An Emergency Department-Based Study to Reduce Adolescent Pregnancy
Phase: NA
Conditions: Pregnancy in Adolescence, Counseling, Contraception Behavior
Sponsor: Children's Hospital of Philadelphia

 
 
 
Title: 
An Emergency Department-Based Study to Reduce Adolescent 
Pregnancy  
Short Title 
Reducing Adolescent Pregnancy 
eIRB Number 
 
Protocol Date: 
7 July 2019 
Amendment 1 Date: 7/23/19 
Amendment 3 Date:  
Amendment 2 Date: 
Amendment 4 Date: 
 
Study Principal Investigator  
Cynthia J. Mollen, MD, MSCE 
 
3501 Civic Center Blvd. 
Philadelphia, PA 19104 
Phone: 215-590-1944 
Email: MollenC@email.chop.edu

 
 
 
 
 
 
 
 
 
 
ii
TABLE OF CONTENTS 
Table of Contents ................................................................................................................... ii 
Abbreviations and Definitions of Terms ............................................................................. iv 
Abstract .................................................................................................................................. v 
Background Information and Rationale ............................................................................. 1 
1.1 
INTRODUCTION ..................................................................................................................................... 1 
1.2 
NAME AND DESCRIPTION OF INVESTIGATIONAL PRODUCT OR INTERVENTION ..................................... 1 
1.3 
RELEVANT LITERATURE AND DATA ..................................................................................................... 1 
1.4 
COMPLIANCE STATEMENT .................................................................................................................... 2 
2 
STUDY OBJECTIVES .............................................................................................................................. 3 
2.1 
PRIMARY OBJECTIVE (OR AIM) ............................................................................................................ 3 
2.2 
SECONDARY OBJECTIVES (OR AIM) ...................................................................................................... 3 
3 
INVESTIGATIONAL PLAN .................................................................................................................... 3 
3.1 
GENERAL SCHEMA OF STUDY DESIGN ................................................................................................. 3 
3.1.1 
Advanced Practice Nurse Screening, Consent, and Training ......................................................... 4 
3.1.2 
Screening Phase .............................................................................................................................. 4 
3.1.3 
Phase 1: Contraceptive Counseling ................................................................................................ 4 
3.1.4 
Phase 2: Feedback and Follow-Up ................................................................................................. 4 
3.1.5 
Phase 3: Subgroup Interview .......................................................................................................... 5 
3.2 
STUDY DURATION, ENROLLMENT AND NUMBER OF SITES ................................................................... 5 
3.2.1 
Duration of Study Participation ...................................................................................................... 5 
3.3 
TOTAL NUMBER OF STUDY SITES/TOTAL NUMBER OF SUBJECTS PROJECTED ...................................... 5 
3.4 
STUDY POPULATION ............................................................................................................................. 5 
3.4.1 
APP Population ............................................................................................................................... 5 
3.4.2 
Patient Population .......................................................................................................................... 6 
4 
STUDY PROCEDURES ............................................................................................................................ 6 
4.1 
SCREENING ........................................................................................................................................... 6 
4.2 
APP TRAINING ..................................................................................................................................... 7 
4.3 
CONTRACEPTIVE COUNSELING ............................................................................................................. 7 
4.4 
FEEDBACK & FOLLOW-UP ................................................................................................................... 8 
4.5 
SUBGROUP INTERVIEW ......................................................................................................................... 8 
4.5.1 
Theoretical Model to Guide Interviews ........................................................................................... 8 
4.6 
SUBJECT COMPLETION/WITHDRAWAL ................................................................................................. 9 
5 
STUDY EVALUATIONS AND MEASUREMENTS ............................................................................ 10 
5.1 
SCREENING AND MONITORING EVALUATIONS AND MEASUREMENTS ................................................ 10 
5.1.1 
Electronic Medical Record Review ............................................................................................... 10 
5.1.2 
Confidential Screening Interviewing to Assess Eligibility ............................................................ 10 
5.1.3 
Contraceptive Counseling ............................................................................................................. 10 
5.1.4 
Post-Counseling Electronic Medical Record Review (at 8 weeks post-ED visit) .......................... 10 
5.1.5 
Semi-Structured Interviews ........................................................................................................... 10 
5.2 
SAFETY EVALUATION ......................................................................................................................... 10 
6 
STATISTICAL CONSIDERATIONS .................................................................................................... 11 
6.1 
PRIMARY ENDPOINT ........................................................................................................................... 11 
6.2 
STATISTICAL METHODS ...................................................................................................................... 11 
6.2.1 
Baseline Data ................................................................................................................................ 11 
6.2.2 
Efficacy Analysis ........................................................................................................................... 11 
6.2.3 
Safety Analysis .............................................................................................................................. 13 
6.3 
SAMPLE SIZE AND POWER .................................................................................................................. 13 

 
 
 
 
 
 
 
 
 
 
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7 
SAFETY MANAGEMENT ..................................................................................................................... 14 
7.1 
CLINICAL ADVERSE EVENTS .............................................................................................................. 14 
7.2 
ADVERSE EVENT REPORTING ............................................................................................................. 14 
8 
STUDY ADMINISTRATION ................................................................................................................. 14 
8.1 
DATA COLLECTION AND MANAGEMENT ............................................................................................ 14 
8.2 
CONFIDENTIALITY .............................................................................................................................. 14 
8.3 
REGULATORY AND ETHICAL CONSIDERATIONS .................................................................................. 14 
8.3.1 
Data and Safety Monitoring Plan ................................................................................................. 14 
8.3.2 
Risk Assessment ............................................................................................................................. 16 
8.3.3 
Potential Benefits of Trial Participation ....................................................................................... 18 
8.3.4 
Risk-Benefit Assessment ................................................................................................................ 18 
8.4 
RECRUITMENT STRATEGY .................................................................................................................. 18 
8.5 
INFORMED CONSENT/ASSENT AND HIPAA AUTHORIZATION ...... ERROR! BOOKMARK NOT DEFINED. 
8.5.1 
Waiver of Parental Consent ............................................................ Error! Bookmark not defined. 
8.6 
PAYMENT TO SUBJECTS/FAMILIES ...................................................................................................... 19 
8.6.1 
Reimbursement for travel, parking and meals .............................................................................. 19 
8.6.2 
Payments to subject for time, effort and inconvenience (i.e. compensation) ................................. 19 
9 
PUBLICATION ........................................................................................................................................ 19 
10 
REFERENCES ......................................................................................................................................... 19 
 

 
 
 
 
 
 
 
 
 
 
iv
ABBREVIATIONS AND DEFINITIONS OF TERMS 
D 
 
Emergency Department 
REDCap 
 
Research Electronic Data Capture 
EMR 
 
Electronic Medical Record 
APP 
 
Advanced Practice Provider  
TPB 
 
Theory of Planned Behavior 
eTPB 
 
Ecologically-expanded Theory of Planned Behavior 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 
 
 
 
 
 
v
ABSTRACT 
Context:  
Unintended adolescent pregnancy is a major public health problem in the United States that 
results in negative, multi-generational effects on the social, educational and health outcomes 
of young mothers and their children. Adolescent pregnancies cost an estimated $9.4 billion 
each year.1,2 Although rates of adolescent pregnancy declined 25% between 2007 and 2011,3 
they remain among the highest in the developed world.4 Importantly, the decline has largely 
been due to increased contraceptive use;5,6 still, half of adolescent pregnancies are due to 
lack of contraceptive use, with another large portion due to incorrect or inconsistent use.5-9 
Efforts to further increase adolescent contraceptive use remain desperately needed. This data 
will help to elucidate factors that affect decision-making as well as barriers and facilitators 
to conception initiation in the ED setting, allowing us a critical understanding that will lead 
to developing patient-centered approaches for increasing contraception initiation among 
these patients. 
Objectives:  
Primary Objective: Assess intention to initiate contraception (“high”=very/somewhat likely 
vs. “low”=unsure/not likely/definitely not on Likert scale survey) among females aged 16 to 
18 years who receive ED-based contraceptive counseling. 
Secondary Objectives: 
1. Among the same population, assess completion of a referral for any contraceptive 
care, defined as attendance at a referral site within 4 weeks after the index ED visit. 
2. Assess the proportion who ultimately initiate contraception through electronic 
medical record documentation (i.e., visit note, procedure note, medication review) 
and participant report (follow-up calls). 
3. Use qualitative interview methodology to explore attitudes, barriers, and facilitators 
that affect decisions to 1) express intention to initiate contraception, 2) complete a 
referral for contraceptive care, and 3) ultimately initiate contraception among this 
unique group of high-risk adolescents.  
Study Design: Prospective Cohort 
Setting/Participants: 
This study will be conducted in the emergency department at the Children’s Hospital of 
Philadelphia, PA and in the emergency department at Children’s Mercy Hospital in Kansas 
City, MO. This will be a multi-site study. 
Advanced Practice Providers (APPs) will be consented and trained to administer 
contraceptive counseling to patients and answer a post-counseling questionnaire. We 
anticipate consenting and training a maximum of 12 APPs per site. 
We anticipate enrolling 300 patients to obtain 270 evaluable subjects. We anticipate 
conducting in-depth in person or over-the-phone interviews with 50 enrolled subjects per 

 
 
 
 
 
 
 
 
 
 
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site. Patients will be eligible for enrollment if they are females aged 16-18 presenting with 
high risk of pregnancy. High risk of pregnancy is defined as adolescent females who report 
recent (within the last 6 months) or likely future sexual activity; do not desire pregnancy 
within the next year; are not using hormonal contraception or an intrauterine device; and are 
not currently pregnant. 
Study Interventions and Measures:  
The study intervention is the implementation of Emergency Department-based contraceptive 
counseling. An APP will provide this confidential, comprehensive, 10-15-minute 
counseling. The counseling will assess patients’ preferences regarding different methods, 
knowledge about methods, personal motivations, and environmental factors that may 
influence contraceptive use, such as partner preference.  
A subgroup of 50 enrolled participants will be interviewed in-person or over the phone, if 
necessary. All interviews will be conducted by trained members of our research staff and 
will be audiotaped and professionally transcribed. These interviews will be used as a 
thematic assessment of adolescents’ attitudes and beliefs about contraception. 
Table 1 explains the schedule of study procedures. 
Figure 1 explains the main study outcome measures as related to each sequenced study 
procedure. 
 
TABLE 1: SCHEDULE OF STUDY PROCEDURES 
 
Study Phase 
Prior to 
Patient 
Enrolment 
Emergency 
Department 
Visit 
8 weeks post-
ED visit 
8-12 weeks 
post-ED visit 
APP Consent and Training 
X
 
Screening & Eligibility Review 
X
 
Consent 
X
 
Patient questionnaire 1 
X
 
Contraceptive Counseling  
X
 
Patient questionnaire 2 
 
X 
 
 
EMR review 
X
X 
Follow-up phone call 
X 
Eligibility Review 
 
 
  
X 
In-person or over-the-phone interview 
 
X

 
 
 
 
 
 
 
 
 
 
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FIGURE 1: Schedule of study procedures with outcome measures 
 
 
 
N=50 per site
Adolescents will be interviewed in-person or over-the-phone to assess 
adolescents' attitudes and beliefs about contraception (week 8).
Measure 4: Thematic assessment of adolescents' attitudes and beliefs
Participants' EMR will be reviewed at 8 weeks after the ED visit. For participants 
who do not have a follow-up visit noted in the hospital EMR, a follow-up phone 
call will be made.
Measure 2: Attendance at a referral site within 
4 weeks after ED visit.
Measure 3: Contraception initiation as 
documented within EMR or participant report
Adolescent completes questionnaire assessing preferred form of contraceitipn 
and intention to initiate a new contraceptive method during ED visit or within the 
next 2 months.
Measure 1: Intention to initiate contraception (in ED or at follow-up) assessed.
APP provides confidential, comprehensive, 10-15-minute contraceptive 
counseling. (See above)
N=300
Adolescent completes brief questionnaire about demographic information, sexual 
history, and contraceptive use and history. 
Screening for Inclusion/Exclusion Criteria

 
 
 
 
 
 
1
 BACKGROUND INFORMATION AND RATIONALE 
1.1 Introduction 
Unintended adolescent pregnancy rates remain unacceptably high in the United States, and 
result in poor health outcomes for the young mothers and their babies, as well as significant 
social and financial costs to communities and society as a whole. While many factors 
contribute to the high rate of unintended pregnancies in this age group, an important issue 
that is potentially amenable to intervention is non-use of contraception. Therefore, research 
focused on increasing initiation of contraception among adolescents, particularly those at 
high risk of pregnancy, is crucial. One approach that has been understudied is reaching these 
adolescents in non-traditional sites of clinical care – care settings that do not currently 
routinely provide contraception services. The Emergency Department (ED) is a setting that 
is well-positioned to provide these services, as almost 19 million adolescents seek care in 
EDs each year, and many adolescents are amenable to receiving reproductive health care 
services in this setting. For the highest-risk patients, the ED is often their only or primary 
contact with the health care system, and so in this setting we have a vital window of 
opportunity to improve contraception access for adolescents who are unlikely to be reached 
through other clinical settings. We seek to capitalize on our prior work and our ED programs 
focused on sexual health education in order to better understand the decision-making around 
contraception initiation of adolescents at high risk for pregnancy.  Our long-term goal is to 
reduce unintended pregnancy by improving access to contraception among adolescents 
seeking care in the ED setting. By elucidating factors that affect decision-making as well as 
barriers and facilitators to conception initiation in the ED setting, we will gain a critical 
understanding that will lead to developing patient-centered approaches for increasing 
contraception initiation among these patients.  
1.2 Name and Description of Investigational Product or Intervention 
An Emergency Department-Based Study to Reduce Adolescent Pregnancy is a multi-site, 
mixed methodology study to assess attitudes, barriers and facilitators to initiating 
contraception in the ED among this high-risk group of patients. We will adapt contraceptive 
counseling approaches used in outpatient clinical settings to deliver counseling during the 
ED visit, and our methods will allow us to explore factors associated with initiation of 
contraception during and after the ED visit as well as issues affecting follow-up after ED 
care. Ultimately, we will develop a toolkit supporting contraceptive counseling and delivery 
in the ED, and design processes to support increased use of contraception among 
adolescents. 
1.3 Relevant Literature and Data 
Unintended adolescent pregnancy is a major public health problem in the United States that 
results in negative, multi-generational effects on the social, educational and health outcomes 
of young mothers and their children. Adolescent pregnancies cost an estimated $9.4 billion 
each year.1,2 Although rates of adolescent pregnancy declined 25% between 2007 and 2011,3 
they remain among the highest in the developed world.4 Importantly, the decline has largely 
been due to increased contraceptive use;5,6 still, half of adolescent pregnancies are due to 

 
 
 
 
 
 
2
lack of contraceptive use, with another large portion due to incorrect or inconsistent use.5-9 
Efforts to further increase adolescent contraceptive use remain desperately needed. 
One approach to increase contraceptive use among the highest-risk adolescents is to utilize 
non-traditional settings, such as the Emergency Department (ED). Adolescents account for 
almost 19 million ED visits annually, and adolescents in the ED frequently report recent 
unprotected intercourse, placing them at risk for unintended pregnancy.10-14 Furthermore, 
there is growing support for providing sexual and reproductive health services in the ED,15-19 
with several research teams, including our own, having explored various approaches for 
providing these services.20-35  In the ED, we have a vital window of opportunity to improve 
contraception access for adolescents who are unlikely to be reached through other clinical 
settings.  
Several studies have investigated feasibility and acceptability of providing ED-based sexual 
health services. These have been primarily single-center studies investigating adolescent 
preferences for theoretical, not actual, services.21-23, 26, 28, 30 Studies of direct service 
provision have been limited by small sample sizes, or used research processes or research 
staff, rather than those that can be sustained long-term. Furthermore, the majority of studies 
have focused on screening for sexually transmitted infections (STIs),36,29,33,34,36,37  rather than 
pregnancy prevention, with the latter focused on emergency contraception.22,34,38 An 
important gap remains in understanding  how to optimally deliver contraceptive counseling 
services in the ED that maximize contraceptive uptake. Important questions remain 
unanswered, such as which contraceptive services (counseling, prescribing, or placement of 
medium and long-acting reversible contraceptives), should be offered in the ED, and which 
should be provided through referral to sites with contraceptive specialists. Recognizing that 
a “one size fits all” model is unlikely to be successful, we must identify patient-centered 
factors that impact preferences to understand what drives decision-making around 
contraceptive initiation for adolescents in the ED. Understanding adolescent decision-
making will allow us to utilize the most effective processes for the ED setting, and to make 
optimal use of resources, while maximizing the likelihood of adolescent contraceptive 
initiation. The goal of this application is to examine whether adolescents who receive 
structured contraceptive counseling in the ED have a stronger preference for initiating a 
method in the ED or prefer to be referred. We will use a theoretical framework to explore 
domains that likely predict these preferences. In addition, we will assess rates of 
contraception initiation after the ED visit.  
This proposal addresses a major gap in health care access for this vulnerable population and 
is consistent with Healthy People 2020 objectives: “Reducing pregnancies among adolescent 
females (FP-8)” and “Increasing the proportion of sexually active persons aged 15 to 19 
years who use hormonal or intrauterine contraception to prevent pregnancy (FP-11).”39 In 
addition, the proposal directly addresses one of the high-priority research areas of the 
Population Dynamics Branch of NICHD: “Behavioral research on the use and non-use of 
contraception.”40 
1.4 Compliance Statement 
This study will be conducted in full accordance all applicable Children’s Hospital of 
Philadelphia and Children’s Mercy Hospital Research Policies and Procedures and all 

 
 
 
 
 
 
3
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 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 purpose of this study is to elucidate factors that impact preferences around same-day 
contraception initiation as well as follow-through after referrals for contraception care 
among adolescents in the ED. The central hypothesis of this research plan is that our work 
will illuminate specific and unique factors that influence adolescent decisions regarding 
contraceptive initiation after a counseling session that will subsequently inform future 
models for patient-centered service provision. We will utilize survey methods (Aims 1, 2 
and 3) and in-depth interviews (Aim 4) to achieve our goal. 
2.1 Primary Objective (or Aim) 
The primary object of this study is to assess intention to initiate contraception among 
adolescent women ages 16 to 18 years who have received ED-based contraceptive 
counseling. 
2.2 Secondary Objectives (or Aim) 
The secondary objectives are to: 
 Assess completion of a referral for any contraceptive care 
 Assess proportion who ultimately initiate contraception 
 Explore attitudes, barriers, and facilitators that affect adolescent women’s decision to 1) 
express intention to initiate contraception, 2) complete a referral for contraceptive 
services, and 3) actually initiate contraception. 
3 
INVESTIGATIONAL PLAN 
3.1 General Schema of Study Design 
This is a prospective cohort study of female patients ages 16-18 years old presenting to the 
Emergency Department at the Children’s Hospital of Philadelphia and Children’s Mercy 
Hospital. Prior to screening and enrolling any patients, a maximum of 12 Advanced Practice 
Providers per site will be approached, consented, and trained in contraceptive counseling. 
During enrollment in the ED and after patients are screened to determine eligibility, a 
trained APP will conduct confidential contraceptive counseling during the ED visit. 
Following this counseling, both the patient and APP will complete a questionnaire to 
provide feedback on the counseling session. At 8 weeks post-ED visit, the study team will 
conduct an EMR review or follow-up phone calls to assess patient initiation of a 
contraceptive method and completion of follow-up visits. A total of 300 patients across both 

 
 
 
 
 
 
4
sites will be enrolled in the study. Of these 300 patients, 50 patients per site will be invited 
to complete an in-depth interview assessing factors that influenced patient follow-up and/or 
initiation of contraception post-contraceptive counseling. 
The proposed study will elucidate factors that affect adolescents’ decisions to initiate 
contraception in the ED, and to follow-through with referrals for contraception services, 
after receiving standardized contraception counseling. This project is the next step in our 
ongoing line of research to improve sexual and reproductive health services in the ED. We 
will build upon existing ED programs focused on sexual health education and evaluate, in-
depth, factors contributing to individual decision-making. This project will move us towards 
our long-term goal: reducing unintended pregnancy by improving access to contraception 
among high-risk teens. 
3.1.1 Advanced Practice Nurse Screening, Consent, and Training 
APPs working in the Emergency Department for at least 6 months will be approached to 
determine interest in participation in this study. Those who are interested will provide 
written consent and subsequently be trained to use patient-centered, semi-structured clinical 
interview techniques, consisting of two 4-hour training sessions.  
3.1.2 Screening Phase 
Potentially-eligible patients will be identified by APP subjects during the course of normal 
clinical care, if the APP subject is part of the patient’s care team. If a patient is eligible 
based on information from clinical care, the APP subject will contact a research assistant. 
Research assistants will verify with the clinical team that patients meet all eligibility criteria 
and whether the patient has the capacity to consent for themselves. If a patient meets all 
inclusion / exclusion criteria, written consent / HIPAA authorization will be obtained. 
Subjects who are 18 years old will provide  written consent and HIPAA authorization for 
their own participation. Subjects who are 16 or 17 years old who are seen in the ED without 
a parent/legal guardian will provide written consent and HIPAA authorization for their own 
participation. Subjects who are 16 or 17 years old who are seen in the ED with a parent/legal 
guardian may elect to have their parent/legal guardian involved in the consent process if 
desired. In this scenario, subjects will provide assent and permission and HIPAA 
authorization will be obtained from the parent/legal guardian that is present. 
3.1.3 Phase 1: Contraceptive Counseling 
Prior to counseling, patients will complete a brief questionnaire to ascertain demographic 
information, sexual history, and contraception use and history. Afterwards, a trained APP 
will provide a confidential, comprehensive counseling session lasting 10-15 minutes. This 
counseling session will include a semi-structured interview regarding contraceptive choice, a 
review of contraceptive options, an assessment of patient preference and understanding of 
contraceptive use, and a short client satisfaction survey. 
3.1.4 Phase 2: Feedback and Follow-Up 
After counseling, patients will complete a questionnaire about their preferred form of 
contraception and intention to initiate a contraceptive method. They will also complete an 
adapted Contraceptive Knowledge Assessment and a short questionnaire about their 

 
 
 
 
 
 
5
experience receiving counseling. The APP who provided counseling will also complete a 
brief follow-up questionnaire regarding the counseling session. Those patients who are 
interested will receive short-acting, reversible contraception or a contraceptive prescription 
before the completion of the ED visit. As part of counseling, all participants will be referred 
to an adolescent gynecologist, a hospital-affiliated adolescent clinic or to a local Title X 
funded clinic (based on patient preference and access) for additional counseling and to 
initiate or follow-up on initiation, as applicable. All participants will have a “warm transfer” 
for follow-up.  
At 8 weeks post-ED visit, participants’ EMR will be reviewed to assess referral completion 
and contraception initiation. If no follow-up visit is noted in the EMR, a follow-up phone 
call will be made. 
3.1.5 Phase 3: Subgroup Interview  
A subgroup of 50 participants per site will be invited to complete an in-depth interview in-
person or, if necessary, over the phone; this interview, informed by the Ecologically-
expanded Theory of Planned Behavior (eTPB) will help assess the factors that supported the 
decision to start new contraception and/or follow-through to initiate or change 
contraception. All interviews will be audiotaped and professionally transcribed. 
3.2 Study Duration, Enrollment and Number of Sites 
3.2.1 Duration of Study Participation 
The total duration of study participation per subject will be up to 12 weeks. Emergency 
Department- specific procedures will total 30 minutes, including screening, contraceptive 
counseling, and counseling feedback, with 10-15 minutes of this time devoted to the 
contraceptive counseling. Participants’ EMR will be reviewed 8 weeks after the ED visit, 
and a subset of participants will be interviewed in-person or over the phone within 4 weeks 
following the EMR review. 
3.3 Total Number of Study Sites/Total Number of Subjects Projected 
The study will be conducted at 2 investigative sites in the United States, the Children’s 
Hospital of Philadelphia and Children’s Mercy Hospital in Kansas City, MO. It is expected 
that a maximum of 12 APPs per site will be consented and trained to administer the 
contraceptive counseling. 
Recruitment will stop when approximately 270 evaluable subjects are enrolled. It is 
expected that approximately 300 subjects will be enrolled to produce 270 evaluable subjects, 
with half at each site.  
3.4 Study Population 
3.4.1 APP Population 
3.4.1.1 Inclusion Criteria 
1. Work in the Emergency Department 

 
 
 
 
 
 
6
2. Have at least 6 months of experience working in the Emergency Department as an 
APP 
3. Are interested in participating in study procedures 
3.4.1.2 Exclusion Criteria 
1. There are no exclusion criteria for this population. 
3.4.2 Patient Population 
3.4.2.1 Inclusion Criteria 
1. Females aged 16-18 years who are at high-risk of pregnancy, defined as sexual 
activity within the last 6 months or likely future sexual activity, defined as within the 
next 3 months. 
2. Females who do not desire to become pregnant within the next year 
3. Eligible individuals must be proficient in speaking and reading in English  
4. Consent of the adolescent  
3.4.2.2 Exclusion Criteria 
1. Females who are currently using hormonal contraception or an intrauterine device 
2. Females who are pregnant 
3. Patient has a developmental delay limiting participation 
4. Patients is presenting in the ED after sexual assault 
5. Patient is too ill to be screened 
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.  
4 
STUDY PROCEDURES 
4.1 Screening  
Potentially-eligible patients will be identified by APP subjects during the course of normal 
clinical care, if the APP subject is part of the patient’s care team. Females ages 16-18 years 
old (inclusive) who present at the Emergency Department with any chief complaint, will be 
eligible. Adolescents will be excluded if they are too ill to be screened; have developmental 
delay limiting participation; present after sexual assault; or are pregnant, as per a pregnancy 
test conducted as part of standard clinical care. Through standard clinical care, APP subjects 
will also be able to determine those patients who are at high risk for pregnancy, defined as 
those who: report recent (within last 6 months) or likely future sexual activity, defined as 
sexual activity in the next 3 months; do not desire pregnancy within the next year; are not 
using hormonal contraception or an intrauterine device; and are not currently 
pregnant.38After identifying a potentially eligible subject based on these criteria, APP 
subjects will contact Emergency Department Research Assistants (RA). Research assistants 
will verify with the clinical team that patients meet all eligibility criteria and whether the 
patient has the capacity to consent for themselves. Both study sites are staffed with RAs 16 

 
 
 
 
 
 
7
hours/day who are trained to monitor the ED electronic track board for potential research 
subjects for ED-based studies. If a patient meets all inclusion / exclusion criteria, written 
consent / HIPAA authorization will be obtained. Subjects who are 18 years old will provide 
written consent and HIPAA authorization for their own participation. Subjects who are 16 or 
17 years old who are seen in the ED without a parent/legal guardian will provide written 
consent and HIPAA authorization for their own participation. Subjects who are 16 or 17 
years old who are seen in the ED with a parent/legal guardian may elect to have their 
parent/legal guardian involved in the consent process if desired. In this scenario, subjects 
will provide assent and permission and HIPAA authorization will be obtained from the 
parent/legal guardian that is present. The consent for the study will encompass the 
contraceptive counseling with an option for completion of the subgroup interview.  
4.2 APP Training 
Experts in gynecological health and adolescent health will train the APPs to employ a 
patient-centered approach that includes a semi-structured clinical interview to determine 
factors that influence contraceptive choice,42,43 followed by a review of contraceptive 
options and their risks, benefits and side effects. APPs will be trained in approaches rooted 
in motivational interviewing (MI) to support adolescent autonomy. Use of communication 
strategies based on open-ended questions and reflective listening greatly enhances the focus 
on patient preference and autonomy, assisting young women with selecting the method that 
works best for her.44 The training will consist two 4-hour training sessions, the first via 
webinar, and the second via an in-person interactive session to learn about contraceptive 
methods and interviewing techniques, and to address common questions. As part of training, 
APPs will perform counseling with mock patients, and be observed by experts in 
gynecological health and adolescent health, who will also provide timely feedback after the 
first counseling session performed by each APP. These experts will use a standardized 
contraceptive counseling assessment form (based on the methods utilized in the CHOICE 
project45 to rate the APP’s performance during each session and provide feedback, and 
subjects will complete a closed-ended survey assessing fidelity to counseling topics and 
principles using a Likert sale (1 [strongly disagree] to 5 [strongly agree].5 Details around the 
surveys are in the Appendix. 
4.3 Contraceptive Counseling 
After screening and consent procedures are complete, adolescents will complete a brief 
questionnaire to ascertain demographic information, sexual history, and contraception use 
and history (based on the NSFG).41 Next, a trained APP (working a regularly-scheduled ED 
shift) will provide confidential, comprehensive contraceptive counseling. The counseling 
session will assess patients’ preferences regarding different methods, knowledge about 
methods, personal motivations, and environmental factors that may influence contraceptive 
use, such as partner preference.  
Counseling will last 10-15 minutes, a duration that is easily integrated into most ED visits, 
as the average length of stay is 249 minutes (CHOP) and 159 minutes (CMH). 

 
 
 
 
 
 
8
4.4 Feedback & Follow-Up 
After counseling, adolescents will complete a questionnaire assessing preferred form of 
contraception and will be asked their intention to initiate a new contraceptive method during 
the ED visit or within the next 2 months, using a 5-point Likert-type scale (“very likely” to 
“definitely not”). Participants will be grouped as “high-intention” to initiate contraception 
(very or somewhat likely) or “low intention” (unsure, not likely or definitely not) for Aims 1 
and 4. Participants will be asked reasons for contraception intention and complete an 
adapted Contraceptive Knowledge Assessment (CKA).46 Study participants will also 
complete a short questionnaire about their experience receiving counseling loosely based on 
the Oregon sexual and reproductive health client satisfaction survey47 to assess acceptability 
of the counseling. These surveys will be reviewed as the study progresses in order to make 
necessary adjustments. Participants will receive a $20 gift card for participation. As part of 
standard clinical care, those who are interested in starting a short acting reversible 
contraception during the visit (e.g., oral pills, patch, vaginal ring, or hormonal shot) will 
receive medication and/or a prescription before completion of the ED visit. APPs will also 
complete a brief questionnaire. 
As part of counseling, all participants will be referred to an adolescent gynecologist, a 
hospital-affiliated adolescent clinic or to a local Title X funded clinic (based on patient 
preference and access) for additional counseling and to initiate or follow-up on initiation, as 
applicable. All participants will have a “warm transfer” for follow-up. The APP will share 
clinic information and contact the receiving site via an electronic medical record (EMR) 
message or phone call. Study staff will assist as needed with making appointments, and will 
call/text appointment reminders 3 days prior, 1 day prior, and on the day of the appointment. 
We seek to limit logistical barriers to follow-up care as much as possible.  
4.5 Subgroup Interview 
We will include a subgroup of the 50 enrolled participants per site, as follows: 6-12 
participants in each of four groups per site: 1) high intention / completed follow-up and 
initiated contraception; 2) high intention and completed follow-up but did not initiate 
contraception; 3) high intention but no follow-up or initiation; 4) low intention. Participants 
will be interviewed until thematic saturation is reached (i.e. no new themes emerge); we 
anticipate no more than 50 interviews per site, based on prior experience and literature 
review of qualitative methods studies.48,49 Participants will receive a $20 gift card for 
completing the interview. Whenever possible, the in-depth interviews will take place in-
person, at a mutually convenient time and in a location easily accessible for the participant. 
If an in-person interview is not feasible, the interview will be completed by phone. All 
interviews will be conducted by trained members of our research staff and will be 
audiotaped and professionally transcribed, and all interviews will be informed by the 
Ecologically-Expanded Theory of Planned Behavior (eTPB) as described below.  
4.5.1 Theoretical Model to Guide Interviews  
The Theory of Planned Behavior (TPB) has been used extensively in behavioral 
interventions with adolescents and sexual health.50-54 However, there is growing support for 
a broader, ecological perspective to amplify and extend efficacy of sexual risk reduction 

 
 
 
 
 
 
9
interventions.55,56 Thus, we will use an over-arching Ecologically-expanded Theory of 
Planned Behavior (eTPB) to inform our interview guide.(see below) The guide will include 
questions around each of the constructs of the eTPB in order to help us identify factors that 
supported the decision to start any new contraception in the ED and/or follow-through to 
initiate or change contraception. In addition, although self-efficacy is not a specific domain 
in the eTPB, we will assess this construct through questions in the Perceived Behavioral 
Control (PBC) domain, as well as additional questions drawn the Contraceptive Self-
Efficacy Scale.57 Sample questions are included in the Appendix.  
 
  
4.6 Subject Completion/Withdrawal 
Subjects may withdraw from the study at any time without prejudice to their care. 

 
 
 
 
 
 
10
5 
STUDY EVALUATIONS AND MEASUREMENTS 
5.1 Screening and Monitoring Evaluations and Measurements 
5.1.1 Electronic Medical Record Review 
 Date of birth 
 Sex 
5.1.2 Confidential Screening Interviewing to Assess Eligibility 
 Level of risk for pregnancy, defined as those who: report recently (within the last 6 
months) or likely future sexual activity (within the next 3 months); do not desire 
pregnancy within the next year; are not using hormonal contraception or an 
intrauterine device; and are not currently pregnant. 
 Currently pregnant 
 Illness limiting ability to be screened 
 Developmental delay limiting patient’s participation 
 Presenting after sexual assault  
5.1.3 Contraceptive Counseling  
Adolescents enrolled in the study will complete a questionnaire prior to their contraceptive 
counseling, to determine participant characteristics, and contraception use and history. After 
the counseling session, participants will complete an additional questionnaire meant to 
assess their preferred form of contraception and their intent to initiate contraception, as well 
as an assessment of the APP’s fidelity to the counseling session principles. Participants will 
be asked reasons for contraception intention and complete an adapted Contraceptive 
Knowledge Assessment (CKA).46 Study participants will also complete a short questionnaire 
about their experience receiving counseling to assess acceptability of the counseling. The 
APP’s who lead the sessions will also complete a standardized survey. 
5.1.4 Post-Counseling Electronic Medical Record Review (at 8 weeks post-ED visit) 
 Referral completion 
 Contraception initiation 
5.1.5 Semi-Structured Interviews 
A subset of participants enrolled in Aim 1 will be grouped into four groups of 6-12 
participants and take part in semi-structured, in-person interviews conducted by trained 
interviewers, utilizing the Ecologically-expanded Theory of Planned Behavior (eTPB) 
described in the Research Strategy. All interviews will be recorded, and data obtained during 
the interviews will be professionally transcribed and coded for analysis by Dr. Mollen and 
the study team. 
5.2 Safety Evaluation 
Subject safety will be monitored by tracking of adverse events by research staff. 

 
 
 
 
 
 
11
6 
 STATISTICAL CONSIDERATIONS 
6.1 Primary Endpoint 
The primary endpoint will be the reported intention to initiate contraception at ED or follow-
up visit from survey responses.  
Secondary endpoints will include the following: 
 The completion of a referral for any contraceptive care as assessed through EMR 
review or follow-up phone calls 
 The initiation of contraception as assessed through EMR review or follow-up phone 
calls  
 Saturation of themes from qualitative interviews that have been coded and analyzed  
 
6.2 Statistical Methods 
6.2.1 Baseline Data  
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). 
6.2.2 Efficacy Analysis 
Proportion who indicate high intention to initiate contraception at ED or follow-up visit will 
be calculated along with 2-sided 95% CIs. Participant characteristics, factors contributing to 
initiation (from survey responses), and contraceptive knowledge scores will be compared 
between “high” and “low” intention groups using chi-square or Fisher’s exact tests for 
categorical variables and t-test or Wilcoxon rank-sum test for continuous variables. We will 
use bivariate analyses to evaluate for potential confounders to determine which are retained 
for final models. Using univariate logistic regression models, we will assess relationships of 
participants’ characteristics, factors contributing to intention and contraceptive knowledge 
with the main outcome (intention to initiate contraception, yes/no). Multivariate logistic 
regression models will be constructed to identify independent predictors of the binary 
outcome. Clinically important variables will be considered in the multivariate models 
regardless of achieving statistical significance in the univariate models. Variables significant 
in the univariate models (P-value ≤ .20) and study site (CHOP versus CMH) will be adjusted 
for covariates in multivariate models. If some variables in the multivariable models may 
result in multi-colinearity, we will use path analysis to identify correlations between the 
predictor variables and outcome and to determine direct and indirect relationships of the 
variables. The path analysis permits the partitioning of the correlation between the variables 
into direct (i.e., direct effect of a predictor on the outcome) and indirect (i.e., indirect effect 
of a predictor on the outcome through another predictor variable) effects and measures the 
relative importance of the causal factors. Potential interaction effects will be examined and 
included in logistic regression models if significant. The effects of the factors on the 
outcome may differ by study site. We will assess the differences in the effects of the factors 

 
 
 
 
 
 
12
on the outcome between the two study sites by including interaction effects of study site 
with the factors in these models. 
For data analysis, every attempt will be made to ensure that the extent of missing data is 
kept at a minimum during the study. Initially we will assess the extent and pattern of missing 
data using frequencies and cross-tabulations. If data are missing for only a few cases (5% or 
less), then data analysis will be conducted only on study participants with complete data.  
However, when such a strategy would result in loss of data from a substantial proportion of 
participants or would lead to biased or inaccurate results, then sensitivity analysis or some 
form of imputation will be performed.  The form of imputation used will depend on the 
nature of the data that are missing. If data are missing for primary endpoint (intention to 
initiate contraception, yes/no), frequencies for missing data by site, patient characteristics, 
factors contributing to initiation, and contraceptive knowledge scores will be examined. If 
there are significant associations of missing-ness with any of these characteristics, we would 
consider imputation methods such as regression technique, hot-deck, or best/worst case (for 
binary outcomes) and choose the one which would be most appropriate for the type of 
missing data pattern (i.e. missing at random). If there is partial follow-up, that partial data 
might inform selection of imputation method. The imputation will be employed if there is a 
clear evidence of bias due to missing data. Sensitivity analyses will be performed to assess 
how sensitive results are to reasonable changes in the assumptions that are made for missing 
data. 
Transcripts of interviews will be imported into NVIVO11 (QSR International, Melbourne, 
Australia) to facilitate coding and analysis, and will be systematically coded as available by 
the study team. Data analysis will use a modified grounded theory approach.  These methods 
consist of systematic inductive guidelines for collecting and analyzing information to build a 
theoretical framework for understanding the interview data. An initial coding tree will be 
developed a priori, based on interview content and the eTPB constructs. Dr. Mollen will 
train 2 team members per site to code the data. For training, each coder will apply codes 
independently to 2 transcripts. Dr. Mollen will code the same 2 transcripts, serving as the 
criterion (or reference) coder to ensure that a high degree of reliability is established. Inter-
rater reliability of coding will be assessed using NVIVO software. Discrepancies will be 
resolved via consensus, with Dr. Mollen serving as the final arbitrator, and the coding tree 
will be adjusted as needed. Transcripts will be re-coded if significant changes to the coding 
tree are made; this iterative process will continue until the tree is finalized. The coding tree 
will be developed into a codebook, with definitions, rules, and examples for each code. Each 
subsequent transcript will be double-coded, and the team will meet weekly to discuss any 
discrepancies that arise.  
We will use a modified ground theory approach to identify emergent themes within and 
across the interviews. After coding, relevant portion of coded text will be re-read to identify 
themes related to each of the eTPB domains, reflecting factors influencing contraceptive 
initiation, as well as to identify additional themes that are outside of the model. This 
approach recognizes that additional domains may emerge from analysis besides those 
already delineated. Moreover, we acknowledge that additional subthemes within each 
domain may emerge. We will explore whether themes differ among young women by 
various characteristics (e.g., high/low intention, demographics, completion of follow-up).  

 
 
 
 
 
 
13
6.2.3 Safety Analysis 
All subjects entered into the study at Visit 1 will be included in the safety analysis. 
Frequencies of AEs will be summarized, and SAEs (if any) will be described in detail. 
6.3 Sample Size and Power 
As this is an exploratory study, we based our sample size on several potential prevalence estimates of 
“high intention” to obtain contraception as the primary outcome for Aim 1. We assumed a 
prevalence of 50% high intention and repeated the calculation if the prevalence was only 20%, and 
calculated the 95% CI around the point estimate. We anticipate similar levels of precision for our 
other outcomes.  
Attrition 
(%) 
Sample size 
Prevalence 
(%) 
95% CI 
0 
300 
50 
44.3 - 55.7 
0 
300 
20 
15.5 - 24.5 
10 
270 
50 
44.0 - 56.0 
10 
270 
20 
15.2 - 24.8 
20 
240 
50 
43.7 - 56.3 
20 
240 
20 
14.9 - 25.1 
30 
210 
50 
43.2 - 56.8 
30 
210 
20 
14.6 - 25.4 
 
Both study sites care for a large number of adolescent females in the study age range (>4600 
CHOP and > 2200 CMH, annually), and each of the trained APPs works 13 to 15 8-hour 
shifts per month. Thus, we anticipate reaching our sample size within 6 months 
(conservatively estimating each APP will enroll one participant every 4 shifts, accounting 
for exclusion criteria and refusals).  

 
 
 
 
 
 
14
7 
SAFETY MANAGEMENT 
7.1 Clinical Adverse Events 
Clinical adverse events (AEs) will be monitored throughout the study.  
7.2 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.  
8 
 STUDY ADMINISTRATION 
8.1 Data Collection and Management 
Data will be collected on a study tablet, where it will be immediately entered into a 
password- and firewall-protected online database, the Research Electronic Data Capture 
(REDCap, © Vanderbilt University), by a participants using a study tablet, and by a study 
team member. Each patient will be assigned a unique study ID. Patient identifiers (date of 
birth and date of visit) will be coded for creation of the analytic dataset. There will be a 
password protected electronic master list linking the unique study IDs to individuals which 
will be kept in REDCap, in a secure and separate folder from all other study data. An 
electronic copy of the password-protected master list will be copied to the office computer 
of the site study investigator for a length of time post-study as specified by their institution. 
At CHOP, the electronic copy of the site’s password-protected master list will be maintained 
on the lead study investigator’s computer for a minimum of 6 years after study closure 
completed in accordance with CHOP policy A-3-9. 
8.2 Confidentiality 
All data and records generated during this study will be kept confidential in accordance with 
Institutional policies and HIPAA on subject privacy. The investigator will not use such data 
and records for any purpose other than conducting the study. 
No identifiable data will be used for future study without first obtaining IRB approval or a 
determination of exemption. The investigator will obtain a data use agreement between 
provider (the PI) and any recipient researchers (including others at CHOP) before sharing a 
limited dataset (dates and zip codes).  
8.3 Regulatory and Ethical Considerations 
8.3.1 Data and Safety Monitoring Plan 
Data and safety will be monitored on multiple levels. Dr. Mollen (PI), the lead Research 
Coordinator and research staff will meet at least weekly to review study progress, safety 

 
 
 
 
 
 
15
issues, recruitment progress, and data quality. The entire research team at both sites will 
meet monthly (via phone) to review study progress. The Research Coordinator will produce 
quarterly reports describing recruitment milestones, adverse events, and data quality. We 
will report any adverse events as directed by the institutional IRB and adverse event (AE) 
reporting policies. Events will be reported promptly to the PI and the lead Research 
Coordinator who will make provisions to respond appropriately, ensuring referral to 
medical/professional resources, as needed. 
8.3.1.1 Breach of Confidentiality:  
The lead Research Coordinator, along with the PI will ensure that all members of the study 
team have completed all mandatory confidentiality statements and research ethics trainings, 
and that data have been handled and stored properly. Annually, research staff will be 
required to sign a statement acknowledging their receipt and understanding of the 
confidentiality requirements and pledging to maintain confidentiality of the data to which 
they have access. If a breach of confidentiality is identified, the PI will immediately notify 
the IRB by submitting a reportable event. The PI will, as necessary, review and identify how 
the breach occurred and determine steps to prevent future problems with ensuring 
participant confidentiality.  
8.3.1.2 Continuous Quality Assurance and Quality Control Procedures (QA/QC):  
QA/QC will be implemented to ensure compliance with study requirements in areas 
including recruitment and data collection. Quality control activities will be performed 
regularly on all Case Report Forms (CRF), electronic data, and participant files to ensure 
that all data collected is complete and accurate. These will include the reconciliation of data 
forms, verification of codes and labels, and careful review of each individual data field for 
omission and errors. This will be the responsibility of the lead Research Coordinator and PI 
to periodically perform secondary review of these data as an additional QA procedure. 
When necessary, Good Clinical Practice (GCP) documentation procedures will be followed 
to amend the data. Any queries generated will be logged, with notification to all applicable 
parties of the issue and resolution. Problems with data capture stemming from user or design 
errors will be addressed, as appropriate, with supplemental training for staff, additional 
instruction for participants, and/or the improvement of problematic entries or procedures. In 
addition, internal reporting will be maintained to manage visit completion metrics. This 
reporting system will be utilized by staff members for real-time scheduling of events, 
checking participant status, determining event completion rates, tracking participants, and 
collating logistical information crucial for participant retention. 
8.3.1.3 Unexpected Adverse Events:  
These are defined as any adverse event occurring in one or more subjects in a research 
protocol, the nature, severity, or frequency of which is not consistent with either: (1) the 
known or foreseeable risk of adverse event associated with the procedures involved in the 
research that are described in (a) the protocol–related documents, such as the IRB-approved 
research protocol, any applicable investigator brochure, and the current IRB-approved 
informed consent document, and (b) other relevant sources of information, such as product 
labeling and package inserts; or (2) the expected natural progression of any underlying 

 
 
 
 
 
 
16
disease, disorder, or condition of the subject(s) experiencing the adverse event and the 
subject’s predisposing risk factor profile for the adverse event. 
8.3.1.4 Expected Adverse Event:  
This is defined as any event not meeting the definition of unexpected adverse event. 
8.3.1.5 Adverse Event Related to Participation:  
This is defined as an event that is at least partially caused by participation in the research 
study. Relatedness is assessed using the following terms: definitely related, probably related, 
possibly related, unlikely to be related, or unrelated. In general, events that are determined to 
be at least partially caused by the procedures involved in the research would be considered 
related to participation in the research. Events determined to be solely caused by an 
underlying disease, disorder, or condition of the subject, or other circumstances would be 
considered unrelated to participation in the research. 
8.3.1.6 Unanticipated Problem:  
This is defined as an incident, experience, or outcome that meets all of the following criteria: 
(1) unexpected (in terms of nature, severity, or frequency) given: (a) the research procedures 
that are described in the protocol-related documents, such as the IRB approved research 
protocol and informed consent document; and (b) the characteristics of the subject 
population being studied; (2) at least possibly related to a subject’s participation in the 
research; and (3) suggests that the research places subjects or others at a greater risk of harm 
(including physical, psychological, economic, or social harm) than was previously known or 
recognized.  
8.3.1.7 Unanticipated Problem Involving Risks to Subjects or Others:  
This is defined as an event that is unexpected, related to the research, and suggests that 
subjects are at greater risk than was previously known or recognized. 
8.3.1.8 Data Safety Monitoring Board 
We will convene a Data Safety Monitoring Board comprised of experts in adolescent 
reproductive health that are not connected to this project or our Institutions. The Board will 
meet quarterly to monitor participant safety and assess study progress, and will be available 
to meet on an ad hoc basis if an immediate safety concern arises.  
8.3.2 Risk Assessment 
Risks to participants are anticipated to be minimal. ED patients with severe illness or who 
experienced sexual assault will be excluded from this study to minimize the physical and 
emotional harm to study participants. Counseling sessions will be administered by trained 
APPs in a confidential setting to avoid emotional discomfort to participants when discussing 
sensitive matters. There is minor risk of variance of counseling content, but this will be 
avoided by extensive training that will be provided to the APPs by an adolescent family 
planning expert at each site. Counseling sessions will be continuously reviewed for quality. 
Additionally, there is minor risk of unauthorized disclosure of confidential information, 
which will be made known to participants and will be minimized by the research team’s 
efforts to ensure confidentiality. Every effort will be made to keep data coded. All 

 
 
 
 
 
 
17
recruitment materials (e.g., signed consent forms) and information linking unique 
identification numbers to participant names will be stored in password-protected electronic 
files within REDCap. Only Dr. Mollen and designated study staff will have access to these 
files. Risks are greatly reduced by using secure files, storing data on secure computers, and 
coding of data. Patients may choose not to participate.  
 
8.3.2.1 Recruitment and Informed Consent 
A maximum of 12 APPs will be recruited from each ED at the two study sites. Advanced 
Practice Providers (APPs) working in the Emergency Department for at least 6 months will 
be approached to determine interest in participation in this study. Those who are interested 
will provide written consent for study procedures. 
A total of 300 participants will be recruited from the ED at the two study sites, Children’s 
Hospital of Philadelphia and Children’s Mercy Hospital in Kansas City. Potentially-eligible 
patients will be identified by APP subjects during the course of normal clinical care, if the 
APP subject is part of the patient’s care team. If a patient is eligible based on information 
from clinical care, the APP subject will contact a research assistant. Research assistants will 
verify with the clinical team that patients meet all eligibility criteria and whether the patient 
has the capacity to consent for themselves. If a patient meets all inclusion / exclusion 
criteria, consent / HIPAA authorization will be obtained. Subjects who are 18 years old will 
provide written consent and HIPAA authorization for their own participation. Subjects who 
are 16 or 17 years old who are seen in the ED without a parent/legal guardian will provide 
written consent and HIPAA authorization for their own participation. Subjects who are 16 or 
17 years old who are seen in the ED with a parent/legal guardian may elect to have their 
parent/legal guardian involved in the consent process if desired. In this scenario, subjects 
will provide assent and permission and HIPAA authorization will be obtained from the 
parent/legal guardian that is present. The consent for the study will encompass the 
contraceptive counseling with an option for completion of the subgroup interview. All 
participants will be given the opportunity to ask questions and decline participation. 
Completed consent documentation will be signed and dated by the designated study staff, 
and a copy will be provided to the participant. As required in 45 CFR 46.116, when a minor 
participant reaches the age of 18, and is still undergoing research procedures, fully informed 
re-consent will be conducted. Original consent forms will be stored electronically, in the 
REDCap Database, only accessible by Dr. Mollen and designated study staff.  Participants 
will be reminded at all study appointments that participation is completely voluntary. 
8.3.2.2 Protections against Risk 
Participants will be informed that their participation in all aspects of the proposed study 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 coded and then 
stored in the secure REDCap database, and all participants will be assigned a unique 
identification number. The master list linking identification numbers to identifying 
information will be stored separately from the study database. All personally identifiable 
information will be kept strictly confidential and stored in an encrypted document, on a 
dedicated research server only accessible by Dr. Mollen and the designated study staff. 
Original, signed and dated consent forms will be in password protected folders within 

 
 
 
 
 
 
18
REDCap only accessible by Dr. Mollen and the designated study staff. Contact information 
for Dr. Mollen and the study team will be included on 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 mentor team and site IRB’s will be informed of 
any concerns, and the IRB and NIH will be informed of any adverse events. 
 
8.3.3 Potential Benefits of Trial Participation 
In the long term, the findings of this study could contribute to a reduction in unintended 
pregnancies among adolescents. It is also possible that the information obtained through this 
study will be used to create new guidelines for adolescent-centered contraceptive services, 
which could directly benefit the study population in the future. The minimal risks of 
participation are reasonable in relation to these generalizable benefits.  
8.3.4 Risk-Benefit Assessment 
As there is no more than minimal risk to study participation, and potential for minimal direct 
benefits and significant indirect benefits, we feel that the benefit outweighs the risk of 
participation.  
8.4 Recruitment Strategy 
APPs who have at least six months of experience will be recruited from each hospital’s 
Emergency Department. Study team members will consent APPs if they are willing and 
interested in study procedures. 
Potentially-eligible patients will be identified by APP subjects during the course of normal 
clinical care in the Emergency Department, if the APP subject is part of the patient’s care 
team. Females ages 16-18 years old (inclusive) who present at the Emergency Department 
with any chief complaint, will be eligible. Adolescents will be excluded if they are too ill to 
be screened; have developmental delay limiting participation; present after sexual assault; or 
are pregnant, as per a pregnancy test conducted as part of standard clinical care. Through 
standard clinical care, APP subjects will also be able to determine those patients who are at 
high risk for pregnancy, defined as those who: report recent (within last 6 months) or likely 
future sexual activity (within the next 3 months); do not desire pregnancy within the next 
year; are not using hormonal contraception or an intrauterine device; and are not currently 
pregnant.38After identifying a potentially eligible subject based on these criteria, APP 
subjects will contact Emergency Department Research Assistants (RA). Research assistants 
will verify with the clinical team that patients meet all eligibility criteria and whether the 
patient has the capacity to provide consent. Both study sites are staffed with RAs 16 
hours/day who are trained to monitor the ED electronic track board for potential research 
subjects for ED-based studies. The RA will confirm eligibility with the clinical care team. If 
a patient meets all inclusion / exclusion criteria, written consent / HIPAA authorization will 
be obtained. Subjects who are 18 years old will provide written consent and HIPAA 
authorization for their own participation. Subjects who are 16 or 17 years old who are seen 
in the ED without a parent/legal guardian will provide written consent and HIPAA 
authorization for their own participation. Subjects who are 16 or 17 years old who are seen 

 
 
 
 
 
 
19
in the ED with a parent/legal guardian may elect to have their parent/legal guardian involved 
in the consent process if desired. In this scenario, subjects will provide assent and 
permission and HIPAA authorization will be obtained from the parent/legal guardian that is 
present.  
8.5 Informed Consent/Assent and HIPAA Authorization 
If eligible, a study team member will obtain APPs informed consent for study procedures. 
If eligible, a study team member will obtain patient’s informed consent for the study 
procedures. HIPAA Authorization will be obtained as part of the consent procedures. Study 
team members will verify with the clinical care team that the patient has the capacity to 
consent. Subjects who are 18 years old will provide written consent and HIPAA 
authorization for their own participation. Subjects who are 16 or 17 years old who are seen 
in the ED without a parent/legal guardian will provide written consent and HIPAA 
authorization for their own participation. Subjects who are 16 or 17 years old who are seen 
in the ED with a parent/legal guardian may elect to have their parent/legal guardian involved 
in the consent process if desired. In this scenario, subjects will provide assent and 
permission and HIPAA authorization will be obtained from the parent/legal guardian that is 
present. Payment to Subjects/Families 
8.5.1 Reimbursement for travel, parking and meals 
APPs will receive no reimbursements. Training will be provided free of cost. 
For those participants attending in-person follow-up interviews, reimbursement for SEPTA 
tokens or CHOP parking vouchers will be provided (as appropriate).  
8.5.2 Payments to subject for time, effort and inconvenience (i.e. compensation) 
APPs will receive no payment for participation. 
Patients will receive remuneration for each completed study assessment according to the 
following schedule: 
 Contraceptive counseling and feedback questionnaire: $20 to participant 
 Post-counseling interview: $20 to participant 
9 
PUBLICATION 
Data from the study will be submitted for abstract presentation and publication. 
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