rPlan Multimedia Dual Protection Intervention to Reduce Health Disparities
Phase: NA
Conditions: Sexually Transmitted Infection
Sponsor: University of Chicago

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Title:  
rPlan Multimedia Dual Protection Intervention to Reduce Health Disparities 
 
NCT number: 
NCT03402217 
 
Most recent update/approval date: 
4/4/2017 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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miPlan: A multimedia dual protection intervention to reduce health disparities 
 
Detailed Protocol 
 
 
1. Background 
 
This research aims to extend previous studies which have used health interventions with 
digital media to provide pregnancy prevention counseling to develop and assess the 
acceptability and efficacy of miPlan, a three-part intervention that includes a precounseling app 
that promotes dual protection (STI and pregnancy prevention), motivational interviewing-
informed counseling, and concomitant printed educational materials. The research will proceed 
in two phases. In Phase I, we will assemble a 10-member stakeholder advisory team to 
enhance the PreCounselor app to focus on dual protection, train reproductive health counselors 
in motivational interviewing, and create concomitant printed educational materials. In Phase II, 
the feasibility, acceptability, and effectiveness of the intervention will be assessed among young 
women (ages 15-25). 
 
Disparities in STI/HIV and Unintended Pregnancies among Young African American 
Women 
Young AA women (15-19 years) experience significant reproductive health disparities, with a 
chlamydia rate nearly six times and a gonorrhea rate sixteen times those of their white 
counterparts.9 If untreated, these infections can lead to infertility or life-threatening ectopic 
pregnancy.9 Further, AA women have a 1 in 32 lifetime chance of contracting HIV.10 Nationally, 
49% of all conceptions are unintended, with high rates for African Americans (AA) of all ages 
(67%) and for women ages 15-19 (82%).2 Unintended pregnancy is associated with abortion, 
delayed or no prenatal care, and multiple increased health risks for infants and children.11 
Recognizing the significant inequity in unintended pregnancies and STI/HIV rates among young 
AA women is an important first step to creating effective sexual and reproductive health 
interventions.   
Limited Use of Highly Effective Contraceptive Methods  
Most contraceptive methods are highly (>90%) efficacious but are prone to user error, 
compromising effectiveness in real-world settings. 48% percent of women with unintended 
pregnancies report using contraception during the month of conception.12 Most young women 
rely on short-acting or coitally-dependent methods like oral contraceptive pills (OCs) or 
condoms.13 Half of young women report imperfect OC use, with about 25% missing ≥2 pills in a 
cycle.14 However, long-acting reversible contraceptive (LARC) methods like the intrauterine 
device (IUD) require few use behaviors while providing effective (>99%) and long-lasting (3-10 
years) protection against pregnancy.15 Yet, <7% of women using contraception in the United 
States (US) use LARC, with rates lowest among those at highest risk of unintended 
pregnancy.13  
 
 

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Need for Novel Dual Protection Interventions 
The significant reproductive health disparities of young AA women demonstrate the need for 
novel interventions that promote dual protection and account for their unique reproductive health 
challenges and life contexts. The few clinic-based interventions designed to increase dual 
protection have largely been unsustained or have failed to result in statistically significant 
effects.16-18 Young women receiving a computer-based, tailored intervention reported increased 
dual method use, but no change in STIs and unintended pregnancies compared to controls.19 
Reanalysis of the data showed 32% initiated dual method use, but only 9% sustained use.20 A 
video counseling intervention for AA and Latino female adolescents increased condom use at 
three months post-intervention, but not at 12-month follow-up.21 However, we should remain 
hopeful about reducing such disparities. In a large-scale study, when barriers to all 
contraceptive methods were lowered and LARC was presented as the optimal method, rates of 
LARC uptake surpassed 65% and pregnancy and abortion rates declined.15,22 While efforts have 
traditionally focused on improving condom use, there is evidence that youth rely on many dual 
protection strategies.23 Thus, interventions must address multiple types of “dual protection”.24 
 
Need for Scalable, Brief Interventions 
Brief, inexpensive, practical, and theoretically-based interventions may hold promise for 
reaching large numbers of people. A growing body of research25-27 suggests that brief 
interventions relying on more than just information can be successful.28-33 Interventions with 
strong behavioral models, focused information, and opportunity to address potential barriers to 
change tend to report stronger effects.28,29  
Importance of E-health, Health Information Technology and Counseling Aids 
Interactive multimedia programs present a novel platform for delivering interventions.34 Digital 
media provides an opportunity to scale interventions and reach the broad population of youth 
necessary to reduce STI rates. Tailored, theory-based digital interventions have been effective 
in smoking cessation,35 reducing repeat births among low-income AA adolescent mothers,32 
promoting adherence to antiretroviral medications,36 and increasing awareness of diabetes 
complications.37 Users of a touchscreen computer intervention were significantly more likely to 
choose highly effective contraception.38 Multiple programs have successfully taken advantage of 
clinic wait times37,39-41 without obstructing patient flow. HIV-positive users of a counseling tablet 
found it reduced social bias, promoted honesty in discussing sensitive topics, and promoted 
privacy.42  
Key Theories and Approaches Informing this Intervention  
The Transtheoretical Model (TTM) and its Stages of Change paradigm posits that in changing 
behaviors, individuals progress through sequential stages of Pre-contemplation, Contemplation, 
Preparation, Action and Maintenance. Transition between steps requires a core set of change 
processes.49 Women seeking contraception are most likely in Pre-contemplation or 
Contemplation stages for adopting dual method use including LARC. For Pre-contemplation, the 

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key change process is enhancing awareness. Video vignettes that present co mmon behavioral, 
normative, and control beliefs, constructs from the Theory of Planned Behavior (TPB), can 
address acquisition of a new behavior. For those who are in or move to the Contemplation 
stage, the key necessary change process is to “tip” decisional balance. Motivational 
interviewing (MI) teaches that an efficient and effective strategy for helping to “tip” the 
decisional balance is to explore and resolve ambivalence, something not typically used in less 
effective counseling processes, which tend to impose a solution. We will employ elements of 
motivational interviewing, which we term MI-informed counseling, including: collaborating as 
partners, empathic understanding, autonomy support, and self-efficacy support. Consistent with 
our conceptual model, a Risk Reduction framework for dual protection is incorporated. LARC 
with condoms is the optimal option, but it is not the only option. Risk reduction frames 
prevention behaviors along a continuum rather than in binary terms, recognizing opportunities 
for incremental behavior change, especially when behaviors are suboptimal.50 Thus, STI/HIV 
messages will also center on behaviors including condom use, partner negotiation, limiting the 
number of sexual partners, STI testing after unprotected sex, avoiding alcohol and drug use, 
and use of expedited partner therapy. These behaviors reduce risk even among condom 
users.24 Finally, both women and men will be portrayed in videos to ensure that the educational 
messages are patient-centered, salient, authentic, and relevant. Human-Centered Design 
(HCD),  a design approach recently applied to health care, ensuring that interventions meet the 
needs of the community of users, will be used to create a usable, sustainable intervention.51 
In HCD, the designer and end-user collaborate to create solutions in an iterative process of 
rapid prototyping with key stakeholder participation. Resulting interventions are based on 
available technology, address true barriers, and are matched to a realistic understanding of 
behaviors, skills, and informational needs. We will use HCD best practices such as iterative low-
fidelity prototyping and multiple course corrections before a final solution is achieved.  
 
2. Hypotheses 
We hypothesize that post-intervention, patients using miPlan will report: 
H1 a significant increase in contraceptive continuation and condom use  
H2 significantly fewer episodes of unprotected sex 
H3 significantly greater levels of self-efficacy and confidence for dual protection  
H4 significantly improved sexual health attitudes regarding STI/HIV prevention behaviors 
H5 significantly fewer negative experiences with condoms and fewer condom use errors and 
problems. 
Ultimately, miPlan has the potential to significantly impact racial and ethnic health disparities in 
STI/HIV and unintended pregnancy. 
 
 
 

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3. Methodology 
 
Aim 1: Develop the miPlan intervention by (1) enhancing the pretested PreCounselor app to 
focus on dual protection, (2) training reproductive health counselors, and (3) creating 
concomitant printed educational materials. 
 
Convene a Stakeholder Advisory Team. A 10-member Stakeholder Advisory Team of young 
women (n=4), young men (n=4), and clinic staff (n=2) will be convened to assist in miPlan 
development, followed by quarterly meetings throughout the project. Young men will help 
capture the dyadic nature of pregnancy and STI prevention, particularly condom use 
motivations, behavioral intentions, and negotiation, framing open dialogue across genders as 
essential to reproductive health. Men’s input will be critical in identifying salient decisional 
balance/self-efficacy beliefs regarding target behaviors and for developing relevant STI/HIV 
prevention videos for miPlan. The Advisory Team will ensure that miPlan reflects the 
experiences and needs of participants. Members will receive $300 over 2 years. 
 
Develop the MiPlan app. We will rely on our extensive experience creating counseling apps 
with clinic populations using HCD.48 Prior to committing resources to app development, we will 
“mock up” miPlan with the Advisory Team, relying on the many assets already created for 
PreCounselor (e.g., graphics, text, video).51 Early paper and pencil sessions help to develop 
algorithms for dual protection decision-making, app pages, and educational content. We then 
“walk through” multiple app scenarios, role-playing users at different stages of change for dual 
method use and various dual protection strategies. We will iteratively revise the elements with 
each round until members are in agreement with the content and form. Next, a tablet with voice 
recordings and Powerpoint slides will simulate the user experience. We will recruit users in the 
clinic waiting room (n=7) to use the app prototype in 20 minute sessions, filming their hands as 
they use it, taking notes as they navigate aloud, and making changes in response to their 
feedback, allowing for immediate course corrections in the user session (compensation=$20). 
We anticipate 5-7 sessions to finalize design decisions. We will create additional videos 
focusing on STI prevention behaviors by recruiting youth who are successfully using the 
method, asking them to address common behavioral, normative, and control beliefs (TPB 
constructs) in their testimonials. We envision that at least one of these videos will include young 
men. The final elements will be programmed as the miPlan app.  
 
Develop Educational Materials. We will create short paragraphs addressing condom use, 
incorporating up-to-date, evidence-based contraceptive and STI guidelines.45,46,54 Materials will 
avoid medical jargon, use short sentences, and focus on general and method-specific 
information and strategies to build self-efficacy and prevent relapse. They will feature the same 
images as the miPlan app to reinforce counseling. The Advisory Team will review and 
recommend changes to materials and we will assess readability. Dr. Holmquist has expertise in 
medical and sexuality education and curriculum development and will lead this activity. 
 
Training in Motivational Interviewing (MI)-informed Counseling. We will train two research 
assistants (RAs) to serve as contraceptive counselors. Separate counselors will ensure swift 

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recruitment and minimize clinic interruptions. Training will include how to use the miPlan app, 
identify and address ambivalence, and support strategies for managing anticipated barriers. Dr. 
Quinn, an experienced MI counselor, will oversee training, providing didactic presentations on 
core concepts of the TTM, including stages and process of change and decisional balance. Dr. 
Holmquist will oversee training related to condoms and contraceptive methods.  
 
Aim 2: Conduct a pre/post feasibility, acceptability, and effectiveness assessment of miPlan to 
examine improvement in dual method use, enhancement of contraceptive adherence 
and continuation, increase of condom use, and decrease of STI/HIV infection. 
Recruitment and Enrollment. All research activities will take place at the DCAM at the 
University of Chicago and select Planned Parenthood-IL clinics(Austin, Englewood, and/or 
Roseland).. We will pre-test the app and study procedures with 5 participants 
(compensation=$50), following the protocol planned for the pilot study. At their clinical visit, 
participants who meet the inclusion criteria (n=100) will be referred by clinic staff to a trained on-
site RA, who will explain the study and complete the informed consent process. Inclusion criteria 
are: (1) Being AA female and sexually active with a male partner(s) within the past 6 months; (2) 
Age 15-25 years; (3) Initiating contraception; (4) Not currently pregnant or intending pregnancy 
within the next 6 months; (5) English speaking; and (6) Not currently using LARC. As Illinois law 
ensures the rights of minors to receive confidential reproductive health care without parental 
consent, we will seek a waiver of parental consent for participation of those 15-17 years old. 
 
Pre-Intervention Baseline (T1) Procedures. Participants will complete a 10-15 minute 
questionnaire on the miPlan app (See appendices). The RA will provide a brief orientation to the 
miPlan app. After viewing miPlan, participants will be guided through a MI informed 
conversation using a worksheet to document the discussion on contraceptives knowledge and 
usage. The completed worksheet will be given to the participant and a copy will be kept for the 
participant’s records. (10 min). The participant will receive educational materials and a 
strategies worksheet to discuss with their clinician. The participant will also be given an STI test.  
Participants will be compensated $30.  
Post-Intervention (T2) Procedures. At 6-weeks post-enrollment, participants will complete a 
15-25 minute phone survey to gauge dual method use, contraceptive adherence/uptake, 
frequency of unprotected penile-vaginal/anal intercourse (PVI/PAI), and risk reduction 
behaviors. Participants will be compensated $20.     
Follow-Up (T3) Procedures. At 3 months post-enrollment, participants will complete a 15-25 
minute in-clinic survey to gauge maintenance of dual protection behaviors, contraceptive 
adherence/uptake, frequency of penile vaginal intercourse/penile anal intercourse, risk reduction 
behaviors, decisional balance/self-efficacy, and an STI test. Participants will receive $40. We 
will also conduct a 3-month retrospective chart review to capture interceding visits (e.g., initial 
contraceptive method selection, method switching, etc.) and diagnoses (e.g., pregnancy, 
STI/HIV). Participants unable to come in to clinic for their followup visit or who do not wish to 
come to clinic will be offered an at-home STI screening kit, to be mailed to the address they 

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provide. Participants who wish to be sent a kit will be mailed a endo-cervical screening kit, via 
USPS priority mail, with pre-paid postage and instructions for using the administering the self 
swab to themselves and packaging and mailing the completed kit back to Ci3. No identifying 
information will be included in the mailing, and all costs with mailing and processing will be paid 
by Ci3. All participants will be offered the at-home screening option upon reaching their three 
month follow-up event, and can complete the survey over the phone or online. 
 
 
4. Duration 
We are requesting IRB approval for a portion of Aim 1 to develop and pilot test the miPlan app 
and Aim 2 which cover months 3-21 of the overall study.  
 
5. Location 
The study will be conducted at the Duchossois Center for Advanced Medicine (DCAM) at the 
University of Chicago . The DCAM is home to adult primary and specialty clinics, pediatric 
specialty clinics, and outpatient diagnostic and treatment facilities of the University of Chicago 
Medicine. The will also be additional sites at Planned Parenhood-IL clinics, Austin, Englewood, 
and/or Roseland. 
 
 
 
6. Special Precautions 
 
The primary risks are loss of confidentiality and potential discomfort associated with answering 
sensitive questions about STIs, HIV, and sexual risk behaviors. All participants will be assigned 
a unique study identifier. Once all data has been collected, identifying subject information 
(including name) will be stripped from the database and from transcripts of focus group and in-
depth interviews Informed consents with the subjects’ names will be stored at the University of 
Chicago and only accessible to designated research staff. Consent forms will be stored in a 
locked filing cabinet in a locked office at the University of Chicago. Reports, manuscripts, and 
presentations will never include identifying information. With respect to potential discomfort 
associated with answering sensitive questions, subjects will be informed that they can skip any 
question they do not want to answer without penalty and that they can opt out of the study at 
any time without penalty. Participants are informed of these protections in the consent forms 
and all relevant study documents. 
 
7. Experimental Controls 
 
Not applicable. This is a pre- and post- intervention  
 
8. Type and number of subjects 
During Aim 1, we will recruit users in the clinic waiting room (n=7) to use the app prototype in 20 
minute sessions, filming their hands as they use it, taking notes as they navigate aloud, and 
making changes in response to their feedback.  
 
During Aim 2, we will pre-test the app and all study procedures with 5 women. In the pre- and 
post-intervention, we will recruit 100 young women (ages 15-25) from the waiting room of a 
gynecology clinic at the University of Chicago and select Planned Parenthood-IL clinics.    
 

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9. Statistical Analysis 
Feasibility & Acceptability: Descriptive statistics will be used to analyze the proportions and 
central tendency for satisfaction, helpfulness, appropriateness, and usefulness of miPlan. 
Effectiveness: Outcome variables will be measured in the following ways: Chi-square or Fisher’s 
Exact Test (categorical variables); t test and Mann-Whitney U test (continuous variables); and 
multinominal logistic and linear regression models. Multinomial logistic regression models will be 
used based on multiple categories for dual method (e.g., use of oral contraceptive with 
condoms; implant with condoms; or IUD with condoms). Linear regression and probability 
models will be used with the categorical dual method collapsed (e.g. any dual method). 
Covariates will be initially screened for potentially significant relationships with variables using 
bivariate testing and those attaining a p<.20 will be assessed in multivariable analyses. 
Because outcome variables may have missing values due to attrition, primary data analyses will 
be performed: (1) with only complete cases (women for whom there were no missing values) 
and (2) using multiple imputation.59 Sensitivity analyses will be performed to address extreme 
outlying variables. We will conduct comparisons of demographic and baseline attributes among 
drop-outs versus retained participants.  
 
10. Risks and Benefits 
Potential risks consist of the actual interview data collection process and potential breaches of 
confidentiality Participants may feel embarrassed with some of the questions that deal with 
sexual health and sexual behavior. However, participants will be allowed to opt out of the study 
and to not respond to questions they are uncomfortable with without any penalty. Study records 
that identify the participant will be kept confidential; however there is a risk of loss of 
confidentiality. Participants will be informed of these risks, protections against loss of 
confidentiality, and their rights to skip any question and to withdraw from the study at any time in 
the consent forms and all relevant study documents. In addition, there is potential risk to 
confidentiality if a 15–17 year old reports sexual abuse or if any participant reports suicide risk 
or intent to harm someone else during any study visit. All university employees are required to 
report suspected cases of abuse or neglect and we are ethically bound to address issues of 
suicide risk. All participants are told in the consent that statements of potential harm to self or 
others require reporting. We have extensive experience dealing with this issue, and specific 
procedures are in place (described in detail below) for referrals and strict confidentiality of 
reports. We will take the utmost caution to protect the confidentiality of responses and have 
detailed these procedures below. 
 
The potential benefits of this research far outweigh the risks. First, African American women are 
the group most affected by unintended pregnancy and STIs. Despite these factors, there are 
few evidence-based interventions that have been specifically developed and tailored for the dual 
protection needs of young African American women. We propose to develop and pilot test an 
innovative mobile app-based intervention to prevent/reduce STI and pregnancy-related risk 
behaviors. The intervention has the potential to reach large numbers of young women. Women 
who participate in the study may benefit from receiving information about pregnancy and STI 
prevention strategies that may not be provided in standard of care or available through other 
mechanisms (e.g., sexual health education, STI clinic information, etc.). Possible risks (i.e. 
discomfort answering questions, potential confidentiality breaches) are outweighed by the new 
knowledge gained regarding the potential of an app-based intervention to reduce STI/pregnancy 
risk among young African American women. We have adequate safeguards to protect against 
these risks and will alert the University of Chicago IRB of any problems. 

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11. Monitoring of Safety 
The PI is responsible for monitoring the data, assuring protocol compliance, and conducting the 
safety reviews at the specified frequency. The Research Manager will oversee day-to-day 
compliance. This protocol presents minimal risks to the subjects and adverse events or other 
problems are not anticipated. The PI and Research Manager will be responsible for monitoring 
the data, assuring protocol compliance, and conducting the safety reviews at regular intervals 
which must be conducted at a minimum of every 6 months (including when re-approval of the 
protocol is sought). During the review process, the PI and Research Manager will evaluate 
whether the study should continue unchanged, require modification/amendment, or close to 
enrollment. The PI, IRB and the Research Manager will ensure that any deviations from the 
protocol or safety concerns are reported according to institutional guidelines. Data and study 
risk will be assessed throughout the study. 
 
 
 
 
 
12. Payments 
During Aim 1, clinic waiting room users (n=7) who will use the app prototype in 20 minute 
sessions will receive $20 compensation for their participation. 
 
During Aim 2 of the research, pre-test participants (n=5) will receive $50 for their participation. 
Pre- and post-intervention participants will receive up to $90 (Time 1-baseline: $30; Time 2- 6 
weeks: $30; Time 3- 3 months: $30) for participating in the intervention.  
 
13. Informed Consent 
Study coordinators and designated research staff will obtain written consent from all 
participants. Research staff will describe the study procedures and anticipated risks and 
benefits to ensure the study participants understand the study. We will document that the 
informed consent process occurred. One copy of the informed consent will be provided to the 
subject and one copy will be placed in the in the subject's research files. Participants will be 
reminded that their participation is completely voluntary and they are free to withdraw from the 
study at any time. All subjects will be re-consented and sign new consent forms if there are any 
changes to the informed consent form (i.e. something occurs that changes the risk/benefit ratio 
of the study). Written consent will be obtained at the beginning of the prototyping, pilot testing, 
and intervention session s and the study will be explained in detail and before the each phase 
begins. In all instances, participation in the sessions (prototyping, pilot test, and intervention) will 
occur immediately after the consent is obtained. 
 
Consistent with our previous studies in this population, we do not require parental consent for 
study enrollment. Parental consent may decrease participation rates because some young 
women will fear that their personal information may be disclosed as a result of participation. In 
addition, Illinois law ensures the rights of minors age 13 years or older to receive confidential 
sexual/reproductive health care (including STI/HIV testing, drug or alcohol abuse counseling, 
etc.) without parental consent. That being said, there may be some participants who fear 
parental consent. The nature and scope of the proposed research do not pose more than 
“minimal risk” to participants (45 CFR Part 46.102): “the probability and magnitude of harm or 
discomfort anticipated in the research are not greater in and of themselves than those ordinarily 
encountered in daily life or during the performance of routine physical or psychological 
examinations or tests.” To compensate for waiver of parental consent, participants receive a 

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formal individual assessment of capacity to consent to ensure their understanding of study 
goals, procedures, and risks from disclosure of sensitive information. Consistent with national 
policy recommendations from the Society for Adolescent Medicine, requiring parental 
permission for the proposed study would have a number of possible negative effects, including: 
(1) reducing the validity of the findings by effectively eliminating potential participants unwilling 
to share permission forms with their parents/guardians; and (2) adding little in the way of actual 
subject protection, given the minimal risk of study participation. 
 
 Both study participants and parents are informed that the PI and/or research staff is required by 
Illinois law to report any self-reported or suspected incidents of child abuse or neglect. These 
will be reported to the Illinois Department of Children and Family Services (IDCFS). As the 
mandated reporter, the PI will initiate this procedure, following the university guidelines on these 
types of incidents.    
 
Therefore, the proposed research protocol will seek a waiver of parental consent from the 
University of Chicago IRB. All consent forms will be securely stored in a locked filing cabinet in a 
locked office at the University of Chicago.  
 
 
14. Confidentiality 
Only the principal investigator and the immediate research staff will have access to the raw 
data. No one outside of the institution will have access to the data. All data will be stored on 
secure network servers that are backed up nightly and password protected.  
 
15. Bibliographic References 
Please see attached 
 
16. Recruiting Methods 
Participants in the iterative design process, pre-test and pilot will be recruited by research staff 
from the clinic waiting room at University of Chicago and select Planned Parenthood-IL clinics. 
A qualified member of the research staff will conduct eligibility screening to ensure participant 
eligibility. This member of the research staff will also work with clinicians in order to identify 
potentially eligible patients who have scheduled appointments during the recruitment phase of 
the study.  These patients will be telephoned in advance and informed that they may be able to 
participate in the study during their medical visit.  Eligible participants will be consented and 
enrolled. Research activities will take place at the University of Chicago and select Planned 
Parenthood-IL clinics. The informed consent process will inform the participant that participation 
is completely voluntary and that a decision not to participate will not affect her care at the 
University of Chicago or Planned Parenthood.  
 
17. Primary Physician Notification 
Not Applicable 
18. Interdepartmental Coordination  
Not Applicable 
19. Pregnancy Test 
Not Applicable 

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20. Rationale for Exclusion 
Because the present study is focused on preventing STIs and pregnancy among young African  
American women, we will exclude non-African American subjects. We also will exclude any 
prospective participant with a cognitive deficit that precludes providing informed assent/consent.  
 
21. Medication Infusion 
Not Applicable