Improving Reproductive Health for Women in Opioid Medication-Assisted Treatment (OMAT)
Phase: NA
Conditions: Contraception
Sponsor: Denver Health and Hospital Authority

PI: Deborah Rinehart, Ph.D., M.A. 
Page 1 
COMIRB Protocol 15-1236 
 
 
COMIRB Protocol 
 
PROTOCOL #   
15-1236 
NCT02794597 
COLORADO MULTIPLE INSTITUTIONAL REVIEW BOARD 
CAMPUS BOX F-490    TELEPHONE:  303-724-1055 Fax:  303-724-0990 
 
 
Project Title: Improving Reproductive Health for Women in Opioid Medication-
Assisted Treatment (OMAT)   
 
 
 
 
Principal Investigator: Deborah Rinehart, PhD, MA 
 
 
Version: 4 
 
Date: 3.9.18  
 
  
 
I. Hypotheses and Specific Aims:   
 Developing effective reproductive health interventions for women in treatment for 
substance use disorders has tremendous potential to improve the health of women and 
children.  In the US nearly half (51%) of all pregnancies are unplanned (L. B. Finer & 
Zolna, 2014).  A recent study of pregnant women entering opioid medication-assisted 
treatment found much higher proportions – 86% described their current pregnancy as 
being unintended and about a third of these pregnancies were described as being 
unwanted (Heil et al., 2011).  Women with unintended pregnancies had higher rates of 
recent substance use and almost all (90%) had a history of prior treatment for substance 
use disorders.  Thus, substance use treatment programs are promising venues for 
addressing contraception. 
Although there is a paucity of interventions specifically focused on preventing 
unintended pregnancies among women with substance use disorders, prior research from 
the addiction treatment and reproductive health fields provides relevant guidance for 
selecting key intervention elements.  The addiction treatment field has an established 
history of using peers to support recovery (White, 2004).  Peers have been used in 
effective HIV prevention interventions with vulnerable and hard to reach populations(Kelly, 
2004; Kelly et al., 1991) and with adolescents (Brindis, Geierstanger, Wilcox, McCarter, & 
Hubbard, 2005; Key, Gebregziabher, Marsh, & O'Rourke, 2008).  Involving individuals 
with similar life experiences may foster trust in intervention programs and increase 
sensitivity to the perspectives of the individuals in the target population. Thus, we propose 
to involve peers in a contraceptive and reproductive health education among women in 
treatment settings.  
Long-acting reversible contraceptive (LARC) methods, such as intrauterine 
devices and subdermal implants, are considered the most effective method of reducing 
rates of unintended pregnancies (American College of Obstetricians and Gynecologists 
Committe Opinion no 450, 2009; Trussel et al., 2009; Trussell, 2012).  Yet little is known 
about LARC use among women who use substances.  LARCs are likely to be acceptable 
among this population as national data indicate similar rates of LARC use among low 
income women (6.1%) and women on Medicaid (6.7%) compared to all women using 
contraception (5.6%) (Kavanaugh, Jerman, Hubacher, Kost, & Finer, 2011).  Furthermore, 
a recent Colorado Initiative promoting LARC use found an increase in uptake (5%-19%) 
among young low-income women (Ricketts, Klingler, & Schwalberg, 2014) and another 

PI: Deborah Rinehart, Ph.D., M.A. 
Page 2 
COMIRB Protocol 15-1236 
 
study among women seeking contraception found high rates (70%) of LARC acceptance 
(Mestad et al., 2011).   
This study proposes to draw upon behavioral theory and prior evidence-based 
interventions to develop an innovative brief peer-led intervention to increase LARC uptake 
for women of child-bearing age entering opioid medication-assisted treatment (OMAT).   
The Health Belief Model HBM (Rosenstock, 1974) will be used to guide intervention 
development.  HBM is a multidimensional social cognitive framework that focuses on 
modifiable factors related to decision making and behavior and was recently 
operationalized specifically to support current contraceptive research and practice.(Hall, 
2012).   
The study will utilize a mixed methods approach and involve two phases. The first 
phase will be a formative evaluation that will include individual qualitative interviews and 
focus groups with women in OMAT; the resulting information will be coupled with prior 
evidence and theory to develop the structure of the intervention.   The second phase will 
involve the piloting and implementation of a peer-led sexual health intervention with 
women in OMAT. Women (150) will be recruited from two clinic sites and randomized to 
usual care (N=80) or intervention (N=80). 
 
Aim 1. To develop a brief theory-based peer-led intervention to prevent unintended 
pregnancies among women entering opioid medication-assisted treatment.  
a. Conduct up to 30 individual qualitative interviews to better understand: 
pregnancy desires/motivation and perceived susceptibility and severity; and 
contraceptive knowledge, perceived benefits/barriers, self-efficacy, social norms, 
behaviors and access to contraception and family planning services, especially 
related to LARCs.  
b. Combine information from the qualitative interviews with HBM theory and results 
of prior research to specify the peer-led intervention.  
c. Assess acceptability and feasibility of the intervention in two focus groups and 
refine.  
d. Pilot the intervention with 10 women and finalize.  
Aim 2. To assess acceptability, feasibility and the initial efficacy of the behavioral 
intervention (n=75) as compared to usual care in substance use treatment (n=75).  
Aim 3. To conduct exploratory analyses to identify HBM constructs that are the most 
influential on LARC use 
Hypothesis 1. Participants randomized to the intervention will be more likely to follow-up 
with a family planning clinic visit. 
Hypothesis 2. Participants randomized to the intervention will be more likely to initiate 
Long Acting Reversible Contraceptive (LARCS) methods. 
 
II. Background and Significance:  
Unintended pregnancies and public health.  Reducing unintended pregnancies is 
an important public health concern and is a national health goal that has been identified 
by the U.S. Department of Health and Human Services’, Healthy People 2020 campaign. 
In 2008, about half (51%) of the pregnancies in the US were unintended (L. B. Finer & 
Zolna, 2014).  Additionally, disparities in unintended pregnancy rates exist for low income 
women, women with less than a high school education and minority women (L. B. Finer & 
Zolna, 2014).  Unintended pregnancies have both financial and public health impacts.  It is 
estimated that unintended pregnancies cost US taxpayers approximately $11 billion 

PI: Deborah Rinehart, Ph.D., M.A. 
Page 3 
COMIRB Protocol 15-1236 
 
dollars a year (Sonfield, Kost, Gold, & Finer, 2011).  This is most likely a conservative 
estimate as costs were limited to public insurance costs for pregnancy and first-year infant 
care. Additionally, unintended pregnancies can lead to unintended childbearing, which is 
associated with adverse maternal behaviors before pregnancy is known, such as delayed 
or inadequate prenatal care, and/or substance use during pregnancy (L. B. Finer & 
Henshaw, 2006).  
Unintended pregnancies in women who use substances.  Studies suggest that 
unintended pregnancy rates are much higher among women with substance use disorders 
than in the general population.  A seminal study of the reproductive health needs of 
women with opioid dependence demonstrated higher rates of lifetime pregnancies and 
abortions compared to national averages, suggesting that many pregnancies in this group 
were unintended (Armstrong, Kennedy, Kline, & Tunstall, 1999).  A small study of 
pregnant women in methadone maintenance found that 67% did not plan their current 
pregnancy (Selwyn et al., 1989).  In a more recent multi-site study of 946 pregnant women 
in treatment for opioid use disorders, 86% reported that their current pregnancy was 
unintended, of which 40% reported it was mistimed, 31% reported it was unwanted and 
30% reported being ambivalent (Heil, et al., 2011).  These numbers underscore the 
importance of targeting this population and developing effective interventions that bridge 
the gap between pregnancy desire and contraceptive behavior.  Additionally, women with 
unintentional pregnancies had significantly more substance use in the past 30 days 
compared with women with intentional pregnancies.  Women often do not find out they are 
pregnant until after the fourth week of pregnancy, well into a critical period for fetal 
development (Floyd, Decoufle, & Hungerford, 1999).  Thus, women with substance use 
disorders, even those in recovery, may be at a much higher risk of having a substance-
exposed pregnancy especially if the pregnancy is unintended.  Continued substance use 
during pregnancy has been associated with immediate and long-term effects on exposed 
children ranging from premature delivery and low birth weight to developmental deficits 
that affect behavior and cognitions over the life course (NIDA., 2011).  Additionally, the 
recent national increases in neonatal abstinence syndrome and antepartum maternal 
opioid use (Patrick et al., 2012), suggest that contraceptive interventions are particularly 
important for women with opioid use disorders. 
Substance use treatment settings:  a missed opportunity for prevention of 
unintended pregnancies.  Reproductive health is an important issue among women in 
treatment for substance use disorders but is often not adequately addressed (Armstrong, 
Kenen, & Samost, 1991).  While most treatment venues include sexually transmitted 
infection (STI) testing and education, most do not include a contraception focus or 
adequate connection to reproductive health services.  In Heil’s (2011) study with pregnant 
opioid-dependent women, almost all of the women (90%) in the study had a history of 
prior treatment for substance use disorders with an average of three or more treatment 
episodes.  This finding strongly supports the idea that treatment programs are a vital 
setting for engaging at-risk women and empowering them to take control over their 
reproductive health.  Treatment is a time of change and self-evaluation.  Integrating a 
peer-led contraception intervention into this setting may provide women with additional 
resources that contribute to greater self-efficacy, empowerment and future stability in their 
lives and that in turn positively support their recovery.   
The potential role of peers in prevention for women with addiction. Within the 
mental health and addiction fields, there is a history of using peer-based recovery support 
groups and recovered/recovering peers in service and support roles (White, 2004).  Peers 
have also been used in health promotion and HIV prevention with hard to engage 
populations (Kelly, 2004; Kelly, et al., 1991) and adolescents (Brindis, et al., 2005; 

PI: Deborah Rinehart, Ph.D., M.A. 
Page 4 
COMIRB Protocol 15-1236 
 
Jemmott, Jemmott, & Fong, 1998; Key, et al., 2008; Siegel, Aten, Roghmann, & Enaharo, 
1998).  The definitional clarity and diversity of interventions that fall under the umbrella of 
“peer education” has hindered the evaluation of the value of this method (Shiner, 1999).  
In a study among adolescents receiving family planning services at a community health 
clinic, patients whose clinic services were augmented with a peer intervention were more 
likely to report consistent and effective contraceptive use at follow-up (Brindis, et al., 
2005).  However, in a sexual health school-based study that utilized peer-educators in 
group settings, differences were not found between students in the intervention and 
control groups (Mason-Jones, Mathews, & Flisher, 2011).  The proposed study will 
rigorously operationalize and measure a peer education intervention that will include 
peers not only in the delivery of the intervention but also in the development of the 
intervention.  Peer education has been more heavily promoted in projects working with 
vulnerable and hard to reach populations.  The premise is that individuals may be more 
likely to personalize health messages if they are delivered by someone who understands 
and is facing similar concerns and pressures.  Using peers who have experienced past 
substance use problems, provides participants with successful real-life role models.  This 
may be particularly helpful in developing trust, ensuring the intervention incorporates the 
cultural context surrounding substance use, and empowering substance-using women to 
engage and take control over their reproductive health.       
The opportunity provided by increased availability of Long-Acting Reversible 
Contraceptives. LARCSwhich include intrauterine devices (Mirena®, ParaGard®, 
Skyla®) and subdermal implants (Nexplanon®), are considered to be safe, cost-effective 
methods to reduce the rates of unintended pregnancies (American College of 
Obstetricians and Gynecologists Committe Opinion no 450, 2009; Trussel, et al., 2009; 
Trussell, 2012).  By requiring little user participation to avoid pregnancy, their failure rates 
are very low (less than 1%) (Hatcher et al., 2007; Kost, Singh, Vaughan, Trussell, & 
Bankole, 2008; Trussel, et al., 2009).  Rates of LARC use have continued to increase over 
the last decade in the US (L. Finer, Jerman, & Kavanaugh, 2012) and LARCs appear to 
be acceptable methods of contraception among low-income women and women on 
Medicaid (Kavanaugh, et al., 2011)  A recent Colorado Family Planning Initiative focused 
on increasing LARC use among young low-income women observed  a population 
increase in LARC use from 5% to 19% as well as a decrease in observed fertility rates, 
high-risk births, abortion rates and infant enrollment in WIC (Ricketts, et al., 2014).  
Another recent project promoting LARC use among women seeking contraception found 
that 70% of the women chose a LARC method as compared to a non-LARC method when 
the barrier of cost was removed and when counseling on the effectiveness of LARC 
methods was provided (Mestad, et al., 2011).  Implementation of the Affordable Care Act 
and greater Medicaid coverage decreases financial barriers in accessing these methods.  
Women entering treatment often have multiple life issues to address and providing 
contraceptive options, especially LARC methods, may be particularly attractive and 
effective in reducing unintended pregnancies.   
Theory to inform the study.  Recent contraceptive interventions have not relied as 
heavily on theory as HIV prevention interventions.  In a review of theory-based 
contraception interventions, the most heavily used theoretical basis was social cognitive 
theory (SCT) (Lopez, Tolley, Grimes, Chen, & Stockton, 2013).  HBM is a social cognitive 
framework that applies a multidimensional approach to decision making and heavily relies 
on modifiable cognitive factors (Rosenstock, 1974).  HBM will be used to guide the overall 
framework for operationalizing intervention content and measurement. HBM consists of 6 
constructs that influence individual health related decision making and behaviors: 
perceived susceptibility (chance of getting a condition); perceived severity (seriousness of 

PI: Deborah Rinehart, Ph.D., M.A. 
Page 5 
COMIRB Protocol 15-1236 
 
the condition and it consequences); perceived benefits (ability of the preventive behavior 
to reduce risk); perceived barriers (the cost of the preventive behavior); cues to action 
(internal and external signals that trigger action) and self-efficacy (confidence in one’s 
ability to take action).   Self-efficacy, a component of HBM and an essential construct in 
Social Cognitive Theory(Bandura, 1986), has been utilized in many health studies and has 
been found to be an important predictor of safer sex behaviors (Brien, Thombs, Mahoney, 
& Wallnau, 1994; Goldman & Harlow, 1993; Longshore, Stein, & Chin, 2006; O'Leary, 
Goodhart, Jemmott, & Boccher-Lattimore, 1992; Sikkema et al., 1995; Wulfert & Wan, 
1993).  Thus, contraceptive self-efficacy will be a specific focus in the intervention.  A 
recent conceptual review of primary research articles applying HBM to family planning, 
consolidated past work to specify a contraception specific HBM framework to be used to 
guide future research, measurement and practice (Hall, 2012). 
Motivational Interviewing (MI) is an empirically supported intervention method and 
style that is effective in a number of health issues within short time frames (Lundahl et al., 
2013; Martins & McNeil, 2009)  MI has been extensively used in the addiction field and 
has been shown to be effective in brief interventions targeting alcohol use and 
contraception behaviors (Ingersoll, Ceperich, Hettema, Farrell-Carnahan, & Penberthy, 
2013).  It is a directive but client-centered approach focused on increasing patient 
motivation to change behaviors through exploring and resolving ambivalence (Miller & 
Rollnick, 2002).  Structured elements of MI will be incorporated into the intervention, 
specifically providing personalized feedback on current contraception methods, 
developing discrepancy between contraception behaviors and pregnancy intentions, and 
goal setting.   
Summary. Gaining a better understanding of the contraceptive and reproductive 
health needs of women struggling with addiction is an important public health issue.  This 
study will develop a brief peer-led intervention that can be integrated into the substance 
use treatment setting and may prove to be a significant contribution to the public health 
effort of both reducing unintended and substance-exposed pregnancies.   Additionally, 
empowering women to take control over their reproductive health may also create more 
long-term stability in their lives and positively support their recovery.  
 
III. Preliminary Studies/Progress Report: None   
 
IV. Research Methods 
 
A.  Outcome Measure(s):   
Phase I Data collection.  Because of the potentially sensitive nature of 
reproductive health behaviors, individual interviews were chosen as the first step to better 
elucidate and explore the issues related to pregnancy desires and contraceptive 
behaviors.  The table below outlines the topics we will explore.  
Level 
Topics to Explore in Individual Qualitative Interviews  
Individual 
 Pregnancy desire/motivation, perceived 
susceptibility/seriousness of an unintended pregnancy (impact 
on woman biologically, financially/economically) 
 Contraceptive knowledge, perceived benefits/barriers 
(effectiveness, side effects) internal cues for using 
contraception (past counseling experience, biological issues), 
overall attitude toward contraception   
 STI knowledge, behavior, condom use and relationship to 

PI: Deborah Rinehart, Ph.D., M.A. 
Page 6 
COMIRB Protocol 15-1236 
 
contraceptive behaviors 
Social/relationship  
 Perceived partner’s knowledge and involvement in 
contraceptive decisions 
 External cues to action - ongoing support and reinforcement 
for contraception 
 Issues specific to different types of partners  
 Familial, peer and cultural norms that influence contraception 
Community 
 Characteristics of family planning and STI services, past 
experience, media messages, access and utilization of 
services  
Intervention 
specific  
 Feedback on the core components of the intervention, 
specifically the role of a peer-educator and connection to 
services, and recommended intervention frequency/duration 
and suggested engagement methods   
 
Information from the individual interviews will be combined with evidence from the 
literature to further specify the intervention.  The intervention will then be operationalized 
by creating a manual as well as a detailed outline that will be used to solicit feedback in 
the focus groups.  We will then conduct two focus groups with the primary aim of obtaining 
women’s feedback on the intervention and their thoughts on the most important aspects of 
HBM as related to contraception decision making and behavior.  Focus groups are a 
strong addition to our formative methods, as they provide a cost-effective method of 
collecting information and a social forum to further evaluate the intervention.  The social 
forum helps to identify salient issues and weed out extreme views that may have been 
obtained in the individual interviews (Agar & MacDonald, 1995).  It also allows participants 
to interact and respond to each other’s ideas.  This synergy will provide valuable 
information in further refining the intervention. After each focus group, suggestions will be 
reviewed and needed modifications will be made to the intervention content and structure.  
Additionally, during this time, processes will be explored and put in place for referral to 
family planning services.  
 
B. 
Phase II. We will then recruit 160 women in OMAT to participate in this 
phase of the study.  Quantitative study data will be collected through participant surveys at 
baseline, 3 months, and 6 months follow-up.  We will collect baseline data on a tablet, and 
3 and 6 months follow-up using RedCap.  A copy of this survey is included in this 
application and the content is as follows: 
• 
Demographic data: Age, religion, sexuality, living situation, partnership 
status, previous pregnancies length of time in treatment and number of 
unique episodes 
• 
Psychosocial: Knowledge of contraceptive methods and pregnancy risk; 
stage of change and level of motivation to prevent unintended 
pregnancies, attitudes towards different contraceptive methods, self-
efficacy regarding condom and birth control use, ability to engage in 
preventive behaviors, partner communication, pregnancy desires 
• 
Current behavior: In last 30 days and most recent: number of partners, 
number of vaginal sex acts, times used contraceptives, times used 
condoms, partner perceptions of contraceptives and condoms, risk 
behaviors. 

PI: Deborah Rinehart, Ph.D., M.A. 
Page 7 
COMIRB Protocol 15-1236 
 
When possible, we will supplement survey data with clinical data from DH’s data 
warehouse, including pregnancy and STI history, number of clinic visits, family planning 
visits, and contraceptive changes for the six month study. 
Additionally, we will collect biological urine and test for pregnancy at baseline. Once the 
biological sample is tested, all clinic guidelines related to testing and follow-up will be 
conducted by appropriate clinic staff. 
 
Description of Population to be Enrolled:   
Study inclusion/exclusion criteria: Phase I: being female; 18-35 years of age; being 
in opioid medication-assisted treatment at one of our two clinic sites; not currently 
pregnant or trying to become pregnant; and have no known medical reason that would 
prevent pregnancy (e.g., hysterectomy, tubal ligation), having sex or intending to have sex 
with biological male (at risk of pregnancy) .  Individuals who are not able to complete the 
interview in English, or who are intoxicated or impaired mentally to the point that they 
cannot voluntarily consent to participate in the project and/or respond to the interview will 
also be excluded.  
Phase II: being female; 18-44 years of age; being in opioid medication-assisted 
treatment at one of our two clinic sites; not currently pregnant or trying to become 
pregnant; and have no known medical reason that would prevent pregnancy (e.g., 
hysterectomy, tubal ligation, menopause), having had sex or intending to have sex with 
biological male (at risk of pregnancy), and not currently using a LARC .  Individuals who 
plan to move out of the area in the next 6 months, have a pending incarceration, and/or are 
not able to complete the interview in English, or who are intoxicated or impaired mentally to 
the point that they cannot voluntarily consent to participate in the project and/or respond to 
the interview will also be excluded.  
 
 
 
C. Study Design and Research Methods   
.  This study will be completed in two phases The first formative phase (Aim 1) will 
include individual qualitative interviews with women in OMAT.  These interviews will be 
used to elucidate and explore the barriers to effective contraceptive use and STD 
prevention.  Findings from these interviews in conjunction with prior literature and 
evidence based models will be used to develop the intervention. Focus groups will then be 
conducted to obtain feedback on the developed intervention and a final intervention will be 
developed. The developed intervention will then be piloted with 10 women who are in 
OMAT.   The second efficacy phase (Aim 2-3) will randomize subjects to the intervention 
or the usual care and assess outcomes 3 and 6 months post-baseline.  
Phase I qualitative and intervention development.  Individual interviews (up to 
30) and 3 focus groups (n=20) will be conducted with women in OMAT of reproductive 
age.  Purposeful convenience sampling is considered most appropriate for formative 
research (Patton, 2002; Schensul, 1999).  Women will be recruited from two treatment 
centers.  Outpatient Behavioral Health Services (OBHS) is a stand-alone substance use 
treatment clinic located on the Denver Health Medical Center campus in central Denver 
and has dispensed methadone (ORT) and provided substance use and mental health 
treatment for over 30 years.  Addiction Research and Treatment Services (ARTS) is in the 
Division of Substance Dependence, Department of Psychiatry, University of Colorado 
School of Medicine.  ARTs began in 1971 as a federally funded methadone maintenance 
program and currently has four outpatient clinics.  The Denver Clinic will serve as a 
treatment clinic for this study and is also located in central Denver.  Clinic providers will be 

PI: Deborah Rinehart, Ph.D., M.A. 
Page 8 
COMIRB Protocol 15-1236 
 
asked to identify and refer eligible women to the research assistant. Participation will also 
be solicited from flyers hanging in the clinics. Additionally, participants may be recruited in 
person by the researcher.  We will attempt to include representation across different ages, 
ethnicities, women with and without prior non-condom contraception use, and women with 
and without children.   
The content of the individual interview has been described above and will explore 
salient issues related to reproductive health among women in OMAT.  We will combine 
information from the individual interviews with evidence from the literature to develop a 
preliminary intervention and proposed content.  We will then conduct focus groups to 
obtain more targeted feedback from the women on the developed intervention.  The 
intervention will be finalized and tested in the second phase which will be submitted as an 
amendment.  
All formative qualitative interviews will be audio-taped and transcribed into Word. The 
qualitative interviews will be transcribed by a consultant who is not part of the research 
team (used in prior studies). The digital files will be saved on (www.box.com) for the 
transcriptionist to access. This is an encrypted storage site that also provides audit logs of 
who accessed the files.  No names will be associated with the digital recordings or 
transcribed files.  Once the transcribed file is received, all digital recording will be removed 
from www.box.  The transcriptionists have also signed all Denver Health confidentiality 
paperwork. Once transcribed the word files will be transported into Atlas.ti for analysis. 
Once transported into Atlas the digital recording will be erased from the Denver Health 
server.  All Atlas.ti files will contain a unique study id and no identifying information.   
Focus group data will be audio-taped and the co-facilitator(s) will take extensive notes.  
The digital files will be reviewed and information will be added to the notes.  These data 
will be used primarily to modify the intervention and all digital recordings will be erased 
after the intervention has been finalized.  
 
Phase II Efficacy Evaluation This study will be conducted at the DH Outpatient 
Behavioral Health Services clinic (OBHS), and at the University of Colorado’s Addiction 
Research and Treatment Services clinic (ARTS).  Potentially eligible patients will be 
identified by the research staff through screening the clinic schedule, and by clerical clinic 
staff.  Patients identified as potentially eligible will be approached at the clinic during 
dosing hours or before/after group sessions, and asked if they would like to participate in 
the study. Additionally, providers will be asked to refer potentially eligible participants to 
the research staff.  Flyers will also be hung at the clinics.  All identified/referred patients 
will be screened for final study eligibility by a trained researcher in a confidential setting, 
and if eligible invited to participate in the study.  If deemed eligible and interested, the 
participant will be consented and will complete the baseline interview electronically. 
Research staff will obtain informed consent from all participants by allowing them to 
review the consent form, and by highlighting particularly important aspects.  The baseline 
interview will be collected using a computerized tablet using ACASI software. ACASI is a 
computer/tablet-based interview and data collection instrument that automatically enters 
and stores the data, eliminating the data entry process.  In addition, this software allows 
the interview to be set up so that participant simultaneously reads the questions on a 
tablet, and hears the questions on headphones.  This method decreases problems with 
low literacy levels and provides increased anonymity, especially with sensitive questions.  
All tablets will have headphones so that each participant can hear the questions privately.  
A researcher will also be there to answer any questions, or help if there are any technical 
problems with the survey.  The survey data will be associated with a study id and initially 
stored in an encrypted file on the tablet as the participant is completing the interview.  At 

PI: Deborah Rinehart, Ph.D., M.A. 
Page 9 
COMIRB Protocol 15-1236 
 
the completion of the interview, the researcher will retrieve the tablet, copy the interview to 
a secure Denver Health network drive, and erase the file from the tablet.  The researcher 
will then pay the participant for her time.  The three and six month interview will be done 
online using RedCap, a secure software that is regularly used in research.  A spreadsheet 
will be developed to manage all aspects of study data.  After the baseline interview, the 
research assistant will assign participants into study groups based on pre-defined 
randomization based on study ID. 
For the first 10 patients recruited, we will ask them to provide feedback on the 
baseline survey and intervention and this information will be used to further refine the 
study survey and intervention. Depending upon the changes made, data from these initial 
participants may be excluded from the final analyses.   
 
Study Condition 
                Usual Care. All participants will be in active OMAT at one of the two clinics. The 
current standard of care is to administer the state mandates Infectious Disease Behavioral 
screen.  If women screen at risk for HIV, they are referred to the Colorado department of 
Public Health and Environment or Denver Public Health for further evaluation and follow 
up.  At this time, neither program has standard work in place to assess pregnancy desire, 
contraception use and/or to provide information on contraception methods or referral to 
services.  Standard care varies depending on the length of time a patient has been in 
treatment, but all are connected to a counselor and a treatment provider.  The intention of 
this study is not to impact the care provided in OMAT, but to support reproductive 
behaviors and connection to a family planning visit.  
 
Peer-Led Reproductive Health Intervention. After randomization, if the participant 
is assigned to the study intervention condition the researcher will introduce them to the 
peer navigator (PN) immediately after the baseline interview. The timing of each session 
is listed in the table below followed by a short summary of core objectives of each 
session.  The PN intervention is specified in the Peer Navigator Handbook included with 
this submission.   
Intervention Components 
Session 
Timing 
Duration 
Session I 
Immediately post-baseline 
15 minutes 
Session II 
2-4 weeks post-baseline 
20 minutes 
 
Session One: The PN will conduct session one as outlined in the Peer Navigator 
Handbook.  Core objectives of this session include engaging the patient in the 
intervention, assessing pregnancy intentions and current behaviors, advising patients on 
birth control options and summarizing the session and preparing for next steps.   
Motivational interviewing techniques will be used throughout the sessions. The primary 
goal of the first session will be to assess interest and readiness to connect to a family 
planning provider and to schedule a same day appointment for those patients who are 
ready to take action.  It is estimated to take approximately 15 minutes.  
• 
If the participant is interested in connecting to a family planning visit: The 
PN will make an appointment with an identified health educator (HE).  A HE 
is a Denver Health employee who specializes in family planning education.  
All attempts will be made to make the appointment on the same day as 
session one. 

PI: Deborah Rinehart, Ph.D., M.A. 
Page 10 
COMIRB Protocol 15-1236 
 
• 
If the participant is not interested in connecting to a family planning visit: 
The PN will use the Topics (aka bubble sheet) and Values Worksheet  
(included in this submission) to determine if there are other areas or issues 
that the participant would like to discuss.  If the participant is interested in 
being connected to a general practitioner, the PN will work to schedule an 
intake appointment from a list of identified DH providers who are 
experienced and interested in working with women in recovery.  The PN 
will also have additional referral resources to provide the participant if there 
are other needs and/or concerns (outlined in the Peer Navigator 
Handbook). 
• Session Two: The PN will attempt to conduct session two in person; 
however, participants will have the option of conducting session two over 
the phone.  This session is expected to  take approximately 20 minutes.  
The core content of this session will vary based on the results of the first 
session.  If needed, motivational interviewing techniques will be used to 
continue to elicit self-change talk and increase motivation for a family 
planning provider visit.  For participants who had a family planning visit, 
the PN will discuss any side effects or concerns the participant has with 
their birth control method.  If the participant did not attend the appointment, 
the PN will facilitate the scheduling of a new appointment.  
 
D.   Description, Risks and Justification of Procedures and Data Collection 
Tools: 
Risks consist of potential embarrassment or discomfort in responding to sensitive 
questions.  Participants may feel discomfort or embarrassment responding to questions 
about sensitive topics such as their knowledge and attitudes about reproductive health, 
STIs, pregnancy, and contraception.  We believe this risk is low.  Participants can choose 
not to response to questions they are uncomfortable with.   Additionally, if they are upset 
by the survey or have additional health related questions, we will refer them to a clinician 
on site (either behavioral health consultant or primary care provider/nurse).  We will also 
provide an informational brochure at the end of the interview or focus group.  The 
brochure will outline contraceptive methods and clinic locations.    
There is a risk of loss of confidentiality but we believe this risk is low.  All study data 
will be collected in a confidential setting and will be associated with a study ID and not 
with identifying information.  Confidentiality cannot be assured in the focus groups 
participants will be informed of this risk.  
As part of the study, we will collect a urine sample to test for pregnancy at baseline.  If 
the participant received a positive pregnancy screening, they will be referred to the 
appropriate clinic staff, and excluded from participating in the study.   
 
    
E.   Potential Scientific Problems:   
In the qualitative formative work, we will use purposeful sampling, which will not be 
representative of all women in OMAT.  However, these data will be used to inform the 
development of an intervention that will be tested in a second phase (to be submitted 
once finalized). 
Participants may not represent all women in treatment in Denver.  We will make every 
attempt to understand and correct any recruiting biases, and recruit and enroll all eligible 
women receiving treatment at ARTS or OBHS during the time of the study. 

PI: Deborah Rinehart, Ph.D., M.A. 
Page 11 
COMIRB Protocol 15-1236 
 
Retention of participants for the second session, and for the three and six month 
follow-up interview is the biggest potential scientific problem.  We intend to ask all 
participants for relevant contact information so that we can find them for their follow-up 
session and interviews. 
These data are self-reported, which comes with limitations.  However, several 
mechanisms are being put in place to reduce this bias, including: conducting the interview 
in a confidential setting; ensuring data is stored in a secure location; and using software 
so that participants can directly enter their answers into the computer.  Literacy levels may 
also be a concern, but we will use survey software that will allow participants to hear and 
see the questions simultaneously.  Additionally, a researcher will be available during the 
interview to address any comprehension concerns. 
 
F.   Data Analysis Plan:   
Phase I Qualitative Data Analysis.  All qualitative data will be digitally recorded and 
in written notes.  The tapes from the individual interviews will be transcribed (and 
translated when necessary), verbatim, directly after the interview.  Coding will begin 
immediately and will be ongoing so that subsequent interviews can be used to clarify 
emerging themes.   
Individual interviews that have been transcribed will be imported into ATLAS.ti for 
coding.  A grounded theory approach will be used to inductively code and analyze the 
individual transcripts.  Coding for the first 3 interviews will take place as a team (the PI 
and research assistant).  The team will immerse themselves in these interviews starting 
with reading each interview transcription several times to begin to identify meaningful 
themes.  The team will code the three interviews, labeling as many concepts as emerge, 
and meet to jointly develop and operationalize codes that will be used in coding 
subsequent interviews.  The team will code the remaining interviews, meeting weekly to 
discuss problems or questions with current codes and make modifications as needed.  
Analysis will be an ongoing iterative process.  Relevant themes/categories and topics will 
be extracted for use in the development of the intervention and focus group interview 
guide.   
The intent of the focus groups is to provide feedback on the intervention 
developed.  Therefore, the focus groups will be digitally recorded and reviewed after the 
group meeting.  Notes from these groups will be summarized and the intervention will be 
modified based on the findings.  Following completion of the analysis and intervention 
development, the recordings will be destroyed. 
 
Phase II Quantitative Data Analysis.  Multivariate regressions will be performed to 
assess statistical differences between the intervention group and usual care group from 
baseline to follow-up with respect to: 
 
Hypothesis 1. Participants randomized to the intervention will be more likely to follow-up 
with a family planning clinic visit. 
• 
Participants with a family planning visit will show an increase in knowledge, self-
efficacy, and perceived benefit of birth control. 
 
Hypothesis 2. Participants randomized to the intervention will be more likely to initiate 
Long Acting Reversible Contraceptive (LARCS) methods. 
 
Prior to conducting the primary analyses, group differences in baseline measures 
will be evaluated to ensure that the group assignment was even.  We will also inspect the 

PI: Deborah Rinehart, Ph.D., M.A. 
Page 12 
COMIRB Protocol 15-1236 
 
distributions of continuous variables (e.g., frequency condom use) for departures from 
normality.  Variables that exhibit non-normal distributions will be subjected to normalizing 
transformations prior to analysis.  If those transformations are unsuccessful, analysis will 
proceed using non-parametric tools.  In addition, the rate of attrition between baseline and 
follow-up interviews will be evaluated to ensure that it is relatively constant across 
intervention conditions, and that there are no systematic differences in the variables of 
interest between participants who completed the study and those lost to follow-up.  
Missing data due to item non-response or loss to follow-up will be handled using the most 
appropriate method, depending on the amount of missing data, the assumptions of the 
missing data (completely at random, at random or non-ignorable) and the assumptions of 
the method of handling missing data.  For example, for small amounts of missing data that 
are assumed to be missing at random, listwise or pairwise deletion (the default in most 
statistical packages) will be sufficient.  Variables that differ significantly between those 
who returned for follow-up and those who did not can also be controlled for in regression 
analyses.  Where appropriate, we will use statistical models that employ maximum 
likelihood techniques of parameter estimation, allowing us to use participants with 
incomplete data and avoid the potential bias caused by listwise deletion.  These 
techniques are robust under conditions of missing at random so comparisons of groups 
will not be biased as long as missing data is ignorable. The number of planned 
comparisons will be limited based on a priori hypotheses, therefore the per comparison 
error rate of .05 will be used to evaluate significance of the specific aims.  Exploratory or 
secondary analyses will be adjusted for multiple comparisons using the Bonferroni test.  
Many of the variables will be either summary index scores or latent variables that 
assess the psychological, behavioral and biological constructs of interest. For example 
knowledge will be a summary score representing the number of variables the participant 
correctly endorsed, while motivation will be a mean score across multiple variables 
representing the underling latent construct.  The variable related to use of LARCs will be a 
dichotomous variable representing current use or no current use of a LARC method (IUD 
or Implanon), as will attending a family planning visit during the study period. 
Separate analyses will be conducted for each of the hypothesis to understand 
differential change over time.  This includes looking at change scores as well as analysis 
of variance.  The expectations for hypotheses 1 and 2 are that they will significantly 
increase in the intervention group. Differences will be assessed from baseline to follow-up 
period for each analysis.   
Additional regression analyses will be conducted to identify significant predictors of  
differential change over time in birth control method and family planning visit.  This 
analysis will determine if the intervention condition is a significant predictor of change.  
The regressions will account for any important statistically significant differences between 
groups at baseline.  These differences may include variables pertaining to demographics, 
psychosocial factors, and behavioral variables.  Generalized estimated equations (GEE) 
will be used to account for the within-subject correlation of repeated measures by 
individual patients.  Group designations for the outcome analyses will adhere to the 
intention to treat threshold.  All Statistical analyses will be performed using SAS (version 
9.1 or later, SAS Institute Inc, Cary, NC) software.  
Engagement variables. We will collect and analyze engagement with the PN and 
attendance to each session.  These analyses will be used to assess intervention fidelity 
and to describe the amount of intervention each participant received to understand 
acceptability of the intervention as well as the relationship of intervention dose to study 
outcomes.  These data will include, intervention activities covered and descriptive 
information such as the number of sessions attended, and the number of interactions with 

PI: Deborah Rinehart, Ph.D., M.A. 
Page 13 
COMIRB Protocol 15-1236 
 
the PN.   
We will also record intervention sessions with the PN to determine the fidelity in 
which each session has been administered. 
Study Statistical Power.  Power analyses were done to assess the minimum 
detectable improvement needed for LARC uptake.  A sample of 75 per group, using ITT 
approaches and assuming outcome if failure (dichotomous only) for patients who do not 
respond to follow-up surveys will provide 80% power to detect 23% difference between 
usual care and intervention patients on dichotomous outcomes, assuming an average 
success rate of 50% for maximum variability. For continuous outcomes, a follow-up 
sample size of 60 per group will provide 80% power to detect a .55 SD difference between 
usual care and intervention patients, or a medium linear effect over time (correlational 
structure CS with rho=.5).  
 
G.  Summarize Knowledge to be Gained:   
This study will provide innovative information on the reproductive issues relevant to 
women in OMAT.  It will use qualitative methods to develop a reproductive health 
intervention that can be delivered within the context of treatment.  It will also provide 
information on the feasibility of this type of intervention.  A randomized control trial in the 
second phase will provide important efficacy information on the impact of the intervention 
on participants’ knowledge, family planning visits, and LARC uptake. 
 
 H. References: 
Agar, M., & MacDonald, J. (1995). Focus groups and ethnography. Human Organization, 54(1), 78-
86. 
American College of Obstetricians and Gynecologists Committe Opinion no 450. (2009). Increasing 
use of contraceptive implants and intrauterine devices to reduce unintended pregnancy. 
Obstetrics and Gynecology, 114, 1434-1438. 
Armstrong, K. A., Kenen, R., & Samost, L. (1991). Barriers to family planning services among 
patients in drug treatment programs. Family planning perspectives, 23(6), 264-266, 270-
261. 
Armstrong, K. A., Kennedy, M. G., Kline, A., & Tunstall, C. (1999). Reproductive health needs: 
comparing women at high, drug-related risk of HIV with a national sample. Journal of the 
American Medical Women's Association, 54(2), 65-70, 78. 
Bandura, A. (1986). Social foundations of thought and action: a social cognitive theory. Englewood 
Cliffs, NJ: Prentice Hall. 
Brien, T., Thombs, D., Mahoney, C., & Wallnau, L. (1994). Dimensions of self-efficacy among three 
distinct groups of condom users. Journal of American College Health, 42, 167-174. 
Brindis, C. D., Geierstanger, S. P., Wilcox, N., McCarter, V., & Hubbard, A. (2005). Evaluation of a 
peer provider reproductive health service model for adolescents. [Evaluation Studies 
Research Support, Non-U.S. Gov't]. Perspectives on sexual and reproductive health, 37(2), 85-91. 
Finer, L., Jerman, J., & Kavanaugh, M. (2012). Changes in use of long-acting contraceptive 
methods in the United States, 2007-2009. Fertility and Sterility, 98(4), 893-897. 
Finer, L. B., & Henshaw, S. K. (2006). Disparities in rates of unintended pregnancy in the United 
States, 1994 and 2001. Perspect Sex Reprod Health, 38(2), 90-96. 
Finer, L. B., & Zolna, M. R. (2014). Shifts in intended and unintended pregnancies in the United 
States, 2001-2008. American journal of public health, 104 Suppl 1, S43-48. 
Floyd, L., Decoufle, P., & Hungerford, D. (1999). Alcohol use prior to pregnancy recognition. 
American Journal of Preventive Medicine, 17(2), 101-107. 
Goldman, J., & Harlow, L. (1993). Self-perception variables that mediate AIDS-preventive behavior 
in college students. Health Psychology, 12, 489-498. 
Hall, K. S. (2012). The Health Belief Model can guide modern contraceptive behavior research and 
practice. [Research Support, N.I.H., Extramural 

PI: Deborah Rinehart, Ph.D., M.A. 
Page 14 
COMIRB Protocol 15-1236 
 
Research Support, Non-U.S. Gov't 
Review]. Journal of midwifery & women's health, 57(1), 74-81. 
Hatcher, R., Trussell, J., Nelson, A., Cates, W., Stewart, F., & Kowal, D. (2007). Contraceptive 
technology, 19th revised ed. New York: Ardent Media. 
Heil, S. H., Jones, H. E., Arria, A., Kaltenbach, K., Coyle, M., Fischer, G., et al. (2011). Unintended 
pregnancy in opioid-abusing women. Journal of substance abuse treatment, 40(2), 199-
202. 
Ingersoll, K. S., Ceperich, S. D., Hettema, J. E., Farrell-Carnahan, L., & Penberthy, J. K. (2013). 
Preconceptional motivational interviewing interventions to reduce alcohol-exposed 
pregnancy risk. [Randomized Controlled Trial 
Research Support, N.I.H., Extramural]. Journal of substance abuse treatment, 44(4), 407-416. 
Jemmott, J. B., 3rd, Jemmott, L. S., & Fong, G. T. (1998). Abstinence and safer sex HIV risk-
reduction interventions for African American adolescents: a randomized controlled trial. 
[Clinical Trial 
Randomized Controlled Trial 
Research Support, U.S. Gov't, P.H.S.]. JAMA : the journal of the American Medical Association, 
279(19), 1529-1536. 
Kavanaugh, M. L., Jerman, J., Hubacher, D., Kost, K., & Finer, L. B. (2011). Characteristics of 
women in the United States who use long-acting reversible contraceptive methods. Obstet 
Gynecol, 117(6), 1349-1357. 
Kelly, J. A. (2004). Popular opinion leaders and HIV prevention peer education: resolving 
discrepant findings, and implications for the development of effective community 
programmes. [Research Support, U.S. Gov't, P.H.S.]. AIDS care, 16(2), 139-150. 
Kelly, J. A., St Lawrence, J. S., Diaz, Y. E., Stevenson, L. Y., Hauth, A. C., Brasfield, T. L., et al. 
(1991). HIV risk behavior reduction following intervention with key opinion leaders of 
population: an experimental analysis. [Research Support, U.S. Gov't, P.H.S.]. American 
Journal of Public Health, 81(2), 168-171. 
Key, J. D., Gebregziabher, M. G., Marsh, L. D., & O'Rourke, K. M. (2008). Effectiveness of an 
intensive, school-based intervention for teen mothers. [Comparative Study 
Evaluation Studies]. The Journal of adolescent health : official publication of the Society for 
Adolescent Medicine, 42(4), 394-400. 
Kost, K., Singh, S., Vaughan, B., Trussell, J., & Bankole, A. (2008). Estimates of contraceptive 
failure from the 2002 National Survey of Family Growth. Contraception, 77(1), 10-21. 
Longshore, D., Stein, J., & Chin, D. (2006). Pathways to sexual risk reduction: gender differences 
and strategies for intervention. AIDS and Behavior, 10(1), 93-104. 
Lopez, L. M., Tolley, E. E., Grimes, D. A., Chen, M., & Stockton, L. L. (2013). Theory-based 
interventions for contraception. [Research Support, N.I.H., Extramural 
Research Support, U.S. Gov't, Non-P.H.S. 
Review]. The Cochrane database of systematic reviews, 8, CD007249. 
Lundahl, B., Moleni, T., Burke, B. L., Butters, R., Tollefson, D., Butler, C., et al. (2013). Motivational 
interviewing in medical care settings: a systematic review and meta-analysis of randomized 
controlled trials. Patient education and counseling, 93(2), 157-168. 
Martins, R. K., & McNeil, D. W. (2009). Review of Motivational Interviewing in promoting health 
behaviors. [Review]. Clinical psychology review, 29(4), 283-293. 
Mason-Jones, A. J., Mathews, C., & Flisher, A. J. (2011). Can peer education make a difference? 
Evaluation of a South African adolescent peer education program to promote sexual and 
reproductive health. [Evaluation Studies 
Research Support, Non-U.S. Gov't 
Research Support, U.S. Gov't, P.H.S.]. AIDS and behavior, 15(8), 1605-1611. 
Mestad, R., Secura, G., Allsworth, J. E., Madden, T., Zhao, Q., & Peipert, J. F. (2011). Acceptance 
of long-acting reversible contraceptive methods by adolescent participants in the 
Contraceptive CHOICE Project. [Research Support, N.I.H., Extramural 
Research Support, Non-U.S. Gov't]. Contraception, 84(5), 493-498. 
Miller, W., & Rollnick, S. (2002). Motivational interviewing: preparing people for change. (2 ed.). 
New York: NY: Guildford Press. 

PI: Deborah Rinehart, Ph.D., M.A. 
Page 15 
COMIRB Protocol 15-1236 
 
NIDA. (2011). Topics in Brief: prenatal exposure to drugs of abuse-May 2011. 
O'Leary, A., Goodhart, F., Jemmott, L., & Boccher-Lattimore, D. (1992). Predictors of safer sex on 
the college campus: a social cognitive theory analysis. Journal of American College Health, 
40, 254-263. 
Patrick, S. W., Schumacher, R. E., Benneyworth, B. D., Krans, E. E., McAllister, J. M., & Davis, M. 
M. (2012). Neonatal abstinence syndrome and associated health care expenditures: United 
States, 2000-2009. JAMA : the journal of the American Medical Association, 307(18), 
1934-1940. 
Patton, M. Q. (2002). Qualitative Research & Evaluation Methods. 3rd ed. Thousand Oaks, CA: 
Sage Publications. 
Ricketts, S., Klingler, G., & Schwalberg, R. (2014). Game Change in Colorado: Widespread Use Of 
Long-Acting Reversible Contraceptives and Rapid Decline in Births Among Young, Low-
Income Women. Perspectives on sexual and reproductive health. 
Rosenstock, I. (1974). The health belief model and preventive health behavior. Health Education 
Monographs, 2, 354-385. 
Schensul, S. (1999). Ethnographic sampling. In S. Schensul (Ed.), Essential ethnographic 
methods: observations, interviews, and questionnaires (Ethnographer's Toolkit) (pp. 231-
269). Walnut Creek, CA: Altamira Press. 
Selwyn, P. A., Carter, R. J., Schoenbaum, E. E., Robertson, V. J., Klein, R. S., & Rogers, M. F. 
(1989). Knowledge of HIV antibody status and decisions to continue or terminate 
pregnancy among intravenous drug users. JAMA : the journal of the American Medical 
Association, 261(24), 3567-3571. 
Shiner, M. (1999). Defining peer education. [Review]. Journal of adolescence, 22(4), 555-566. 
Siegel, D. M., Aten, M. J., Roghmann, K. J., & Enaharo, M. (1998). Early effects of a school-based 
human immunodeficiency virus infection and sexual risk prevention intervention. 
[Comparative Study 
Research Support, U.S. Gov't, P.H.S.]. Archives of pediatrics & adolescent medicine, 152(10), 961-
970. 
Sikkema, K., Koob, J., Cargill, V., Kelly, J., Desiderato, L., Roffman, R., et al. (1995). Levels and 
predictors of HIV risk behavior among women in low-income public housing developments. 
Public Health Reports, 110, 707-713. 
Sonfield, A., Kost, K., Gold, R. B., & Finer, L. B. (2011). The public costs of births resulting from 
unintended pregnancies: national and state-level estimates. Perspectives on sexual and 
reproductive health, 43(2), 94-102. 
Trussel, J., Lalla, A., Doan, Q., Reyes, E., Pinto, L., & Gricar, J. (2009). Cost-effectiveness of 
contraceptives in the United States. Contraception, 79, 5-14. 
Trussell, J. (2012). Update on and correction to the cost-effectiveness of contraceptives in the 
United States. [Comment 
Letter]. Contraception, 85(6), 611. 
White, W. (2004). The history and future of peer-based addiction recovery support services. paper 
developed for the Consumer Direction Initiative Summit, held by the Substance Abuse and 
Mental Health Services Administration. 
Wulfert, E., & Wan, C. (1993). Condom use: a self-efficacy model. Health Psychology, 12, 346-353