Clinical trial NCT02735551
Conditions: Contraception
Keywords: LARC IUD Contraceptive Implant Contraception Community college
Sponsor: Oregon Health and Science University
Start date: 2016-04-01; Completion date: 2017-03-31
Enrollment: 3 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This prospective randomized controlled study will evaluate if Long Acting Reversible Contraceptive (LARC) forward counseling in combination with same-day LARC placement increases overall LARC uptake within a community college population compared to LARC forward counseling and referral to a secondary clinic for LARC placement. The study will be conducted at Mount Hood Community College (MHCC) in Oregon. Participants will be enrolled into three groups. All groups will receive the same standardized contraceptive counseling ("LARC forward counseling") and participants will be able to choose between a LARC method and short-acting method of birth control.

Detailed description:
The purpose of this study is to evaluate the benefit of an on-campus birth control counseling and services clinic. Currently there are no health services that provide access to birth control located on the Mount Hood Community College (MHCC) campus. We are offering a temporary 'Birth Control Resource Center' for eligible students. All forms of birth control in this study are FDA approved.

During the study participants will undergo counseling to choose the method of birth control that is right for them. This will include watching an informational video and having a discussion with study staff. If participants choose pills, the patch the ring, or a diaphragm and do not have any contraindications to this method, they will receive a prescription for this method to be filled at the pharmacy of their choice. If participants choose Depo-Provera (the shot), they will receive their first shot on the day of their visit and a prescription for repeat shots every 3 months. If participants choose to have an IUD or Implant as their method of birth control, they will be randomized to one of two groups. There is a 50% chance of having the intrauterine device (IUD) or Implant placed immediately after the counseling session and a 50% chance of receiving a list of local clinics that can place the device at a later time.

Arms: arm 1: All groups will receive the same standardized contraceptive counseling ("LARC forward counseling"). Participants who chose a short-acting hormonal method (e.g. contraceptive pills, ring, or patch) will receive a prescription to the pharmacy of their choice, as is the current practice for students who present for contraceptive services arm 2: All groups will receive the same standardized contraceptive counseling ("LARC forward counseling"). Randomized to referral for LARC placement to local clinic. arm 3: All groups will receive the same standardized contraceptive counseling ("LARC forward counseling"). Randomized to same day LARC placement (intervention).
Interventions: intervention 1: Long Acting Reversible Contraception (LARC) intervention 2: Referral for Long Acting Reversible Contraception (LARC) intervention 3: Prescription for Short-Acting Hormonal Contraception
Intervention descriptions: intervention 1: Same day LARC placement (intervention) of Mirena, Skyla, Paragard, Implanon intervention 2: Referral to local clinic for LARC placement of choice (Mirena, Skyla, Paragard, Implanon, etc.) intervention 3: Participants who chose a short-acting hormonal method (e.g. contraceptive pills, ring, or patch) will receive a prescription to the pharmacy of their choice

Protocol documents:
Prot_SAP_000.pdf: 
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Official Title:  
Effectiveness of LARC Forward Contraceptive Counseling and Same Day Placement in a 
Community College Population: A randomized intervention project 
 
 
Principal Investigator: 
Jacqueline Lamme, MD 
 
Professor, Department of Obstetrics and Gynecology 
Oregon Health & Science University  
 
 
 
 
 
NCT No: 
NCT02735551 
 
 
 
Protocol Version Date: 
January 31, 2017 
 
 


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1) 
Protocol Title 
Effectiveness of LARC Forward Contraceptive Counseling and Same Day Placement in a 
Community College Population: A randomized intervention project 
 
2) 
Objectives 
 
Hypothesis: Contraceptive options counseling highlighting LARC methods in combination with same 
day, LARC placement will increase overall LARC uptake within a Community College population as 
compared to LARC forward counseling and referral to a secondary clinic for LARC placement.  
 
Primary objective:  To determine whether same day, on site provision of LARC methods compared to 
standard off-site provision will increase LARC uptake within a community college population. 
 
Secondary objectives:  
1. To examine the effect of LARC usage within a community college population on overall 
unplanned pregnancy rates. 
2. To evaluate the effect of LARC usage within a community college population on the 2-year 
certificate completion rate and continuation of education (exploratory).  
 
Intermediate outcomes: 
1. To measure continuation rates of the participants chosen method of birth control. 
2. To assess student satisfaction with the intervention group at 6 and 12 month follow up surveys. 
 
3) 
Background 
 
Among the 50% of pregnancies that are unintended in the United States[2], about half of these 
women report current contraceptive use[3][8]. Long acting reversible contraceptive (LARC) methods 
are known to be more effective than shorter acting, user dependent methods such as oral contraceptive 
pills as they are not dependent on any action by the user once they have been placed[8]. While 
intrauterine devices (IUDs) have failure rates similar to permanent contraception (0.1% to 0.8% in the 
first year of use), the typical first year failure rate for oral contraceptives is 9%[8]. However, in 2012 only 
9.3% of women at risk of unintended pregnancy in the U.S. were using an IUD for contraception and 
1.2% were using the contraceptive implant[5], the two forms of LARC available. The CHOICE study 
found that women tended to both underestimate the effectiveness of LARC methods and overestimate 
the effectiveness of short acting methods such as the pill, patch and vaginal ring, but after counseling 
over 70% chose a LARC method[13]. This highlights the importance of directed structured counseling 
regarding typical use failure as a motivating factor to increase LARC usage (LARC forward counseling). 
Recent studies by Bednarek, et al. demonstrated that same day placement of an IUD after an abortion 
instead of standard delayed insertion may prevent as many as 70,000 unplanned pregnancies per year 
in the U.S[8]. Additionally, of women who seek abortions, recent studies have shown that delayed 
placement may increase the risk of repeat unintended pregnancy as 25% to 68% of patients will not 
return to the clinic for IUD placement if they are not provided with same day insertions[2][8]. 
 The risk of unintended pregnancy is increased in patients of minority racial and ethnic 
backgrounds, of low socioeconomic status and in those less than 25 years of age[13]. Research has 
shown that LARC methods are less likely to be used by women in these groups[7]. According to the 
National Health Statistics Report in October 2012, only 31% of teenagers aged 15-19 years use any 
form of contraception at the time of the interview, though 59% of the women in this age group reported 
either never having intercourse or no intercourse in the last 3 months[7].  Of those teenagers who did 
report using contraception, 53% of those women use the pill, despite the fact that fertility is higher in 
these women and they are at greater risk of contraceptive failure.  Conversely, only 10% of women 


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aged 40-44 years use the pill for contraception, while over 30% have chosen permanent 
contraception[7].  In 2008, the most recent year national data on unplanned pregnancy rates is 
available, the unplanned pregnancy rate was 5 times higher in women below the poverty level 
compared to women at 200% of the poverty level[14]. The unplanned pregnancy rate in women below 
the poverty level was 137 per 1000 women as opposed to 26 per 1000 women at higher socio-
economic statuses, which significantly contributes to the overall national rate of 54 unplanned 
pregnancies per 1000 women[14]. Oregon’s unplanned pregnancy rate among women aged 15-44 is 
lower than the national average at 41 per 1000[14]. This is in large part due to the ability of women to 
access effective contraception through a combination of programs including Medicaid, Title X and 
CCare.  Obviously more needs to be done, as this is still a significant unplanned pregnancy rate. 
A variety of programs exist both nationally and within Oregon to assist with the cost of 
contraceptive care for low-income women.  Title X is the only federally funded grant program dedicated 
to providing family planning services.  It was enacted in 1970 as part of the Public Health Service 
Act[15]. Any public or nonprofit entity within the U.S. may apply for a Title X family planning services 
grant[16]. Through this program, family planning services may be provided to patients 100% or below 
the federal poverty level on a specified sliding scale.  While this program makes contraceptive options 
more financial feasible for many women, it requires clinics to apply for and receive a Title X grant, 
which takes the control out of the patient’s hands and requires the individual clinics to ensure these 
services are provided.  Under the Patient Protection and Affordable Care Act of 2010, women who have 
health insurance can receive FDA approved forms of contraception with no additional cost beyond their 
annual premiums.  However, this requires women be enrolled in an insurance plan.  In 2013, 13.4% of 
the population did not have health care for the entire year[17].  
In Oregon, women can access all methods of contraception either through their private 
insurance or through various publically funded sources for low-income families. Women in Oregon have 
an additional option referred to as Oregon Contraceptive Care (CCare).  Within this program, residents 
of Oregon who are legal US citizens who make $566/week or less qualify for a one year supply of birth 
control of their choice or full coverage of LARC methods, which remain effective for three to 10 years 
depending on the device[18]. Despite this, LARC methods remain underutilized among certain 
populations[19][20].  Simply removing cost barriers is not always enough to increase LARC usage 
among high-risk populations[21]. Same day insertion significantly increases LARC uptake[2]. However, 
programs such as CCare and Title X that help to remove the cost barrier for these populations may 
require prior approval[15], which prohibits same day placement.  In other words, the cost of the device 
may be covered but then these women have to take additional time off work (or miss classes in our 
study population), find child-care and/or transportation back to the clinic for a second appointment once 
the device has been approved.  This in itself may be cost prohibitive and an often-unrecognized barrier.  
The community college population is a diverse and unique population within the U.S.  Students 
tend to be within a lower socioeconomic bracket prior to starting school, unlike many students who 
pursue a traditional 4-year college or university education[9].  At Mount Hood Community College, our 
proposed study site, 34.5% of students surveyed reported an annual household income of less than 
$10,000 and over 70% reported an income of less than $25,000.  These students have chosen to 
pursue their education thereby potentially improving their socioeconomic standing.  An event such as 
an unplanned pregnancy may delay or even prevent their completion of their educational goals. As 
described in the 2015 Reproductive Health Technologies Project, women must have the opportunity to 
plan their pregnancies “in order to have the best opportunity to achieve their education, employment 
and economic goals” as their reproductive years overlap with their time in school and entering into the 
workforce[10]. Pregnancy is the major reason for teenage girls dropping out of school in the U.S[21] 
and it can be inferred that this is also a significant contributing factor within a community college 
population.  At our proposed study site, approximately 34% of the student body is non-white, 
approximately 55% of the student body is female (14,521 students in 2014-2015) and about half are 
degree seeking[22][23].  However, in 2014 only 1.8% were noted to have completed their 2-year 
associates degree or equivalent certificates within the program’s allotted timeframe[11]. It is unknown 
whether unintended pregnancy contributes to poor completion rates for women. 


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The Contraceptive CHOICE project, more commonly known as the CHOICE Study is a highly 
successful intervention project which enrolled 9256 women between 2007 and 2010 in the St Louis, 
Missouri area. The goal of this study was to decrease the high unintended pregnancy rate in the city by 
increasing uptake of LARC methods of birth control[13]. All women in the study received standardized 
contraceptive counseling, after which they were provided the contraceptive method of their choice free 
of charge for up to 3 years. By removing both financial and knowledge barriers, LARC usage within the 
study population was increased to 67%[3]. The cost of this project limits its utilization in other settings 
but components of it may prove just as successful. The study has made its counseling script, as well as 
English and Spanish version counseling videos available online for continued use outside of their study. 
The increased patient knowledge of contraceptive options alone is expected to increase LARC usage 
among patients. Our study will use the contraceptive options counseling made available by the 
CHOICE Study to counsel all study participants. Another aspect of the CHOICE Study that could be 
beneficial in a variety of populations is increasing access to same-day LARC placement.  Studies of 
immediate post-partum and post-abortion LARC placement have shown increased LARC usage at 6-
month follow-up, highlighting the importance of same day placement over interval placement[2][8][24].  
The primary aim of our study is to determine whether a “LARC forward” counseling method 
similar to the Choice Study, and the availability of on-site same day LARC placement will increase the 
usage of LARC methods in a community college population. We plan to randomize women to same 
day/on-site placement or referral.  While the overarching goal of our research is to help decrease 
unplanned pregnancies in female students to help them complete their certificate (2 year degree), our 
primary outcome will be the proportion of each group using a LARC method at 6 months.  
We anticipate that by providing LARC forward contraceptive counseling with same-day on 
campus LARC provision, we will be able to significantly increase LARC usage among at-risk female 
students at Mount Hood Community College.  Additionally, we anticipate that by increasing LARC 
usage we will decrease the rate of unplanned pregnancies and observe a higher rate of certificate 
completion.  This study, however, is limited to an 18-month period. Results of this study will inform 
future efforts in which follow-up of participants will include a greater number of years to assess 
certificate completion rate as well as to evaluate the financial/social impact of same-day LARC access 
on this population.  The community college population has thus far been a little studied population 
within the contraceptive literature.  This study will be the first step in filling in this gap in the literature 
and providing the groundwork for further studies within this population. 
The community college population is rarely a focus in the contraceptive literature. This project 
will be one of the first to examine contraceptive use in this population.  It will provide critical information 
on methods to increase LARC usage within this population.  Additionally, by showing that LARC usage 
is increased with same day on site placement, this study may help inform policies supporting the return 
of funding to student health clinics in Oregon.  We plan to provide on site LARC placement within 
facilities at Mount Hood Community College of Gresham, Oregon.  We will recruit female students and 
after informed consent randomize them to counseling with or without same day LARC placement.  Our 
primary outcome will be the proportion using a LARC method at 6 months, we plan to follow subjects 
for at least one year after to evaluate not only uptake but also the effect this has on their continuation in 
school.  Results of this study will inform future efforts in which follow-up of participants will include a 
greater number of years to assess certificate completion rate as well as to evaluate the financial/social 
impact on this population. 
 
 
4) 
Study Design  
 
This prospective randomized controlled study will evaluate if LARC forward counseling in 
combination with same-day LARC placement increases overall LARC uptake within a community 
college population compared to LARC forward counseling and referral to a secondary clinic for LARC 
placement.  The study will be conducted at Mount Hood Community College (MHCC) in Oregon.  
Currently, no opportunity exists to receive same-day LARC placement on-campus at MHCC, as no 


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student health clinic exists at this site. Currently, a space at MHCC is being remodeled into clinic space 
and an exam rom in which the research visits would take place. During the study period, the Principal 
Investigator (PI) or another provider listed on the study protocol will be present to place LARC devices 
to study participants. 
Participants will be enrolled into three groups. All groups will receive the same standardized 
contraceptive counseling (“LARC forward counseling”).  After the participant has made a decision to 
use a LARC method, she will be randomized to same day (intervention) or referral for (usual) LARC 
placement.   Participants who chose a short-acting hormonal method (e.g. contraceptive pills, ring, or 
patch) will receive a prescription to the pharmacy of their choice, as is the current practice for students 
who present for contraceptive services. For women that elect to use a vaginal diaphragm, the one size 
Caya device will be prescribed.  Women that chose non-LARC methods will be followed the same as 
women picking a LARC method, but will not be randomized. Included in the follow-up questionnaires 
will be a question on if they have experienced a pregnancy since their initial study visit and the outcome 
of that pregnancy, including termination.  
Baseline demographic information and reproductive health practices and knowledge will be 
obtained prior to contraceptive counseling. A post-placement survey completed three months after the 
initial visit and additional questionnaires at six and 12 months will be completed for all groups (see 
Appendix).  These questionnaires will be used to determine ongoing contraceptive use and satisfaction.   
 
Questionnaires will assess if participants: 
1) are still using the contraceptive method initiated at the study onset 
2) are happy with this method  
3) would recommend the method to a friend 
4) have had any unplanned pregnancies during the study period as well as the outcome of that 
pregnancy.   
In addition to the standard research participation consent, participants will be consented to allow 
our team access to electronic medical records for care outside of OHSU pertaining to pregnancy and 
contraception and to access their student records to confirm completion of their certificate at MHCC in 
the case that they are lost to follow up. 
 
Study Events by Study Arm 
 
Non-LARC 
group 
Control group 
Intervention 
group 
Encounter 1 
 
 
 
- Intake Questionnaire 
X 
X 
X 
- Informed Consent 
X 
X 
X 
- Enrollment 
X 
X 
X 
- Standardized “LARC forward” 
Counseling 
X 
X 
X 
-Participant chooses birth control 
method 
X 
X 
X 
-Randomization of participants 
choosing LARC 
- 
X 
X 
- Same-day LARC offered 
- 
- 
X 
- Post-LARC placement survey  
(3 months) 
X 
X 
X 
Encounter 2 
 
 
 
- 6-month Questionnaire 
X 
X 
X 
Encounter 3 
 
 
 
12-month Questionnaire 
X 
x 
x 
 


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5) 
Study Population 
a) Number of Subjects 
 
OHSU personnel will recruit all participants from MHCC. We anticipate that of all participants 
randomized to the control and intervention groups that desire a LARC, 60% in the control group will 
have had them placed by the 3-month follow-up and 85% in the intervention group will continue to be 
using their LARC method at the 3-month follow-up. Using PASS software, we determined that a sample 
size of 100 (50 in each of the control and intervention groups) allows us to determine this 25% 
difference in LARC uptake between groups (e.g., OR of 1.25) with an 80.9% power and an alpha of 
0.05.   
The CHOICE Study saw a 67% increase in LARC uptake with their interventions.  From this we 
anticipate that 70% of our study population will be interested in LARC.  We anticipate approximately 
150 total participants in the study if 30% choose short acting methods.  However, as the short acting 
arm of the study is for descriptive purposes only, we will not limit this arm to exactly 50 participants as 
in the control and experimental LARC arms of the study.  Given that we anticipate approximately 100 
screen fails, we anticipate approximately 250 participants will initially be enrolled in the study prior to 
screening. 
A second goal of this study is to estimate the difference in LARC uptake between the two 
populations.  Based on these same parameters and assumptions the study will enable us to report the 
difference in proportions with a precision (95.0% confidence level) of approximately plus/minus 0.17 
points. Specifically, an observed difference of 0.25 would be reported with a 95.0% confidence interval 
of 0.08 to 0.42. The precision estimated here is the approximate expected precision. 
Power calculations were not performed for our secondary outcomes as we anticipate that given 
the short time period of the study, they will be descriptive only.  
 
 
b) Inclusion and Exclusion Criteria 
Subjects: Subjects will be recruited from the female student population at Mount Hood Community 
College. All subjects will be pre-screened using the telephone screening script to ensure eligibility prior 
to signing consent and enrollment into the study.  
Inclusion criteria: 
1. English or Spanish-speaking women. 
2. 17-30 years of age. 
3. Currently enrolled in a 2-year certificate program at Mount Hood Community College. 
4. At risk for pregnancy (sexually active with men or anticipate becoming sexually active in the 
next 6 months). 
5. Do not desire pregnancy within the next 12 months. 
6. No contraindications to LARC according to the CDC MEC (medical eligibility criteria) [23][24].   
Exclusion criteria: 
1. Women who are not currently sexually active with men and who do not anticipate becoming 
sexually active with a male partner in the next 6 months.   
2. Women who have had a tubal ligation or other sterilization procedure.   
3. Women who desire pregnancy within the next 12 months. 
4. Women currently already using a LARC method for contraception. 
Any participant who does not meet the above inclusion and exclusion criteria will not be enrolled 
in the study and all PHI will be stored confidentially with the research study information in a 


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locked cabinet and archived with other study-specific documents at the close of the trial (see 
Privacy, Confidentiality, and Data Security for more information).  
 
c) Vulnerable Populations 
 
No vulnerable populations will be specifically recruited or included in this study. Subjects under the 
age of 18 may be enrolled in this study, but will not be considered a vulnerable population since 
research procedures involve providing birth control information and services. 
 
d) Setting 
 
This study will be conducted by OHSU personnel and will undergo an OHSU Institutional Review 
Board.  All participants will be recruited from Mount Hood Community College (MHCC) and the initial 
visit will occur on the MHCC campus.  MHCC does not have an IRB and no additional IRB approval will 
be required.  Participants will complete follow-up questionnaires online via REDCap.  The REDCap 
database will be maintained through OHSU and all analysis of study data will take place at OHSU. 
 
 
e) Recruitment Methods 
 
Participants will be recruited from MHCC through a combination of flyers on campus, emails, 
and mailed recruitment letters sent to all female students fitting our inclusion criteria. The MHCC 
Student Government has agreed to assist with this process.  With the assistance of the student 
government at MHCC, we will send recruitment letters to all eligible female students. Students will be 
eligible if they are enrolled in a 2-year certificate program at MHCC with at least one semester 
remaining, 17 – 30 years of age, and needing/ seeking contraception with no known contraindications 
to LARC, similar to the CHOICE study [11]. Informed written consent, including consent to obtain 
participants medical records concerning pregnancy, abortion and contraception via CareEverywhere 
and from surrounding clinics and hospitals, will be obtained. We anticipate a two-month recruitment 
process, during which time each of the above methods will be utilized once.  If adequate recruitment 
has not been achieved by this time, additional e-mails will be sent to eligible students.  Subjects that 
are interested in the study will be screened using a telephone script prior to enrollment in the study. 
Participants will receive a $50 gift card at time of enrollment if they qualify for the study and 
agree to participate.  They will receive an additional $10 gift card for completion of the 3 and 6 month- 
questionnaires and an additional $50 at the completion of the 12-month questionnaire if they have 
completed all 3 questionnaires. Participants completing the final questionnaire who have missed one or 
more previous questionnaires will receive a $10 gift card for each questionnaire they completed but not 
the total $120 available to participants who complete all questionnaires.   
 
f) Consent Process 
 
After initial intake confirming potential participants fit our inclusion and exclusion criteria (see 
above), individual students will attend their first research appointment at the MHCC health clinic space 
and complete an informed consent form confirming their participation in the initial study visit and their 
willingness to be contacted for follow-up questionnaires for up to one year after their initial visit. The 
consent will include pregnancy testing for all participants, and explanation of the randomization process 
and allowing for follow-up questionnaires for a minimum of 12 months after their enrollment in the 
study, with the potential for an additional 2 years of follow-up.  A one page, plain language description 
of the project will be provided to all participants upon initial presentation.  This will include an 
explanation that participants may withdraw from the study at any time if they so chose.  The study 
coordinator, PI or co-investigator will then be available to answer any additional questions the 
participant may have concerning the study.    


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All questionnaires will be conducted electronically via REDCap.  Participants will be initially 
contacted via e-mail with a link to the follow-up questionnaires.  They will receive weekly reminder e-
mails via the REDCap system.  If they have not completed their questionnaire within 30 days of the first 
reminder, they will be contacted via phone by study personnel and a reminder with the REDCap 
website will be mailed to them if they cannot be reached by phone.   
 
Modifications to the Consent Process  
 
All participants will be consented with an OHSU IRB approved consent form at the start of the 
study to receive the LARC forward counseling and choose a method of birth control, once eligibility is 
confirmed.  Consents will take place prior to randomization.  For participants who chose a LARC 
method and are randomized to same day placement, they will then be consented using the 
manufacturer’s standard consent form for the LARC device of their choosing at the time of placement. 
 
Non-English Speaking Subjects 
 
All documentation and consents will be available in both English and Spanish to provide 
participants with documentation in their primary language.   
 
Assent of Children and Parent Permission 
 
No minors will be included in this study and parental permission is not required. 
 
Adults Unable to Consent/Decisionally Impaired 
 
All participants in the study must be capable of informed consent for themselves. 
 
6) 
Procedures 
 
 
Potential participants who respond to recruitment methods will be screened over the phone by 
study staff to verify they meet basic inclusion and exclusion criteria, including absolute contraindications 
to IUD and Nexplanon usage.  This will take about 15 minutes.  If they meet criteria they will then 
scheduled for their initial intake visit.  Every effort will be made to schedule participants not currently on 
a highly effective form of contraception during the first two weeks of their menstrual cycle to facilitate 
same day placement.   
At the initial visit, participants will be consented for the study and an initial questionnaire 
including demographic information (age, race, BMI, obstetric history, sexual history, prior contraceptive 
use, current contraceptive use) and contraceptive knowledge (efficacy of sterilization, LARC methods, 
Depo-Provera, pills/patches/ring, condoms and withdrawal) will be administered.  The participants will 
then watch a standard LARC forward counseling video (available at http://larcfirst.com/sessions.html).  
After the counseling video is complete, either the PI, co-investigator or Research Coordinator will then 
discuss with the participant their contraceptive method of choice, establish if they have any 
contraindications to that method and answer any questions they have concerning their contraceptive 
options.  Participants desiring a short acting method such as pills, the patch or the ring will be provided 
with a prescription to be filled at their convenience.  Participants desiring Depo-Provera will receive 
their first injection at that time with a prescription for repeat injections every 3 months to be received at 
one of the surrounding clinics.  All participants requesting a short-acting method will receive the same 
list of local clinics as the delayed LARC placement group for their reference for future refills, Depo-
Provera injections or if they desire a LARC at a future date. For participants choosing LARC methods, 
they will then be randomized to either the same day placement group or the control group using block 
randomization of groups of 6 and 8. Those randomized to the same day placement group will receive 
their method of choice that day (or within 2 weeks at their convenience) on the MHCC campus within 


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the designated research space.  For participants randomized to the control group, they will receive a 
listing of local clinics with the capability to place the device of their choice.  The initial visit will take 
between 1-2 hours depending on the method of birth control they choose, and which group they are 
randomized into. 
 
Participants will receive a 3-month follow-up questionnaire asking what contraceptive method 
they chose at their initial visit and if they received this method to evaluate if those participants in the 
control group did in fact pursue LARC placement at another facility as well as to assess the expulsion 
and discontinuation rates of the same day placement group.  All participants will receive 6- and 12-
month follow-up questionnaires to evaluate our secondary and intermediate objectives.  Multiple 
attempts will be made to contact each participant over a 2-month period, including reminder emails and 
phone calls to participants who have not completed their follow-up surveys.  If they do not respond 
within a 60-day window, after the target completion date they will be considered lost to follow-up for that 
survey period and their EMR data and MHCC student data will be used for that period only.  
Participants who do not respond to the six-month questionnaire will again be contacted to complete the 
12-month questionnaire.  Each survey will take about 10 minutes to complete. 
 
Study participation will last approximately one year.  Patients have the right to withdraw from the 
study at any time.  The reason for their withdrawal will be recorded if known.  Additionally, as this is 
frequently a transient population we may have a proportion of our sample that is lost to follow-up and 
not available for inclusion in our secondary aims.  Participants who choose to discontinue their LARC 
device will not be discontinued from the study, but the timing and reason for removal will be 
documented within the study.  Removal of devices is not included within the scope of the study 
protocol. 
 
7) 
Data and Specimens 
a) Handling of Data and Specimens 
 
All participant responses will be de-identified, assigned a randomly generated study ID number 
and stored in a secure database for analysis. We will use REDCap, an online data management 
platform, for the initial intake questionnaire and to screen for eligibility for study participation.  All follow-
up questionnaires will also be administered via REDCap, both to allow the participant to maintain 
confidentiality and to allow them to access the questionnaires even after they have graduated and/or 
moved from the local area.  
No laboratory evaluations will be conducted as part of this study except for a urine pregnancy 
test. Other evaluations will take place according to standard of care but will not be study related. 
Specifically, for participants enrolled in the same day placement group, all will receive urine 
GC/Chlamydia testing per standard of care.  Additionally, for those participants choosing an IUD who 
require a pap smear, these will be performed at the time of their pelvic exam.  Participants requiring 
further follow-up based on their pap results will be referred to their PCP for further management. 
 
b) Sharing of Results with Subjects 
 
We anticipate sharing the de-identified results of the study with MHCC prior to publication, 
specifically any information on student certificate completion and student satisfaction with having an on-
site reproductive health clinic. 
 
Additionally, for participants in the same day placement group who undergo GC/CT or pap 
testing, the results of their tests will be provided to them.  All GC/CT and pap testing will be sent to 
OHSU to be performed at the OHSU lab. 
 
c) Data and Specimen Banking 
 
No specimen banking will be utilized in this study.  However, all data collected during the intake, initial 
visit and questionnaires will be stored in REDCap for future analysis. The de-identified results and data 


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will be stored in the WHRU Repository (IRB# 6748) and follow all storage guidelines and policies 
outlined by the repository.  
 
8) 
Data Analysis 
 
Our primary outcome of interest is the proportion of LARC uptake among women, by group 
assignment. This will be evaluated based on participants’ self-reported LARC usage on the 3-month 
questionnaire. Additional outcomes of interest will be evaluated using the 6- and 12-month follow-up 
questionnaires. 
 
Primary outcome:  
1. LARC uptake. This will be measured on the 3-month questionnaire and will be defined as the 
prevalence of LARC uptake in the study group after the initial visit. The 3-month questionnaire 
will be used to compare LARC uptake in the control and study groups using a test for two 
independent proportions (Chi Squared).  We will perform descriptive analyses of the 
demographic information obtained for each group. If there is a statistically significant difference 
in the demographics between the groups, we will instead us a logistic regression model to 
adjust for these confounders    
 
Secondary outcomes:  
3. Unplanned pregnancy rate. Unplanned pregnancy will be defined as any pregnancy while using 
a highly reliable form of birth control or any pregnancy defined as unplanned by participant 
questionnaire response. It will be measured at 6- and 12-months using the questionnaires. Data 
from CareEverywhere, a database that links multiple medical records, will be used to validate a 
subsample of self-report responses. (All groups)  However, the actual number of unplanned 
pregnancies in this study group is expected to be to small to perform any meaningful 
quantitative analysis. 
4. 2-year certificate completion rate and continuation of education will be measured both by 
participant self-reported questionnaire and student record review at MHCC.  Success will be 
defined as either certificate completion within the parameters defined by the college or 
continued enrollment in classes for those participants who were in their first year of study at the 
time of enrollment in the study. 
 
Intermediate outcomes: 
1. Continuation of birth control method: We will also measure the continuation rates of the birth 
control provided at the initial visit on the 6- and12-month questionnaires, the results of which will 
be used both for descriptive purposes and to evaluate LARC continuation rates at 12 months 
post placement. To evaluate this, we will perform a survival analysis using a Kaplan-Myer curve 
for the 3 groups and a Rogue Length Test will be used to compare the three curves for a 
significant difference between them.  Any discontinuation of the birth control method will be 
considered discontinuation, even if they have restarted their birth control method by the 
subsequent questionnaire. 
2. Life satisfaction. Life satisfaction will be measured using the participant responses provided in 
the 6- and 12-month follow-up questionnaires. Scores on this measure range from not at all, a 
little bit, somewhat, quite a bit, to very much and will be analyzed as a categorical variable using 
a Fischer’s exact test. (all groups). 
3.  Satisfaction with their birth control method will be measured by participant response to the 
question “How satisfied are you with your current method of birth control” with responses 
ranging from very satisfied, satisfied, somewhat satisfied, unsatisfied and very unsatisfied. 
 
Tests of hypotheses 


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The three -month follow-up questionnaires will be used to compare our primary outcome of 
LARC uptake between our two randomized groups.  We can use a test for two independent proportions 
(Chi-Squared) for this analysis assuming our two randomized groups are similar.  If there is a 
statistically significant differences in the two groups we will instead use a logistical regression model.  
We will estimate the effect of forward-counseling plus immediate placement on LARC uptake using 
logistic regression analysis. Odds Ratios and 95% confidence intervals will be generated.  We will also 
use a Chi-Squared analysis to evaluate demographic information we collected from participants and 
their contraceptive choices.  A multivariate analysis will be performed to control for age, socio-economic 
status, history of prior pregnancy termination and prior contraception usage if there is any significant 
difference in the 2 groups.  To determine socio-economic status, not only will we ask household income 
but we will also ask questions on parent’s education level and occupation, as well as if students are 
eligible for any government programs (such as food stamps and Section 8). We will also be looking at 
whether women continue to use the contraceptive method they initially chose and if they are still 
satisfied with this method (all groups).  To look at the change in usage and satisfaction between the 6- 
and 12-month questionnaires we will use a logistic mixed effects model. 
To calculate the unplanned pregnancy rate, we will use a Fisher exact test, as it can be 
considered a rare event.  However, we do not anticipate a large enough sample of events to perform 
any meaningful quantitative analysis. We will collect self-reported data from the participants on if they 
completed their course of study at the 12-month follow-up questionnaire.   Their completion/enrollment 
status will be confirmed with MHCC.  The difference between the two groups will be evaluated using a 
Chi-Squared test.  We will also obtain data from MHCC on their overall certificate completion rates in 
2015 (the year prior to initiating the study) compared to 2016-2017 (the years incorporated in the study) 
for descriptive purposes.  
 
9) 
Privacy, Confidentiality and Data Security 
 
Standard institutional practices will be followed as described in the OHSU Information Security 
and Research Data Resource Guide (http://ozone.ohsu.edu/cc/sec/isg/res_sec.pdf) to maintain the 
confidentiality and security of data collected in this study. Study staff will be trained with regard to these 
procedures. Paper files will be stored in locked filing cabinets in restricted access offices at OHSU and 
MHCC. Electronic data is stored on restricted drives on the OHSU network and stored in a web-
accessible REDCap database housed on an OHSU secure server. Access to data/specimens is 
restricted to study personnel. Access to data requires OHSU ID/password authentication. Upon 
enrollment, subjects will be assigned a code that will be used instead of their name, medical record 
number or other personally identifying information. Electronic files for data analysis will contain only the 
subject code. 
Codes will not contain any part of the 18 HIPAA identifiers (initials, DOB, MRN) The key 
associating the codes and the subjects personally identifying information will be restricted to the PI and 
study staff. The key will be kept secure on a restricted OHSU network drive a in a limited access folder. 
The collecting of PHI for phone screening follows HIPAA requirements and standard institutional 
practices and is stored in a confidential and secure manner. The phone screens are stored in a secure 
location and kept in a locked file or password-protected document on a password protected computer. 
This access is restricted to the study staff. Upon enrollment, the phone screening will be added to the 
protected research record and follow all coding procedures for that record.  
All telephone screenings and website submission forms will be stored in a locked office at 
OHSU and MHCC, with access limited to study staff. For subjects electing to enroll in the study, this 
information will become a part of their protected research record. For subjects choosing not to enroll or 
who screen fail, all PHI will be stored confidentially with the research study information in a locked 
cabinet and archived with other study-specific documents at the close of the trial. All potential 
participants that contact the department  for research studies will be added to a password-protected log 
listing their contact information, only accesible through OHSU password-protected computers by study 
staff. Phone screens (including for individuals who choose not to participate or are ineligible) and the 


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log containing potential participants’ information are saved  to ensure that our department has a record 
of contact with the participant and to monitor our recruitment outreach efforts. Confidentiality of 
personal health information will be maintained according to HIPAA requirements for research and all 
data will be kept in locked files or in a password-protected document on a password protected 
computer.  
 
10) 
Provisions to Monitor the Data to Ensure the Safety of Subjects 
 
The investigators and study staff are responsible for recording the data, and they will be 
verifying its accuracy throughout the process. Dr. Jacqueline Lamme, the PI, will be reviewing 
the data in-depth periodically throughout the study. The PI will also be overseeing that the study 
procedures are being carried out as per the approved protocol via close supervision of the study 
visit and procedures and through frequent communication with the other investigators and staff. 
Anytime that an AE, SAE, UP or protocol deviation is reported by an investigator or study staff, 
the PI will review and assess the data, and proceed as per OHSU reporting policy. Otherwise, 
the PI entity will be reviewing the records periodically throughout the study. All adverse events 
will be assessed and reportable UPs will be submitted to the IRB, if judged related to the study 
protocol.  All data will be stored within the REDCap database at the completion of the study for 
future analysis and stored in the WHRU Repository. 
 
 
11) Risks and Benefits  
a) Risks to Subjects 
 
Possible risks of the study include a low risk of breach of confidentiality.   
 
The Principal Investigator (Dr. Lamme) will oversee the project. A Research Coordinator will 
assist with participant recruitment, intake and enrollment, and LARC forward counseling sessions, and 
regulatory paperwork.  A licensed practitioner listed on the protocol (either the PI or additional 
investigators) will perform all birth control prescriptions or on-site insertion of LARC devices as per 
standard clinical practice. This study does not include any additional risks of these devices than those 
found during routine use.  All devices used within this study are FDA approved devices.  Any adverse 
events associated with the LARC placements (uterine perforations, device expulsion, infection, etc.) will 
be tracked in the password secured database with the other study data. This entry will be completed by 
the Research Coordinator and verified by the PI and reported to the Oregon Health and Science 
University (OHSU) Institutional Review Board (IRB).  Any complications requiring additional procedures 
(uterine perforation, etc.) will be managed by the PI and associated clinical staff at OHSU.  All 
participants who receive an IUD or Nexplanon device will be given a standard research clinic phone 
number, which they can call and be evaluated for complications and treated as indicated. 
 
b) Potential Benefits to Subjects 
 
Participants in the study will receive highly effective contraception counseling.  Those desiring a 
short acting method, with no contraindications to this method, will receive a written prescription for one 
year, which they can fill at a pharmacy of their choice.  For those participants choosing a LARC 
method, the 50 participants randomized to the same day placement group will receive the LARC device 
of their choice, free of charge, that day.  For the participants randomized to the delayed placement 
group, they will be provided resources including a list of local clinics that provide LARC placement 
either utilizing their insurance, Title X or CCare. 
Additionally, if the study shows that student retention is increased by providing on site LARC 
placement or that student satisfaction is increased by having an on site reproductive health clinic, this 


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data may help to support the inclusion of a Student Health Clinic within the newly planned Allied 
Healthcare building or elsewhere on campus. 
 
12) 
Drugs or Devices  
 
All birth control drugs and devices used within this study are FDA approved.  Please see appendix 
D-H for prescribing information on the devices that will be provided during the course of the study. 
 
1.8 References 
[1] 
Family Planning | Healthy People 2020 n.d. http://www.healthypeople.gov/2020/topics-
objectives/topic/family-planning (accessed January 25, 2016). 
[2] 
Harper CC, Rocca CH, Thompson KM, Morfesis J, Goodman S, Darney PD, et al. Reductions in 
pregnancy rates in the USA with long-acting reversible contraception: a cluster randomised trial. The 
Lancet 2015;386:562–8. doi:10.1016/S0140-6736(14)62460-0. 
[3] 
Secura GM, Allsworth JE, Madden T, Mullersman JL, Peipert JF. The Contraceptive CHOICE 
Project: reducing barriers to long-acting reversible contraception. Am J Obstet Gynecol 
2010;203:115.e1–7. doi:10.1016/j.ajog.2010.04.017. 
[4] 
Finer LB, Zolna MR. Shifts in Intended and Unintended Pregnancies in the United States, 2001–
2008. Am J Public Health 2014;104:S43–8. doi:10.2105/AJPH.2013.301416. 
[5] 
Jones et al. Contraceptive Use in the United States n.d. 
http://www.guttmacher.org/pubs/fb_contr_use.html (accessed August 24, 2015). 
[6] 
Finer LB, Jerman J, Kavanaugh ML. Changes in use of long-acting contraceptive methods in 
the United States, 2007–2009. Fertil Steril 2012;98:893–7. doi:10.1016/j.fertnstert.2012.06.027. 
[7] 
Jones et al. National Health Statistics Reports, Number 60 October 18, 2012 - nhsr060.pdf n.d. 
http://www.cdc.gov/nchs/data/nhsr/nhsr060.pdf (accessed August 24, 2015). 
[8] 
Bednarek PH, Creinin MD, Reeves MF, Cwiak C, Espey E, Jensen JT. Immediate versus 
Delayed IUD Insertion after Uterine Aspiration. N Engl J Med 2011;364:2208–17. 
doi:10.1056/NEJMoa1011600. 
[9] 
Laska MN, Pasch KE, Lust K, Story M, Ehlinger E. The differential prevalence of obesity and 
related behaviors in two vs. four-year colleges. Obes Silver Spring Md 2011;19:453–6. 
doi:10.1038/oby.2010.262. 
[10] 
Reproductive Health Technologies Project. Two Sides of the Same Coin: Integrating Economic 
and Reproductive Justice. 2015. 
[11] 
personal communication. Personal Communication with Dean of Student Affairs Mount Hood 
Community College n.d. 
[12] 
Sonfield A. Popularity Disparity: Attitudes About the IUD in Europe and the United States n.d. 
https://www.guttmacher.org/pubs/gpr/10/4/gpr100419.html (accessed December 11, 2015). 
[13] 
Mcnicholas C, Madden T, Secura G, Peipert JF. The Contraceptive CHOICE Project Round Up: 
What We Did and What We Learned. Clin Obstet Gynecol 2014;57:635–43. 
doi:10.1097/GRF.0000000000000070. 
[14] 
State Facts About Unintended Pregnancy: Oregon - OR.pdf n.d. 
http://www.guttmacher.org/statecenter/unintended-pregnancy/pdf/OR.pdf (accessed November 21, 
2015). 
[15] 
Title X Family Planning n.d. http://www.hhs.gov/opa/title-x-family-planning/index.html (accessed 
November 23, 2015). 
[16] 
Program Requirements for Title X Funded Family Planning Projects - ogc-cleared-final-april.pdf 
n.d. http://www.hhs.gov/opa/pdfs/ogc-cleared-final-april.pdf (accessed November 23, 2015). 
[17] 
Income, Poverty and Health Insurance Coverage in the U.S.: 2013 n.d. 
http://census.gov/newsroom/press-releases/2014/cb14-169.html (accessed November 23, 2015). 
[18] 
What is CCare? | Oregon CCare n.d. 
http://public.health.oregon.gov/HealthyPeopleFamilies/ReproductiveSexualHealth/OregonContraceptive
Care/Pages/whatsavailable_t1.aspx (accessed November 23, 2015). 


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[19] 
Sonfield A. The Case for Insurance Coverage of Contraceptive Services And Supplies Without 
Cost-Sharing - gpr140107.pdf n.d. https://www.guttmacher.org/pubs/gpr/14/1/gpr140107.pdf (accessed 
December 12, 2015). 
[20] 
Grady CD, Dehlendorf C, Cohen ED, Schwarz EB, Borrero S. Racial and ethnic differences in 
contraceptive use among women who desire no future children, 2006–2010 National Survey of Family 
Growth. Contraception 2015;92:62–70. doi:10.1016/j.contraception.2015.03.017. 
[21] 
Gilmore K, Hoopes AJ, Cady J, Amies Oelschlager A-M, Prager S, Vander Stoep A. Providing 
long-acting reversible contraception services in Seattle school-based health centers: key themes for 
facilitating implementation. J Adolesc Health Off Publ Soc Adolesc Med 2015;56:658–65. 
doi:10.1016/j.jadohealth.2015.02.016. 
[22] 
Mt. Hood Community College - MHCC - The College Board n.d. 
https://bigfuture.collegeboard.org/college-university-search/mt-hood-community-college# (accessed 
July 28, 2015). 
[23] 
Mt Hood Community College n.d. http://www.educationnews.org/career-index/mt-hood-
community-college/ (accessed July 28, 2015). 
[24] 
Levi EE, Stuart GS, Zerden ML, Garrett JM, Bryant AG. Intrauterine Device Placement During 
Cesarean Delivery and Continued Use 6 Months Postpartum: A Randomized Controlled Trial. Obstet 
Gynecol 2015;126:5–11. doi:10.1097/AOG.0000000000000882. 
[25] 
Medical Eligibility Criteria for Contraceptive Use. World Health Organization; 2015. 


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APPENDICES 
Appendix A: Initial Intake questionnaire 
 
Initial Study Intake and Clinical Questionnaire 
 
Patient Information 
LAST NAME: 
 
FIRST NAME: 
TODAY’S DATE: 
DATE OF BIRTH: 
 
AGE: 
 
ETHNICITY: 
___ Not Hispanic or Latino 
___ Hispanic or Latino 
___ Not reported 
RACE: 
___ White 
___ Black 
___ Asian 
___ American Indian or  
Alaska Native 
 
___ Native Hawaiian or Other    
Pacific Islander 
___ Other:______________ 
___ Declines 
PRIMARY GYN HEALTHCARE PROVIDER: 
INSURANCE COMPANY: 
 
 
Smoking History 
SMOKER 
_________Yes    
_________No 
If yes, for how many years? 
Current # of cigarettes 
_________per day/week 
 
 
Socioeconomic status: 
Please answer the below questions for YOURSELF 
What is your employment 
status? (choose only one) 
 
___Employed full-time 
___Employed part-time 
___Unemployed 
___Other:                     
What is your yearly income? (choose  
only one) 
___10,000 or less  ($833 per month or 
less) 
____$10,001 – $30,000 ($834 - $2,500 
per month) 
____$30,001 - $50,00 ($2,501 - $4,166 
per month) 
____$50,001 - $70,000 ($4,167 - $5,833  
            per month) 
____$70,001 - $100,000 ($5,834-$8,333 
per month) 
____More than $100,000 (more 
than$8,334 per month) 
____Don’t know 
How many people 
living in your 
household are 
supported by this 
income (including 
subject)? __________ 
 
____ Don’t know 
 
 
 


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Socioeconomic status: 
Please answer the below questions for your PARENTS 
What is your mother’s employment status? 
____Employed full-time 
____Employed part-time 
____Unemployed 
____Other 
____Don’t know 
 
What is your father’s employment status? 
____Employed full-time 
____Employed part-time 
____Unemployed 
____Other 
____Don’t know 
What is your family’s yearly household 
income? (choose only one) 
___10,000 or less  ($833 per month or less) 
____$10,001 – $30,000 ($834 - $2,500 per 
        month) 
____$30,001 - $50,00 ($2,501 - $4,166 per  
         month) 
____$50,001 - $70,000 ($4,167 - $5,833 per 
month) 
____$70,001 - $100,000 ($5,834 – $8,333 per 
month) 
____More than $100,000 (more than $8,334 per 
month) 
____Don’t know 
How many years of school did your mother 
complete? 
____Less than 8 
____Some high school (9-11 years) 
____High school of GED (12 years) 
____ Some college or associate’s degree or 
Technical school 
___College (Bachelor’s Degree) 
____ Graduate or professional school 
____ Other, specify: ____ 
____ Don’t know 
 
How many years of school did your father 
complete? 
____Less than 8 
____Some high school (9-11 years) 
____High school of GED (12 years) 
____ Some college or associate’s degree or 
Technical school 
___College (Bachelor’s Degree) 
____ Graduate or professional school 
____ Other, specify: ____ 
____ Don’t know 
How many people living in your household 
are supported by this income (including 
subject)? _____________________ 
 
_____ Don’t know 
 
 
 
 
 
 
Contraception Information 
Current Contraception: 
 
Consistent use: 
Date of last use: 


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         __________Yes     ____________No 
_______/______/______ 
How long has participant been using this method? 
       _____________ years  _____________months  _____________days 
Desired Method(s) (check all that apply): 
____ Hormonal IUD 
____ Copper IUD 
____ Diaphragm 
____Patch 
____ Birth Control Shot     ____ Birth Control Pill 
____ Vaginal Ring 
____Nothing 
____ Condoms 
____ Implant 
Other (specify):  
 
 
Contraception Knowledge 
Please rank the below methods of birth control from most effective to least effective  
(#1 is most effective and #10 is least effective) 
 
Birth Control Pill 
 
Condoms 
 
Patch 
 
Implant 
 
Birth control shot 
 
Rhythm method 
 
Hormonal IUD 
 
Copper IUD 
 
Diaphragm 
 
Nothing 
 
Vaginal Ring 
 
Other (specify): ________________________________________________  
 
 
Gynecological History 
Last Menstrual Period (LMP):  ____/____/_______ (MM/DD/YYYY) 
                           ______ Too long ago to remember   ______ Have never had a period 
Periods are:                                  ______ Regular                             _____ Irregular 
Periods come every: 
_____ to _____ days 
_____Too irregular to tell 
Periods are painful: 
_____ Yes 
_____ No 
Flow is: 
_____ Light    ____Normal  
_____ Heavy 
Bleeding lasts: 
______ to _____days 
_____ Too irregular to tell 
Last Intercourse: ____/____/____ (MM/DD/YYYY) 
 _____ Used a condom 
Year of last Pap Smear:  ____/____/_____         _____ Unknown      _______ Never had a pap 
Result of last pap:           _______Normal      _______ Abnormal      _______ Unknown 
 
 
If Currently Pregnant 
Gestational Week: __________                                         Estimated Due Date: ___________ 
Obstetrical History 
Number of pregnancies: ___________                 Date(s): 
# of term births (>37 weeks): _________             Date(s): 
# of premature births (<37 weeks): __________  Date(s): 


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# of miscarriages (< 20 weeks): ___________      Date(s): 
# of stillbirths (>20 weeks):  _________               Date(s): 
# of elective abortions: __________                     Date(s): 
# of ectopic pregnancies: _______                        Date(s): 
 
 
Infection History 
Have you ever had or do you currently have any of the following Infections?  (Check all that 
apply) 
___ Gonorrhea  
Date(s) diagnosed: 
Dates treated: 
___ Chlamydia 
Date(s) diagnosed: 
Dates treated: 
___ Trichomoniasis 
Date(s) diagnosed: 
Dates treated: 
___ Syphilis 
Date(s) diagnosed: 
Dates treated: 
___ Genital Herpes 
Date(s) diagnosed: 
Do you take medication for it? 
If yes, what? 
___ Genital Warts 
Date(s) diagnosed: 
Dates treated: 
___ HPV 
Date(s) diagnosed: 
Has it resolved? 
If yes, when? 
___ Bacterial    
Vaginosis 
Date(s) diagnosed: 
Dates treated: 
 
 
Allergies 
Allergies 
_______ No Known Drug Allergies 
1. 
2. 
3. 
 
 
Current Medications 
Medication 
Dose 
How many times a day? 
1. 
 
 
2. 
 
 
3. 
 
 
4. 
 
 
 
 
Surgical History 
Surgery 
Year Performed 
 
 
 
 
 
 
 
 
Medical History 


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Have you ever had any of the following? 
 
 
 
Currently Being Treated? 
Condition 
No 
Yes 
No 
Yes 
Resolved 
N/A 
Cancer 
         Type: ____________________ 
 
 
 
 
 
 
HIV: 
 
 
 
 
 
 
Hypertension: 
 
 
 
 
 
 
Heart attack: 
 
 
 
 
 
 
Stroke/CVA/TIA: 
 
 
 
 
 
 
Migraines: 
     If yes, with Aura: 
 
 
 
 
 
 
High Cholesterol 
 
 
 
 
 
 
Blood Clot (thromboembolism): 
 
 
 
 
 
 
Diabetes: 
 
 
 
 
 
 
Gestational Diabetes: 
 
 
 
 
 
 
Thyroid problems: 
 
 
 
 
 
 
Liver Disease: 
 
 
 
 
 
 
Pelvic infection (PID): 
 
 
 
 
 
 
Abnormal Vaginal Bleeding: 
 
 
 
 
 
 
Uterine Fibroids: 
 
 
 
 
 
 
Uterine Abnormalities 
 
 
 
 
 
 
Depression Anxiety: 
 
 
 
 
 
 
Wilson’s Disease: 
 
 
 
 
 
 
Other: 
 
 
 
 
 
 
 
 
General Health Information 
HEIGHT 
________feet 
________inches 
WEIGHT (LBS) 
BLOOD PRESSURE 
_______/______mmHg 
URINE PREGNANCY 
TEST 
 
 
_________Negative 
_______ Positive.  Explain: 
_______Not done because pregnancy terminated/miscarriage in last 4 weeks (circle) 
_______Not done because patient currently pregnant 
NOTES: 
 
 
 
 
 
Signatures 
Form Completed by: ________________________________________________________ 
             Signature:  __________________________________ Date: _______/_______/_______ 
Form Reviewed by: ________________________________________________________ 


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             Signature:  __________________________________ Date: _______/_______/_______ 
Method Approved? 
_________Yes 
 ________ No 
If no, explain: 
 
 
 
 
 
Appendix B: Counseling video (go to http://larcfirst.com/sessions.html) 
 
Appendix C: Post-counseling video script  
 
Post-video script to be read by PI, co-investigator or Research Coordinator after participant has finished 
watching the LARCFirst video. 
 
“The video you just watched discussed the different types of birth control options available.  One 
clarification that we would like to mention is that there are now two types of hormonal IUD available.  
They both contain the same hormone, levonorgestral and work in the same manner. The Mirena IUD 
was the one mentioned in the video and is good for 5 years.  The Skyla IUD has the same hormone but 
is slightly smaller, has a lower dose of hormone, and is good for 3 years not 5.  If you think you are 
interested in a hormonal IUD for birth control, we can talk about these options in more detail. 
Do you have any questions about the methods of birth control discussed in the video? 
Which of the types of birth control discussed do you think would be right for you?” 
 
Appendix D: Prescribing information for Nexplanon 
(http://www.merck.com/product/usa/pi_circulars/n/nexplanon/nexplanon_pi.pdf) 
 
Appendix E: Prescribing information for Paragard (http://www.drugs.com/pro/paragard.html) 
 
Appendix F: Prescribing information for Mirena 
(http://labeling.bayerhealthcare.com/html/products/pi/Mirena_PI.pdf) 
 
Appendix G: Prescribing information for Depo-Provera (http://www.drugs.com/pro/depo-provera.html) 
 
Appendix H: Prescribing information for Skyla 
(http://labeling.bayerhealthcare.com/html/products/pi/Skyla_PI.pdf) 
 
Appendix I: Letter of support from Mount Hood Community College (MHCC) 
 
 
 
 
Mt. Hood Community College 
Student Union  
David Sussman, Manager 
26000 SE Stark Street 
Gresham, OR 97030 
Phone: 503-491-7258 · Fax: 503-
491-6077 
Email: david.sussman@mhcc.edu 
 
December 1, 2015 
 
To: Jacqueline Lamme 
 


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Re: Research Collaboration 
  
I am pleased to support your research proposal titled “Effectiveness of LARC Forward Contraceptive 
Counseling and Same Day Placement in a Community College Population: A Randomized Intervention 
Project.”  
 
This project intends to increase the usage of Long Acting Reversible Contraception (LARC) within the 
Community College population at Mt. Hood Community College (MHCC) with the goal of decreasing 
unplanned pregnancies and increasing certificate and degree completion rates within this population.  
This research project benefits the female student population at MHCC and we are very excited about 
the potential to support it through our participation. 
 
At this time, we anticipate that our College’s current community partner, Wallace Medical Concern, will 
be using their Mobile Healthcare Van to place intrauterine devices in study participants who desire that 
method of birth control.  This will be done on the day that the mobile van is already present on the 
MHCC campus.  Administrative portions of the study (participant enrollment, counseling, provision of 
other types of birth control not requiring a pelvic exam) will be performed in administrative offices 
provided by MHCC, not Wallace Medical Concern.  The Associated Student Government of MHCC will 
assist in distributing promotional materials to eligible female students at MHCC 
 
Again, we are very enthusiastic to support this mutually beneficial community research project through 
this partnership, and we look forward to collaborating with you on this work. Best of luck with your grant 
application. 
 
If you have any questions, or if I can be of any help, please feel free to contact me. 
 
Sincerely, 
 
David Sussman 
 
David Sussman 
Manager, Student Union, Student Life, and Specialized Student Services 
Mt. Hood Community College 
 
 
 
Appendix J:  Follow-up questionnaire (3-month) 
 
3-Month Questionnaire 
 
1) What method of birth control did you receive on the day of your first study visit? 
___Birth Control Pill Prescription 
___Hormonal IUD (Mirena, Skyla) 
___Copper IUD (Paragard) 
___Birth Control Shot 
___Implant 
___Vaginal Ring Prescription 
___Birth Control Patch Prescription 
___Diaphragm 
___Condoms 
___Referral information for IUD/Implant placement at a different clinic 
___Other: 
 


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2) Did you go to another clinic to get your birth control method? 
___Yes 
___No 
If yes, where: 
 
3) Are you still using this method of birth control? 
___Yes 
___No 
If no, why not? 
 
4) Are you happy with your current method of birth control? 
___Yes 
___No 
If no, why not? 
 
5) Have you seen a healthcare provider in the last 3 months because of problems or concerns 
about your birth control method? 
___Yes 
___No 
If Yes, describe concerns/problem: 
(We may follow up with you to collect more information about this) 
 
6) Did you like having the clinic available on campus to find out about birth control options and 
receive them? 
___Yes 
___No 
What did you like about this setup? 
 
 
Appendix K: Follow-up questionnaire (6- and 12-month) 
 
6 and 12-Month Questionnaire 
1) What method of birth control did you receive on the day of your first study visit? 
___Birth Control Pill Prescription 
___Hormonal IUD (Mirena, Skyla) 
___Copper IUD (Paragard) 
___Birth Control Shot 
___Implant 
___Vaginal Ring Prescription 
___Birth Control Patch Prescription 
___Diaphragm 
___Condoms 
___ Referral information for IUD/Implant placement at a different clinic  
___Other: 
 
2) Did you go to another clinic to get your birth control method? 
___Yes 
___No 
If yes, where: 
 
3) Are you still using this method of birth control? 
___Yes 


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___No 
If no, why not? 
 
4) If no, when did you stop using the birth control method provided at your initial visit? 
Date:  
 
 
5) How satisfied are you with your current method of birth control? 
__Very satisfied 
__Satisfied 
__Somewhat satisfied 
__Unsatisfied 
___Very unsatisfied 
 
7) Would you recommend this method of birth control to a friend? 
___Yes 
___No 
If no, why not? 
 
8) Have you seen a healthcare provider since your first study visit because of problems or concerns 
about your birth control method? 
___Yes 
___No 
If Yes, describe concerns/problem: 
(We may follow up with you to collect more information about this) 
 
 
9) I am content with the quality of my life right now. 
__Not at all 
__A little bit 
__Somewhat  
__Quite a bit 
___Very much 
 
10) Have you completed your certificate in your area of study at MHCC? 
__Yes.  Go to #11 
__No.  Go to #10 
 
11) If no, are you still enrolled in school? 
__Yes 
__No 
If no, why not? 
 
12) Are you planning further education? 
___Yes 
___No 
 
13) Have you become pregnant since enrolling in the study? 
___Yes, go to question 13 
___No, stop questionnaire 
 
14) If yes, what was the date of your last period before that pregnancy? 


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15) If yes, what was the outcome of that pregnancy? 
___Miscarriage 
___Abortion 
___Delivery 
 
16) Where did you receive care for the above pregnancy? 
 
 
17) Were you using the birth control you received at your initial visit when you became pregnant? 
___Yes, stop questionnaire 
___No, go to question #16 
 
18) What method of birth control where you using when you became pregnant? 
___Birth Control Pill 
___Hormonal IUD  
___Copper IUD 
___Birth Control Shot 
___Implant 
___Vaginal Ring 
___Birth Control Patch 
___Diaphragm 
___Condoms 
___Nothing 
___Other: 
 
Appendix L: Supplemental Student Questionnaire 
 
Due to unforeseen enrollment challenges with this study, an anonymous survey will be distributed to Mt 
Hood Community College students to gather information to better understand the lack of enrollment.  
The survey will be distributed electronically via Qualtrix.  An invite to participate in the survey will be 
sent to students via email, MHCC student life app, the MHCC Facebook page, and in person to 
students at tabling events on campus.  For use of the MHCC student life app and Facebook page, the 
“email/social media” text will be used as the post with a link to the survey.  The first page of the 
electronic survey will be an information sheet and the first question will be asking them to agree to 
participate in the survey.   
 
 
Appendix M: Elimination of Month 6 and Month 12 surveys 
 
Due to unforeseen enrollment challenges that resulted in enrolling 3 students in the study, who each 
selected a SARC method of birth control, the follow data collection will be limited to 3 month surveys 
only.  The 3 month surveys will be useful for understanding student’s perception of the Birth Control 
Resource Center.  The 6 month and 12 month surveys are not considered necessary at this point, due 
to the low enrollment number, and the lack of enrollment in the LARC arm.  All currently enrolled 
subjects will be notified of this change in the study protocol.