A Prospective Observational Study of the Implementation of Telehealth-Supported LARC Provision in School-Based Health Centers
Conditions: Long Acting Reversible Contraception, Contraception Behavior
Sponsor: Columbia University

 
 
 
 
 
 
 
 
A Prospective Observational Study of the Implementation of Telehealth-
Supported LARC Provision in School-Based Health Centers 
 
 
NCT04840836 
 
IRB approval: Jan 5, 2024 
 
 

 
 
 
1. Study Purpose and Rationale 
Study Purpose 
In this proposed prospective observational study, we will describe in detail the implementation of a hybrid 
model of telehealth-supported long-acting reversible contraception (LARC) service provision in a 
network of 6 school-based health centers (SBHCs) in New York City that serve adolescents and young 
adult high school students age 13-22 years (hereafter referred to as “adolescents”). We will use quantitative 
and qualitative data, leveraging surveys combined with electronic health record data, to assess satisfaction 
with telehealth-supported LARC care, and uptake and continuation of LARC methods following introduction 
of telehealth-supported LARC service delivery in SBHCs. The findings from this study, given the SBHC 
setting, have the potential to inform and improve LARC service delivery for adolescents far beyond New 
York City and the SBHC setting. 
 
Specific Aims: 
Aim 1. Quantify uptake of LARC (contraceptive implant, IUD) within the SBHC network following 
implementation of telehealth-supported LARC provision. 
Aim 1.1 Among all patients who had a telehealth visit for contraceptive counseling, quantify the number 
and rate of telehealth LARC consultations and LARC initiations overall, and compare by LARC type 
(contraceptive implant vs. IUD). 
Aim 1.2 Subgroup analyses of LARC initiation (overall and by type) by patient characteristics (e.g. age 
group, race/ethnicity, sexual activity in last 90 days). 
Aim 2: Describe the implementation of telehealth-supported long-acting reversible contraception 
(LARC) service provision in school-based health centers (SBHCs) using mixed methods. 
Aim 2.1 Assess, through quantitative surveys among LARC initiators, patients’ experience and 
satisfaction with telehealth-supported care. 
Aim 2.2 Explore, through qualitative surveys with a purposive-sampled subset of LARC initiators, 
adolescents’ experience with the telehealth-supported care and perceived benefits and drawbacks of 
telehealth care overall and for supporting LARC services (Ambresin et al., 2013). 
Aim 3: Quantify LARC continuation over a 6-18 month follow-up period among LARC initiators within 
the SBHC network following implementation of telehealth-supported LARC provision. Using EHR data 
for all patients who initiated LARC, we will use Kaplan-Meier survival curves to assess LARC discontinuation 
overall, and Cox proportional hazard models to compare LARC continuation by LARC type. 
Aim 3.1 (Primary Efficacy Outcome): 12-month continuation of LARC using telehealth-supported care 
among SBHC patients compared to LARC continuation rates among adolescents age 25 years and 
under as documented in a recent meta-analysis. Continuation rates will be expressed both as rates at 6 
months and 12 months post-initiation, and using Kaplan-Meier curves to model discontinuation. 
Continuation rates in this setting will be compared to rates from a recent meta-analysis among 
adolescents and young adults that found 12-month continuation rates of 85.3% (primary efficacy 
outcome) for contraceptive implants and IUDs in the US-based studies (Usinger, Gola, Weis & 
Smaldone, 2016). 
 
Aim 3.2 (Exploratory, pending feasibility) Continuation compared to pre-Telehealth. Compare 12-
month continuation rate following introduction of telehealth to 12-month continuation among LARC 
initiators seen during the 18 month period prior to introduction of telehealth (June 2018-December 2019) 
pending ability to export data from the prior electronic health record. 
 
Hypothesis: 
We hypothesize that, in this sample of adolescents receiving telehealth-supported LARC services in a 
network of SBHCs, the LARC continuation rate at 12 months will be non-inferior to the 12-month 
continuation rate among adolescents and young adults age <25 (85.3%) as documented in a meta-analysis 

 
comparing contraceptive implants and IUDs, in the absence of telehealth. The non-inferiority margin is 
chosen to be 10 percentage points less than that of the current standard of care (SOC) in US as such 
difference represents the maximum tolerable margin for inferiority while clinically important impact of 
proposed intervention can still be preserved. 
 
Background/ Rationale 
 
Long acting reversible contraceptives (LARCs) are safe and effective for adolescents, but low rates of use 
among this population and early discontinuation due to method dissatisfaction limits their potential to reduce 
unintended pregnancy. LARCs have been recognized as safe and appropriate first line contraceptive 
methods for adolescents by ACOG, American Academy of Pediatrics (AAP), and other expert bodies. Large 
studies have shown that adolescents are no more likely than adults to discontinue LARC methods early 
(Danielle et al., 2013). Side effects (e.g. unscheduled or unpredictable bleeding) are the primary reasons for 
discontinuation of contraceptive implants and IUDs among adolescents (Teal & Sheeder, 2012; McNicholas 
& Peipert, 2012; Hoggart et al., 2013). 
 
Access to information and counseling prior to initiation of the method may increase satisfaction with and 
continuation of LARC methods (Davie et al.), particularly for adolescents (Wilson et al.). Our prior work 
showed that young people who received method-specific health education prior to IUD insertion were half as 
likely to discontinue within 6 months (Garbers et al. 2013); this comports with prior research of the positive 
impact of counseling on continuation of contraceptive implants (Davie et al.). LARC-related side effects 
improve between 6-12 months post-insertion, with corresponding increases in satisfaction (Hubacher & Park, 
2009) suggesting that information on managing side effects prior to initiation may be critical. 
 
Reducing barriers for obtaining LARCs by adolescents who want to use them is key in reducing risk of 
unintended pregnancy. Same-day provision of LARC has been proposed as a way to reduce the barriers to 
LARC initiation, as evidence has shown that requiring multiple visits to a clinical practice reduces uptake. 
One study with Medicaid-insured women found that almost half of women who were ordered an IUD at the 
first visit did not return for IUD insertion (Bergin et al., 2012). At the same time, other large-scale studies of 
same-day LARC provision in networks have shown that multiple visits are required to support patient 
decision-making (Biggs et al., 2013). 
 
The rapid initiation of telehealth services, precipitated by the COVID-19 emergency, represents a novel 
opportunity to assess a “hybrid” care model that eliminates the need for two in-person visits to the office 
setting, while also providing sufficient time to support patient education, decision-making, and screening prior 
to the LARC insertion visit, specifically among adolescents. This work can inform youth-friendly 
reproductive health care (Ambresin et al., 2013) more broadly, building on our prior work on providing 
youth-friendly contraceptive care in SBHCs (Sangraula et al., 2017). Providing youth-friendly reproductive 
health care to adolescents via telehealth is a field that is in its infancy (Barney et al., 2020; Williams, 
Meredith, Ott 2018), and the field has called for national organizations to develop guidance on best 
practices in using telehealth to deliver sensitive care to adolescents (World Health Organization, 2020). 
 
School-based health centers (SBHCs) -- of which there are more than 2,580 in urban (46%), rural (36%) and 
suburban (18%) areas in the United States (Love, Schlitt, et al., 2019) reaching more than 6 million school- 
aged youth -- represent a unique opportunity to assess the promise of a hybrid model of reducing barriers to 
initiation of LARC among adolescents to inform broader replication in other clinical settings. SBHCs 
provide a wide range of reproductive health services, including pregnancy testing (80%) and contraceptive 
counseling (70%) (Love, Suleimanpour, et al., 2019).1 And, almost half of SBHCs used some telehealth in 
2017 (Love, Panchal, et al., 2019), so the networks are well-positioned to integrate telehealth-supported 
LARC services. This implementation model, therefore, has the potential for replication and scale-up with wide 
reach. Analyses of continuation by telehealth experience (Aim 4), coupled with the findings from the mixed 
methods surveys and interviews (Aim 2) will inform modifications to the telehealth model before 
replication. 
 

 
2. Study Design and Statistical Procedures 
 
This is a prospective observational cohort study that will include all enrolled SBHC patients at the 6 
participating SBHCs who receive a telehealth reproductive health visit in the 12-month period following IRB- 
approved study initiation date, and will follow over a 6-18-month period all patients who initiate a LARC 
method during the study period. 
 
This two-year study will have three phases: 1) a 4-month study initiation phase; 2) a 12-month enrollment 
and surveying phase; 3) and a 6-month follow-up observation phase. Continuation analyses will rely on 
person-time, so that study participants will contribute a minimum of 6 to a maximum of 19 months 
observation time, depending on their time of enrollment. 
 
Statistical Procedures. Dr. Garbers will have lead responsibility for conducting statistical analyses, 
supervising data cleaning, and logic checks conducted by the Research Coordinator, and working with the 
Biostatistician on model building. As this is a prospective observational study that seeks to enroll all patients 
who receive telehealth-supported LARC services over a 12-month period, the sample size will be determined 
by patient flow and participation rates. 
 
Aim 1 (Secondary Outcome): Quantify uptake of LARC (contraceptive implant, IUD) within the SBHC 
network following implementation of telehealth-supported LARC provision 
 
Aim 1.1 Making use of a newly-implemented electronic health record (EHR) system, Epic, we will 
assess uptake of contraception, quantifying the number and proportion of contraceptive method 
initiation (uptake), assessing each month: 
 
1) absolute number of contraceptive counseling visits via telehealth; 
 
2) absolute number of LARC telehealth consultations (a LARC consultation being defined as a visit in 
which an insertion is scheduled); 
 
3) absolute number of LARC initiations by type (contraceptive implant, IUD); 
 
4) LARC initiation visits as a proportion of contraceptive counseling visits (overall, and by LARC type 
[contraceptive implant, IUD]); 
 
1 The current SBHA Census does not provide data on how many SBHCs dispense contraception; the most recent data on 
this are from the 2007-08 census and are not presented here. 
5) LARC initiation visits as a proportion of all contraceptive method initiation visits (overall, and by 
LARC type); 
 
6) LARC initiation visits as a proportion of LARC telehealth consultations (defined as a visit in which a 
LARC initiation was scheduled; overall and by LARC type; 
and 7) relative share of initiations of contraceptive implant and IUD, among LARC initiators. 
Statistical Methods (Aim 1.1) 
1) Descriptive analyses (frequency tables) will present, by month, the absolute numbers of 
contraceptive counseling visits, LARC consultations (with a scheduled insertion) (overall, and by LARC 
type [contraceptive implant, IUD]); and initiations (overall, and by LARC type [items 1-3 above]. 
 
2) Descriptive analyses will present the proportion of LARC initiations out of the number of 
contraceptive counseling visits [item 4], contraceptive initiations for all methods [item 5], and telehealth- 
based LARC consultations [item 6]. A consultation is defined as a visit for which a LARC initiation was 

 
scheduled. These analyses will be presented in frequency tables. 
 
3) For each of the uptake outcomes listed above [items 4-7], bivariate statistical analyses will compare 
the outcome proportions for contraceptive implant vs. IUD, using Chi-square tests. 
 
Aim 1.2 Bivariate analyses will assess the uptake of LARC methods (overall, and contraceptive 
implant vs. IUD) by patient subgroup, examining LARC initiation (in absolute numbers, and as a 
proportion of telehealth consultations) by patient characteristics (age, race/ethnicity, gender identity, 
sexual orientation, sexual activity in last 90 days, gravidity, parity). 
 
Statistical Methods (Aim 1.2) 
Bivariate Chi-square tests will compare the proportion who initiated out of those who had 1) a telehealth 
contraceptive counseling consultation and 2) a LARC consultation for which an insertion was scheduled 
across subgroups defined by age group (using age categories consistent with the CDC’s Youth 
Behavior Risk Surveillance System, ages 13-14, 15-17, 18-19, 20 and older); race/ethnicity (Hispanic + 
Black, Black non-Hispanic, Hispanic of any other race, non-Hispanic race other than Black); gender 
identity (female, male, transmale, gender non-conforming); sexual orientation (straight/heterosexual, 
gay/lesbian, bisexual, asexual); sexual activity (any/no sexual activity in last 90 days); gravidity (any/no 
pregnancy history); parity (any/no live birth). 
 
Aim 2: Describe the implementation of telehealth-supported long-acting reversible contraception 
(LARC) service provision in school-based health centers (SBHCs) using mixed methods. 
 
Aim 2.1 For all patients who initiate a LARC method over the 12 month enrollment period (estimated 
n=102), we will conduct online follow-up quantitative surveys with all adolescent patients who 
completed their in-person visit to initiate LARC method (contraceptive implant, IUD) to assess their 
experience with telehealth-supported care, including: when, where, and using what device they 
participated in the telehealth video session (e.g. laptop, smartphone, or tablet; with or without 
headphones); satisfaction with telehealth session (comfort in using telehealth, perceived privacy, extent 
to which questions were answered); how prepared they felt for the insertion visit; self-efficacy to 
manage side effects; time (in days) from telehealth visit to method initiation visit; whether attended 
scheduled follow-up telehealth visit (yes/no); and time (in days) between initiation and follow-up 
telehealth visit. These surveys will also collect data on interaction with health educators and/or peer 
health educators. We conservatively estimate a survey sample size of 87 for these surveys (85% 
participation). 
Statistical Methods (Aim 2.1) 
Descriptive analyses (frequency tables, means with standard deviations) will describe the telehealth 
experiences for all survey respondents. Bivariate statistical analyses will compare experiences between 
contraceptive implant and IUD initiators. We will use Chi-square for dichotomous outcomes, t-tests for 
means, and Wilcoxon Mann Whitney tests for medians (e.g. time in days between visits). 
 
Aim 2.2 Qualitative interviews with 30 patients, using purposive sampling to ensure a range of 
perspectives (e.g. age, LARC method, health educator engagement). These qualitative surveys will 
expand on the aspects covered in the quantitative surveys and will explore, in greater detail, 
adolescents’ experience with the telehealth-supported care from the SBHC, including prior experience 
with telehealth, perceived benefits and drawbacks of telehealth care overall and for supporting LARC 
services, specific domains of questions or concerns about side effects and maintenance of their LARC 
method, and dimensions of youth-friendly care (Ambresin et al., 2013). 
 
Statistical Methods (Aim 2.2) 
Thematic analysis will be used to describe the qualitative data generated from the interviews. Using an 
inductive approach, two coders will scan a random selection of transcripts to generate initial codes; 
working from these, we will generate a code-book that lists major themes, specifies categories 

 
emerging from the data, and descriptions of each theme. The first 10 transcribed interviews will be 
jointly coded using Dedoose; then, inter-rater coding agreement will be assessed. The entire study 
team will: resolve discrepancies in coding, clarify theme definitions, and collapse or expand themes as 
needed. 
 
Primary efficacy outcome (Aim 3): Continuation post-LARC initiation 
The primary outcome for this study (3.1) will be absolute continuation rate 12 months post-initiation 
(dichotomous yes/no continuation), with analyses also examining continuation at 6 months (yes/no). 
 
Aim 3.1 (Primary Efficacy Outcome): Overall 12-month continuation of LARC using telehealth- 
supported care compared to LARC continuation rates among adolescents age 25 and under as 
documented in a meta-analysis of US studies. 
 
The primary outcome will be the proportion of patients continuing their initiated LARC method at 12 
months post-initiation. Hypothesis: We hypothesize that, with the non-inferiority margin of 10 
percentage point difference, in this sample of adolescents receiving telehealth-supported LARC 
services in a network of SBHCs, the LARC continuation rate at 12 months will be non-inferior to the 
reported 12-month continuation rate among adolescents and young adults age under 25 years (85.3%) 
in the US who initiated contraceptive implants or IUDs the absence of telehealth (Usinger, Gola, Weist 
& Smaldone, 2016). 
 
Statistical Methods (Aim 3.1): 
 
Continuation rates will be expressed as rates at both 6 months and 12 months post initiation, and time 
to discontinuation will be visualized using Kaplan-Meier curves. 
 
We will test the primary null hypothesis H0: p ≤ 0.753 (i.e., 10 percentage points less than the reference 
rate of 0.853) using one-sample, one-tailed Z-test, where p is the LARC continuation rate at 12 months 
for participants who receive telehealth-supported LARC services in a network of SBHCs, and the 
reference the proportion (of 0.853) was chosen from the finding of the meta-analysis mentioned above. 
 
Additionally, we will use Chi-squared tests to compare continuation (yes, continued/no, discontinued) 
between LARC types (contraceptive implant vs. IUD) at two time points: 6 months and 12 months post- 
initiation. Adjusted analyses using logistic regression will be conducted to compare the continuation at 6 
and12 months (yes or no) separately between contraceptive implant and IUD patients, adjusting for 
covariates (age, race/ethnicity, gender identity, sexual orientation, sexual activity in last 90 days, 
gravidity, parity). Operationalization of these covariates is outlined in Aim 1. 
 
Power/Sample Size (Aim 3.1): 
The study anticipates enrolling 113 patients, with 102 patients included in the continuation analyses for 
Aim 3 (primary outcome). Our sample size estimates are based on conservative SBHC clinical data 
from 2018-2019 and from the first seven months of 2019-20 (which was disrupted by both the transition 
to a new EHR Epic system and school and SBHC closures due to COVID-19); during the July 2018 to 
January 2020 time period, there were, respectively, 129 LARC initiations (86 contraceptive implant, 43 
IUD), and 44 LARC initiations (41 implant, 3 IUD). These sample size estimates are conservative, as 
the SBHCs have three newly-hired and trained medical providers since the 2019-20 disrupted year. 
 
We anticipate having complete data for the continuation analyses sample size (n=102). Using the new 
Epic EHR, at each visit within the NYP clinical network – the participating study sites in the SBHCs, as 
well as the emergency department, inpatient and outpatient clinics – the health care provider is required 
to conduct reconciliation of medications and document it in the Epic EHR. The medical providers ask 
every patient at every visit what their current contraceptive method is – confirming the presence of the 
method, and documenting in two places in the EHR (in the contraception and in medications sections). 
These analyses will be able to assess continuation (presence of the device at a visit) and censoring 

 
(device removal, device removal with re-insertion). 
 
With a sample size of 102 and the margin of non-inferiority of 10 percentage points, the proposed study 
has 80% power to declare the non-inferiority of the telehealth-supported LARC services in a network of 
SBHCs in a one sample, one-sided Z test. This power analysis is for the primary efficacy outcome of 
interest, i.e., LARC continuation rate at 12 months. The reference LARC continuation rate at 12 months 
of 0.853 was obtained from the meta analysis conducted by Usinger, Gola, Weis & Smaldone in 2016. 
The studies included in their meta-analysis collected sample in the US with participants in those studies 
being young women aged 25 years and younger using a range of contraceptive methods. Therefore, if 
the true LARC continuation rate at 12 months is 0.753 or higher, the study is adequately powered to 
establish the non-inferiority of telehealth-supported approach. In the CHOICE Project, 12-month 
continuation of Copper IUDs among participants age 14-19 was 75.6% (Rosenstock et al., 2012). 
 
 
Aim 3.2 (Exploratory, pending feasibility) Continuation compared to pre-Telehealth. Pending 
examination of the feasibility of constructing a pre-telehealth research database using the prior EHR 
system, compared to continuation rates within the same network prior to the implementation of 
telehealth-supported care, we will compare 12-month continuation (yes/no) following introduction of 
telehealth to 12-month continuation among LARC initiators seen the 18 month period prior to 
introduction of telehealth (June 2018-December 2019) pending ability to export data from the prior 
electronic health record. 
 
 
3. Study Procedures 
AIM 1 
Participant enrollment – Aim 1: All patients who receive care at the SBHC provide informed consent for 
care, as well as record review for quality assurance purposes. Analyses for Aim 1 will include all female 
patients who have a “reproductive health visit,” which includes contraceptive counseling, contraceptive 
management, or contraceptive method initiation, during the study period. All patients who have a telehealth 
consultation with a SBHC medical provider for LARC services (conservatively estimated n=113) will be 
considered enrolled patients once the data are extracted from the EHR, and these will inform uptake 
analyses for Aim 1. 
 
AIM 2 
 
Participant enrollment – Aim 2: For the surveys (Aim 2), participant enrollment will take place after the in- 
person LARC initiation procedure at the SBHC, to avoid having the decision-making around survey 
participation influence contraceptive decision-making. At the visit, the medical provider (nurse practitioner) 
will pre-screen the patient for eligibility, describe the study, and ask for the patient’s permission to be 
contacted via text, email, or telephone by the Research Coordinator to conduct a survey. If the patient agrees 
to be contacted, the nurse practitioner will: 
1. Send the chart by secure message in Epic to Melanie Gold, DO (the Medical Director of NYP School- 
Based Health Centers), as part of the usual chart review that Dr. Gold conducts per SBHC protocol, 
with documentation in the message that patient has been given permission to be contacted by the 
Research Coordinator. 

 
2. Dr. Gold will send the patient name, contact information, and DOB to the Research Coordinator, as two 
points of identification are needed for Step 5. 
3. The Research Coordinator will contact the patient via text or email with more information. 
4. The Research Coordinator will create a study ID in RedCap and send a link to a REDCap or Qualtrics 
survey site that includes study info, information sheet, and the full survey. Full informed consent will be 
solicited and documented in the survey site. 
5. Once the survey is completed, the Research Coordinator will provide the Grant Reporting Manager for 
the Center for Community Health & Education (via encrypted communication) patient name, DOB, and 
study ID, which can then be linked (by Grant Reporting Manager) to the Epic record. 
6. The Grant Reporting Manager identifies patient within the larger exported file and adds study ID 
provided by the Research Coordinator. 
Each week, as a supplement to this process and as part of reviewing the completed charts for any LARC 
insertions, Dr. Gold will send a “SmartText” (included in SBHC Provider Scripts) to any LARC patient who 
does not have documentation of declining or accepting to be contacted by the Research Coordinator. Dr. 
Gold will send a secure message to the patient asking permission to be contacted by the Research 
Coordinator. The message will also include the Research Coordinator’s contact information if the patient 
wants to learn more about the survey. 
 
This model of enrollment has been successfully used by Dr. Gold in prior studies among SBHC patients 
receiving LARC services (Sangraula et al., 2017). 
 
Quantitative surveys: The quantitative surveys will be programmed into CUIMC-hosted REDCap or 
Qualtrics, which are HIPAA-compliant. The link to the Initial Survey, with an average of 30-40 questions 
about the patient’s LARC counseling and insertion appointments, will be sent via text message or email to 
each participant who provided consent to be contacted. The link to the Follow-Up Survey, with 25-30 
questions about the follow-up appointment post-insertion, will be sent via text or email once after the date of 
their follow-up visit (indicated by the patient in the Initial Survey). Participants who have had their follow-up 
visit at the time of completing the Initial Survey will be directed to complete the Follow-Up Survey in tandem. 
 
The surveys, survey invitations and reminders, and informed consent forms will be in both English and 
Spanish; patients can choose which language they prefer to complete the survey. Participants will be sent up 
to 4 reminders at different times of the day to remind them to complete the survey (over 8 weeks). The 
English surveys will include, at the end, the option of consenting to be contacted for a follow-up qualitative 
interview if selected. 
 
Qualitative interviews: Each month, in a phase of 5 per month, a total subset of up to 30 participants will be 
purposively sampled from the sample who responded to the quantitative survey and provided consent to be 
contacted for a follow-up telephone or Zoom interview. Given the small sample size, these interviews will be 
conducted among English-speaking patients (identified by the language in which they completed the survey). 
Participants will be purposively sampled (using quota sampling) to ensure distribution of respondents across 
LARC type, age, and race/ethnicity. Interviews will be audio recorded (with the voice print and study number 
being the only voice data recorded) and transcribed, using only the study ID number. 
 
EHR abstraction and data completion tracking: The Grant Reporting Manager for the Center for 
Community Health & Education (CCHE), Division of Community and Population Health, (Ryan Levy) will 
construct a patient management database that maintains a linkage between the consent status, EHR 
number, and the study number, which will be linked to the survey. All data for export will be de-identified 
(maintaining only the study number) before sharing with the analytic team. The Research Coordinator will 
work with the Grant Reporting Manager to facilitate the export of linked, de-identified data for analyses. The 
fields that will be exported from the EHR are fields that would be used to monitor patient satisfaction 
outcomes consistent with quality assurance activities (see Wish List of Data Points in documents). 

 
Linkage of survey data with EHR data: The Grant Reporting Manager will be the only person to maintain a 
link between the participant’s EHR number and a study number. The Research Coordinator will program 
each survey to be individually linked to the unique study ID code; the survey data can then later be linked to 
the patient’s electronic health record by the Grant Reporting Manager. The data can be linked using the 
study ID; the surveys will not include the EHR number. 
 
AIM 3 
 
Follow-up observation (Continuation Analyses, Aim 3): Follow-up observation will continue for 6 months 
after the enrollment phase has completed; therefore, participants enrolled in the first month will have 18 total 
months observation, while those enrolled in the last month will have 6 months. In 2018-19, in the network of 
6 SBHCs, 2,425 unique female patients had a total of 12,398 visits (for any purpose), representing an 
average of 5 SBHC visits per female patient in the academic year.2 At each visit to the SBHC, regardless of 
visit type, all female patients have their medications, including contraceptive method, reconciled and 
confirmed in the medical record. With the new Epic EHR system, export of all LARC-related procedure codes 
(insertions, removals, removal with replacement) and device codes (e.g. Nexplanon, Liletta, Paragard) in 
addition to all visits (with corresponding data on current contraceptive method) will enable us to identify 
person-time events including censoring. At all New York Presbyterian (NYP) sites, the health care provider is 
required to conduct reconciliation of medications and document it in the EHR at every visit. The SBHC 
medical providers ask every SBHC patient at every visit what their current contraceptive method is – 
confirming the presence of the method, and documenting this in two places in the EHR (in the contraception 
history section, and in the medications section). 
 
Compensation. 
All Aim 2 survey and interview participants will receive compensation for their time and effort in the form of an 
Amazon electronic gift card, purchased through the Mailman School of Public Health. Compensation is as 
follows: 
 
Quantitative survey participants will receive, as compensation for their time and effort, an Amazon 
gift card valued at $10 at the conclusion of the survey. The card will be sent to participants 
electronically. 
 
Qualitative interview participants will receive, as compensation for their time and effort, an Amazon 
gift card valued at $25. The card will be sent to participants electronically. 
 
4. Study Subjects 
 
Subject Population Justification: 
Adolescents and young adult high school students are the primary study participants. This study will describe 
in detail the implementation of a hybrid model of telehealth-supported LARC service provision in a network of 
6 SBHCs in New York City that serve students who are between the ages of 13 and 22 years. The specific 
age range of the students was selected because it reflects the age range of students served by the 6 
SBHCs. We are limiting our enrollment to high school students because the study is based in SBHCs. We 
have used the enrollment and retention strategies proposed in this application in our past research. 
 
Patient population. Based on SBHC clinical data from the full academic year (2018-19), we estimate that, 
over the 12 month cohort there will be 113 telehealth consultations, defined as a visit in which an 
appointment is scheduled to initiate a LARC methods (Aim 1), and 102 LARC insertions (Aim 2). The SBHC 
 
 
2 This figure represents total number of visits for all patients, including patients receiving mental health care, who have 
regularly scheduled repeat visits. The average number of visits per year per unique female patient among LARC users is 
anticipated to be lower. 

 
patient population, as a whole, is 69% Hispanic and 26% Black (not mutually exclusive), with an average age 
of 16 years. The majority of patients have their visits covered by Medicaid. 
 
Participants will be eligible to participate in the study if they are: 1) an enrolled patient at the participating 
SBHC; 2) age 13-22 years; 3) female; 4) had a visit at the SBHC during the study period that is coded as a 
“reproductive health visit” including contraceptive counseling, contraceptive management, and contraceptive 
method initiation. 
 
For Aims 2 and 3, individuals will be excluded if they: 1) are younger than age 13 years; 2) are older than 
age 22; 3) are not an enrolled patient of the participating SBHCs; 4) did not initiate a LARC method; 5) are a 
person without a uterus; 6) are unable to read, speak, and understand either English or Spanish. 
 
5. Recruitment 
 
Aim 2.1: Adolescent Survey Participants: 
Adolescent participants will be recruited by the treating clinician (SBHC providers, including Dr. Gold) 
following in-person LARC initiation procedures. Flyers and scripts will be provided to SBHC providers to 
share with patients in person or via secure message through EPIC, the SBHCs’ electronic health record 
system. Adolescents who are interested in participating in the survey will either provide permission to be 
contacted by the Research Coordinator, or will be provided with the Research Coordinator’s CUIMC email 
address and cell phone number to learn more about the study. 
 
Eligibility Screening – Survey Participants. The Research Coordinator will initially screen potential 
survey participants for eligibility by asking 1) if they would like to determine their eligibility to participate 
in a study; 2) if so, their age. 
 
Aim 2.2: Adolescent Interview Participants (n=30): 
A purposive sampling method will be used to recruit participants who gave consent in the survey to be re- 
contacted for an interview. All eligible adolescent participants will be sent (via REDCap) a detailed Study 
Information sheet (included in documents) which will explicitly convey who is conducting the study, the 
purpose of the study, the procedures (e.g., time needed, study risks and benefits, a discussion of 
compensation, and a statement that participation is voluntary and will not affect their care at the SBHCs). E- 
consent will be solicited and documented in REDCap. All informed consent processes for Zoom or telephone 
interviews will be conducted prior to the interview with the trained study staff. Recording will start only after 
the participant has been consented. 
 
6. Informed Consent Process 
 
All Informed Consent procedures will start with a concise presentation, in lay language, of the key information 
about the research study. Sufficient information about the study purpose, procedures, risks, and benefits will 
be provided to all potential subjects. 
 
Adolescent Survey and Interview Participants. We are seeking a waiver of parental permission for 
participants under the age of 18, as the study meets the following criteria: 1) the research involves no more 
than minimal risk to the subjects; 2) the waiver will not adversely affect the rights and welfare of the subjects; 
3) the research could not practicably be carried out without the waiver or alteration; and 4) the subjects will 
be provided with additional pertinent information after participation. 

 
All adolescent survey and interview participants are expected to be able to provide consent to participate, as 
they are currently enrolled students in high school and English or Spanish speaking. A written information 
sheet will be included on the survey site or sent electronically to interview participants via REDCap prior to 
the interview date. The REDCap e-consent program will meet all elements of e-consent (per the September 
24, 2020 CUIMC e-Consent seminar, which Dr. Garbers attended). The e-consent program is easy to navigate, 
allowing the user to proceed forward or backward in the system and to stop and continue at a later time. The 
platform provides standardized tools to obtain consent and store consent documentation with a certification 
screen and a storage function which automatically generates a ‘hard-copy’ PDF of the signed form. The 
‘Auto-Archiver + e-Consent Framework’ survey option adds two things to the typical survey taking process: 1) 
before a participant completes the survey, an extra certification page is added to the end of the survey that 
displays an in-line PDF copy of the document in which they will be asked to confirm that all information in the 
document is correct; 2) upon completion of the survey, a static copy of their responses in the form of a 
consent-specific PDF will be stored in the project’s File Repository. HIPAA authorization will be obtained as 
part of the e-consent. All hyperlinks included on the sheet will be maintained and the information will be 
accessible until study completion. The process is secure with access restricted to authorized study personnel 
along with methods to ensure confidentiality of the subject’s identity, study participation, and personal 
information. E-consent will be solicited remotely. The information sheet states that if the subject has any 
question, they can call Dr. Garbers at 646-494-7163. 
 
The materials will explain that the study is being conducted to improve IUD and contraceptive implant 
services at the school-based health center, and will include contact information for the study team so 
participants will be given the opportunity to contact the investigators to have any questions answered or 
concerns addressed. The informed consent forms provided will explain, in plain language written at no higher 
than 8th grade reading level, who is conducting the study, the purpose of the study, the procedures 
(including the length of the survey and interview), study risks and benefits, a discussion of compensation, 
specific steps that will be taken to protect confidentiality, and a statement that participation is voluntary and 
their participation will not affect their care at the SBHC. E-consent will be documented in the survey site or in 
REDCap prior to initiation of the survey or interview. All consent forms will be IRB and HIPAA compliant, and 
will include mention that the study will be registered with the ClinicalTrials.gov website. 
 
Any adolescent participant who turns 18 during the course of their active participation in the study will be re- 
consented. 
 
Note: It is a funding requirement by Merck MISP that the study be posted on ClinicalTrials.gov. There will be 
no prospective assignment to intervention. The study is exploring aspects of quality and satisfaction with 
services. The study will not be open to enrollment outside existing SBHC patients. 
 
7. Study Instruments 
 
Quantitative Survey. We will use quantitative surveys among LARC initiators to assess patients’ experience 
and satisfaction with telehealth-supported care. The Initial Survey will have on average 30-40 questions 
about the patient’s LARC counseling and insertion appointments, and will be sent via text message or email. 
The Follow-Up Survey will have 25-30 questions about the patient’s follow-up appointment following their 
LARC insertion. Please see attached Initial Survey and Follow-Up Survey for an overview of the questions 
we will ask. 
 
Qualitative Interviews. Using a semi-structured interview guide, trained study staff will interview English- 
speaking patients to explore adolescents’ experience with the telehealth-supported care from the SBHC and 
inform modifications to the telehealth model before replication. Please see attached Qualitative Interview 
Guide for the semi-structured interview guide. 

 
8. Confidentiality of Study Data 
 
Data collection and storage protocols will minimize the use of identifying information. All EHR data will be de- 
identified by the Grant Reporting Manager before being shared with the study team for analysis. All research 
participants will be identified on all research forms and logs (other than the study ID linkage forms) by unique 
but non-identifying codes. Code linkage files relating ID codes to names will be maintained on RedCap, a 
password-protected site, accessed only by the lead study staff (Garbers, Gold, and Maier). Zoom and 
telephone interviews will be recorded only using CUIMC-hosted Zoom accounts, with a password required 
for entry into the room. Recordings of the interviews will only be recorded onto encrypted, password- 
protected endpoint computer temporarily. This electronic data will be maintained on the encrypted, 
password-protected computer files on encrypted devices with limited access to data by staff – different levels 
of access will depend on the person’s specific level on the staff, and server security safeguards that in the 
aggregate provide a high degree of protection from unauthorized users. Interviews will be transcribed as 
quickly as possible; once transcribed and checked for accuracy, the recordings will be deleted. 
 
All qualitative and quantitative information will be coded by identification number, so that no full names or 
other personally identifying information (PII) are associated with any of the data. Identity of participants – 
including deductive disclosure -- will not be revealed in the presentation or publication of any results from the 
project. All personnel working on the project will be regularly trained and re-trained about the importance of 
strictly respecting participants’ rights to confidentiality and specific approaches to ensure such protections. 
The only data for which PII cannot be inextricably separated from the data is a voice print. Special steps will 
be taken to protect this data. 
 
Confidentiality and privacy for audio/video recording of human subjects 
The project will ensure the following steps are followed, and will include these steps in the consent forms for 
participants: 
 
1. Participants will be informed that the interviews will be recorded. Their voices will be recorded, but no 
other likenesses will be recorded. Names and likenesses (pictures or live video) will not be recorded. The 
interviewer will instruct participants to change their screen name on Zoom to their study ID. 
2. The recording will not start until the participant has turned off their video camera and changed their screen 
name to their study ID. 
3. The video recording will be recorded and viewed by the Research Coordinator and the Principal 
Investigators. The recording will be downloaded to extract the transcription of the audio feed. No identifiers 
will be included in the transcriptions. The Research Coordinator will review the transcript for accuracy, 
consulting the original audio as needed. As soon as the accuracy of the transcription is confirmed, the 
recordings will be destroyed from all locations. 
4. The video recordings (before destruction) and the transcriptions (without identifiers) will be stored 
temporarily on an encrypted and password protected computer. 
5. There will be no future use of the recordings, once the recordings are transcribed. 
 
Participants will be consented prior to the start of the interview, and all of these points will be reviewed. 
 
9. Privacy Protections 

 
We will ensure confidentiality is protected by taking several steps. Per CUIMC Institutional Review Board 
(IRB) guidelines, all members of the study staff must complete trainings in human subjects protection and 
HIPAA requirements, as well as ongoing training by the PIs in all aspects of human subjects protection. The 
platforms we will use for data collection, Zoom and either REDCap or Qualtrics, will use only the CUIMC- 
hosted versions, which are HIPAA compliant. For purposes of the research database, each participant will be 
assigned a unique identifier that bears no systematic relation to the family, or school, or SBHC records. 
Information to be excluded from the research database includes names of study participants, addresses, 
telephone numbers, school, clinician, and other information that has the potential to identify individuals. All 
outcome data will be de-identified by HIPAA standards using the “safe-harbor” method (i.e., all 18 PII 
elements will be stripped) prior to being stored on a password-protected, encrypted server. 
 
10. Potential Risks 
 
Participation in this research involves minimal risk, defined in the Federal guidelines as "the probability and 
magnitude of harm anticipated in the research are not greater in and of themselves than those ordinarily 
encountered in daily life or during the performance of routine physical or psychological examinations or tests." 
 
(1) 
It is possible that the adolescent participants will experience some inconvenience, embarrassment, or 
distress while participating in the interviews or completing surveys. 
Survey and interview participants will be reminded of the option to not answer any questions or to stop the 
survey or interview at any time. Adolescent participants reporting distress to the study team will be referred to 
onsite mental health providers that are always available at the SBHCs. Adolescent participants have access 
to primary care through the SBHCs, if parental permission is on file for them to receive primary care. 
 
Since the risks to individual study participants are minimal, the study appears to be readily justifiable. 
 
11. Data and Safety Monitoring 
 
This is a minimal risk study. The PIs (Garbers and Gold) will be responsible for all data safety and 
monitoring. They will have responsibility for ensuring that the policies outlined above to minimize risk – 
including staff training, storing identifiers separately from survey and interview data, and storing all data on 
encrypted, password-protected servers – are followed. The PIs will conduct regular checks of data storage 
procedures, ensuring, for instance, that: any recordings have been destroyed following transcription; access 
to electronic data is limited to trained study staff, and the research database does not include any personally 
identifying information. 
 
In their weekly team meetings, Drs. Garbers and Gold will review with the study staff weekly data reports 
regarding all study-related activities. This will include the sample size and proportion of approached contacts, 
eligibility rates (and reasons), consent/refusals, and surveys and interviews completed. 
 
All study personnel will report any study-related adverse events and/or unanticipated problems involving risks 
to participants to Drs. Garbers and Gold. In the case of any adverse event or unanticipated problem, Drs. 
Garbers and Gold will notify the CUIMC IRB. Dr. Garbers will, if appropriate, inform the Merck Project Officer 
in writing of any actions taken by the IRBs as a result of such adverse events. 
 

 
12. Potential Benefits 
Reducing barriers for obtaining LARCs by adolescents who want to use them is key in reducing risk of 
unintended pregnancy. Access to information and counseling prior to initiation of the method may increase 
satisfaction with and continuation of LARC methods, particularly for adolescents. A “hybrid” care model 
involving telehealth eliminates the need for two in-person visits, while also providing sufficient time to support 
patient education, decision-making, and screening prior to the LARC insertion visit. This work can inform 
youth-friendly IUD and contraceptive implant services, and the SBHC implementation model has the potential 
for replication and scale-up in other clinical settings. 
 
13. Alternatives 
 
Participants have the alternative to not participate in this research. 
 
REFERENCES 
 
Ambresin AE, Bennett K, Patton GC, Sanci LA, Sawyer SM. Assessment of youth-friendly health care: a systematic 
review of indicators drawn from young people's perspectives. Journal of Adolescent Health. 2013 Jun 1;52(6):670-81. 
 
Barney A, Buckelew S, Mesheriakova V, Raymond-Flesch M. The COVID-19 pandemic and rapid implementation of 
adolescent and young adult telemedicine: challenges and opportunities for innovation. Journal of Adolescent Health. 
2020 May 14. 
 
Bell DL, Garbers S, Catallozzi M, Hum RS, Nechitilo M, McKeague IW, Koumans EH, House LD, Rosenthal SL, Gold 
MA. Computer-assisted motivational interviewing intervention to facilitate teen pregnancy prevention and fitness 
behavior changes: A randomized trial for young men. Journal of Adolescent Health. 2018 Mar 1;62(3):S72-80. 
 
Bergin A, Tristan S, Terplan M, Gilliam ML, Whitaker AK. A missed opportunity for care: two-visit IUD insertion protocols 
inhibit placement. Contraception. 2012 Dec 1;86(6):694-7. 
 
Biggs MA, Arons A, Turner R, Brindis CD. Same-day LARC insertion attitudes and practices. Contraception. 2013 Nov 
1;88(5):629-35. 
 
Danielle S, Casner T, Secura GM, Peipert JF, Madden T. Characteristics associated with discontinuation of long-acting 
reversible contraception within the first 6 months of use. Obstetrics and Gynecology. 2013 Dec;122(6):1214. 
 
Davie JE, Walling MR, Mansour DJ, Bromham D, Kishen M, Fowler P. Impact of patient counseling on acceptance of 
the levonorgestrel implant contraceptive in the United Kingdom. Clinical Therapeutics. 1996 Jan 1;18(1):150-9. 
 
Garbers S, Haines-Stephan J, Lipton Y, Meserve A, Spieler L, Chiasson MA. Continuation of copper-containing 
intrauterine devices at 6 months. Contraception. 2013 Jan 1;87(1):101-6. 
 
Hoggart L, Newton VL, Dickson J. “I think it depends on the body, with mine it didn't work”: explaining young women's 
contraceptive implant removal. Contraception. 2013 Nov 1;88(5):636-40. 
 
Hubacher D, Chen PL, Park S. Side effects from the copper IUD: do they decrease over time?. Contraception. 2009 
May 1;79(5):356-62. 
 
Love H, Panchal N, Schlitt J, Behr C, Soleimanpour S. The use of telehealth in school-based health centers. Global 
pediatric health. 2019 Oct;6:2333794X19884194. 
 
Love HE, Schlitt J, Soleimanpour S, Panchal N, Behr C. Twenty years of school-based health care growth and 
expansion. Health Affairs. 2019 May 1;38(5):755-64. 
 
Love H, Soleimanpour S, Panchal N, Schlitt J, Behr C, Even M. 17 national schoolbased health care census report. 

 
Washington, DC: School-Based Health Alliance. 2018. McNicholas C, Peipert JF. Long-acting reversible 
contraception (LARC) for adolescent. Current Opinion in Obstetrics & Gynecology. 2012 Oct;24(5):293. 
 
Rosenstock JR, Peipert JF, Madden T, Zhao Q, Secura GM. Continuation of reversible contraception in teenagers and 
young women. Obstetrics and gynecology. 2012 Dec;120(6):1298. 
 
Sangraula M, Garbers S, Garth J, Shakibnia EB, Timmons S, Gold MA. Integrating long-acting reversible contraception 
services into New York City school-based health centers: quality improvement to ensure provision of youth-friendly 
services. Journal of Pediatric and Adolescent Gynecology. 2017 Jun 1;30(3):376-82. 
 
Shakibnia EB, Timmons SE, Gold MA, Garbers S. “It's pretty Hard to tell your mom and dad that you're on a method”: 
exploring how an app could promote adolescents' communication with partners and parent (s) to increase self-efficacy 
in long-acting reversible contraception use. Journal of pediatric and adolescent gynecology. 2018 Apr 1;31(2):116-21. 
 
Teal SB, Sheeder J. IUD use in adolescent mothers: retention, failure and reasons for discontinuation. Contraception. 
2012 Mar 1;85(3):270-4. 
 
Timmons SE, Shakibnia EB, Gold MA, Garbers S. MyLARC: A theory-based interactive smartphone App to support 
adolescents' use of long-acting reversible contraception. Journal of pediatric and adolescent gynecology. 2018 Jun 
1;31(3):285-90. 
 
Usinger KM, Gola SB, Weis M, Smaldone A. Intrauterine contraception continuation in adolescents and young women: 
a systematic review. Journal of Pediatric and Adolescent Gynecology. 2016 Dec 1;29(6):659-67. 
 
Williams RL, Meredith AH, Ott MA. Expanding adolescent access to hormonal contraception: an update on over-the- 
counter, pharmacist prescribing, and web-based telehealth approaches. Current Opinion in Obstetrics and Gynecology. 
2018 Dec 1;30(6):458-64. 
 
Wilson SF, Degaiffier N, Ratcliffe SJ, Schreiber CA. Peer counselling for the promotion of long-acting, reversible 
contraception among teens: a randomised, controlled trial. The European Journal of Contraception & Reproductive 
Health Care. 2016 Sep 2;21(5):380-7. 
 
World Health Organization. (2020). Continuing essential Sexual Reproductive, Maternal, Neonatal, Child and 
Adolescent Health services during COVID-19 pandemic: practical considerations.