Optimizing a Multi-Modal Intervention to Reduce Health-Risking Sexual Behaviors: Component Selection
Phase: NA
Conditions: Sexually Transmitted Infections, Pregnancy, Unplanned, Military Personnel
Sponsor: Uniformed Services University of the Health Sciences

NCT04661566 
Protocol ID: USUHS.2020-055 
Optimizing a Multi-Modal Intervention to Reduce Health-Risking Sexual Behaviors: Component Selection 
Protocol with Statistical Analysis Plan
IRB-approved: 10/11/2022

EIRB Protocol Template (Version 1.24)
1.0
General Information
*Please enter the full title of your study:
Optimizing a multi-modal intervention to reduce health-risking sexual behaviors: Component 
selection
 
 
*Please enter the Protocol Number you would like to use to reference the protocol:
MWHR Phase II
* This field allows you to enter an abbreviated version of the Protocol Title to quickly identify 
this protocol.
 
 
Is this a multi-site study (i.e. Each site has their own Principal Investigator)?
No
 
 
Does this protocol involve the use of animals?
Yes
No
 
 
2.0
Add Site(s)
2.1 List sites associated with this study:
Primary 
Dept?
Department Name
R and E - Uniformed Services University of the Health Sciences (USUHS)
 
3.0
Assign project personnel access to the project
3.1 *Please add a Principal Investigator for the study:
 
Landoll, Ryan R
Select if applicable
Student
Site Chair
Resident
Fellow
 
3.2 If applicable, please select the Research Staff personnel:
 
A) Additional Investigators
Quinlan, Jeffrey D, MD CAPT 
 Co-Investigator
G

B) Research Support Staff
Clark, Madison Fitzgerald 
Research Coordinator
3.3 *Please add a Protocol Contact:
Clark, Madison Fitzgerald 
Landoll, Ryan R 
The Protocol Contact(s) will receive all important system notifications along with the Principal 
Investigator. (i.e. The protocol contact(s) are typically either the Protocol Coordinator or the 
Principal Investigator themselves).
3.4 If applicable, please select the Designated Site Approval(s):
Add the name of the individual authorized to approve and sign off on this protocol from your Site 
(e.g. the Site Chair).
4.0
Project Information
4.1  
Has another IRB/HRPP reviewed this study or will another IRB/HRPP be reviewing this study?
*
 If
Yes, answer the questions according to the IRB/HRPP Determination.
  Yes   
  No
IRB Name
Review Date
Determination
No records have been added
4.2  
Is this a research study or a Compassionate Use/Emergency Use/HUD project?
*
 Yes   
 No
4.3  What type of research is this?
Biomedical Research
Clinical trial (FDA regulated)
Behavioral Research
Educational Research
Psychosocial Research
Oral History
Other
4.4  Are you conducting this project in pursuit of a personal degree?
  Yes   
  No
4.6  
Is this human subjects research? (As defined by 32 CFR 219) 
* 
   Human subject means a living 
individual about whom an investigator (whether professional or student) conducting research: 
(i) Obtains information or biospecimens through intervention or interaction with the individual, and

uses, studies, or analyzes the information or biospecimens; or 
  (ii) Obtains, uses, studies, analyzes or generates identifiable private information or identifiable 
biospecimens.  
 Yes   
 No
4.7  
 Do you believe this human subjects research is exempt from IRB review?
*
  Yes   
  No
5.0
 
Personnel Details
5.1  List any Research Team members without EIRB access that are not previously entered in the protocol:
Name:
(Last, First, M.I.)
Thornton, Kade
Role on Protocol:
Graduate Student 
Assistant
Phone Number:
 
Email Address:
 
kade.
thornton@usuhs.
edu
Associated 
Institution:
 
USUHS
Name:
(Last, First, M.I.)
De Hoyos, Victoria
Role on Protocol:
Graduate Student 
Assistant
Phone Number:
 
Email Address:
 
victoria.de-
hoyos@usuhs.edu
Associated 
Institution:
 
USUHS
Name:
(Last, First, M.I.)
Austin, Katherine
Role on Protocol:
Recruitment Site 
Collaborator
Phone Number:
 
Email Address:
 
katherine.c.
austin2.mil@mail.
mil
Associated 
Institution:
 
Naval Hospital 
Camp Pendleton
Name:
(Last, First, M.I.)
Taylor, Stephanie
Role on Protocol:
Graduate Student 
Assistant
Phone Number:
 
Email Address:
 
stephanie.
taylor@usuhs.edu
Associated 
Institution:
 
USUHS
Name:
(Last, First, M.I.)
Email Address:

Iqbal, Abeer
Role on Protocol:
Research Assistant
Phone Number:
 
 
abeer.iqbal.
ctr@usuhs.edu
Associated 
Institution:
 
USUHS
Name:
(Last, First, M.I.)
Norris, Colby
Role on Protocol:
Graduate Student 
Assistant
Phone Number:
 
Email Address:
 
colby.
norris@usuhs.edu
Associated 
Institution:
 
USUHS
Name:
(Last, First, M.I.)
Gist, Galen
Role on Protocol:
Graduate Student 
Assistant
Phone Number:
 
Email Address:
 
galen.gist@usuhs.
edu
Associated 
Institution:
 
USUHS
Name:
(Last, First, M.I.)
Iwuagwu, Richard
Role on Protocol:
Graduate Student 
Assistant
Phone Number:
 
Email Address:
 
richard.
iwuagwu@usuhs.
edu
Associated 
Institution:
 
USUHS
5.2  
Will you have a Research Monitor for this study?
Yes 
No 
N/A 
6.0
 
Data/Specimens
6.1  Does the study involve the use of existing data or specimens only (no interaction with human 
subjects)?
  Yes   
  No
7.0
 
Funding and Disclosures
7.1  Source of Funding:

Funding Source
Funding Type
Amount
:
Other
USU Intramural
:
Research 
Development 
Testing and 
Evaluation (RDT&E) 
funds
MWHR
1176318
Total amount of funding:
1176318
7.2  Do you or any other Investigator(s) have a disclosure of a personal interest or financial nature 
significant with sponsor(s), product(s), instrument(s) and/or company(ies) involved in this study?
  Yes   
  No
If Yes, complete and attach Conflict of Interest forms for all key personnel
8.0
 
Study Locations
8.1  Is this a collaborative or multi-site study? (e.g., are there any other institutions involved?)
 Yes   
 No
8.2  Study Facilities and Locations:
Institution Site Name
Site Role
FWA or DoD 
Assurance 
Number
Assurance 
Expiration 
Date
Is there an 
agreement?
IRB Reviewing 
for Site
The 
Miriam 
Hospital
Coordinating 
center
FWA00003538
:
USUHS 
IRB 
#1
Navy
Naval 
Hospital 
Camp 
Pendleton
Recruitment
:
USUHS 
IRB 
#1
Joint Base 
Elmendorf-
Richardson
Recruitment
:
USUHS 
IRB 
#1
Navy
US Naval 
Hospital 
Okinawa
Recruitment
:
USUHS 
IRB 
#1
Army
Fort Drum
Recruitment
:
USUHS 
IRB 
#1

Joint Base 
Lewis-
McChord
Recruitment
:
USUHS 
IRB 
#1
Air 
Force
Offutt Air 
Force Base
Recruitment
:
USUHS 
IRB 
#1
Army
Fort 
Jackson
Recruitment
:
USUHS 
IRB 
#1
Navy
Camp 
Lejeune
Recruitment
:
USUHS 
IRB 
#1
Air 
Force
Keesler 
Air Force 
Base
Recruitment
:
USUHS 
IRB 
#1
Navy
Naval 
Station 
Great 
Lakes
Recruitment
:
USUHS 
IRB 
#1
Air 
Force
Travis Air 
Force Base
Recruitment
:
USUHS 
IRB 
#1
Other:
Other 
Institution Site
Site Role
FWA or DoD 
Assurance 
Number
FWA or DoD 
Expiration Date
Is there an 
agreement?
IRB Reviewing 
for Site
No records have been added
8.3  Are there international sites?
Attach international approval documents, if applicable, when prompted. Note: Ensure local 
research context has been considered
 Yes   
 No
8.4  Is this an OCONUS (Outside Continental United States) study?
  Yes   
  No
Select  the area of responsibility:
Have you obtained permission from that area of responsibility? (This is a requirement prior to 
study approval)
  Yes   
  No
9.0
 

Study Details
9.1  Key Words:
Provide up to 5 key words that identify the broad topic(s) of your study
Women’s health; sexual and reproductive health; military
9.2  Background and Significance:
Include a literature review that describes in detail the rationale for conducting the study. Include 
descriptions of any preliminary studies and findings that led to the development of the 
protocol.  The background section should clearly support the choice of study variables and 
explain the basis for the research questions and/or study hypotheses.  This section establishes 
the relevance of the study and explains the applicability of its findings
Sexual and reproductive health (SRH) issues such as unintended pregnancy, sexually transmitted 
infections (STIs), and STI-related cancers affect both servicemen and -women in the United 
States (US) military, and the rates of unintended pregnancy (Biggs, Douglas, O'Boyle, & Rieg, 
2009; Heitmann et al., 2016) and STIs (Stahlman & Oetting, 2019) are, in fact, considerably 
high in the US military. In addition, SRH issues such as unintended pregnancy and STIs pose a 
threat to mission readiness (de Kanter et al., 2018; Erickson et al., 2017). Unintended 
pregnancy can disrupt military operations when service women must be removed from certain 
roles and/or be medically evacuated out of theater (K. Grindlay & Grossman, 2013; Krulewitch, 
2016). In addition to the clear, direct effects of unintended pregnancy on the mission, 
unintended pregnancy among service members has been linked with negative physical and 
mental health outcomes for mothers and their babies and concerns from servicewomen about 
the advancement of their military career (Evans & Rosen, 1997; Krulewitch, 2016).
Despite access to contraceptives and other SRH services, rates of contraceptive use among 
servicewomen, particularly use of long-acting reversible contraceptives (LARCs), remain low 
(Erickson et al., 2017; Harrington, Shaw, & Shaw, 2017). Similarly, rates of STIs are also 
relatively high in active duty service members, and the rates of certain STIs like chlamydia, 
gonorrhea, and syphilis have increased among service members (Stahlman & Oetting, 2019). 
Strides have been made to identify barriers to sexual and reproductive healthcare (Manski, 
Grindlay, Burns, Holt, & Grossman, 2014), such as deployment (ACOG, 2012), improper 
contraceptive use (Stahlman, Witkop, Clark, & Taubman, 2017). However, a further need to 
explore and implement programs and processes to subvert these barriers remains (de Kanter et 
al., 2018; Erickson et al., 2017; Kate Grindlay et al., 2017; Seymour, Grindlay, Fix, & Grossman, 
2018).
Health-risking sexual behaviors (HRSBs) like binge drinking and multiple sexual partners can 
lead to negative SRH outcomes like unintended pregnancy and STIs are well-documented in the 
military (Stahlman et al., 2014; Stahlman et al., 2015). For example, alcohol misuse during 
deployment has been associated with STIs and other HRSBs (O’Malley et al., 2017). HRSBs offer 
potential targets for improving the SRH of service members.
The Multiphase Optimization Strategy (MOST) is a framework for developing behavioral 
interventions efficiently, effectively, and economically (Collins, Kugler, & Gwadz, 2016). MOST 
involves three phases: Preparation (i.e., using or collecting data to inform development of 
intervention components), Optimization (i.e., conducting component selection experiments 
[CSEs] to experimentally evaluate the effectiveness of the intervention components), and 
Evaluation (i.e., conducting a randomized controlled trial [RCT] to experimentally evaluate the 
effectiveness of the overall intervention; (Collins et al., 2016). The critical element to MOST is 
the optimization phase. Using a factorial design in the optimization phase allows the effect of 
each intervention component to be evaluated and for observation of interaction effects (Collins, 
Chakraborty, Murphy, & Strecher, 2009) while maximizing statistical power using a smaller 
sample size compared to an RCT powered similarly to explore individual components of an 
intervention (Collins et al., 2009). The optimization phase then allows for time and resources to 
be saved by ensuring only optimized components are retained after the RCT in the final 
intervention package (Chakraborty, Collins, Strecher, & Murphy, 2009; Collins et al., 2009).
In civilian populations the MOST strategy has been implored successfully to develop electronic 
health (ehealth) interventions to reduce HRSBs that can lead to negative SRH outcomes such as 
STIs (Kari Christine Kugler et al., 2017; Kari C. Kugler et al., 2018; O’Malley et al., 2017). 
Generally, ehealth interventions are cost-effective and dynamic, and have the potential affect a 

large audience (Elbert et al., 2014; Noar & Willoughby, 2012). In civilian populations ehealth—
including mobile health (mhealth)—interventions repeatedly demonstrate success in positively 
affecting health behaviors and, specifically, HRSBs (Hogben, Ford, Becasen, & Brown, 2015; 
Lelutiu-Weinberger et al., 2018; Noar & Willoughby, 2012; Swendeman & Rotheram-Borus, 
2010). Successful ehealth interventions are beginning to emerge in the military (Armstrong, 
Hoyt, Kinn, Ciulla, & Bush, 2017). Several electronic SRH interventions, most focusing solely on 
sexual assault, exist; however, it is unclear whether these programs have been successfully 
evaluated and if they are effective, and they would benefit from optimization (Orchowski, Berry-
Cabán, Prisock, Borsari, & Kazemi, 2018).
The information-motivation-behavioral skills (IMB) model has been successfully used as 
theoretical framework in SRH interventions (Anderson et al., 2006; Chang, Choi, .Kim, & Song, 
2014) as it can be used to explain HRSBs (C. M. Fisher, 2012; Mittal, Senn, & Carey, 2012). 
Theoretically-relevant, effective IMB-based interventions for SRH typically include: (1) the 
provision of information (e.g., STI transmission, STI and/or pregnancy prevention methods), (2) 
efforts to increase motivation to engage in non-risky sexual behaviors (e.g., normative and 
attitudinal support, values clarification), (3) behavioral skills training (e.g., sexual risk 
communication skills), and (4) accessible resources (e.g., acceptable medical services), delivered 
in acceptable formats (CDC, 2016; Fagerlin et al., 2013; J.D. Fisher, W.A. Fisher, Bryan, & 
Misovich, 2002; Long et al., 2016; Swendeman & Rotheram-Borus, 2010). In addition, 
interventions thrive when they are optimized for the environment and populations in which they 
are used (Barrera, Castro, Strycker, & Toobert, 2013).
An intervention for military personnel must consider the specific values, mission, and context of 
military populations and settings. Conducting an RCT using civilian-derived interventions for 
military personnel risks wasting valuable time and resources by evaluating an intervention that is 
not optimized to its setting. The MOST strategy is particularly well-suited to complex challenges 
like SRH in the military in that it allows for military culture and norms to be well-integrated into 
an intervention, as successful sexual assault prevention programs in the military have shown 
(Bennett, 2018).
This project aims to develop and optimize effective interventions within the US military to 
supplement standard SRH care at Military Treatment Facilities, reduce HRSBs in service 
members, and, overall, improve SRH within the military. Intervention components will be 
optimized such that they yield the greatest effects while conserving valuable healthcare service 
resources for service members and their families.
 
9.3  
Objectives/Specific Aims/Research Questions:
Describe the purpose and objective(s) of the study, specific aims, and/or research questions
/hypotheses
This protocol covers data collection for Phase II of our funded research (the optimization phase). 
Phase II involves conducting component selection experiments (CSEs) to determine which 
intervention component(s) elicit the greatest improvements in outcomes of interest (i.e., 
improved knowledge, motivation, and behavior skills related to sexual and reproductive health 
[SRH] and reduced health-risking sexual behaviors [HRSBs]) in no more than 25 minutes of e-
health content (i.e., the optimization criteria). The intervention components used in these 
experiments were determined by a previous research protocol (the preparation phase, Phase I). 
Deliverable will be determination by the research team if the optimized brief e-health 
intervention is suitable to advance to an randomized controlled trial (RCT) or if further 
preparation and optimization is necessary.
 
9.4  Study Design:
Describe study design in one to two sentences (e.g., prospective, use of existing records/data
/specimens, observational, cross-sectional, interventional, randomized, placebo-controlled, 
cohort, etc.). Specify the phase – Phase I, II, III, or IV – for FDA-regulated investigational drug 
research

This study is the second phase in the multi-phase optimization strategy (MOST) framework (the 
optimization phase) to develop an optimized electronic health (ehealth) intervention to reduce 
health-risking sexual behaviors (HRSBs). This study involves a randomized (factorial) experiment 
to evaluate the individual effect of intervention components.
9.5  Target Population:
Describe the population to whom the study findings will be generalized
Active duty service members, across all services.
9.6  Benefit to the DoD:
State how this study will impact or be of benefit to the Department of Defense
The proposed research ultimately aims to reduce health-risking sexual behaviors (HRSBs) in 
military service women and men, which is expected to have a significant and positive effect on 
reducing sexually transmitted infections (STIs), STI-related cancer rates, and unintended 
pregnancy. This, in turn, is expected to improve service member physical and mental well-being 
and readiness to serve.
10.0
 
Study Procedures, Data Management, and Privacy
10.1  Study Procedures:
Describe step-by-step how the study will be conducted from beginning to end
Participants will be recruited via advertisement (e.g., physical posters and brochures, social 
media, condoms), word of mouth, or by approaching or being approached by a research team 
member (e.g., tabling around a base, giving a speech to a group). Participants may also be 
recruited via email or listserv (e.g., a base contact emails a flyer to their unit). Individuals who 
are interested in participating in the study will be directed to the anonymous, electronic Eligibility 
Screening Assessment (attached) in an online data collection software (e.g., REDCap, 
SurveyMonkey) via a URL, QR code, and/or bitly. Directly after completing the screening, eligible 
individuals will be prompted via an electronic link to the electronic informed consent (e-consent) 
form in a secure, online collection software (e.g., REDCap, SurveyMonkey) to provide informed 
consent to participate in the research study. Eligible individuals will then be engaged in an e-
consent process and be asked to sign an e-consent form. Total involvement in the study is 
expected to take up to three hours of a participant’s time over three-to-five sessions over 
approximately three months.
 
After signing the e-consent form, participants will be prompted to complete a contact information 
form to provide the research team with an email and telephone number. Participants will then be 
asked to complete a pre-intervention assessment, the study intervention, and a post-
intervention assessment, respectively, which will all only be identified by a research identification 
number (RIN). Not until after completion of informed consent will participants be assigned a RIN 
and randomized to a treatment condition. A master document linking a participant’s identity with 
her or his RIN will be accessible only by the PI and designees.
 
Participants will be randomized to one of the 32 treatment conditions, corresponding to all 
factorial combinations of randomized components. The randomization scheme will be generated 
based on a permutated block randomization procedure, with small random sized blocks. 
Randomization will be stratified by sex. The length of the intervention will vary based on which 
components (which treatment condition) the participant receives. The components include: (1) a 
basic sexual and reproductive health (SRH) education (not randomized), (2) video narratives, (3) 
skills building videos, (4) interactive scenarios, (5) a future life planning tool, and (6) 
epidemiological risk scenario. 
 
The basic SRH education component is the only component that every participant will receive; all 
other components will have two levels (i.e., "on" or "off"). The exact educational content the 
participant receives in this component will be determined based on baseline SRH knowledge, 
which will be assessed in a pre-test (discussed below). In the basic SRH education component in 

the app, participants will be presented with a series of screens with interactive content and 
occasional videos.
 
The narrative video component contains videos about situations related to SRH. This component 
is randomized and is either "on" or "off" (i.e., received or not received by a participant). 
Narrative videos will include stories of individuals engaging in positive and negative sexual health 
behaviors that leads to either positive and negative outcomes, respectively. Those who receive 
the narrative video component in the app will be expected to watch the assigned videos.
 
The skills building video component contains videos on how to perform or engage positive SRH 
behaviors, such as correctly using a condom and what to expect when having a Pap smear. This 
component is randomized and is either "on" or "off". Participants who receive this video 
component in the app will be expected to watch the assigned videos.
 
The interactive scenarios component guides participants through conversations surrounding SRH 
with select individuals (e.g., partner, healthcare provider, commander), providing suggestions on 
how conversations with these individuals may be had and why the conversations may be worth 
having. This component is randomized and is either “on” or “off”. In the interactive scenarios 
component in the app, participants will select a type of individual from a list (pre-determined) to 
receive a list of topics to discuss with that individual. From there the participant will select the 
topic they wish to “discuss” and receive a click-through interactive scenario of how to discuss 
that topic with the selected individual. For example, an avatar (representative of the selected 
individual) approaches the foreground and says something (word bubble with text and audio). 
Then the screen changes to present the participant with three text options. The participant is 
prompted to select one of the options. The screen goes back to the avatar who responds 
(programmed algorithms) to that selected response. The participant is then prompted with 
another set of options on how to respond. Participants may have the option to turn on 
notifications related to this component (e.g., “Upcoming [conversation]? Want a reminder of 
what to say?”).
 
The future life planning component involves a series of questions to help users plan future goals 
to put current decision making related to SRH into perspective and provide suggestions on how 
to stay healthy now to be able to achieve those goals later. This component is randomized and is 
either “on” or “off”. In the future life planning component in the app, a participant will be 
presented with various goals (e.g., personal, career) to select and/or drag and drop. After goals 
have been selected, the participant will be given a summary page of feedback and suggestions 
that corresponds with their goals. Participants may have the option to turn on notifications 
related to this component.
 
The epidemiological risk scenario component involves tailored epidemiological risk information 
about relative risk of contracting a sexually transmitted infection (STI) and/or having an 
unintended pregnancy. Relative risk information will be determined by adjusting variables within 
the component (e.g., number of partners within the last month, percent of time using condoms). 
The epidemiological risk component is a randomized component and will be "on" or "off". In this 
component a participant will be able to set different factors (e.g., number of sexual partners, 
frequency of use of contraception/other preventative measures) and then “run” a simulation 
which shows a survival curve, or some other graphic, of his or her likely risk for contracting STI 
or experiencing unplanned pregnancy.
 
Participants will be emailed a link to complete the Participant Pre-Intervention Assessment 
(attached) in an online data collection software (e.g., REDCap, SurveyMonkey). The Pre-
Intervention Assessment will be identified by RIN only. All questions must be answered. 
However, a participant may respond that she or he "Prefer Not to Answer" for any question. It is 
anticipated that this questionnaire will take a participant approximately 20-30 minutes to 
complete.
 
After completing of the Participant Pre-Intervention Assessment, a participant will be given an 
access code and PIN to use to access the app. She or he will then be instructed to download the 
application (app; intervention) to her or his smart phone (Andriod or iOS). A USU-based research 
team member will provide these codes and instructions to participants. Once the app is 
downloaded, a participant will open the app and immediately be prompted by the app to enter 
the given access code and PIN. After the access code and PIN are entered, the participant will be 
asked to complete the in-app SRH Knowledge Pre-Test Assessment (attached).
 
The SRH Knowledge Pre-Test Assessment will assess baseline SRH knowledge that will determine 
educational content received in the intervention. For example, if a participant answers the pre-
test question(s) related to female reproductive anatomy correctly, then she or he will not have 
female reproductive anatomy content in the educational component of the intervention. All 
questions in the SRH Knowledge Pre-Test Assessment must be answered. After completion of the 
SRH Knowledge Pre-Test Assessment, the participant will complete the intervention in the app 

that corresponds with the assigned treatment condition and that is tailored based on her or his 
completion of the SRH Knowledge Pre-Test Assessment. All interaction with the app will be 
identified only by the access code and PIN combination. It is anticipated that the app will take up 
to one hour to complete, depending on how many and what components a participant receives.
A USU-based research team member will then contact the participant via email to ask her or him 
to complete the Participant Post-Intervention Assessment (attached; identified by RIN only) in an 
online data collection software (e.g., REDCap, SurveyMonkey) around two weeks after the 
participant was asked to complete the app. All questions in the Participant Post-Intervention 
Assessment must be answered. However, a participant may respond that she or he "Prefer Not 
to Answer" for any question. It is anticipated that this questionnaire will take a participant 
approximately 20-30 minutes to complete. If the participant completes the Post-Intervention 
Assessment within the specified time frame then she or he will be eligible to receive an electronic 
$5 Amazon gift card (or code).
In addition to the quantitative surveys, participants may be invited to participate in a brief 15-to-
30-minute, structured interview about their experiences using the app if they consent to do so 
on the informed consent document. Participants will be selected for interviews based on the 
criteria outlined in Section 13.1. If selected for an interview, participants will be contacted via 
email by a member of the USU team about scheduling the interview two-to-six weeks after being 
sent the code and instructions to access the app. Interviews will be conducted by a member of 
the USU team via telephone. Participants who complete the interview off duty will be eligible to 
receive an additional $5 Amazon gift card (or code). Non-completion of an interview, for any 
reason, will not affect a participant’s primary participation in the research study.
10.2  Data Collection:
Describe all the data variables, information to be collected, the source of the data, and how the 
data will be operationally measured.
There are four assessments associated with this study: the Eligibility Screening Assessment, 
Participant Pre-Intervention Assessment, SRH Knowledge Pre-Test Assessment, and Participant 
Post-Intervention Assessment. The measures used in these assessments are in the attached 
"Measures" document. In addition to these assessments, data will also be collected on 
application (app; the intervention) usage and interaction. All Eligibility Screening Assessment 
data will be anonymous. All other data will be identified by a research identification number 
(RIN), not by participant name or any other identifying information. RIN will be assigned in the 
electronic data collection software (e.g., REDCap, SurveyMonkey) when a participant begins a 
Pre-Intervention Assessment. A master document linking a participant’s identity with her or his 
RIN will be accessible only by the PI and designees at the Unifromed Services University of the 
Health Sciences (USU).
 
The Eligibility Screening Assessment is an anonymous screening assessment that will be 
administered to prospective participants electronically via an online data collection software (e.
g., REDCap, SurveyMonkey). The Eligibility Screening Assessment will ask questions related to 
eligibility (e.g., age, military status) and, to ensure a purposive sample, demographics (e.g., 
gender, rank, military branch). All questions in the Eligibility Screening must be answered for an 
individual to be considered for eligibility in the research study.
 
The Participant Pre-Intervention Assessment will be administered to participants electronically via 
an online data collection software (e.g., REDCap, SurveyMonkey) following completion of 
informed consent. The Participant Pre-Intervention Assessment will collect demographic 
information and assess sexual and reproductive health (SRH) knowledge, attitudes, self-efficacy, 
sexual behavior, healthcare experiences, healthcare provider interactions, and general mental 
health.  All questions in the Participant Pre-Intervention Assessment must be answered. 
However, a participant may mark that she or he "Prefer Not to Answer" for any question.
 
The SRH Knowledge Pre-Test Assessment will be administered to participants in the application 
at the onset of the intervention. The SRH Knowledge Pre-Test will assess baseline SRH 
knowledge that will be used to tailor select content in the app to the participant (see Study 
Procedures for more information and examples).
 
The Participant Post-Test Assessment will be administered to participants after completion of the 
intervention via an online data collection software (e.g., REDCap, SurveyMonkey). All questions 
in the Participant Post-Test Assessment must be answered. However, a participant may respond 
that she or he "Prefer Not to Answer" for any question. The Participant Post-Test Assessment 
assess sexual and reproductive health (SRH) knowledge, attitudes, self-efficacy, and 
acceptability of the intervention.

 
Data will also be collected on participants’ interactions with the app. This data includes 
information such as information on how long participants spent on each component, how many 
times participants opened the app, and how many times participants accessed and completed 
components.
Participants who consent to opt-in to an additional structured, qualitative interview will be asked 
to complete an interview with a member of the USU team via telephone two-to-six weeks after 
receiving the intervention. The interview will ask participants about their experiences using the 
app, including-but-not-limited-to questions about graphics (aesthetics), barriers to use, and ease 
of use (see attached interview agenda). Interviews will be recorded, and recordings will be used 
to expand notes taken during the interview. Recordings will be deleted upon completion of 
interview notes.
10.3  At any point in the study, will you request, use, or access health information in any form, including 
verbal, hard copy and electronic?
  Yes   
  No
11.0
 
Statistical/Data Analysis Plan
11.1  Statistical Considerations:
List the statistical methods to be used to address the primary and secondary objectives, specific 
aims, and/or research hypotheses.  Explain how missing data and outliers will be handled in the 
analysis.  The analysis plan should be consistent with the study objectives.  Include any sub-
group analyses (e.g., gender or age group).  Specify statistical methods and variables for each 
analysis.  Describe how confounding variables will be controlled in the data analysis
It is hypothesized that each intervention component will reduce at least some health-risking 
sexual behaviors (HRSBs) and increase health-promoting behaviors (e.g., condom use, obtaining 
effective contraception) and that each component will increase at least one antecedent to 
behavior--knowledge, motivations, or perceptions of behavioral skills. It is expected that each 
intervention component will have a small-to-medium effect on associated outcomes. Descriptive 
statistics will be calculated for all data including demographics and outcome variables (e.g., scale 
scores for attitudes, rates of condom use). Effect coding will be used to indicate the presence or 
absence of each intervention component. Per the multi-phase optimization strategy (MOST) 
framework, factorial analysis of variance will be used to calculate both main effects and the 
theoretically-relevant two-way interaction effects. Secondary analyses will be conducted to 
examine the information-motivation-behavioral skills (IMB) model whereby behavioral skills 
serves as a mediator between information and behavior change and between motivation and 
behavior change. Statistical software such as SAS and R will be utilized for analyses.
Interview data (typed notes) will be analyzed using framework matrix analysis.
11.2  Sample Size:
900 active duty service members
11.3  Total number of subjects requested (including records and specimens):
900
11.4  If you are recruiting by study arm, please identify the arms of the study and how many subjects will 
be enrolled in each arm
11.5  Please provide a justification for your sample size

Power analysis indicates that a sample of 720 will be sufficient to have 80% power to detect 
small main effects and interaction effects at a 5% significance level. Accounting for 20% 
attrition, up to 900 service members will be enrolled to reach target sample size.
Of this total sample, it is anticipated that 40 participants will be needed and selected to complete 
an interview. Qualitative data analysis does not lend itself to power analysis. Sample size was 
selected based on the experiences of our qualitative experts.
11.6  Data Analysis Plan: Complete description: Background, Objectives, Design, Step by Step how the 
project is going to be done, Data analysis plan:
Data analysis will be conducted consistent with the methods described in the "Statistical 
Considerations" section.
12.0
 
Participant Information
12.1  Subject Population:
Active duty service members
12.2  Age Range:
Check all the boxes that apply. if the age range of potential subjects (specimens, records) does 
not match the range(s) selected, please specify in the text box.
0-17
18-24
25-34
35-44
45-54
55-64
65-74
75+
17-75+ will be eligible as that is the age range for service members
12.3  Gender:
Male
Female
Other
12.4  Special categories, check all that apply
Minors /Children
Students
Employees - Civilian
Employees - Contractor
Resident/trainee
Cadets /Midshipmen
Active Duty Military Personnel
Wounded Warriors
Economically Disadvantaged Persons

Educationally Disadvantaged Persons
Physically Challenged (Physical challenges include visual and/or auditory impairment)
Persons with Impaired Decisional Capacity
Prisoners
Pregnant Women, Fetuses, and Neonates
Non-English Speakers
International Research involving Foreign Nationals - Headquarters Review is necessary
You must also consider the requirements of DoDI 3216.02, Enclosure 3, paragraph 7.e.
12.5  Inclusion Criteria:
Order 
Number
Criteria
1 
Participants are eligible if they are:
1) age 17 or older,
2) active duty military personnel, and
3) willing to be participate in all study activities if eligible and enrolled.
 
12.6  Exclusion Criteria:
Order 
Number
Criteria
1 
Any participant (i.e., service member or provider) will be deemed ineligible to 
participate if they do not meet the eligibility criteria or are 1) unable to read, 
speak, or comprehend English, or 2) unable or unwilling to give informed consent.
 
13.0
 
Recruitment and Consent
13.1  Please describe the recruitment process, including how subjects will be identified and selected for 
the study.
Participants will be recruited across services via advertisement (e.g., physical posters, social 
media, condoms, nominal items like stress balls), word of mouth, or by approaching or being 
approached by a research team member, as well as via email or listserv. Individuals who express 
interest in taking part in the study will be asked to provide consent to be screened for eligibility 
(Eligibility Screening Questionnaire attached). After completing the screening, eligible individuals 
will be asked to provide informed consent, which will be collected by USU-based research team 
members.
The study sample will represent a convenience sample of individuals who voluntarily express 
interest in participating. Purposive sampling will also be employed to ensure adequate 
representation of female and male participants and each branch of the military. Participants will 
complete the intervention off-duty to minimize impact on military operational effectiveness.
Purposive sampling will also be employed when selecting interview participants from the group of 
participants who consented to complete an interview if selected. Participants will be selected to 
ensure appropriate representation of gender, sexual, and/or ethnic/racial identity and military 
rank and/or service and to ensure that there is a good mix of those who have and have not used 
the app. Demographics information from the Pre-Intervention (baseline) Assessment and 
analytics data on app use will be used to inform the selections. It will still be expected that 
participants complete this part of the study off duty as well.
13.2  Compensation for Participation:

Participants will be compensated for their participation via electronic Amazon gift cards (codes). 
Participants will be eligible to receive an electronic $5 Amazon gift card upon completion of the 
Participant Post-Intervention Assessment within the specified period of time if they indicate that 
they completed the survey off duty. Participants who complete the interview will be eligible to 
receive an additional $5 Amazon gift card upon completion of the interview off duty.
13.3  Please describe the pre-screening process. If no pre-screening, enter Not Applicable in the text editor
Participant eligibility in the overall study will be determined by anonymous self-reported 
responses to screening questions including age and active duty military status. Participants will 
be invited to complete an interview based on their answers to demographic questions in the de-
identified Pre-Intervention Assessment and whether or not they used the app (pulled from de-
identified app analytics data). Medical records from the Military Health System (MHS) will not be 
utilized at any point during the study, and will not be used to identify subjects or confirm 
eligibility.
 
13.4  Consent Process:   Revised Common Rule, Section 219.116:  General requirements for informed 
consent, whether written or oral, are set forth in this paragraph and apply to consent obtained in 
accordance with the requirements set forth in paragraphs (b) through (d) of this section. Broad 
consent may be obtained in lieu of informed consent obtained in accordance with paragraphs (b) and 
(c) of this section only with respect to the storage, maintenance, and secondary research uses of 
identifiable private information and identifiable biospecimens.
Are you requesting a waiver or alteration of informed consent?
  Yes   
  No
Please explain the consent process:
After completing the Eligibility Screening Assessment, all eligible and interested individuals will 
be engaged in an electronic informed consent process via a secure, online collection software (e.
g., REDCap, SurveyMonkey) prior to completing any other assessments, the study intervention, 
or qualitative interview. The informed consent document (ICD; attached) includes an explanation 
of the nature and purpose of the study, study procedures, risks and befits, confidentiality, and 
the voluntary nature of research studies. Prospective participants will be instructed on the 
consent form to call or email the Uniformed Services University of the Health Sciences (USU) 
research team with any questions. Once the signed ICD is returned to the study team, the 
participant will be permitted to be engaged with the intervention, assessments, and all other 
aspects of the study for which they consent (see Study Procedures). Participants will be informed 
to check an additional box after the signature line if they consent to be contacted about and 
participate in the qualitative interview. Participants will be offered a copy of their signed ICD.
13.5  DoDI 3216.02 requires an ombudsman to be present during recruitment briefings when research 
involves greater than minimal risk and recruitment of Service members occurs in a group setting. If 
applicable, you may nominate an individual to serve as the ombudsman.
N/A 
Propose ombudsman 
13.6  Withdrawal from Study Participation:
Explain the process for withdrawal and specify whether or not the subjects will be given the 
opportunity to withdraw their data their data/specimens in the event they wish to withdraw from 
the study
Prior to the destruction of the link between participant name and research identification number 
(RIN; maintained and accessible only by the PI or designee in a password protected file stored 
on a secure server), participants will be able to withdraw their participation in the study by 
contacting the PI (or designee). Those who request to withdraw will be allowed to do so and their 
data will be removed from analysis for both this study and any future research for which the 
participant originally consented. After a link between a participant's name and her or his RIN has 

been destroyed, we will no longer have the ability to identify the participant's data and, thus, she 
or he will no longer be able to have their data removed from the data set.
14.0
 
Risks and Benefits
14.1  
Risks of Harm:
Identify all research-related risks of harm to which the subject will be exposed for each research 
procedure or intervention as a result of participation in this study.  Consider the risks of breach 
of confidentiality, psychological, legal, social, and economic risks as well as physical risks.  Do 
not describe risks from standard care procedures; only describe risks from procedures done for 
research purposes
Potential risks include: 1) breach of confidentiality, 2) coercion, and 3) discomfort and/or offense 
due to intervention content (i.e., sexual and reproductive health [SRH]). Risks associated with br
 are always a consideration, but , these risks are considered low in this 
each of confidentiality
instance as all data will be identified by a research identification number (RIN). Risk of 
 
coercion
is possible as military personnel may feel compelled to participate in the research study if they 
are informed about the study by their medical provider or someone in their chain of command. 
Risks associated with 
prompted by the content of the intervention are 
feelings of discomfort 
possible as the intervention and associated assessments concern SRH. However, content was 
developed in consultation with experts to ensure the information presented is focused on 
medically relevant and operationally focused concerns.
14.2  
Measures to Minimize Risks of Harm (Precautions, safeguards):
For each research procedure or intervention, describe all measures to minimize and/or eliminate 
risk of harms to subjects and study personnel
The potential risks (outlined above in "Risks of Harm") include: 1) breach of confidentiality, 2) 
coercion, and 3) discomfort and/or offense due to intervention content (i.e., sexual and 
reproductive health [SRH]).
 
Protecting Confidentiality. Every precaution will be taken to ensure data will be kept strictly 
confidential. During the informed consent process, potential participants will receive information 
about confidentiality, including who is able to view their data throughout the study. Data will 
anonymous or identified by a research identification number (RIN); thus, the only way to identify 
whether or not an individual participated will be via documentation of informed consent. All 
electronic informed consent documents (ICDs) will be kept on a secure network. Only the PI 
and designees will have access to ICDs.
 
Protection Against Coercion. Protocols and research staff trainings related to ethics, 
confidentiality, and other topics in human subject protection will ensure participants are informed 
of their rights as a research volunteer. Throughout the recruitment process potential participants 
and others involved in the recruitment process by word of mouth will be told that participation is 
voluntary. During the informed consent process potential participants will be informed of their 
rights as a research volunteer, including the right to not participate in the research study without 
repercussions, to refuse to answer any question, to withdraw from the study at any time. 
Although supervisors/commanders may share information to participate in this study with service 
members, they will not be involved in group recruitment or consent. The majority of the consent 
process will be conducted by civilian members of our lab team.
 
Protection Against Feelings of Discomfort. Participants may feel uncomfortable by the 
intervention content (i.e., SRH) and associated assessment questions. The intervention was 
planned to attempt to minimize making participants feel uncomfortable. However, it is possible 
that some may still fell some discomfort by the topic nonetheless. Participants will be instructed 
during the consent process to contact the study team via telephone or email with any concerns 

or to report discomfort. Participants will also be permitted to skip any questions in the 
assessments they do not feel comfortable answering.
 
14.3  
Confidentiality Protections (for research records, data and/or specimens):
Describe in detail the plan to maintain confidentiality of the research data, specimens, and 
records throughout the study and at its conclusion (e.g., destruction, long term storage, or 
banking). Explain the plan for securing the data (e.g., use of passwords, encryption, secure 
servers, firewalls, and other appropriate methods). If data will be shared electronically with 
other team members/collaborators outside the institution, describe the method of transmission 
and safeguards to maintain confidentiality. Explain whether this study may collect information 
that State or Federal law requires to be reported to other officials or ethically requires action, e.
g., child or spouse abuse
As described in the section above ("Measures to Minimize Risks of Harm"), confidentiality 
protections include:
Collecting data only identified by a research identification number (RIN)
Using the informed consent process as an opportunity to inform potential participants 
about their rights as a research participant and to provide transparency in plans for data 
management.
14.4  
Potential Benefits:
Describe any real and potential benefits of the research to the subject and any potential benefits 
to a specific community or society
If the individuals in the research are considered experimental subjects (per 10 USC 980), and 
they cannot provide their own consent, the protocol must describe the intent to directly benefit 
all subjects
Potential benefits to the participant include an increased knowledge in sexual and reproductive 
health (SRH) information, self-efficacy related to reducing health-risking sexual behaviors 
(HRSBs), and decrease HRSBs. The intervention has the potential to significantly benefit the 
overall health and readiness of military personnel, as SRH issues such as sexually transmitted 
infections (STIs) and unplanned pregnancy degrade mission readiness.
14.5  
Privacy for Subjects:
Describe the measures to protect subject’s privacy during recruitment, the consent process, and 
all research activities, etc.
In accordance with HIPAA policies at the Uniformed Services University of the Health Sciences 
(USU) and The Miriam Hospital (TMH), and despite data only being used for study purposes, 
participants' data will be treated in a manner similar to protected health information to afford it 
equivalent privacy protections. Recruitment will most be via word of mouth and advertisement 
online and on paper, so there are no privacy risks associated with this type of recruitment. 
Consent will be done electronically in a HIPAA-compliant software.
14.6  
Incidental or Unexpected Findings:

Describe the plan to address incidental findings and unexpected findings about individuals from 
screening to the end of the subject’s participation in the research. In cases where the subject 
could possibly benefit medically or otherwise from the information, state whether or not the 
results of screening, research participation, research tests, etc., will be shared with subjects or 
their primary care provider. State whether the researcher is obligated or mandated to report 
results to appropriate military or civilian authorities and explain the potential impact on the 
subject
Incidental findings are not anticipated as the app is not collecting personal health information.
15.0
 
Study Monitoring
15.1  Your study requires either Data and Safety Monitoring Plan (DSMP) or a Data and Safety Monitoring 
Board (DSMB).
DSMP 
DSMB 
Both 
Not Applicable 
A DSMP should describe the plan to monitor the data to verify that the data are collected and 
analyzed as specified in the protocol. Include who will conduct the monitoring, what will be 
monitored, and the frequency of monitoring. It should also include the plan to ensure the safety 
of subjects
The Principal Investigator (PI) or designee(s) will verify that all data has been collected and 
analyzed as specified. The project coordinator (or designee to be appointed by the PI) is 
responsible for reporting findings to the PI on a weekly basis. Deviations from the protocol will be 
reported to the PI within 24 hours of discovery by the research team so that a determination of 
notification to the Institutional Review Board (IRB) and any mitigation procedures can be 
implemented in a timely manner.
 
It is possible that participants may feel discomfort answering questions or consuming information 
related to sexual and reproductive health (SRH), despite the benefits that come from gaining 
knowledge about SRH. Participants will be encouraged to contact the research study or their 
healthcare providers if they experience distress. All research study members will be trained to 
refer participants to their healthcare providers.
16.0
 
Reportable Events
16.1  Reportable Events: Consult with the research office at your institution to ensure requirements are 
met. Describe plans for reporting unexpected adverse events and unanticipated problems. Address 
how unexpected adverse events will be identified, who will report, how often adverse events and 
unanticipated problems will be reviewed to determine if any changes to the protocol or consent form 
are needed and the scale that will be used to grade the severity of the adverse event. 
Consult with the research office at your institution to ensure requirements are met
 
• Describe plans for reporting expected adverse events. Identify what the expected adverse 
events will be for this study, describe the likelihood (frequency, severity, reversibility, short-
term management and any long-term implications of each expected event)
 
• Describe plans for reporting unexpected adverse events and unanticipated problems. Address 
how unexpected adverse events will be identified, who will report, how often adverse events and 
unanticipated problems will be reviewed to determine if any changes to the research protocol or 
consent form are needed and the scale that will be used to grade the severity of the adverse 
event

No adverse events are anticipated. It may be possible that a participant may experience 
embarrassment, discomfort, or offense due to the subject matter of the intervention. If 
participants contact the research team reporting such feelings, the research team will be trained 
to refer them to appropriate services such as those for psychological and/or medical care if they 
have further concerns. Such feelings that cause greater than minimal interference with usual 
social and functional activities will be considered an adverse event. The PI will report any 
unanticipated adverse events to the Institutional Review Board (IRB) within 72 hours of 
discovery. When reporting the unanticipated adverse event to the IRB the PI will propose any 
amendments to the research protocol if applicable and as necessary.
17.0
 
Equipment/non-FDA Regulated Devices
17.1  Does the study involve the use of any unique non-medical devices/equipment?
 Yes   
 No
Please describe:
The study involves the use of an electronic health (ehealth) intervention, a smartphone (Android 
and iOS) application (app). A description of the components of this app can be found in Study 
Procedures. Attached is a rough schematic of what the app will look like.
18.0
 
FDA-Regulated Products
18.1  Will any drugs, dietary supplements, biologics, or devices be utilized in this study?
Drugs
Dietary Supplements
Biologics
Devices
N/A
18.5  Sponsor (organization/institution/company):
N/A
If applicable, provide sponsor contact information:
19.0
 
Research Registration Requirements
19.1  ClinicalTrials.gov Registration:
Registration is not required 
Registration pending 
Registration complete 
“NCT” number:
NCT04661566
19.2  Defense Technical Information Center Registration (Optional):

Registration is not required 
Registration pending 
Registration complete 
20.0
 
References and Glossary
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20.2  Abbreviations and Acronyms:
App - Application
CSE - Component selection experiment
ehealth - electronic health
HSRB - Health-risking sexual behavior
LARC - Long-acting reversible contraceptive
ICD - Informed consent document
IMB - Information-motivation-behavioral skills
IRB - Institutional Review Board
mhealth - mobile health
MHS - Military Health System
MOST - Multi-phase optimization strategy
MTF - Military Treatment Facility
RCT - Randomized controlled trail
RIN - Research identification number
SA - Sexual assault
SRH - Sexual and reproductive health
STI - Sexually transmitted infection
US - United States