. In addition, the study team will take additional 
precautions for those participants completing focus groups or in-depth interviews on a 
phone or via video conferencing using a HIPAA compliant CHOP approved vendor. 
We will have two research team members moderating each focus group. The virtual 
conference rooms will be password protected, and a study team member must admit 
each participant into the group. Before admitting them to the larger group, a study 
team member will individually and confidentially confirm the physical location of 
each participant and their best contact information. Participants will also choose a 
pseudonym (e.g., favorite superhero, cartoon character, or color) prior to entering the 
virtual focus group and the moderator will change their screen name to that 
pseudonym prior to entry. Urine assays will be collected into specimen cups labeled 
with study ID number, date of collection, type of specimen (urine) and storage 
conditions prior to shipment. Urine assay results will be sent to CHOP at the Center 
for Clinical Pharmacology Laboratory. Once received, results will be entered into 
REDCap. After REDCap entry, the original excel file will be deleted. 
2. 
Security. Upon completion of the data collection and data cleaning, a finalized copy 
of the data will be used for data analysis and stored on a private CHOP-supported 
research SAN drive. The file will also be password protected and PHI will be replaced 
with non-identifiers. If the finalized copy of the data becomes corrupted, data will be 
downloaded from REDCap and procedures used to clean the data will be carried out 
again 
3. 
Anonymization, de-identification or destruction. PHI will be coded at the earliest 
possible moment in data cleaning processes. PHI will be replaced with non-identifiers 
(e.g., Date of birth will be replaced with age at study visit). As all data with be 
recorded on REDCap, a separate master list will not be created. Contact information 
will be stored in a separate database on the secure SAN network drive and will not be 
linked to study identification numbers. However, if they chose not to have their 
information used in future studies, once data is cleaned, all information is verified, 
and investigators successfully publish findings from the study, their PHI will be 
removed rendering all data deidentified. Electronic data will be retained and later 
destroyed in accordance with CHOP retention and destruction procedures. 
9.3 Confidentiality 
Data records collected during this study will be kept confidential in accordance with 
Institutional policies and HIPAA on subject privacy and that the Investigator and other site 
personnel will not use such data and records for any purpose other than conducting the 
study. PHI will be coded, de-identified, or removed at the earliest convenience of the study. 
No PHI will be shared outside of the primary research team. Due to the sensitive nature of 

 
  
 
 
 
26
study data, a certificate of confidentiality will be obtained from the NIH prior to initiation of 
any study procedures.  
No identifiable data will be used for future study without first obtaining IRB approval. The 
investigator will obtain a data use agreement between the provider (the PI) of the data and 
any recipient researchers (including others at CHOP) before sharing a limited dataset (PHI 
limited to dates and zip codes).  
9.4 Regulatory and Ethical Considerations 
9.4.1 Data and Safety Monitoring Plan 
This research project has no more than minimal risk to the participants. Throughout the 
study, risks (loss of confidentiality, psychologic distress etc.) to the participants will be 
monitored by the co-investigators with oversight and monitoring responsibility falling 
primarily on the PI of the research team. All study information will be stored be stored on 
CHOP SAN drives, CHOP managed REDCap web application, password protected, and for 
paper copies and interview tapes in a locked cabinet in a locked office until information can 
be entered into electronic form. 
Safety of research participants will be ensured through a Data and Safety Monitoring Plan 
consistent with NIMH guidelines. The PI will be responsible for ensuring that research 
adheres to this plan. We will train all research staff consenting participants to ensure all 
elements of informed consent are being performed. We will conduct routine monitoring of 
data throughout the study to ensure data is collected and recorded in adherence to the 
research plan, and that confidentiality of participants is maintained. Although the study is 
minimal risk, it still requires a high level of scrutiny and vigilance with respect to participant 
safety and data management, particularly given the sensitive nature of the data and 
enrollment of minor adolescents. At least once every three months, we will review data 
storage and integrity at the CHOP Roberts Center for Pediatric Research where the study 
team and the study data will reside. In addition, we will jointly review and report any 
unanticipated or adverse events (i.e. breach of privacy) to the CHOP IRB and NIMH in 
accordance with the NIMH reportable events policy.  
We will establish protocols to address potential disclosure of sensitive information to study 
team members (i.e. depression, substance abuse or intimate partner violence). In addition, 
protocols will be established to address any psychological distress on the part of participants 
during the course of data collection, involving existing clinical providers and social workers 
to evaluate and provide appropriate resources to the participant as appropriate. During the 
course of the study, research data will be stored in password protected files on secure servers 
in accordance with CHOP policy. We will be responsible for ensuring that all study team 
members understand the requirements for data storage and protection. All completed study 
documents will be stored in locked cabinets, and all computer-entered data will be stored 
and analyzed on password-protected computers at CHOP. Access to documents and data 
will be limited to myself and members of my research team. We will be responsible for 
ensuring that all those with access to the information understand the requirements for use of 
the data on password protected computers and servers. Any transfer of data between 
members of the research team will be done through CHOP's encrypted file sharing system. 

 
  
 
 
 
27
In addition, during the randomized controlled trial in Aim 3, we will conduct routine 
monitoring of data throughout the study to ensure data is collected and recorded in 
adherence to the research plan, and that confidentiality of participants is maintained. As this 
is an experimental study, it requires a high level of scrutiny and vigilance with respect to 
participant safety and data management, particularly given the sensitive nature of the data 
and enrollment of minor adolescents. At least once per month during Aim 3 data collection 
and analysis, we will review data storage and integrity and jointly review and report any 
unanticipated or adverse events (i.e. breach of privacy) to the CHOP IRB and NIMH in 
accordance with the NIMH reportable events policy. 
9.4.2 Risk Assessment 
Aim 1: Risks to participants are anticipated to be minimal. There is a minor risk of 
unauthorized disclosure of PHI, which will be made known to participants. There is a risk of 
loss of confidentiality due to using video conferencing, however, the study team will take 
additional precautions for those participants completing focus groups or in-depth interviews 
on a phone or via video conferencing using a HIPAA compliant CHOP approved vendor. 
We will have two research team members moderating each focus group. The virtual 
conference rooms will be password protected, and a study team member must admit each 
participant into the group. Before admitting them to the larger group, a study team member 
will individually and confidentially confirm the physical location of each participant and 
their best contact information. Participants will also choose a pseudonym (e.g. favorite 
superhero, cartoon character, or color) prior to entering the virtual focus group and the 
moderator will change their screen name to that pseudonym prior to entry. Risks will be 
greatly reduced by the data protection procedures in section 8.2 above. 
Aim 2: There is a minor risk of unauthorized disclosure of confidential information, which 
will be made known to participants.  
Aim 3: Risks to participants are anticipated to be minimal. Coaching sessions will be 
administered by trained coaches in a confidential setting to avoid emotional discomfort to 
participants when discussing sensitive matters. There is minor risk of variance in the quality 
of coaching content, but this will be avoided due to extensive training provided to the 
coaches in accordance with the Motivational Interviewing Network of Trainers training 
system. Coaching sessions will be continuously reviewed for quality and fidelity to the 
treatment protocol. There is the minor risk that the CASIs may uncover previously 
undiagnosed depression or substance abuse. There is a minor risk of unauthorized disclosure 
of confidential information, which will be made known to participants.  
Aim 1, 2, 3: Participants will be informed that their participation in all aspects of the 
proposed research is entirely voluntary, and that they are free to withdraw at any time. Strict 
measures will be taken to ensure participant privacy and confidentiality. All data will be de-
-identified then stored in the secure REDCap database, and all participants will be assigned a 
unique identification number. All personally identifiable information will be kept strictly 
confidential and stored in an encrypted document, on a dedicated research server only 
accessible by myself and the designated study staff. Original, signed and dated consent 
forms will be stored in a locked file cabinet, separate from study data, only accessible by 
myself and the designated study staff. Contact information for the PI will be included on 

 
  
 
 
 
28
consent forms to allow participants to ask questions or raise concerns about the study. 
Should any specific concerns arise, the study team would intervene to address problems 
including, if needed, a change or discontinuation of study procedures. The IRB will be 
informed of any concerns, and the IRB and NIMH will be informed of any adverse events. 
9.4.3 Potential Benefits of Trial Participation 
There will be no direct benefit to participants from study participation. However, the 
proposed study could provide significant insights in the field of adolescent HIV prevention, 
increasing potential for adolescents to achieve better health outcomes and receive the sexual 
health care they need in their primary care physician’s office. In the long term, the findings 
of this study could contribute to increased PrEP delivery in pediatric primary care and 
increased healthy sexual behavior. Those in the intervention arm of Aim 3 could directly 
benefit if the intervention helps subjects to achieve better health outcomes and receive 
sexual healthcare. The minimal risks of participation are reasonable in relation to these 
generalizable benefits.  
9.4.4 Risk-Benefit Assessment 
This study consists of surveys, interviews and focus groups, and health coaching 
intervention, and is no more than minimal risk for study subjects. The information gathered 
in this study will inform development of interventions to improve STI and HIV prevention 
care delivery to participants. The potential benefit of enhanced care to a disproportionately 
burdened population outweighs the unlikely, yet potential, risk of loss of confidentiality or 
psychological distress. Safeguards will be put in place to protect all patient study 
information and limit any disclosure in the limited and coded dataset and in the final de-
identified dataset. 
9.5 Recruitment Strategy 
Aim 1: Recruitment for Aim 1 will occur on site at the proposed clinics when possible, or by 
phone or email. Existing participants may also refer friends or individuals from their social 
networks by sharing the study phone number and an electronic copy of the IRB-approved 
study flyer with them. On a regular basis, study staff will cross-reference adolescents 
scheduled for clinic visits with the CHOP STI database to identify patients who may be 
eligible for the study based on age criteria and history of at least one STI. The password-
protected dataset application is only accessible to the PI and the study team. In the case of 
in-person recruitment, study staff will confirm with the visit provider whether they can 
approach the adolescent about study participation. If permitted, study staff will meet with 
potential participants, present information about the study, and if interested, participants can 
consent for study participation. A potential participant list will also be provided by the 
Pediatrics Research Consortium (PeRC).  Study staff will confirm participant eligibility 
criteria through the electronic health record (EHR). For those youth who may express 
interest in the study to their provider, but are unable to stay to screen for inclusion, 
provider's may relay the best contact information for individuals to the study team and the 
team will contact them with information about the study. If in-person recruitment is not 
possible, study staff will contact youth from the STI database by their phone or email 
information listed in their EPIC record. For any recruitment or retention contact via phone, 
email or online, no information about the nature or the study or sexual health will be 

 
  
 
 
 
29
included in email subject lines or on voicemail due to the sensitive nature of the content, and 
instead the study will be identified as "the coaching study." When potential participants are 
reached by phone or email, the study staff will provide a brief description of the study and 
inquire regarding interest in participation. For participants who screened for this study 
remotely, the study team will obtain verbal HIPAA authorization for screening. Study staff 
will go over the verbal HIPAA authorization for screening via telephone. The verbal HIPAA 
authorization for screening for has been uploaded to the eIRB application for approval. After 
HIPAA authorization, study staff will confirm the inclusion criteria for screening, including 
their prior STI status. It they are interested in participating and are eligible, study team will 
then email them a link of the currently approved Aim 1 written HIPAA 
authorization/consent form to complete via REDCap. The Aim 1 written HIPAA 
authorization/Consent form is in its final format and uploaded to REDCap. Study staff will 
go over the REDCap HIPAA authorization/consent form with participants via telephone as 
they complete the form. For participants recruited in person, an analogous process will occur 
with written HIPAA authorization prior to screening, and written informed consent/HIPAA 
authorization prior to enrollment if eligible.  Participants will be offered the option of 
receiving a copy of the consent/assent form via email, postal mail, or at the time of their 
enrollment visit. In Cobbs Creek, Karabots, and Adolescent Specialty Clinic (ASC) we will 
have flyers to provide adolescents with information about the study. This sample flyer is 
provided in the application within eIRB.  
Eligible participants will complete informed consent and the CASI prior to the focus group 
session, which will be scheduled once 9-12 participants have been recruited. If participants 
opt for doing an in-depth interview, the interview will be scheduled at their convenience. 
We will attempt to conduct all focus groups and interviews in-person, however given 
structural barriers with transportation that youth may face and concerns about safety during 
the COVID-19 pandemic, we will allow for phone or video conferencing focus groups and 
interviews as needed using a HIPAA compliant CHOP approved vendor. If a potential 
participant indicates they are not interested in participating in the study, this will be noted in 
a recruitment database and they will not be re-approached. Participants who complete Aim 1 
may be eligible for the Aim 3 trial and will have the option at the time of informed consent 
of consenting for future contact. 
Aim 2: Recruitment: We will recruit and enroll clinicians, clinical staff and coaches who 
referred patients to or participated in the pilot intervention, or who cared for youth with STIs 
during the study period. Potential clinician and staff participants will be identified by 
querying the CHOP STI database for all providers who cared for youth with STIs during the 
study period. All potential participants will be sent an email through the secure CHOP 
system asking if they are interested in participating in a research study and detailing brief 
study information. From an email survey link, potential participants can access the secure 
Research Electronic Data Capture (REDCap) screening survey to determine eligibility. 
Eligible individuals will be contacted by the study team, who will obtain informed consent 
in-person or by phone. Study staff will also be available on site at the two clinics and will 
approach clinicians and staff directly about the study.  
Aim 3: Potential clinical trial participants will be identified and referred for recruitment by 
any of three strategies: 1) when nurses or clinical providers call with positive STI results, 

 
  
 
 
 
30
they will provide adolescent patients with information about the study; 2) the STI database 
will be checked daily by the study team to identify new STI diagnoses and obtain the 
confidential contact information for potential participants to contact them directly by phone; 
and 3) potential participants will be approached in-person at the time of STI testing or 
treatment. Potential participants approached in-person can be provided with a recruitment 
flyer by a clinician or study team member. Screening for the study will occur via a REDCap 
form and can occur in person or by phone. 
9.6 Informed Consent/Assent and HIPAA Authorization 
Informed consent or assent (with parental permission) will be obtained from participants by 
phone or in-person (see section 8.5 above) before any study-related procedures are 
performed. Participants under age 18 years may consent for studies related to reproductive 
health services that adolescents legally can access without parental permission in the state of 
Pennsylvania. Those who wish to involve a parental caregiver in the decision to participate 
will complete an assent form (verbal or written and their parental caregiver will complete a 
parental permission form. All subjects will be recruited from primary care settings where 
they are seeking sexual health services for diagnosis, treatment, or prevention of STIs and 
HIV.  
For participants who screened for this study remotely, the study team will obtain verbal HIPAA 
authorization for screening. Study staff will go over the verbal HIPAA authorization for screening 
via telephone. The verbal HIPAA authorization for screening for has been uploaded to the eIRB 
application for approval. After HIPAA authorization, study staff will confirm the inclusion criteria 
for screening, including their prior STI status. It they are interested in participating and are eligible, 
study team will then email them a link of the currently approved Aim 1 written HIPAA 
authorization/consent form to complete via REDCap. The Aim 1 written HIPAA 
authorization/Consent form is in its final format and uploaded to REDCap. Study staff will go over 
the REDCap HIPAA authorization/consent form with participants via telephone as they complete the 
form. For participants recruited in person, an analogous process will occur with written HIPAA 
authorization prior to screening and written informed consent/HIPAA authorization prior to 
enrollment if eligible.   
Research staff will document the consent process via an electronic consent form in REDCap by 
indicating in the name and digital signature of the person obtaining consent who will attest that they 
have explained the study procedures and that the subject’s participation in the study is voluntary. 
Participants will be offered the option of receiving a copy of the consent/assent form via e-mail, via 
postal mail, or at the time of their enrollment visit (for those who are eligible and agree to move 
forward with study procedures). 
 
The text of the electronic consent form will be identical to that of the in-person consent form and 
will follow the CHOP Clinical Research Support Office “General Guidance on e-consent in 
REDCap” document. Electronic signature will be obtained within a signature field in the REDCap 
form and dated in a date field.   
 
Research staff will complete the Documentation of Informed Consent (DOIC) to assess for 
completeness, as well as update additional information regarding the consent process. A 
copy of the signed informed consent document will be provided to each participant, if they 
want a copy. 

 
  
 
 
 
31
When obtaining informed consent, all study staff must: 
• 
Deliver comprehensive information about the study including its rationale and risks.  
• 
Ensure that potential participants and their parent(s)/legal guardian, if applicable, 
understand the information provided and can ask any questions they may have regarding 
the study. 
• 
Allow potential participants and their parent(s)/legal guardian, if applicable, to ask 
questions at the end of each section of the informed consent document.  
• 
Assess potential participants’ and their parent(s)/legal guardians’ comprehension of the 
details in the consent, assent, and/or parental permission documents. 
• 
Assure potential participants that participation is completely voluntary and that their 
regular care will not be affected should they choose to not participate in this study. 
• 
Review the informed consent process to check for completeness and update additional 
information (DOIC). 
 
All participants will be provided with a copy of their signed consent form in-person, via 
email, or via US mail.  
 
9.7 Payment to Subjects/Families 
Aim 1: The participants in Aim 1 will receive $40 in total for their participation in the study.  
After completing the CASI at time of enrollment, they will receive $10 and then will receive 
$30 once they complete the focus group or in-depth interview.  
Aim 2: The participants in Aim 2 will receive $20 for their participation in the study. 
Aim 3: Participants in both arms of the RCT will receive $40 each at the baseline visit, the 
three-month visit and the six-month follow up visit. Participants who complete baseline 
surveys within 3 business days of link receipt will receive $10. Participants in the health 
coaching arm of the RCT will receive an additional $5 if they complete a feedback survey in 
REDCap after the 1-week coaching session, and they will receive an additional $5 if they 
complete a feedback survey in REDCap or a feedback interview after the 3-month coaching 
session. At the 3-month time point, participants in the health coaching arm who completed a 
baseline coaching session but have missed subsequent visits, including a missed 3-month 
coaching session, will be offered $15 compensation for completing a feedback survey in 
REDCap. 
Compensation will be paid using the ClinCard system. As per CHOP guidelines, all subjects 
will need to provide their contact information in order to process their ClinCard. They will 
also need to sign and date the ClinCard Compensation Receipt (CCR) as proof of receipt of 
their ClinCard as study payment, except for those participants who complete a visit by 
phone. Participants who complete a visit by phone or video conferencing will receive a 
ClinCard via mail. A member of the research team will contact them to confirm receipt of 
the ClinCard before loading any funds onto their card. 
 

 
  
 
 
 
32
10 PUBLICATION 
We will disseminate the findings of the RCT in peer reviewed scholarly publications and 
presentations at national and international academic meetings. The findings of the RCT will 
be used to build an R01 funding application for a multi-site, fully powered randomized 
controlled trial of the intervention, if successful. We will work with PolicyLab at CHOP to 
develop dissemination plans, as well. PolicyLab has extensive experience distilling research 
findings into policy relevant summaries and disseminating research findings to end users. 
 
 

 
  
 
 
 
33
11. REFERENCES 
 
1. 
New CDC analysis shows steep and sustained increases in STDs in recent years 
[press release]. Online: National Center for HIV/AIDS, Viral Hepatitis, STD, and TB 
Prevention, August 28, 2018 2018. 
2. 
Adolescents and Young Adults Sexually Transmitted Diseases 2017; 
https://www.cdc.gov/std/life-stages-populations/adolescents-youngadults.htm. 
3. 
Grant RM, Anderson PL, McMahan V, et al. Uptake of pre-exposure prophylaxis, 
sexual practices, and HIV incidence in men and transgender women who have sex 
with men: a cohort study. Lancet Infect Dis. 2014;14(9):820-829. 
4. 
McCormack S, Dunn DT, Desai M, et al. Pre-exposure prophylaxis to prevent the 
acquisition of HIV-1 infection (PROUD): effectiveness results from the pilot phase 
of a pragmatic open-label randomised trial. Lancet. 2016;387(10013):53-60. 
5. 
Hosek SG, Rudy B, Landovitz R, et al. An HIV Preexposure Prophylaxis 
Demonstration Project and Safety Study for Young MSM. J Acquir Immune Defic 
Syndr. 2017;74(1):21-29. 
6. 
Hosek SG, Landovitz RJ, Kapogiannis B, et al. Safety and Feasibility of 
Antiretroviral Preexposure Prophylaxis for Adolescent Men Who Have Sex With 
Men Aged 15 to 17 Years in the United States. JAMA Pediatr. 2017;171(11):1063-
1071. 
7. 
Centers for Disease Control and Prevention. PREEXPOSURE PROPHYLAXIS 
FOR THE PREVENTION OF HIV INFECTION IN THE UNITED STATES – 2017 
UPDATE. Online: US Public Health Service; 2018. 
8. 
Montano MA, Dombrowski JC, Dasgupta S, et al. Changes in Sexual Behavior and 
STI Diagnoses Among MSM Initiating PrEP in a Clinic Setting. AIDS Behav. 2018. 
9. 
American Academy of Pediatrics. Adolescents and Sexual Health STI Screening 
Guidelines https://www.aap.org/en-us/advocacy-and-policy/aap-health-
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