MKit: A Pilot Study Testing a Life Skills Application to Address Interpersonal Relationships in College
Phase: NA
Conditions: Sexual Violence, Primary Prevention
Sponsor: University of Michigan

 
 
i 
Clinical Study Protocol 
 
Testing a Life Skills Application to Address Interpersonal Relationships in 
College (MKit) 
 
Sponsor: 
 
Michigan Institute for Clinical and Health Research 
1600 Huron Parkway 
Building 400 
Ann Arbor, MI 48109 
 
 
Clinical Research Organization: 
 
University of Michigan School of Nursing 
400 North Ingalls Building 
Ann Arbor, MI 48109 
 
Principal Investigator: 
 
Michelle L. Munro-Kramer, PhD, CNM, FNP-BC 
University of Michigan School of Nursing 
400 North Ingalls Building 
Room 3188 
Ann Arbor, MI 48109 
 
Version Number: 
 
1.1 
Date:  
24 August 2018 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
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Table of Contents 
STATEMENT OF COMPLIANCE ................................................................................................ 1 
1          PROTOCOL SUMMARY ................................................. Error! Bookmark not defined. 
1.1       SYNOPSIS ......................................................................... Error! Bookmark not defined. 
1.2       SCHEMA ............................................................................................................................ 4 
1.3       SCHEDULE OF ACTIVITIES (SOA) ............................................................................... 5 
2          INTRODUCTION .............................................................................................................. 6 
2.1       STUDY RATIONALE ....................................................................................................... 6 
2.2       BACKGROUND ................................................................................................................ 6 
2.3       RISK/BENEFIT ASSESSMENT ....................................................................................... 8 
3          OBJECTIVES AND ENDPOINTS .................................................................................... 8 
4          STUDY DESIGN.............................................................................................................. 10 
4.1       OVERALL DESIGN ........................................................................................................ 10 
4.2       SCIENTIFIC RATIONALE FOR STUDY DESIGN ...................................................... 11 
4.3       JUSTIFICATION FOR DOSE ......................................................................................... 11 
4.4       END OF STUDY DEFINITION ...................................................................................... 11 
5         STUDY POPULATION .................................................................................................... 12 
5.1       INCLUSION CRITERIA.................................................................................................. 12 
5.2       EXCLUSION CRITERIA ................................................................................................ 12 
5.3       LIFESTYLE CONSIDERATIONS .................................................................................. 12 
5.4       SCREEN FAILURES ....................................................................................................... 12 
5.5       STRATEGIES FOR RECRUITMENT AND RETENTION ........................................... 12 
6         STUDY INTERVENTION ................................................................................................ 13 
6.1       STUDY INTERVENTION ADMINISTRATION ........................................................... 13 
6.1.1      STUDY INTERVENTION DESCRIPTION .................................................................. 13 
6.1.2      DOSING AND ADMINISTRATION ............................................................................ 13 
6.2       PREPARATION/HANDLING/STORAGE/ACCOUNTABILITY ................................. 14 
6.2.1      ACQUISITION AND ACCOUNTABILITY ................................................................. 14 
6.2.2      FORMULATION, APPEARANCE, PACKAGING, AND LABELING ...................... 14 
6.2.3       PRODUCT STORAGE AND STABILITY .................................................................. 14 
6.2.4       PREPARATION ............................................................................................................ 14 

 
 
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6.3       MEASURES TO MINIMIZE BIAS: RANDOMIZATION AND BLINDING ............... 14 
6.4       STUDY INTERVENTION COMPLIANCE .................................................................... 14 
6.5       CONCOMITANT THERAPY.......................................................................................... 14 
6.5.1     RESCUE MEDICINE ...................................................................................................... 14 
7          STUDY INTERVENTION DISCONTINUATION AND PARTICIPANT .................... 15 
7.1      DISCONTINUATION OF STUDY INTERVENTION .................................................... 15 
7.2      PARTICIPANT DISCONTINUATION/WITHDRAWL FROM THE STUDY .............. 15 
7.3      LOST TO FOLLOW-UP ................................................................................................... 15 
8          STUDY ASSESSMENTS AND PROCEDURES ............................................................ 15 
8.1      EFFICACY ASSESSMENTS ........................................................................................... 15 
8.2      SAFETY AND OTHER ASSESSMENTS ........................................................................ 16 
8.3      ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS .......................................... 16 
8.3.1     DEFINITION OF ADVERSE EVENTS (AE) ................................................................ 16 
8.3.2     DEFINITION OF SERIOUS ADVERSE EVENTS (SAE) ............................................ 16 
8.3.3     CLASSIFICATION OF AN ADVERSE EVENT ........................................................... 16 
8.3.3.1   SEVERITY OF EVENT ................................................................................................. 16 
8.3.3.2   RELATIONSHIP TO STUDY INTERVENTION ......................................................... 17 
8.3.3.3   EXPECTEDNESS .......................................................................................................... 17 
8.3.4     TIME PERIOD AND FREQUENCY FOR EVENT ASSESSMENT AND FOLLOW-
UP ................................................................................................................................................. 17 
8.3.5     ADVERSE EVENT REPORTING.................................................................................. 17 
8.3.6     SERIOUS ADVERSE EVENT REPORTING ................................................................ 18 
8.3.7     REPORTING EVENTS TO PARTICIPANTS ............................................................... 18 
8.3.8     EVENTS OF SPECIAL INTEREST ............................................................................... 18 
8.3.9     REPORTING OF PREGNANCY.................................................................................... 18 
8.4      UNANTICIPATED PROBLEMS ..................................................................................... 18 
8.4.1     DEFINITION OF UNANTICIPATED PROBLEMS (UP) ............................................. 18 
8.4.2     UNANTICIPATED PROBLEM REPORTING .............................................................. 19 
8.4.3     REPORTING UNANTICIPATED PROBLEMS TO PARTICIPANTS ........................ 19 
9          STATISTICAL CONSIDERATIONS.............................................................................. 19 
9.1      STATISTICAL HYPOTHESES ........................................................................................ 19 

 
 
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9.2      SAMPLE SIZE DETERMINATION ................................................................................ 19 
9.3      POPULATIONS FOR ANALYSES.................................................................................. 20 
9.4      STATISTICAL ANLYSES ............................................................................................... 20 
10         SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS .. 22 
10.1       REGULATORY, ETHICAL, AND STUDY OVERSIGHT CONSIDERATIONS ...... 22 
10.2      ADDITIONAL CONSIDERATIONS ............................................................................. 26 
10.3      ABBREVIATIONS ......................................................................................................... 27 
10.4      PROTOCOL AMENDMENT HISTORY ....................................................................... 27 
11       REFERENCES .................................................................................................................. 28 
 
 
 
 

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The trial will be carried out in accordance with the International Conference on Harmonisation 
Good Clinical Practice (ICH GCP) and the following: 
• United States (US) Code of Federal Regulations (CFR) applicable to clinical studies (45 
CFR Part 46, 21 CFR Part 50, 21 CFR Part 312, and/or CFR Part 812) 
National Institutes of Health (NIH)-funded investigators and clinical trial site staff who are 
responsible for the conduct, management, or oversight of NIH-funded clinical trials have 
completed Human Subjects Protection and ICH GCP Training. 
The protocol, informed consent form(s), recruitment materials, and all participant materials will 
be submitted to the Institutional Review Board (IRB) for review and approval. Approval of both 
the protocol and consent form must be obtained before any participant is enrolled. Any 
amendment to the protocol will require review and approval by the IRB before the changes are 
implemented to the study. In addition, all changes to the consent form will be IRB-approved; a 
determination will be made regarding whether a new consent needs to be obtained from 
participants who provided consent; using a previously approved consent form. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
STATEMENT OF COMPLIANCE 
 
 

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1          PROTOCOL SUMMARY 
1.1       SYNOPSIS 
 
Title: 
MKit: A Pilot Study Testing a Life Skills Application to Address 
Interpersonal Relationships in College 
Study Description: 
This study will conduct a second pilot test of the MKit web-based 
application (WebApp). MKit was previously adapted to a diverse (race, 
ethnicity, gender/sexual identity) college population with a focus on 
life skills and holistic self-care as reinforcement to currently available 
primary prevention programming available to freshman students. Our 
hypothesis is that the adapted WebApp will be safe, acceptable, and 
students will be willing to use it as a reinforcement to current 
university primary prevention programming. 
Objectives: 
• Primary: To evaluate the safety, usability, acceptability, and 
willingness of using the adapted WebApp among a randomized 
sample of 300 first year university students. 
• Secondary: To complete preliminary evaluations on retention and 
efficacy measures such as sexual and intimate partner violence 
knowledge, attitudes, and experiences (victimization and 
perpetration) to allow for power calculations for a future R-level 
submission. 
Endpoints: 
• Primary: Safety (qualitative interviews), Usability (System 
Usability Scale, Brooke, 1986), Acceptability (investigator 
generated), and willingness to use (qualitative interviews). 
• Secondary: Retention (percent completing follow-up surveys), 
Sexual and Intimate Partner Violence Knowledge (adapted from 
Texas Education Program Participant Response Form), Self-
Efficacy of Protective Behaviors Related to Sexual and Intimate 
Partner Violence (investigator generated), Intimate Partner 
Violence Attitude Scale (adapted from Finchman, Cuit, 
Braithwaite, & Pasley, 2008), Consensual Sexual Activity 
(investigator generated), Sexual victimization/perpetration (Sexual 
Experiences Survey, Koss et al., 2007), and Universal Violence 
Prevention Screening (adapted from Heron, Thompson, Jackson, 
& Kaslow, 2003). 
Study Population: 
300 first year university students (150 Control Group, 150 Intervention 
Group) 
Phase: 
Pilot  
Description of 
Sites/Facilities 
Enrolling 
Participants: 
 
University of Michigan Residence Halls (Alice Lloyd and Couzens) 

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   Participant Duration:     For pilot study – 6 months  
 
Description of Study 
Intervention: 
Web-based app that uses a life skills approach to address healthy 
relationships and sexual violence. 
Study Duration: 
2 years 9 months 

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1.2       SCHEMA 
 
ADAPT-IT Process Completed to create Web-App Intervention 
Semi-Structured 
Interviews with 
interested control 
participants 
N=10 
Semi-Structured 
Interviews with 
interested 
intervention 
participants 
N=15 
Intervention 
Group 
interacts 
with 
WebApp 
Randomization by Residence Hall 
Control Group 
N=150 
Intervention 
Group  
N=150 
All participants will be consented and will perform baseline assessments online via 
Qualtrics. 
All participants complete 1-month survey 
All participants complete 5-month survey 

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1.3       SCHEDULE OF ACTIVITIES (SOA) 
 
 
 
 
 
Procedures 
Preparation 
before 
recruitment 
 
Baseline 
 
1-month 
follow-up 
 
5-month 
follow-up 
Post-study 
semi-
structured 
interviews 
Randomization by 
residence hall 
X 
 
 
 
 
Demographics 
 
X 
X 
X 
 
Sexual and Intimate 
Partner Violence 
Knowledge 
 
X 
X 
X 
 
 
Self-Efficacy of 
Protective Behaviors 
Related to Sexual and 
Intimate Partner 
Violence 
 
X 
X 
X 
 
Intimate Partner 
Violence Attitude 
Scale 
 
X 
X 
X 
 
Consensual Sexual 
Activity 
 
X 
X 
X 
 
Sexual Experiences 
Survey (Victimization 
and Perpetration) 
 
X 
X 
X 
 
Universal Violence 
Prevention Screening 
 
X 
X 
X 
 
System Usability 
Scale  
 
 
X 
X 
 
System Acceptability 
 
 
X 
X 
 
User Data 
 
 
X 
X 
 
Reaction to content 
 
 
 
 
X 
Perceived safety 
 
 
 
 
X 
Desirability 
 
 
 
 
X 
Willingness for future 
use 
 
 
 
 
X 

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There have been minimal attempts at providing reinforcement for students around the primary 
prevention of sexual violence and nobody has approached this topic with the consideration of 
holistic well-being in mind. Many of the currently available primary prevention programs 
include a one-time interaction and do not provide reinforcement throughout the student’s college 
career (Banyard, Moynihan, & Plante, 2007; Foshee et al., 2004; Moynihan et al., 2015; Taylor, 
Mumford, & Stein, 2015; Taylor, Mumford, Stein, & Woods, 2015). Principles of learning 
suggest that attitude change and skill training are more effective with reinforcement (Skinner, 
1958). There is a need for holistic interventions that provide students with the means to address 
all of the physical, emotional, and social changes they may be experiencing during their 
transition to young adulthood. Past research has emphasized that life skills and social 
competency are promising approaches that address individuals within their ecological context 
(Krug, Mercy, Dahlberg, & Zwi, 2002). 
With a national annual incidence rate of 5%, rape is the most frequent violent crime that occurs 
on college campuses (Finn, 1995; Fisher, Cullen, & Turner, 2000). Nearly 80-90% of college 
students know the perpetrator, which increases the likelihood that the rape will be completed, 
rather than attempted (Fisher et al., 2000; Karjane, Fisher, & Cullen, 2005). Furthermore, many 
college survivors do not perceive or acknowledge their experiences as a rape, often because of 
lack of evidence, the absence of a weapon, or because alcohol and/or drugs were involved 
(Fisher, Daigle, Cullen, & Turner, 2003; Karjane et al., 2005). These characteristics of sexual 
assault in college therefore contribute to the underestimation, under reporting, under prosecution, 
and low rates of seeking post-assault services among college survivors (Bondurant, 2001; 
Karjane et al., 2005). 
Despite the high prevalence of rape in the United States, an event with long-term negative effects 
on a survivor’s health, few survivors receive comprehensive post-assault care. In the period 
immediately following a rape, about half of all survivors will have evidence of physical trauma, 
up to 30% contract a sexually transmitted infection (STI), and 5% of female survivors become 
pregnant (Resnick et al., 2000). Specific to college survivors, about 20% report physical injuries 
(Fisher et al., 2000), many fear social consequences so they alienate themselves from campus 
activities or drop out of school, and it appears that college women who experience post-traumatic 
stress disorder (PTSD) from an assault may use substances and/or sexual behavior to reduce 
distress (Messman-Moore, Ward, & Brown, 2009). Post-assault, survivors can access 
comprehensive health services through referral by rape crisis centers or via the emergency 
department from specially trained sexual assault nurse examiner (SANE) programs. 
Comprehensive care includes 1) treatment of physical injuries or other sequelae of the assault, 2) 
pregnancy prevention, including options if emergency contraception is not effective, 3) STI 
screening and treatment, 4) psychological care for PTSD, 5) forensic and victim services, and 6) 
legal care, including safety from the perpetrator and the ability to report the assault and press 
2          INTRODUCTION 
2.1       STUDY RATIONALE 
 
2.2       BACKGROUND 
 

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charges if the survivor desires (Tjaden & Thoennes, 2006). However, only one in five women 
raped as an adult reported their rape to the police and of these reported rapes, prosecution rates 
were only 37% (Tjaden & Thoennes, 2006). Thus, the prevalence of rape is under reported, 
under prosecuted, and many women do not seek care after experiencing rape due to multiple 
barriers to care (Munro, 2014).  
Even with the high prevalence and severe physical health, mental health, and social outcomes 
associated with sexual violence, there are limited data available on effective primary prevention 
programs (Centers for Disease Control, 2016). A recent systematic review of primary prevention 
programs for sexual violence identified only three primary prevention strategies that have 
demonstrated significant effects on sexual violence, including Safe Dates, Shifting Boundaries, 
and the 1994 Violence Against Women Act (VAWA) Funding (DeGue et al., 2014). However, 
there are promising trends that favor multisectoral programs that engage stakeholders to 
challenge the acceptability of violence and the underlying social risk factors. There is strong 
consensus among researchers that more rigorous evaluation of promising programs is needed in 
order to continue to address sexual violence (Ellsberg et al., 2015).  
Furthermore, recent national legislation has also highlighted the need for primary prevention of 
sexual violence. The Dear Colleague Letter issued by the Obama Administration in 2011 
recommended that institutions of higher education implement preventive education programs 
focused on sexual violence for incoming students. The 2014 VAWA prescribed more specific 
recommendations that new students and employees must be offered primary prevention and 
awareness programs focused on domestic violence, sexual assault, stalking, and rape. The 2014 
VAWA acknowledged specific content that should be included in these programs but did not 
stipulate how these programs were to be administered to incoming students. Thus, each institute 
of higher education implements primary prevention programming individually, often using a 
combination of web-based, in-person, and performance-based methods.  
Many college campuses rely on online learning modules to meet the requirements of the 2014 
VAWA; however, there is a lack of evidence on the effectiveness of these programs and the 
potential that mobile or web-based applications hold for the prevention of sexual violence. 
Technology has become a ubiquitous modality for communication and accessing knowledge 
across the United States. In 2011 the White House called for initiatives that leveraged technology 
to prevent dating and sexual violence (Rosenthal, 2013). This resulted in the creation of a mobile 
application called Circle of 6 (http://www.circleof6app.com/), which makes it easy to contact a 
person in your circle to let them know where you are and what you need. More recently, a 
randomized controlled trial at a university in the Southeastern United States found a web-based 
bystander intervention approach, RealConsent, significantly reduced sexual violence perpetration 
and increased knowledge around consent, intervening, and rape myths and decreased negative 
attitudes around hostility toward women (Salazar, Vivolo-Kantor, Hardin, & Berkowitz, 2014). 
However, neither of these technology-based approaches targets the social and cultural 
constructions of sexual violence that promote gender inequality and discrimination nor do they 
offer holistic approaches to primary and secondary prevention (Dartnall & Jewkes, 2013). 
A holistic approach recognizes college students as individuals transitioning into young 
adulthood. The transition into young adulthood is associated with myriad of preventable health 
problems including higher rates of mortality and more involvement in health risk behaviors 
(Ozer et al., 2012). Additionally, college students are often learning to manage school, work, 
new relationships, stress, conflict, and their own health for the first time as independent young 

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adults. A holistic approach aims to identify the student’s goals and needs by increasing their 
ability to make decisions based on their personal values while also addressing communication 
skills in interpersonal relationships as an upstream approach to reduce sexual violence in the 
campus community. Positive and respectful communication within interpersonal relationships 
may help prevent some types of unwanted sexual activity. Furthermore, when students make 
decisions consistent with their values, they may be less likely to engage in behaviors or 
encounter situations where sexual assault perpetration or victimization could occur. 
 
2.3.1     KNOWN POTENTIAL RISKS 
There is no more than minimal risk to the study subjects. There is a rare risk that a participant 
may experience emotional discomfort related to survey or semi-structured interview questions. 
All participants will receive resources to help alleviate any potential discomfort and will have the 
opportunity to skip any questions they choose. The rare possibility of breach of confidentiality 
exists. All data will be stored on a secure, HIPAA-compliant server and drive with monitored 
and controlled access to reduce this risk. 
2.3.2     KNOWN POTENTIAL BENEFITS 
The study participants will have the direct benefit of receiving information through a holistic, 
life-skills approach to addressing interpersonal relationships and sexual violence. This content 
may help them to navigate their own relationships. 
2.3.3     ASSESSMENT OF POTENTIAL RISKS AND BENEFITS 
The minimal risks associated with this study are reasonable given the potential impact of the 
project. The results of this study will provide the basis to scale-up this innovative intervention to 
reach a high-risk and vulnerable group, as college females are among those at the highest risk for 
sexual violence. This study therefore provides the opportunity to develop a low-cost/high-impact 
reinforcement intervention that could improve interpersonal relationships and reduce sexual 
violence within college campuses. As such, the available information suggests that the present 
clinical study has an acceptable risk-benefit ratio. 
 
Objectives 
Endpoints 
Justification for 
Endpoints 
Primary 
 
 
To evaluate the 
safety, usability, 
acceptability, and 
willingness of using 
the adapted 
WebApp among a 
randomized sample 
Safety will be assessed through qualitative 
interviews 
 
Usability will be measured through the System 
Usability Scale (Brooke, 1986) 
 
The endpoints are 
common outcomes 
of interest for studies 
of technological 
interventions. These 
outcomes will be 
measured throughout 
2.3       RISK/BENEFIT ASSESSMENT 
 
3          OBJECTIVES AND ENDPOINTS 

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of 300 first year 
university students. 
Acceptability will be measured through an 
investigator generated scale 
 
Willingness to use will be assessed through 
qualitative interviews 
the study, to observe 
changes overtime 
with continued 
exposure to the 
intervention. These 
endpoints are 
important outcomes, 
as interventions must 
be safe, acceptable, 
and usable to ensure 
broad scale uptake. 
Secondary 
 
 
To complete 
preliminary 
evaluations on 
retention and 
efficacy measures, 
such as sexual and 
intimate partner 
violence knowledge, 
attitudes, and 
experiences 
(victimization and 
perpetration) to 
allow for power 
calculations for a 
future R-level 
submission. 
Retention will be measured as the percentage of 
participants completing the 1- and 5-month 
follow-up surveys. 
 
Sexual and Intimate Partner Violence 
Knowledge will be measured with 20 items 
adapted from the Texas Education Program 
Participant Response Form 
(https://www.wcasa.org/file_open.php?id=787). 
 
Confidence in the ability to handle situations 
related to sexual and intimate partner violence 
will be measured using 15 investigator created 
items that called the, Self-Efficacy of 
Protective Behaviors Related to Sexual and 
Intimate Partner Violence. 
 
Attitudes related to Intimate Partner Violence 
Attitude Scale will be measured using 34 items 
adapted from Finchman, Cuit, Braithwaite, & 
Pasley (2008). 
 
Consensual Sexual Activity will be measured 
with 2 primary questions developed by the 
investigators. 
 
Sexual victimization (n=10) and perpetration 
(n=10) will be measured with the Sexual 
Experiences Survey (Koss et al., 2007). 
 
Experiences of intimate partner violence will be 
measured with 26 items adapted from the 
Universal Violence Prevention Screening 
(Heron, Thompson, Jackson, & Kaslow, 2003). 
The endpoints are 
important, as the 
WebApp under study 
is a primary sexual 
violence prevention 
intervention with a 
focus on healthy 
relationships. As 
such, knowledge, 
attitudes, and 
experiences of sexual 
and intimate partner 
violence 
victimization and 
perpetration are 
outcomes of interest. 
Though this pilot 
study is not powered 
to detect changes in 
these secondary 
outcomes, obtaining 
data for power 
calculations for a 
larger study is a key 
component of this 
study. 

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This project builds on the current momentum to address the primary prevention of sexual 
violence within United States institutions of higher education as well as the proliferation of web-
based applications. A before-and-after quasi-experimental, mixed-method pilot design will be 
used to gather acceptability and safety data as well efficacy trends. Two residence halls (Alice 
Lloyd and Couzens) at the University of Michigan will be randomized to receive either: (1) the 
control arm (n=150) which will receive usual care only (all incoming students receive three 
programs about healthy relationships and sexual violence including Haven, Relationship Remix, 
and Change it Up) or (2) the usual care (n=150) described above and the web-based intervention 
(MKit). We will use cluster-randomization by residence hall (to minimize contamination 
associated with individual-level randomization of students living in the same residence hall). 
Following the informed consent process, students in both conditions will complete a baseline 
survey of xx questions. Baseline measures will include: 1) demographic data (n=12), 2) 
investigator developed questions on knowledge about sexual and intimate partner violence 
(n=20) adapted from the Texas Education Program Participant Response Form 
(https://www.wcasa.org/file_open.php?id=787), 3) investigator developed questions on self-
efficacy (n=15), 4) 34 questions from the Revised Intimate Partner Violence Attitude Scale 
(Finchman, Cuit, Braithwaite, & Pasley, 2008), 5) investigator developed questions on 
consensual sex (n=2), 6) 10 items from the Sexual Experiences Survey (SES) will measure past 
experiences with sexual violence (Koss et al., 2007) and 10 items from the Sexual Experiences 
Survey (SES) will measure past experiences with perpetration (Koss et al., 2007), and 7) 26 
questions from the Universal Violence Prevention Screening Protocol – Adapted questions 
(Heron, Thompson, Jackson, & Kaslow, 2003). All of these are measures have been validated 
and used extensively in the United States to measure knowledge and attitudes related to gender-
based violence. Following the survey, students in the Intervention group will be given the 
opportunity to interact with the application at their own pace, choosing which content to view in 
the order they prefer.  
The Control group will only receive the usual care delivered to all incoming University of 
Michigan students, which includes Haven (an online course about sexual violence), Relationship 
Remix (an interactive program about healthy relationships and sexual violence delivered by 
peers), and Change it Up (a theater based performance on bystander intervention). The 
Intervention group will receive the usual care described above as well as access to MKit. They 
will be encouraged to interact with MKit throughout the study. Data will be collected on the 
content viewed by the participants, as well as the amount of time they spend within each content 
area, and the order in which they view the content. 
At 1 and 5 months, we will repeat all baseline measures in both groups. Participants in the 
Intervention group will also be asked to complete the 10-item System Usability Scale (Brooke, 
1996) and an investigator created 5-item acceptability scale.  
4          STUDY DESIGN 
4.1       OVERALL DESIGN 
 

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Post-intervention semi-structured interviews will be conducted with 25 participants, including 15 
participants from the intervention group and 10 participants from the control group, to assess 
perceived safety, reaction to content, desirability, willingness to continue using the content, and 
willingness to recommend the content to others. Prior to commencing the interviews, we will ask 
each participant to complete a paper demographic survey.  
This is a before-and-after quasi-experimental, mixed-method pilot design with three survey 
collection points and a post-study semi-structured interview component. This study will be 
performed with healthy college students to determine the safety, acceptability, and usability of 
MKit.  
The endpoints are common outcomes of interest for studies of technological interventions. These 
outcomes will be measured throughout the study, to observe changes over time with continued 
exposure to the intervention. These endpoints are important outcomes, as interventions must be 
safe, acceptable, and usable to ensure broad scale uptake. MKit is a primary sexual violence 
prevention intervention focused on healthy relationships. As such, knowledge, attitudes, and 
experiences of sexual and intimate partner violence victimization and perpetration are outcomes 
of interest. Though this pilot study is not powered to detect changes in these secondary 
outcomes, obtaining data for power calculations for a larger study is a key component of this 
study.  
This study compares usual care for the prevention of sexual and intimate partner violence with 
care as usual plus the intervention. Both groups will receive interventions currently in place, 
ensuring that standard care is not withheld from any participant. As the intervention under study 
is intended to supplement and reinforce current primary prevention programming, the study 
design will measure the acceptability and preliminary efficacy of broad scale-up of the 
intervention to the broader college campus. 
Intervention group participants will have five months to interact with MKit content, as this time 
period should present sufficient time for meaningful short-term change in the outcomes of 
interest. Further, the study will run for the duration of the school year, allowing study staff to 
follow students from the beginning of the school year to the end of the school year as they 
interact with MKit. 
A participant is said to have completed the study if he or she has completed all three surveys, 
including the baseline, 1-month, and 5-month surveys, shown in the schedule of activities. 
 
 
4.2       SCIENTIFIC RATIONALE FOR STUDY DESIGN 
 
4.3       JUSTIFICATION FOR DOSE 
 
4.4       END OF STUDY DEFINITION 
 

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For the pilot study, individuals who meet the following criteria will be considered eligible to 
participate in the study: 
1. Currently enrolled as a student at the participating university 
2. Participated in Relationship Remix in Fall 2018 as a first-year or transfer student 
3. Willing to participate in the study 
4. Able to speak and read English 
For the semi-structured interviews, individuals who meet the following criteria will be 
considered eligible to participate in the study: 
1. Currently enrolled as a student at the participating university 
2. Participated in Relationship Remix in Fall 2018 as a first-year or transfer student 
3. Participated in the pilot study 
4. Willing to participate in the study 
5. Able to speak and read English 
Not Applicable 
Not Applicable 
As all participants will be recruited directly from Relationships Remix, a program for currently 
enrolled University of Michigan students, all participants are exceedingly likely to be eligible for 
the study given the inclusion criteria. 
Students from the target sample, first-year University of Michigan college students, will be 
recruited for the study. Two residence halls (Alice Lloyd and Couzens) at the University of 
Michigan will be randomized to receive either: (1) the control arm (n=150) which will receive 
usual care only (all incoming students receive three programs about healthy relationships and 
sexual violence including Haven, Relationship Remix, and Change it Up) or (2) the usual care 
(n=150) described above and the web-based intervention (MKit). We will use cluster-
randomization by residence hall (to minimize contamination associated with individual-level 
randomization of students living in the same residence hall). At the end of the Relationship 
5         STUDY POPULATION 
5.1       INCLUSION CRITERIA 
 
5.2       EXCLUSION CRITERIA 
 
5.3       LIFESTYLE CONSIDERATIONS 
 
5.4       SCREEN FAILURES 
 
5.5       STRATEGIES FOR RECRUITMENT AND RETENTION 
 

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Remix program, a brief announcement will be made about the opportunity to participate in a 
research study about healthy relationships and palm cards will be distributed (see recruitment 
materials). We will recruit specifically from Relationship Remix to ensure that all experimental 
and control subjects receive the same primary prevention programming currently in place on 
campus. Interested students will receive a palm card with a link to either the MKit web-based 
application (Intervention) with an access code to sign-up for the website, or a link to the baseline 
consent and Qualtrics survey (Control) without access to the web-based application. At the end 
of the study, students from each condition will be invited to participate in an in-person semi-
structured interview. Students will receive the invitation to participate in the semi-structured 
interview on the final page of their 5-month follow-up survey. Students who opt to share their 
email address with the study team at that time will be contacted to set-up an in-person interview 
based on user status for the intervention (consistent user of MKit, frequent user of MKit, 
minimal user of MKit) and a diverse group based on gender, race/ethnicity, and age for the 
control group. Semi-structured interviews will be conducted with participants from both the 
Control group (n=10) and the Intervention group (n=15). 
The Intervention group will receive the usual care described above, as well as access to MKit. 
They will be encouraged to interact with the web-based application throughout the study. Built-
in reminders to the web-based application, an email alert, and a text-message alert (if the 
participant chooses to share their phone number) remind participants about their goals and 
encourage retention and continued engagement. 
 
 
This study will test a web-based application focused on healthy relationships and sexual 
violence. The web-based application will provide information and resources using a life-skills 
approach. Participants will also have the opportunity to set personal goals, find resources, and 
evaluate their interpersonal relationships and self-care. This web-based application will have the 
ability to be utilized on any smartphone, tablet, laptop, or desktop computer. 
Intervention group participants will have five months to interact with the WebApp content, as 
this time period should present sufficient time for meaningful short-term change in the outcomes 
of interest. Further, the study will run for the duration of the school year, allowing study staff to 
follow students from the beginning of the school year to the end of the school year as they 
interact with the WebApp content. Study participants can choose to interact with the WebApp 
and take study surveys whenever is comfortable and safe for them to do so. 
 
6         STUDY INTERVENTION 
6.1       STUDY INTERVENTION ADMINISTRATION 
 
6.1.1      STUDY INTERVENTION DESCRIPTION 
 
6.1.2      DOSING AND ADMINISTRATION 
 

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MKit was created through collaboration with students, stakeholders, and topical experts and 
developed by the Center for Health Communications Research (CHCR) through a modification 
of the pre-existing iCON platform. After development the management of the WebApp was 
transferred to Arbormoon Software, Inc. Arbormoon will maintain the WebApp servers 
throughout the entirety of the study. 
Not Applicable 
Not Applicable 
MKit was created through collaboration with students, stakeholders, and topical experts and 
developed by CHCR through a modification of the pre-existing iCON platform. 
Study subjects will be randomized into one of two groups: 1) Intervention (WebApp and current 
prevention programming on campus) or 2) Control (current prevention programming on campus 
only), with 150 students in each group. We will use cluster-randomization by residence hall (to 
minimize contamination associated with individual-level randomization of students living in the 
same residence hall).  
This study will not involve blinding. 
Not Applicable 
Not Applicable 
Not Applicable 
6.2       PREPARATION/HANDLING/STORAGE/ACCOUNTABILITY 
 
6.2.1      ACQUISITION AND ACCOUNTABILITY 
 
6.2.2      FORMULATION, APPEARANCE, PACKAGING, AND LABELING 
6.2.3       PRODUCT STORAGE AND STABILITY 
 
6.2.4       PREPARATION 
 
6.3       MEASURES TO MINIMIZE BIAS: RANDOMIZATION AND BLINDING 
6.4       STUDY INTERVENTION COMPLIANCE 
6.5       CONCOMITANT THERAPY 
6.5.1     RESCUE MEDICINE 
 

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All participation is voluntary. There is no penalty to anyone who decides not to participate or 
who wishes to end participation during the study. All participants may choose not to answer a 
question at any point in the study.  
If a participant discontinues use of the intervention during the research study, their data will be 
retained for attrition analyses. 
All participation is voluntary. There is no penalty to anyone who decides not to participate or 
who wishes to end participation during the study. All participants may choose not to answer a 
question at any point in the study. All participants may choose to withdraw from the study at any 
time. 
If a participant withdraws from the research study, their data will be retained for attrition 
analyses. 
If a participant withdraws from the research study or is lost to follow-up, their data will be 
retained for attrition analyses. 
 
The efficacy of this study is not a primary outcome as this is a pilot study focused on safety, 
acceptability, usability, and willingness to use. However, a number of measures will be used to 
gather preliminary data for future scale-up at all three time points (baseline, 1-month, and 5-
months). Study participants’ knowledge, attitudes, and experiences will be measured with the 
following measures: 
1) Investigator developed questions on knowledge about sexual and intimate partner 
violence (n=20) adapted from the Texas Education Program Participant Response Form 
(https://www.wcasa.org/file_open.php?id=787) 
2) Investigator developed questions on self-efficacy (n=15) 
3) 34 questions from the Revised Intimate Partner Violence Attitude Scale (Finchman, Cuit, 
Braithwaite, & Pasley, 2008) 
4) Investigator developed questions on consensual sex (n=2) 
7          STUDY INTERVENTION DISCONTINUATION AND PARTICIPANT    
               DISCONTINUATION/WITHDRAWAL 
7.1      DISCONTINUATION OF STUDY INTERVENTION 
7.2      PARTICIPANT DISCONTINUATION/WITHDRAWL FROM THE STUDY 
7.3      LOST TO FOLLOW-UP 
8          STUDY ASSESSMENTS AND PROCEDURES 
8.1      EFFICACY ASSESSMENTS 

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5) 10 items from the Sexual Experiences Survey (SES) will measure past experiences with 
sexual violence (Koss et al., 2007) and 10 items from the Sexual Experiences Survey 
(SES) will measure past experiences with perpetration (Koss et al., 2007) 
6) 26 questions from the Universal Violence Prevention Screening Protocol – Adapted 
questions (Heron, Thompson, Jackson, & Kaslow, 2003).  
All of these are measures have been validated and used extensively in the United States to 
measure knowledge and attitudes related to gender based violence.  
The safety of MKit will be assessed through post-intervention semi-structured interviews, 
conducted with 25 participants including 15 participants from the intervention group and 10 
participants from the control group. 
 
Adverse event means any untoward medical occurrence associated with the use of an 
intervention in humans, whether or not considered intervention-related (21 CFR 312.32 (a)). 
An adverse event (AE) or suspected adverse reaction is considered "serious" if, in the view of 
either the investigator or sponsor, it results in any of the following outcomes: death, a life-
threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a 
persistent or significant incapacity or substantial disruption of the ability to conduct normal life 
functions, or a congenital anomaly/birth defect. Important medical events that may not result in 
death, be life-threatening, or require hospitalization may be considered serious when, based upon 
appropriate medical judgment, they may jeopardize the participant and may require medical or 
surgical intervention to prevent one of the outcomes listed in this definition. 
 
For adverse events (AEs) not included in the protocol defined grading system, the following 
guidelines will be used to describe severity. 
• Mild – Events require minimal or no treatment and do not interfere with the participant’s 
daily activities.  
• Moderate – Events result in a low level of inconvenience or concern with the therapeutic 
measures. Moderate events may cause some interference with functioning. 
8.2      SAFETY AND OTHER ASSESSMENTS 
8.3      ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS 
8.3.1     DEFINITION OF ADVERSE EVENTS (AE) 
 
8.3.2     DEFINITION OF SERIOUS ADVERSE EVENTS (SAE) 
 
8.3.3     CLASSIFICATION OF AN ADVERSE EVENT 
 
8.3.3.1   SEVERITY OF EVENT 
 

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• Severe – Events interrupt a participant’s usual daily activity and may require systemic 
drug therapy or other treatment. Severe events are usually potentially life-threatening or 
incapacitating. Of note, the term “severe” does not necessarily equate to “serious”. 
All adverse events (AEs) must have their relationship to study intervention assessed by the study 
staff. The degree of certainty about causality will be graded using the categories below. In a 
clinical trial, the study product must always be suspect. 
• Related – The AE is known to occur with the study intervention, there is a reasonable 
possibility that the study intervention caused the AE, or there is a temporal relationship 
between the study intervention and event. Reasonable possibility means that there is 
evidence to suggest a causal relationship between the study intervention and the AE. 
• Not Related – There is not a reasonable possibility that the administration of the study 
intervention caused the event, there is no temporal relationship between the study 
intervention and event onset, or an alternate etiology has been established. 
The Principle Investigator will be responsible for determining whether an adverse event (AE) is 
expected or unexpected.  An AE will be considered unexpected if the nature, severity, or 
frequency of the event is not consistent with the risk information previously described for the 
study intervention. 
The occurrence of an adverse event (AE) or serious adverse event (SAE) may come to the 
attention of study personnel during study visits and interviews of a study participant upon review 
by a study monitor. 
All AEs including local and systemic reactions not meeting the criteria for SAEs will be captured 
on the appropriate case report form (CRF). Information to be collected includes event 
description, time of onset, clinician’s assessment of severity, relationship to study product 
(assessed only by those with the training and authority to make a diagnosis), and time of 
resolution/stabilization of the event. All AEs occurring while on study must be documented 
appropriately regardless of relationship. All AEs will be followed to adequate resolution. 
Changes in the severity of an AE will be documented to allow an assessment of the duration of 
the event at each level of severity to be performed. AEs characterized as intermittent require 
documentation of onset and duration of each episode. 
The Clinical Research Coordinator will record all reportable events with start dates occurring 
any time after informed consent is obtained until the last day of study participation. Events will 
be followed for outcome information until resolution or stabilization. 
8.3.3.2   RELATIONSHIP TO STUDY INTERVENTION 
 
8.3.3.3   EXPECTEDNESS 
 
8.3.4     TIME PERIOD AND FREQUENCY FOR EVENT ASSESSMENT AND FOLLOW-UP 
8.3.5     ADVERSE EVENT REPORTING 
 

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The Primary Investigator will immediately report to the sponsor any adverse event, whether or 
not considered study intervention related, including breach of confidentiality or lack of safety 
whether there is a reasonable possibility that the study intervention caused the event. All adverse 
events (AEs) will be followed until satisfactory resolution or until the site investigator deems the 
event to be chronic or the participant is stable. Other supporting documentation of the event may 
be requested by the study sponsor and should be provided as soon as possible. 
The Primary Investigator will immediately report to the sponsor any serious adverse event 
including lack of safety whether there is a reasonable possibility that the study intervention 
caused the event. All serious adverse events (SAEs) will be followed until satisfactory resolution 
or until the site investigator deems the event to be chronic or the participant is stable. Other 
supporting documentation of the event may be requested by the study sponsor and should be 
provided as soon as possible. 
Not Applicable 
Not Applicable 
Not Applicable 
 
The Office for Human Research Protections (OHRP) considers unanticipated problems involving 
risks to participants or others to include, in general, any incident, experience, or outcome that 
meets all of the following criteria: 
• Unexpected in terms of nature, severity, or frequency given (a) the research procedures 
that are described in the protocol-related documents, such as the Institutional Review 
Board (IRB)-approved research protocol and informed consent document; and (b) the 
characteristics of the participant population being studied; 
• Related or possibly related to participation in the research (“possibly related” means there 
is a reasonable possibility that the incident, experience, or outcome may have been 
caused by the procedures involved in the research); and 
• Suggests that the research places participants or others at a greater risk of harm (including 
physical, psychological, economic, or social harm) than was previously known or 
recognized. 
8.3.6     SERIOUS ADVERSE EVENT REPORTING 
 
8.3.7     REPORTING EVENTS TO PARTICIPANTS 
 
8.3.8     EVENTS OF SPECIAL INTEREST 
 
8.3.9     REPORTING OF PREGNANCY 
 
8.4      UNANTICIPATED PROBLEMS 
8.4.1     DEFINITION OF UNANTICIPATED PROBLEMS (UP) 
 

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The Primary Investigator will report unanticipated problems (UPs) to the reviewing Institutional 
Review Board (IRB). The UP report will include the following information: 
• Protocol identifying information: protocol title and number, PI’s name, and the IRB 
project number; 
• A detailed description of the event, incident, experience, or outcome;  
• An explanation of the basis for determining that the event, incident, experience, or 
outcome represents an UP;  
• A description of any changes to the protocol or other corrective actions that have been 
taken or are proposed in response to the UP. 
To satisfy the requirement for prompt reporting, UPs will be reported using the following 
timeline:   
• UPs that are serious adverse events (SAEs) will be reported to the IRB and to the study 
sponsor within 7 days of the investigator becoming aware of the event.  
• Any other UP will be reported to the IRB and to the study sponsor within 14 days of the 
investigator becoming aware of the problem.  
• All UPs should be reported to appropriate institutional officials (as required by an 
institution’s written reporting procedures), the supporting agency head (or designee), and 
the Office for Human Research Protections (OHRP) within 7 days of the IRB’s receipt of 
the report of the problem from the investigator. 
Not Applicable 
 
Primary Endpoint: MKit is safe, usable, acceptable, and participants will be willing to use it. 
Secondary Endpoint: To explore preliminary differences between the intervention and control 
groups in regards to retention, knowledge, attitudes, and experiences related to sexual and 
intimate partner violence. 
Formal sample size calculations were not performed because this is a pilot feasibility study. The 
number of subjects was chosen based on feasibility and is considered sufficient to meet the study 
objectives. 
8.4.2     UNANTICIPATED PROBLEM REPORTING 
 
8.4.3     REPORTING UNANTICIPATED PROBLEMS TO PARTICIPANTS 
9          STATISTICAL CONSIDERATIONS 
9.1      STATISTICAL HYPOTHESES 
9.2      SAMPLE SIZE DETERMINATION 

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All data collected through the pilot study process will be utilized for the analyses related to 
feasibility, usability, and acceptability. The data collected from the semi-structured interview 
subjects will be utilized to analyze the safety of the application and the willingness of 
participants to use the application. 
 
9.4.1     GENERAL APPROACH 
The survey data will be analyzed using the Statistical Package for the Social Sciences (SPSS); all 
p-values will be set at <.05. Descriptive statistics will be assessed first. The baseline, 1-month 
post, and 5-month post-intervention tests will be examined for measures of central tendency, 
measures of dispersion, and frequency distribution on outcomes. Analysis of variance (ANOVA) 
will be utilized to determine if the scores on the baseline and follow-up tests differ significantly 
among the two arms. Usability and acceptability scores will be assessed among those in the 
intervention group. 
We are not powered to assess outcome measures (sexual violence experiences/behaviors, rape 
myth acceptance, or sexual relationship power); however, we will look at the direction of effects 
for our outcome measures to allow for power calculations for a future R-Level submission. The 
results of this project will establish the safety and usability of this adapted web-based application 
for future scale-up. 
For the semi-structured interviews, all audiotapes will be transcribed verbatim. Data analyses 
will be conducted using an iterative process and the constant comparative method of analysis 
(Glaser, 1992). Member checking will contribute to credibility through validation of the research 
findings by participants. A codebook will be developed after repeated high-level reading of the 
transcripts by the study team. Data will be coded and grouped into categories to facilitate 
abstraction and concept analysis.  
9.4.2      ANALYSIS OF THE PRIMARY ENDPOINT 
The safety of MKit and the willingness of participants to use it will be assessed through post-
intervention semi-structured interviews, conducted with 25 participants including 15 participants 
from the intervention group and 10 participants from the control group. The usability for the 
WebApp will be assessed at two time points (1-month and 5-months) using the 10-item System 
Usability Scale (Brooke, 1996). The acceptability of the WebApp will be assessed at two time 
points (1-month and 5-months) using an investigator created 5-item acceptability scale. Usability 
and acceptability scores will be assessed among those in the intervention group.  
For the semi-structured interviews, all audiotapes will be transcribed verbatim. Data analyses 
will be conducted using an iterative process and the constant comparative method of analysis 
(Glaser, 1992). Member checking will contribute to credibility through validation of the research 
findings by participants. A codebook will be developed after repeated high-level reading of the 
9.3      POPULATIONS FOR ANALYSES 
9.4      STATISTICAL ANLYSES 

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transcripts by the study team. Data will be coded and grouped into categories to facilitate 
abstraction and concept analysis. An audit trail will be established to allow others to follow the 
decisions made by the research team (Sandelowski & Barroso, 2003). The results of the semi-
structured interviews will be used to: 1) update the content of MKit, as needed; 2) assess the 
safety of MKit; 3) assess the usability and willingness to use MKit; and 4) assess the 
acceptability of MKit. 
9.4.3      ANALYSIS OF THE SECONDARY ENDPOINT 
Preliminary analyses of the survey data (knowledge, attitudes, and experiences related to sexual 
and intimate partner violence) will be analyzed using the Statistical Package for the Social 
Sciences (SPSS); all p-values will be set at <.05. Descriptive statistics will be assessed first. The 
baseline, 1-month post, and 5-month post-intervention tests will be examined for measures of 
central tendency, measures of dispersion, and frequency distribution on outcomes. Analysis of 
variance (ANOVA) will be utilized to determine if the scores on the baseline and follow-up tests 
differ significantly among the two arms. Usability and acceptability scores will be assessed 
among those in the intervention group. 
We are not powered to assess outcome measures; however, we will look at the direction of 
effects for our outcome measures to allow for power calculations for future scale-up. 
9.4.4      SAFETY ANALYSES 
The safety of MKit will be assessed through post-intervention semi-structured interviews, 
conducted with 25 participants including 15 participants from the intervention group and 10 
participants from the control group. 
9.4.5      BASELINE DESCRIPTIVE STATISTICS 
Study groups will be compared on baseline characteristics, including age, race/ethnicity, gender, 
student group involvement, sexual orientation, and relationship status. 
9.4.6      PLANNED INTERIM ANALYSES 
Not Applicable 
9.4.7      SUB-GROUP ANALYSES 
Primary and secondary endpoints will be analyzed based on gender, race/ethnicity, student group 
involvement, sexual orientation, and relationship status. 
9.4.8      TABULATION OF INDIVIDUAL PARTICIPANT DATA 
Individual participant data will be listed by measure and time point. 
9.4.9      EXPLORATORY ANALYSES 
We are not powered to assess outcome measures; however, exploratory analyses will be 
performed to assess the direction of effects for our outcome measures to allow for power 
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10.1.1      INFORMED CONSENT PROCESS 
 
10.1.1.1     CONSENT/ASSENT AND OTHER INFORMATIONAL DOCUMENTS  
                  PROVIDED TO PARTICIPANTS 
Consent forms describing in detail the study intervention, study procedures, and risks are given 
to the participant and electronic documentation of informed consent is required prior to starting 
intervention/administering study intervention.  The following consent materials are submitted 
with this protocol: 
• Pilot Control Group Consent Form 
• Pilot Intervention Group Consent Form 
• Semi-Structured Interview Consent Form 
10.1.1.2     CONSENT PROCEDURES AND DOCUMENTATION 
Informed consent is a process that is initiated prior to the individual’s agreeing to participate in 
the study and continues throughout the individual’s study participation. Consent forms will be 
Institutional Review Board (IRB)-approved and the participant will be asked to read and review 
the document. For the pilot study, participants will read through the consent online prior to 
completion of the baseline survey and make the determination to participate in the study 
individually. The participant will sign the informed consent document prior to any study 
activities. Participants will be informed that participation is voluntary and that they may 
withdraw from the study at any time, and that the study is not connected to their schooling. 
For the semi-structured interview, the investigator will explain the research study to the 
participant and answer any questions that may arise. A verbal explanation will be provided in 
terms suited to the participant’s comprehension of the purposes, procedures, and potential risks 
of the study and of their rights as research participants.  Participants will have the opportunity to 
carefully review the written consent form and ask questions prior to signing. The participant will 
sign the informed consent document prior to any study activities. Participants will be informed 
that participation is voluntary and that they may withdraw from the study at any time, and that 
the study is not connected to their schooling. A copy of the informed consent document will be 
offered to the participants if they would like it. The informed consent process will be conducted 
and documented in the source document (including the date), and the form signed, before the 
participant undergoes any study-specific procedures.  
10.1.2     STUDY DISCONTINUATION AND CLOSURE 
This study may be temporarily suspended or prematurely terminated if there is sufficient 
reasonable cause. Written notification, documenting the reason for study suspension or 
termination, will be provided by the suspending or terminating party to study participants, 
10         SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS 
10.1       REGULATORY, ETHICAL, AND STUDY OVERSIGHT CONSIDERATIONS 

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funding agencies, and regulatory authorities. If the study is prematurely terminated or suspended, 
the Principal Investigator will promptly inform study participants, the Institutional Review Board 
(IRB), and sponsor and will provide the reason(s) for the termination or suspension.  Study 
participants will be contacted, as applicable, and be informed of changes to study visit schedule. 
Circumstances that may warrant termination or suspension include, but are not limited to: 
• Determination of unexpected, significant, or unacceptable risk to participants 
• Insufficient compliance to protocol requirements 
• Data that are not sufficiently complete and/or evaluable 
• Determination that the primary endpoint has been met 
• Determination of futility 
Study may resume once concerns about safety, protocol compliance, and data quality are 
addressed, and satisfy the sponsor and/or IRB. 
10.1.3     CONFIDENTIALITY AND PRIVACY 
Participant confidentiality and privacy is strictly held in trust by the participating investigators, 
their staff, and the sponsors and their interventions. Therefore, the study protocol, 
documentation, data, and all other information generated will be held in strict confidence. No 
information concerning the study or the data will be released to any unauthorized third party 
without prior written approval of the sponsor.  
All research activities will be conducted in as private a setting as possible. Study participants can 
choose to interact with MKit and take study surveys whenever is comfortable and safe for them 
to do so.  
The information we collect will only be seen by the research team. We will not link the email 
address or any identifiable information of any participant to any of the survey or application use 
data collected. All data will be reported in aggregate. Research data will be stored on a secure, 
HIPAA-compliant server and drive with monitored and controlled access for study staff and 
investigators. The web-based survey will be hosted on secure servers.  
The WebApp is hosted on virtualized servers provided by the University of Michigan 
Information Technology Services group. The virtualized servers are housed at two redundant 
data centers. These data centers provide protection from lengthy outages, 24/7 staffing, restricted 
physical access and disaster recovery. Virtual servers are backed up automatically onto 
encrypted tape for recovery and security. The data centers also reduce the use of physical 
resources such as electricity and air conditioning.  
All servers and the back end databases are password protected. The server runs the RedHat 
Linux 7 Enterprise operating system. Security patches and updates are downloaded and installed 
automatically. Each server is also protected by firewalls to restrict network access to the server. 
The study web application software communicates directly with the database on the same server 
so unencrypted participant data is not transmitted on the Internet.  
For the semi-structured interviews, we will not use names on any written documents or on digital 
audio recordings. All participants will be assigned unique, coded, confidential identifiers (code 
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participant’s identity to their unique coded identifier will be kept in a confidential manner in a 
database on a secure server, with access only by the Primary Investigator and the research staff. 
We will protect all physical documents by securing them in a locked file drawer in the PI’s 
locked office.  
For both the quantitative and qualitative data, we will discuss data in aggregate with no reference 
to identification of any individual in particular. The participants will decide if they want to share 
their email address with the study team to participate in the semi-structured interview portion of 
the study. Interviews will be held in a private room on campus. 
10.1.4     FUTURE USE OF STORED SPECIMENS AND DATA 
All retained data will be stored for five years and will be de-identified. We will protect all 
physical documents by securing them in a locked file drawer of the PI’s locked office. Research 
data will be stored on a secure, HIPAA-compliant server and drive with monitored and 
controlled access for study staff and investigators. We will discuss data in aggregate with no 
reference to identification of any individual in particular. 
10.1.5     KEY ROLES AND STUDY GOVERNANCE 
 
Principal Investigator 
Clinical Research Coordinator 
Michelle L. Munro-Kramer, PhD, CNM, FNP-
BC 
Lindsay M. Cannon, MPH, MSW 
University of Michigan School of Nursing 
University of Michigan School of Nursing 
400 North Ingalls Building Room 3188 
Ann Arbor, MI 48105 
400 North Ingalls Building Room 3235A 
Ann Arbor, MI 48105 
(734) 647-0154 
(734) 647-9371 
mlmunro@umich.edu 
lmcannon@umich.edu 
 
10.1.6     SAFETY OVERSIGHT 
This study does not qualify for oversight by a Data and Safety Monitoring Board (DSMB). 
10.1.7     CLINICAL MONITORING 
Clinical monitoring is conducted to ensure that the rights and well-being of trial participants are 
protected, that the reported trial data are accurate, complete, and verifiable, and that the conduct 
of the trial is in compliance with the currently approved protocol/amendment(s), with 
International Conference on Harmonisation Good Clinical Practice (ICH GCP), and with 
applicable regulatory requirement(s).  
• Arbormoon Software, Inc. will ensure the WebApp remain in good working condition 
throughout the duration of the study. 
• Independent audits of the survey data will be conducted by study staff to ensure 
monitoring practices are performed consistently. 
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The investigators will perform internal quality management of study conduct, data, 
documentation, and completion.   
Any study problems with MKit, including any problems with the study and surveys, 
communicated through the study email address (umhealthyrelationships@umich.edu) by study 
participants, will be addressed by the study team in a timely fashion.  
10.1.9     DATA HANDLING AND RECORD KEEPING 
 
10.1.9.1     DATA COLLECTION AND MANAGEMENT RESPONSIBILITIES 
Data collection is the responsibility of the clinical trial staff at the site under the supervision of 
the site investigator. The investigator is responsible for ensuring the accuracy, completeness, and 
timeliness of the data reported. 
MKit is hosted by Arbormoon Software, Inc. They will make de-identified data available for 
study personnel on a dashboard.  
Semi-structured interview recordings are the responsibility of the study staff and will be saved to 
a secure, password-protected computer in a timely manner. Digital audio files will be transcribed 
and deleted within 6 months of recording. 
10.1.9.2     STUDY RECORDS RETENTION 
Study documents should be retained for a minimum of 2 years after the last approval of a 
marketing application in an International Conference on Harminosation (ICH) region and until 
there are no pending or contemplated marketing applications in an ICH region or until at least 2 
years have elapsed since the formal discontinuation of clinical development of the study 
intervention. These documents should be retained for a longer period, however, if required by 
local regulations. No records will be destroyed without the written consent of the sponsor, if 
applicable. It is the responsibility of the sponsor to inform the investigator when these documents 
no longer need to be retained. 
10.1.10     PROTOCOL DEVIATIONS 
A protocol deviation is any noncompliance with the clinical trial protocol, International 
Conference on Harmonisation Good Clinical Practice (ICH GCP), or Manual of Procedures 
(MOP) requirements. The noncompliance may be either on the part of the participant, the 
investigator, or the study site staff. As a result of deviations, corrective actions are to be 
developed by the site and implemented promptly.  
These practices are consistent with ICH GCP:  
• 
4.5 Compliance with Protocol, sections 4.5.1, 4.5.2, and 4.5.3  
• 
5.1 Quality Assurance and Quality Control, section 5.1.1  
• 
5.20 Noncompliance, sections 5.20.1, and 5.20.2.  
It is the responsibility of the site investigator to use continuous vigilance to identify and report 
deviations. All deviations must be addressed in study source documents and sent to the 

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reviewing Institutional Review Board (IRB) per their policies. The site investigator is 
responsible for knowing and adhering to the reviewing IRB requirements. 
10.1.11     PUBLICATION AND DATA SHARING POLICY 
This study will be conducted in accordance with the following publication and data sharing 
policies and regulations: 
National Institutes of Health (NIH) Public Access Policy ensures that the public has access to the 
published results of NIH funded research. It requires scientists to submit final peer-reviewed 
journal manuscripts that arise from NIH funds to the digital archive PubMed Central upon 
acceptance for publication. 
This study will comply with the NIH Data Sharing Policy and Policy on the Dissemination of 
NIH-Funded Clinical Trial Information and the Clinical Trials Registration and Results 
Information Submission rule. As such, this trial will be registered at ClinicalTrials.gov. In 
addition, every attempt will be made to publish results in peer-reviewed journals. 
10.1.11     PUBLICATION AND DATA 
The independence of this study from any actual or perceived influence is critical. Therefore, any 
actual conflict of interest of persons who have a role in the design, conduct, analysis, publication, 
or any aspect of this trial will be disclosed and managed. Furthermore, persons who have a 
perceived conflict of interest will be required to have such conflicts managed in a way that is 
appropriate to their participation in the design and conduct of this trial. The study leadership has 
established policies and procedures for all study group members to disclose all conflicts of 
interest and will establish a mechanism for the management of all reported dualities of interest. 
Not Applicable 
 
 
10.2      ADDITIONAL CONSIDERATIONS 

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ADAPT-ITT 
Assessment, Decision, Administration, Production, Topical Experts, Integration, 
Training, Testing 
AE 
Adverse Events 
ANOVA 
Analysis of Variance 
CFR 
Code of Federal Regulations 
CHCR 
Center for Health Communications Research 
CRF 
Case Report Form 
DSMB 
Data and Safety Monitoring Board 
GCP 
Good Clinical Practice 
HIPAA 
Health Insurance Portability and Accountability Act of 1996 
ICH 
International Conference on Harmonisation 
IRB 
Institutional Review Board 
MOP 
Manual of Procedures 
NIH 
National Institutes of Health 
OHRP 
Office for Human Research Protections 
PI 
Principal Investigator 
PTSD 
Post-Traumatic Stress Disorder 
SAE 
Serious Adverse Events 
SANE 
Sexual Assault Nurse Examiner 
SES 
Sexual Experiences Scale 
SOA 
Schedule of Activities 
SPSS 
Statistical Package for the Social Sciences 
STI 
Sexually Transmitted Infection 
UP 
Unanticipated Problems 
US 
United States 
VAWA 
1994 Violence Against Women Act 
WebApp 
Web-Based Application 
 
 
Not Applicable
10.3      ABBREVIATIONS 
10.4      PROTOCOL AMENDMENT HISTORY 

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evaluation of a dating violence prevention program in middle schools. Prevention 
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3. Foshee VA, Bauman KE, Ennett ST, Linder GF, Benefield T, Suchindran C. Assessing 
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4. Taylor BG, Mumford EA, Stein ND. Effectiveness of “Shifting Boundaries” Teen dating 
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education: An experimental evaluation. J. Community Psychol. 2007;35(4):463-481. 
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Encouraging responses in sexual and relationship violence prevention what program 
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7. Skinner BF. Reinforcement today. American Psychologist. 1958;13(3):94-99. 
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8. Pulerwitz J, Gortmaker SL, DeJong W. Measuring sexual relationship power in 
HIV/STD research. Sex Roles. 2000;42(7/8):637-660. 
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Francis; 1996:189-194. 
10. Koss MP, Abbey A, Campbell R, Cook S, Norris J, Testa C, Ullman S, West C, White J. 
Revising the SES: A collaborative process to improve assessment of sexual aggression 
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12. Finn P. Preventing alcohol-related problems on campus: Acquaintance rape. Newton, 
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