Perfect- and Typical-use Effectiveness of the Dot Fertility App Over 13 Cycles: Results From a Prospective Contraceptive Effectiveness Trial
Conditions: Desire to Avoid Pregnancy
Sponsor: Georgetown University

January 2017 
 
Study Title: Dot Efficacy Study Effectiveness of a Personalized Approach for Pregnancy 
Prevention: Dynamic Optimal Timing  
 
Clinical Trials Number: NCT02833922 
 
 

 
1
. 
* Please enter the title of your study: 
Dot Efficacy Study 
Effectiveness of a Personalized Approach for Pregnancy Prevention: Dynamic Optimal Timing 
Below is a system generated "short title". It will only be used to reference the protocol in 
the system. All official letters and minutes will include the long title entered above. 
Dot Efficacy Study Effectiveness of a Personalized Approach for Pregnancy Prevention: 
Dynamic Optimal Timing (original version) 
2
. 
* Please specify the Principal Investigator: 
Victoria Jennings 
3
. 
If the Responsible Participant is somebody other than the Principal Investigator, please specify 
that individual here: 
Investigator(s): Any person who is responsible for the design, conduct or reporting of 
research. 
Engaged Study Team Members: An individual is "engaged" in human subjects research when 
the individual, (i) intervenes or interacts with living individuals for research purposes; or (ii) 
obtains individually identifiable private information for research purposes [45 CFR 
46.102(d),(f)]. 
Please note:  All members of the study team that are “engaged in research” (i.e. investigators, 
co-investigators, consultants, etc.) or who appear on the grant will be required to submit a 
Study Specific Disclosure Form at the time of initial and continuing review for this study. 
4
. 
Please specify the Co-Investigators: 
Name 
Department 
E-Mail 
Rebecca Simmons  Institute For Reproductive Health 
(IRH) 
rebecca.simmons@georgetown.edu 
Dominick 
Shattuck 
Institute For Reproductive Health 
(IRH) 
ds1380@georgetown.edu 
5
.
 
Please specify the Regulatory Coordinator(s) 
Name 
Department 
E-Mail 
There are no items to display 
6
. 
Please specify the Study Coordinator(s): 
Name 
Department 
E-Mail 
Elizabeth Menstell 
Institute For Reproductive Health (IRH) 
ecm104@georgetown.edu 
7
. 
Please specify the Research Nurse(s): 

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8
. 
Please specify the Biostastician(s): 
Name 
Department 
E-Mail 
There are no items to display 
9
. 
Please list additional study team members engaged in research, if any, including consultants, 
and/or anybody not listed above who appears on the grant or 1572 (if applicable): 
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1
0
. 
Please list any study team members who do not have a Georgetown University NetID (i.e. 
sponsored university associates, outside consultants, etc.): 
  
Last 
Nam
e 
First 
Nam
e 
Affiliati
on 
Email Address 
Engage
d In 
Resear
ch 
SSDF 
Vie
w 
Fries Fran
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HITLab ffries@hitlab.or
g 
yes 
GU_IRB_SSDF_FrankFries_HITLAB_Part1
.pdf(0.01)  
Vie
w 
Need
le 
Kati
e 
HITLab kneedle@hitlab
.org 
yes 
Katie Needle_Georgetown SSDF.pdf(0.01)  
1
1
. 
* If you are applying to the GU SFS-Qatar IRB, please select "State of Qatar". Otherwise, 
please select "United States of America" 
United States of America 
1.1 - Training Certification Summary: 
 

Note: The dates in this section are intentionally blank as we move toward digitizing the IRB 
training records.  In the future the fields will be populated with real data. 
1. 
Training Certifications for all Study Team Members engaged in research 
Person 
Rebecca Simmons  
Dominick Shattuck 
Elizabeth Menstell 
Victoria Jennings  
 
2. 
Training Certifications for additional team members listed on grant: 
Last Name 
First Name 
Dept. Title Certification Date 
IRB Renewal Deadline 
There are no items to display 
 
 
 
1.3 - Is the Study Human Subject Research? 
1.
* Is the activity a systematic investigation designed to develop or contribute to 
generalizable knowledge? In other words, do you intend to publish or 
otherwise share the results outside the institution?  
 
Yes 
No 
 
2.
* Does the research involve obtaining information about living individuals? 
 
Yes 
No 
 
3.
* Does the research involve intervention or interaction with the individuals? 
 
Yes 
No 
 
4.
Is this activity an individual use of a Humanitarian Use Device (HUD)? 
 
Yes 
No 
Help 
Information on 
HUD  
1.5 - Type of Review 
 
Please select the review type that you are seeking.  
If you believe that your research is eligible for either Expedited or Exempt Review, you may 
select it below.  Otherwise you should apply for Full Board Review.   
 
Expedited Review 
Research activities that (1) present no more than minimal risk to human subjects and (2) involve 
only procedures listed in one or more of the categories (link) may be reviewed by the IRB 
through the expedited review procedure. Minimal risk means that the risks of harm anticipated in 
the proposed research are not greater, considering probability and magnitude, than those 
ordinarily encountered in daily life or during the performance of routine physical or 
psychological examinations or tests. 
 
Exempt Review 
Some research involving human subjects may be exempt from IRB review. The categories (link) 
describe these exemptions. Please note that an exemption can be invoked only if all components 

of the research fit the category as described. You might find the following decision charts 
helpful: http://www.hhs.gov/ohrp/policy/checklists/decisioncharts.html 
Full Board Review 
All research that does not meet the criteria listed above should apply for Full Board Review. 
1. 
* Please select the review type you are seeking: 
Exempt Review 
Expedited Review 
Full Board Review 
Facilitated (NCI CIRB or IRB of Record) 
Facilitated: Commercial IRB (IRB of Record) 
 
2.0 - Type of Research 
 
1. 
* Please select the research type that best describes the current study 
Biomedical 
Oncology 
Social/Behavioral 
 
 
 
2.0.1 - Status of Research 
1.* What is the status of your research? 
Other 
"Other" should be selected if: 
 
No participants have been enrolled to date 
 
Recruitment and/or enrollment of new participants or review of records/specimens 
continue; OR 

 
The study is no longer actively enrolling, but subjects are still involved in research-
related activities. (e.g., still receiving treatment, obtaining blood draws) 
"Long Term Followup" should be selected when the study is no longer enrolling and 
participants have completed research-related activities. The study remains active only for 
long-term follow-up. 
 
"Data Analysis" is intended for studies where study enrollment is permanently closed, all 
participants have completed all research-related activities, and long-term followup has been 
completed. All data collection is complete and the remaining research activities are related to 
data analysis only. 
2.1 - GHUCCTS 
 
1.
* Is this study a GHUCCTS study? 
 
Yes 
No 
GHUCCTS is the Georgetown-Howard Universities Center for Clinical and Translational 
Science. 
2.3 - Thesis or Dissertation 
 
1. 
* Is this research done for your thesis/dissertation? 
 
Yes 
No 
 
2.7 - NCI Central IRB 
 
1.
* Are you using the NCI Central IRB 
(NCI-CIRB) for this study? 
 
Yes 
No 
NCI is the National Cancer Institute at the National 
Institutes of Health (NIH) 
 
2.9 - Collaboration With Another Institution 
 
1. 
* Are you collaborating with another institution for this study? 
 
Yes 
No 
 
2.10 - IRB of Record 
 
1. 
* Is the Georgetown University IRB the IRB of Record for the study? 
 
Yes 
No 
 
 
 

Note: It is the responsibility of the Georgetown University PI to ensure that all collaborating 
sites have obtained IRB approval and that procedures are in place to ensure that approved 
protocol, informed consent documents, and adverse event reports are disseminated to all 
participating sites  You must also complete a "Determination/Notification IRB of Record for 
Human Subject Research Projects" form, which can be found on the IRB's website 
at http://ora.georgetown.edu/irb. 
 
Please inform the investigators from the collaborating sites that their local IRB should contact 
the Georgetown University IRB directly to discuss institutional agreements. 
 
3.0 - Funding 
 
1.
* Is the project being sponsored or funded by GHUCCTS? 
 
Yes 
No 
2.
*  
Does the project utilize GHUCCTS services or facilities? 
(for example study is conducted on the Clinical Research Unit 
(CRU) http://cru.gumc.georgetown.edu/) 
 
Yes 
No 
3.
* Please select the source(s) of funding for your project: 
No Funding 
PI's internal department funds and/or unrestricted 
University (discretionary) funds 
Industry/Commercial Sponsor 
Cooperative Group 
Federal, non-NIH 
Federal, NIH 
Local/State Government 
Foundation/Non-Profit 

Other external support (for example, PI initiated or other) 
3.6 - Funding - Federal Non-NIH 
You selected: 
Federal Non-NIH funding. 
1. * Please select the funding mechanism: 
Other 
 
2. If you selected "Other", please specify: 
United States Agency for International Development 
 
3. * Has the grant been awarded, or is the award pending? 
Awarded 
 
4. * Is Georgetown University (GU) the primary awardee institution? 
GU is the primary awardee institution 
 
3.11 - Funding - Grant and PI Information 
You selected: 
GU is the primary awardee institution 
1.
* Is the PI on the grant the same as the PI of the study? 
 
Yes 
No 
2.
* Is the title of the grant the same as the title of this human subject research application? 
 
Yes 
No 
3.* Please provide the identifying grant number: 
GR409775 
4.
* Please attach a copy of the entire grant proposal (excluding appendices) AND the Grants & 
Contracts Transmittal Form submitted to the Office of Sponsored Research, if 
available. Please remove salary information, SSNs, and DOBs. 
Name 
Version 
FACT Project budget TRACS (2).pdf | History 
0.01 
FACT Project fully executed mod (2).pdf | History 
0.01 
Georgetown University - FACT Cooperative Agreement fully executed 
(2).pdf | History 
0.01 
IRH Budget Justification FINAL.docx | History 
0.01 
IRH USAID - 5 yr Breakdown Budget 6-12-13 FINAL. (3).pdf | History 
0.01 
Note: The IRB is required by the Federal Office of Human Research Protection (OHRP) to 
review the grant proposal and human research application for consistency. You may be asked 
to explain discrepancies, if any, identified by the IRB during the review process. 
See http://www.hhs.gov/ohrp/humansubjects/guidance/aplrev.htm for more information about 
IRB responsibilities regarding grant review. 

3.13 - Funding - Grant Title Detail 
You indicated that the title of the grant is different from the title of this human subject research 
application. 
1. * Please specify the title of the grant: 
FACT: Fertility Awareness for Community Transformations Project 
 
 
 
 
 
4.0 - Conflict of Interest 
 
Each “investigator” must submit a Georgetown University Study Specific Disclosure Form 
(SSDF) as part of this protocol application. “Investigator” includes the principal investigator and 
any other person who is responsible for the design, conduct, or reporting of research. 
The SSDF can be submitted from the study workspace. Financial interests related to the research 
must be disclosed in the consent form; you will receive guidance on what needs to be disclosed 
and how you should proceed from the Office of Regulatory Affairs via the IRB office.  The 
institution will also determine if a conflict management plan is appropriate to address an 
investigator's related financial interests. 
Questions about the Georgetown University Study Specific Disclosure Form can be directed to 
the Office of Regulatory Affairs at (202) 687-3354 or amc461@georgetown.edu. 
 
Guidance for Conflicts Disclosure in Publications and Presentations 
Financial and/or Intellectual property interests (e.g. patents or patent applications) must be 
disclosed in all related consent forms, press releases, publications, and presentations. 
 
6.15 - Data Repositories 
 
1.
* Does this study include a data repository? 
 
Yes 
No 
Note: The collection and storage of specimens/data becomes a research repository when there 
is a specific intention for the data/specimens to be used repeatedly for research purposes, or 
stored for future research and/or shared with other investigators. 
2.
If you answered yes to #1, are family members being asked to provide data? 
 
Yes 
No 
3.
If you answered yes to #1, please specify what resources are needed to maintain this data 
repository: 
Ensuring the security and confidentiality of the research data collect is paramount. Research 
data entered into the DOT app will be transmitted and stored in an encrypted fashion and be 
inaccessible to outside networks. Once data is entered into the DOT application, it will be 
transmitted over a Transport Layer Security (TLS) encrypted connection to the projects 

Research Web Portal application. 
The Research Web Portal consists of a web application and database. The web application will 
be the user facing interface for research participants, call center staff and IRH research staff. 
Each will have a separate and role specific interface. Research participants will have access to 
study and general health information. Call center staff will be able to interact with research 
participants on an as needed basis. Call center staff will have read only access to specific and 
limited participant data in order to carry out elements of the research protocol. Authorized 
IRH research staff will be able to view built-in reports and pull down data sets as necessary. 
The research database will be setup on a separate dedicated server and isolated from the public 
Internet. Data stored on in the research database will be encrypted at the cell level. Direct 
access to the research database will be restricted to authorized IRH and HITLAB staff. 
Access to the Research Web Portal and DOT application transactions will be logged and 
monitored for unusual activity, unauthorized access attempts and to support compliance 
requirements (e.g. HIPAA). 
All data security measures will be pre-tested prior to implementation, both to ensure feasibility 
and to test security features. 
10.0 - Information for Protocol Review - Study Description 
 
Please summarize the protocol according to the following: 
1. 
* Purpose of project (one or two sentences): 
The purpose of this study is to determine the efficacy and effectiveness of the mobile app 
Dot. The use of mobile phones for family planning is novel, and women’s ability to 
understand and use the app is unknown. Thus, the study will also explore usability and assess 
acceptability of a mobile phone app to support use of this family planning method based on 
fertility awareness. 
2. 
* Which methods will this study include? 
Qualitative Social Science 
Survey Research 
3. 
* Study design (for example, hypothesis, research questions, standard and experimental 
procedures/drugs/devices or equipment, etc.): 
The primary objective of this study is to determine the efficacy/effectiveness of the DOT 
algorithm under two conditions: 1) correct (or perfect) use, when a woman does not have 
unprotected intercourse on days identified as fertile; and 2) typical use, when a woman has 
occasional unprotected intercourse on days identified as fertile. We hypothesize that: 
Hypothesis 1: For correct use DOT will have a failure rate <3 (no more than 3 pregnancies 
per 100 woman years of correct use), and; 
Hypothesis 2: For typical use DOT will have a failure rate <12 (no more than 12 pregnancies 
per 100 woman years of typical use) 
Hypothesis 1 is based on calculations described in the following abstract submitted for 
publication: Personalized Estimation of a Woman’s Most Fertile Days 
Li, Heyer, Jennings, Smith, & Dunson 

Abstract 
Objective: To propose a new personalized approach of estimating a woman’s most fertile 
days that only requires recording the first day of menses and can leverage the capabilities of 
smartphone applications to convey this information to a user so she can plan or prevent 
pregnancy. 
Methods: We performed a retrospective analysis of two prospective cohort studies (one 
North Carolina based Study and the Early Pregnancy Study [EPS]) and a prospective 
multicenter trial (World Health Organization [WHO] study). One North Carolina study 
consisted of 68 sexually active women with either an intrauterine device or tubal ligation. 
The second North Carolina study comprised 221 women who planned to become pregnant by 
discontinuing any use of birth control and had no known fertility problems. The WHO study 
consisted of 706 women from five geographically and culturally diverse settings. Bayesian 
statistical methods were used to design our proposed method (DOT), and simulation studies 
were used to estimate the cumulative pregnancy risk. 
Results: For one method of flagging days, simulation analyses indicate a 4.4% cumulative 
probability of pregnancy over 13 cycles with correct use. After a calibration window, this 
method flags between 11 and 13 days where unprotected intercourse should be avoided per 
cycle. Eligible women should have cycle lengths between 20-40 days and a range less than or 
equal to 9 days. 
Conclusions: DOT can be easily implemented by computer or smart phone apps, allowing for 
women to make more informed decisions about their fertility. This approach is already 
incorporated into a patent-pending system and is available for free download on iPhones and 
Androids.) 
Hypothesis 2 is based on previous studies calculated by IRH on a similar method of family 
planning, the Standard Days 
Method (Arevalo, Jennigs, & Sainai, 2002, Efficacy of a new method of family planning: the 
Standard Days Method) 
Research Questions 
The research questions associated with each study objective are described below. 
Objectives Research Questions 
Primary objective: To determine the efficacy/effectiveness of the DOT algorithm under 
correct use. 
• What is the efficacy/failure rate of DOT when used correctly (no unprotected intercourse on 
days identified as fertile)? 
• What is the difference in efficacy/failure rate of DOT with no reported intercourse on days 
identified as fertile compared to protected intercourse on those days? 
• On what days of their cycle (with what percentage risk as calculated by DOT) did women 
who became pregnant report having intercourse? 
Primary objective: To determine the efficacy/effectiveness of the DOT algorithm under 
typical use. 
• What is the effectiveness/failure rate of DOT with typical use (unprotected intercourse on 

days identified as fertile, misunderstanding of fertile days or disregarding risk)? 
Secondary objective: Describe the profile of DOT users. 
• What are the demographic characteristics of DOT users (age, parity, marital status, etc.)? 
• What method(s) were they using prior to choosing DOT (ever, immediately before)? 
• How do women find out about Dot? 
• Why do they choose to use it? 
• What percent of women use Dot correctly in all of their cycles (correctly understand app 
information about fertile days, avoid unprotected intercourse on all fertile days)? 
Secondary objective: Describe how DOT is being used. 
• In what percent of cycles is DOT used correctly? 
• In what percent of cycles is there no reported intercourse on fertile days? 
• When are users engaging in unprotected intercourse on fertile days? (i.e., are they more 
likely to do this in the first few cycles when the window is longer and/or before they become 
accustomed to it? 
• In what percent of cycles, and on what percent of days, is there condom use on fertile days? 
EC use? 
• What strategies do women use to avoid having unprotected intercourse on fertile days? 
• What percentage of women chose to IGNORE a cycle? If so, why did they IGNORE it? 
(Note: Dot has an “ignore” option for women who have a cycle that is “unusual” for them. It 
allows the woman to tell Dot to ignore that cycle for purposes of calculating her fertile days. 
The explanation is that something unusual happened during that cycle, such as EC use, a 
pregnancy loss, serious illness, etc.) Note, that IGNORED cycles are still included in 
efficacy/effectiveness calculations. 
Secondary objective: Understand reasons for discontinuation of DOT. 
• Why do women stop using DOT for pregnancy prevention? 
• What do women who stop using DOT and want to avoid pregnancy do to prevent 
pregnancy? 
• What is the profile of women who discontinue use of the method? 
Secondary objective: Determine user understanding of DOT messages. 
• Do women generally understand the messaging that appears on the Dot app about high and 
low risk? 
• Do they understand messaging about when their next period is likely to start? 
• If it is determined that a woman is not a good candidate for using DOT (she has cycles 
shorter than 20 days, longer than 40 days or highly variable), does she understand that she 
should not use DOT for pregnancy prevention? 
Secondary objective: Describe user feedback on using DOT interface and method. 
• How can DOT be improved (e.g., identified fertile time reduced, efficacy increased)? 
• Do women experience any technical problems in using Dot? What are the problems? 
• What specific pages do women most utilize (e.g., profile page, FAQ’s, other) within the 
app? What information do they report is most helpful? 

Study related data will come from four sources: 
• Information provided through women’s interaction with and regular use of the app 
- Period start date 
- How each day is flagged in terms of probability of pregnancy (high/low) 
- Distribution of daily probability of pregnancy 
• Information entered by an individual woman via the research module of the app 
- Daily intercourse information, protected/unprotected 
- Period start dates 
- Responses to periodic questions/self-administered questionnaires transmitted by the app 
• Information provided by women during interviews (with an interviewer trained by IRH and 
based in a carefully-selected health-focused call center), consisting of 
- Verbal consent obtained and noted in participant file 
- Enrollment interview (responses to screening questions, additional demographic data) 
- Phone interview following the first cycle of study participation (confirming continued intent 
to avoid pregnancy and to use Dot, perceptions of Dot) 
- Exit interview (assessing reason for exit, e.g., completed study, pregnancy, not eligible to 
use DOT, preference for another method) 
• Pregnancy information (women who state that they are- or believe that they are- pregnant 
during the study will be sent a pregnancy test kit and asked to provide a photo of a positive or 
negative pregnancy test result) 
We will use a prospective, non-randomized, non-controlled design to test the 
efficacy/effectiveness of DOT among culturally diverse populations in the United States, 
with the intention of utilizing study findings to assess the introduction, use, and effect of Dot 
in a variety of additional countries, pending study findings. We proposed this approach 
because there is no app currently available to which Dot can reasonably be compared. 
Women using the CycleBeads app, for example, should meet certain cycle length and 
variability criteria, a limitation Dot is designed to address. Women who use apps requiring 
daily checking of temperatures and/or cervical secretions have opted to use an approach that 
is considerably more complex and requires much more monitoring than Dot.Therefore, a 
comparative study is not feasible. 
In designing this study, we followed the guidelines recommended by Trussell and Kost 
(1987). Data collection, participant enrollment, and pregnancy definition are all influenced 
by their recommendations. Their guidelines also affect the way we will analyze the data. We 
will apply this approach by 1) assessing both perfect and typical use, 2) using life-table 
analysis (in additional to establishing a Pearl index), and 3) observing women for up to 13 
cycles of use. The approach will need to be adapted to meet the requirements of an app-based 
fertility awareness method. As there is virtually no experience conducting an app-based 
efficacy study for a method women access on their own prior to being recruited for the study, 
we will 4) attempt to minimize loss to follow-up by engaging women over time via the app 
and through communication with a call center. We will 5) count pregnancies as reported by 
the woman, inquiring about her pregnancy status as soon as she fails to enter her period start 
date at the expected time to minimize undercounting pregnancies. Pregnancy results will be 
reported via a photo of a completed home pregnancy test kit, provided by the study to women 

who believe they are or might be pregnant. While ideally we would enter women into the 
study the day they begin using Dot, that is not possible logistically (a woman can download 
and begin using Dot on any day of her cycle by entering the day her most recent period 
started). Because she needs to enter the study at the beginning of a cycle (to ensure she is not 
pregnant prior to entering the study and to obtain a complete history of sexual intercourse 
throughout the cycle), we will recruit women when they enter their second period start date. 
4. 
* Rationale and justification for study (i.e. historical background, investigator’s personal 
experience, pertinent medical literature, etc.): 
A number of smartphone apps have been developed that help women track their menstrual 
cycle including Period Tracker, Clue, and Glow. However, most of these are limited to 
tracking and are not appropriate for pregnancy prevention. Some appear to model cycle 
lengths with a normal distribution and then estimate the day of ovulation by fixing the luteal 
phase to be 13 or 14 days, with days around ovulation identified as fertile. There are a 
number of drawbacks to such an approach. A normal model is sensitive to unusual cycle 
lengths and may be less accurate when few observations are available. There are problems 
with fixing the luteal phase as constant. Most important, this approach does not incorporate 
uncertainty inherent in estimating the day of ovulation. 
Some other apps use a symptothermal approach, collecting information about fertility signs 
(e.g., cervical secretions, basal body temperature, cervix position) and other symptoms (e.g., 
mood, abdominal pain) and state that they can be used for pregnancy prevention. These 
include Kindara, Lily, or Groove). While some women are willing to track these variables 
throughout their cycles and have access to the hardware they sometimes require, others prefer 
a simpler approach – especially for ongoing pregnancy prevention. Some symptothermal 
apps are based on proven approaches, but others do not indicate the basis of their claims. 
An exception to the issues of unclear or undisclosed algorithms, as well as the input and 
hardware requirements of some apps, is the CycleBeads® app, based on the Standard Days 
Method® (SDM) of family planning. SDM is effective for women with self-reported cycles 
of 26-32 days and flags days 8 through 19 as the days to avoid unprotected intercourse 
(Arevalo, et al, 2002). The SDM algorithm was derived from calculations of the variability of 
cycle length, timing of ovulation, and fecundability in relation to ovulation. SDM accounts 
for these factors while maximizing pregnancy prevention and minimizing the number of 
flagged days. Results of an efficacy/effectiveness study of SDM indicated a correct use 
failure rate of <5 and a typical use failure rate of <12 per 100 women/years (Arevalo, et al, 
2002). Most SDM users have relied – and continue to rely – on CycleBeads, the physical tool 
that supports correct provision and use of the method. More recently, to create an additional 
means to help women understand and use SDM, Cycle Technologies developed the 
CycleBeads app. Available worldwide to those with access to iPhones and Androids, the app 
recently has been tested in Kenya, where users reported that it was easy to download and use 
correctly. Kenya users reported a high rate of continued use (number, citation) over time. 
Additionally, data from this study found that some women who used the app were new FP 
users (Ashcroft and Shelus 2016). 
However, SDM, and thus the CycleBeads app, has certain limitations. Women eligible to use 

the method should have most menstrual cycles between 26 and 32 days long. Regardless of 
cycle variability or consistent cycle length within that range, 12 days (days 8-19) each cycle 
are considered fertile. A method that allows shorter or longer cycles and adapts to an 
individual woman’s cycle lengths and variability has the potential to increase access to and 
use of a fertility awareness method. Dot meets these criteria. 
Since its launch in August, 2015, over 130,000 women have downloaded the iPhone version 
of Dot. Marketing for Dot has been largely limited to a few targeted promotional activities 
within social media (Facebook) and buzz resulting from media articles (Buzzfeed, Digital 
Trends, Technically DC ). Women’s interactions with the app reflect consistency (monthly 
37,000 users). Daily, 1,359 users interact with the app with approximately 70% using it for 
pregnancy prevention, 10% for pregnancy planning and 20% for tracking cycles. Users are 
interacting with the app for an average of 30.4 seconds, which is enough time for a woman to 
either read her risk of pregnancy for that day, or enter a new period start date. Across the 
total number of interactions, 51% are entering a new cycle date. Currently, after four months 
of use, approximately 15% of women are continuing to use the app. Note, this statistic is very 
preliminary, as the app has only been available to users for 5 months. Within the context of 
the proposed study, several efforts, described below and in the Retention Plan, will be 
implemented to increase retention rates of users. 
We will recruit, screen, consent, enroll, admit, and follow-up with women who have 
downloaded the Android version of the app for the purpose of preventing pregnancy, entered 
their second period start date, expressed interest in the study, and meet eligibility 
requirements for using DOT (usual cycle length self-assessed as 20-40 days long with <10 
days variation, have not used hormonal contraception for at least 3 months, and, if 
breastfeeding, have had at least 3 cycles post-partum). They also will meet eligibility 
requirements for participating in the study, including age (18-39), being sexually active with 
a male partner, intent to use Dot for at least one year, have (or will install) password or 
biometric protection on their phone, and subsequently consent to participate in the study. 
Data on user behavior will be collected primarily through the Dot app. Women who choose 
to participate will use Dot via the research module, which is attached to a study-specific 
version of the app. This version will be functionally identical to the commercially available 
product, but will include an additional research module to enable data collection. This 
module will: 
• Provide the participant with additional information on the research study, 
• Prompt women to enter sexual intercourse data weekly for the prior 7 days, 
• Track continued intention to use the app for pregnancy prevention each cycle, 
• Allow the study team to track the participants’ individual data, and 
• Administer a questionnaire after cycles 4, 7, and 10. 
Additional demographic data and information about previous family planning use will be 
collected via a 15-20 minute structured interview conducted over the phone with up to 1200 
consenting participants. Data regarding participants’ experience with the app and their 
intention to continue using the app will be collected via phone interview after their first cycle 

in the study. An exit interview will be conducted with all participants when they stop using 
the app (for any reason) or when they complete 13 cycles of Dot use. 
Participants also will be given access to a website that will include information about the 
study, study progress and frequently-asked questions about the study. They will be reminded 
to seek information about the app in the Frequently-Asked-Questions section of the app 
itself. In addition, they will receive a token reimbursement for their time in the form of a gift 
card sent directly to their phones each time they complete a cycle in the study, when they are 
interviewed after their first cycle in the study, and when they complete their exit interview 
(regardless of when or why they exit). 
Rationale 
With advancements in technology, it is possible to implement more sophisticated algorithms 
while also making information about their fertility easily accessible to women. DOT uses 
Bayesian statistical methods and utilizes information from various fertility studies to identify 
potentially fertile days. Using the smartphone app, women only need to record their first day 
of menses each cycle; DOT flags days with the estimated probabilities of pregnancy above 1-
2.25% depending on the number of cycles whose start date she has entered. As more data are 
collected, DOT appropriately updates these estimates. A prospective study of the efficacy 
and effectiveness of this approach, as well as an examination of usability, satisfaction, and 
continuation, are now required. 
5. 
* Primary objective: 
The primary objective of this study is to determine the efficacy/effectiveness of the DOT 
algorithm under two conditions: 1) correct (or perfect) use, when a woman does not have 
unprotected intercourse on days identified as fertile; and 2) typical use, when a woman has 
unprotected intercourse on days identified as fertile. 
6. 
* Secondary objective: 
The secondary objectives of this study are to: 
• Describe the profile of DOT users, 
• Understand how DOT is being used, 
• Understand reasons for discontinuation of DOT, 
• Determine user understanding of DOT messages, and 
• Describe user feedback on using DOT interface and method. 
7. 
* Inclusion criteria: 
Study participants will be recruited from the pool of women who choose to download the app 
to an Android phone to prevent pregnancy, as determined when they select “prevent 
pregnancy” as their mode of use. 
To be eligible to use the app to prevent pregnancy, women must meet the following criteria: 
• Have self-reported usual cycle length between 20 and 40 days with less than 10 days 
variation in cycle length. The evidence suggests that the fertile days of women with cycle 
length within this range are more likely to be covered by the identified fertile days. The app 

notifies women with cycles outside this range that the method is not appropriate for them. 
• Have not used hormonal contraception during their 3 most recent cycles. This gives enough 
time for fertility and regular cycling to resume. 
• Breastfeeding women can be admitted into the study if they meet all other inclusion criteria, 
delivered at least 6 months ago, and have had at least 3 menstrual cycles post-partum. 
To be included in the study, participants will: 
• Have downloaded the Android app for pregnancy prevention and indicated that they are 
interested in participating in the study; 
• Meet the DOT eligibility criteria listed above; 
• Have provided contact information to learn more about the study or called the call center; 
• Be between 18 and 39 at the time of admission. As these are peak years of fertility and 
menstrual regularity, limiting participants to women in this age group will increase the 
validity of study results; 
• Be potentially at risk of pregnancy (i.e., sexually active with a male partner and not using 
any form of family planning except condoms or other barrier methods); 
• Provide informed consent to participate in the study; 
• Have, or be willing to install, a password or biometric protection on their phone to further 
ensure the confidentiality of data; and 
• Live in the U.S. 
8. 
* Exclusion criteria: 
Women who do not meet one or more of the inclusion criteria will be excluded from the 
study. 
9. 
* Describe the tasks subjects will be asked to perform: 
Monitoring intercourse information 
The Dot research module will be programmed to provide women with brief weekly questions 
(which she will receive at approximately 9:00 a.m. or at a time of her choosing) about the 
days in which they had intercourse during the previous week, and whether it was protected 
(using a barrier method) or not. Once a woman has submitted her data, she will only be able 
to edit it by contacting the call center. She will be prompted to approve the final submission 
prior to completion. 
The participant will be able to enter data for up to seven days in the past. 
- If she does not provide this information by 9:00 p.m. on the eighth day, she will receive a 
message via push notification asking her to complete DOT information for the previous 
week. If she does not respond, she will receive the same message at 10:00 p.m. 
- For the next 4 days, she will receive a message at 9:00 a.m., followed by messages at 9:00 
p.m. and 10:00 p.m., asking her to enter her data for the previous week. 
o On the fourth day, the message will be complemented with a notification reminding her to 
complete the data entry activity. If she does not complete it, she will receive a call from an 
interviewer. 
- On the fifth day the necessary intercourse data is missing, she will receive a message at 
9:00 a.m. asking her to enter it. If she doesn’t enter the missing data, a call will be placed by 
the call center staff. 

- The interviewer will attempt to reach the woman, up to three times over 3 consecutive days. 
- If the call center reaches her AND the participant is unable to enter or provide the 
information to the interviewer for the specified dates, the call center will ask the participant if 
she wants to remain in the study. 
o If the participant does not want to remain in the study, the call center will conduct the exit 
interview processes (see below). 
o If the participant wants to remain in the study, the call center will review her records to 
determine her retention. 
 If she has had missing sexual intercourse data for more than three seven-day periods, the 
interviewer will conduct the exit interview process 
OR 
 If she is missing more than two consecutive weeks of data on days flagged either fertile or 
non-fertile, the call center will conduct the exit interview process (see below) 
• If after three tries, the call center is unable to reach her, an automated exit questionnaire 
will be pushed to the participant’s phone. This questionnaire will ask: 
1. Why she has not entered data (wants to become pregnant, does not like Dot, wants to use 
another method, does not want to continue in the study, etc.) 
 If she responds that she wants to use another method, the participant will be asked which 
method (with methods listed in check boxes). 
2. The participant will receive this questionnaire until she responds for up to three days. If 
she does not respond after the third day, she will be considered lost to follow up. 
 If she responds, her responses will be captured and she will be exited from the study. 
Monitoring period start-date information 
The app routinely tells users when their next period is expected (a range of days). Women 
participating in the study will receive the standard Dot reminder via push notifications during 
the expected range of days. The following is a description of the process during each cycle. 
• Each time she enters the start date of her period, the participant will receive the “Period 
Start Date” message, which thanks her for participating in the study and reminds her to call 
the 800 number or visit the study website if she has any questions. 
• If she does not enter her period start date before or during the range of days when Dot 
calculates that it will start, she receive the “Enter Period Start Date Reminder” for the next 5 
days. This reminder asks the participant to please enter her period date as soon as it starts. 
• If she has not entered her start date by the 41st day (because DOT is appropriate for women 
with cycles between 20 and 40 days long), she will receive the “41 Day” message (See 
Attachment E) inquiring why she has not entered her start date. She will have the options of 
stating that she thinks she is having a long cycle, stating that she did not enter her period start 
date because she no longer wants to participate in the study, entering the date her period 
started, or indicating that she thinks she might be pregnant. 
If she thinks she is having a long cycle, she will be exited from the study and be advised (via 
the routine Dot pop-up shown in Attachment B) that she should use a different method 
because Dot is not appropriate for her. It will also trigger a pop-up that asks the participant if 
she is concerned about a possible pregnancy. If the participant responds yes, then the 
Pregnancy Procedures will be implemented. 

If she does not want to continue in the study, she will be exited from the study. 
Period Dates: 
- If she enters her start date and her cycle was between 20 and 40 days long, she will be 
continued in the study. 
- If the start date she enters indicates a cycle length less than 20 days or more than 40 days, 
or if it reflects 10 days or more variation in length from her previous cycle(s) in the study, 
she will be notified that Dot is not appropriate for her based on her cycle length or variability 
(see routine Dot pop-up in Attachment B), and exited from the study. 
Pregnancy Procedures 
- If she indicates on the Period Start Date form that she thinks she is pregnant, the call center 
will be notified, and an interviewer will attempt to reach her (up to five attempts). The 
interviewer will administer a questionnaire (see Attachment F, Pregnancy Questionnaire), 
asking whether and how she confirmed her pregnancy and confirming her intercourse 
history. If she had unprotected intercourse on a day flagged by Dot as fertile, she will be 
asked if she was aware that was a fertile day. 
- The interviewer will remind her that, as was explained to her when she entered the study, 
we need a photo of her pregnancy test results and that she will receive a home pregnancy test 
kit (3 tests) via express mail. Prior to recording any address or other personal information, 
the interviewer will administer a second consent form that is relevant to obtaining the 
personal information and agreeing to receive the pregnancy test (See attachment in section 
12.9). The interviewer will request the best address for mailing the test kit and a name to 
include on the package. The tests/kits will be sent, along with instructions to 1) use her phone 
to take and send a photograph of the pregnancy test results (photograph of the completed 
test) to the interviewer. Note: the camera phone will be activated through an in-app 
mechanism that will facilitate the photograph and send it without linking the woman’s 
personal information to the photograph. The photograph will be sent directly to the 
participant file on the interviewer’s screen. 2) if the results of the first test are negative or 
ambiguous, wait 5 days and use the second test. Regardless of test results, she will be 
encouraged to contact her health care provider for advice. If results are negative, she will be 
exited from the study and advised to seek another method. 
If after five attempts, the call center is unable to reach her, she will receive a questionnaire on 
her phone asking her why she has not entered data (wants to become pregnant, does not like 
Dot, wants to use another method, does not want to continue in the study, whether she is 
using/plans to use another method, and which one). She will receive this questionnaire for up 
to three days. If she does not respond, she will be considered lost to follow up. If she 
responds, her responses will be captured and she will be exited from the study. 
See the Exit section below for further information about the exit process. 
The process related to completing Cycle 1 in the study is different from the above. 
When she completes Cycle 1 in the study, she will receive a message via push notification 
asking her to call the 800 number to speak with an interviewer about her experience using 

Dot. 
- If she calls, the interviewer will ask her questions regarding her experience with Dot, the 
opinions about Dot expressed by her partner and others with whom she has discussed it, 
whether she wants to continue using it to prevent pregnancy, and whether she wants to 
continue in the study. She also will be asked about her strategies for avoiding unprotected 
intercourse on fertile days. If she does not want to continue using Dot for pregnancy 
prevention or if she does not want to continue in the study, she will be exited from the study. 
- If she does not call within 24 hours, she will continue to receive this message for another 3 
days. If she has not responded, the call center will attempt to contact her (up to three tries) to 
administer a questionnaire. 
- If the call center is unable to reach her after three attempts, she will receive a self-
administered questionnaire on her phone asking her about her experience with Dot, what she 
thinks is her partner’s opinion of Dot, whether she has discussed Dot with anyone and if so 
their opinion about it, and whether she wants to continue to use Dot and participate in the 
study. 
- Some women may not call the number, but continue providing intercourse data. Missing 
data will be noted, and the woman will continue in the study. 
- If she does not respond to the request for an interview or complete the self-administered 
questionnaire but continues to enter intercourse data, this will be flagged as “missing data” 
for this participant and she will be considered lost to follow up. 
See the Exit section below for further information about the exit process. 
Similar procedures will be followed and similar questions asked when she completes cycles 
4, 7, and 10. However, for these cycles, she will be asked these questions via a self-
administered phone questionnaire instead of an interview. 
The 13th cycle completion process is also different from other cycles. 
When she completes cycle 13, that is, when she enters the start date of her 14th period in the 
study, she will receive a pop up alert thanking her for completing the study and requesting 
that she call the 800 number within the next 24 hours. Alternatively, she can choose to have 
an interviewer call her by selecting a button. Whether she calls the interviewer or is called by 
the interviewer, her personal information will not be shared with the interviewer or the call 
center. This information will be automated and only information relevant to the purpose of 
the call (study ID number, purpose of interview, relevant interview questions) will appear on 
the interviewer’s computer screen. 
If she does not call, the call center will attempt to reach her (up to three attempts). If the 
interviewer reaches her and she is willing to be interviewed, she will be asked questions 
about her experience with Dot, her recommendations for any changes to Dot, and her plans to 
continue using it. If she does not plan to continue using it, she will be asked why (e.g., wants 
to become pregnant, wants to use another method). If she wants to use another method, she 
will be asked which one and why she prefers it. 
If the call center is not able to reach her after three attempts, she will receive a self-
administered questionnaire asking her about her future plans re pregnancy, using Dot, and 

using another method. 
If she does not respond to either the phone call or the self-administered questionnaire, she 
will be exited from the study and this will be considered “missing data” for this participant. 
10.
* Please indicate who will monitor the study and to whom the monitor will report. Describe 
the frequency of the monitoring: 
IRH 
Victoria Jennings (Primary Investigator) as the primary investigator of this study, she will be 
responsible for all study supervision, monitoring and data analysis. She will ensure that the 
study receives all ethical approvals from Georgetown University and adheres to those 
standards throughout the life of this study. 
Dominick Shattuck (co-Investigator) will conduct analyses captured through electronic data 
collection systems and interviews as described in the protocol and ensure that results are 
reviewed and validated by a secondary, trained statistician. Shattuck, in collaboration with 
the Research Assistant (TBD) will lead coordination of data tracking, training activities and 
collaboration between IRH and the entities listed below. 
TBD (Research Coordinator) IRH will hire a research coordinator to assist in the daily 
management of study activities, development of materials for training call center staff, 
training and monitoring of the call center, facilitation of data checks, and coordination of 
partner meetings and communication. 
Lizzy Menstell (Study Coordinator) will support the Research Coordinator in daily 
management of study activities, and coordination of partner meetings and communication. 
Call center 
(Key Staff TBD): A specialized health call center will be identified and engaged to 
administer informed consent, conduct enrollment, conduct phone surveys and serve as a 
helpline for study participants. The call center will be trained in data collection and research 
ethics and monitored by IRH. 
IRH will lead the training of initial call-center employees and at least one manager at the call 
center, who can then lead trainings with any additional call center employees who may work 
on the Dot study. The training will include an overview of the study, research ethics, data 
security protocols, and each of the data collection components that the call center will be 
involved in (e.g., consenting, follow-up, exit interviews). Training will include role-play 
scenarios and practice calls, to assure interviewers understand various potential scenarios. 
HITLab: 
Frank Fries is the Project Lead for HITLab. He will oversee the development of the research 
module. He and his team will ensure the functionality of the tool in accordance with the 
study protocol. During the study, they will continuously monitor and trouble-shoot the 
research module, respond to queries from IRH, and support other aspects of the study as 

needed. They will transfer data to secure servers as described elsewhere in this protocol. 
11.* Primary Study Endpoint: 
Final reports will be submitted to the funder in September 2018. 
12.* Setting in which the study will be conducted: 
The continental United States 
13.If this is a multicenter study, please select the type below: 
National 
14.* Please provide the estimated local number of subjects (including controls): 
1,200 
15.* Please provide the estimated total number of subjects (including controls): 
1,200 
16.* Please specify how long the study will be open for accrual: 
Two years and three months, June 2016 to September 2018. 
17.
* Please provide the total study duration, including subject follow-up and data analysis: 
Data collection: Two years and three months, June 2016 to September 2018. Data analysis: 
three month, September to December 2018 
18.* Please provide the estimated duration of the study procedures: 
Two years six months, June 2016 to December 2018. 
10.2 - Information for Protocol Review - Risks 
 
1. 
* Does the research involve any of these possible risks or harms to subjects? 
Collection of personal or sensitive information in surveys or interviews 
2. 
* Please describe the nature and degree of risk or harm for the items you selected above: 
There is no physical risk to participating in the study. Participants will be drawn from a pool 
of women who have voluntarily – and completely outside the study – downloaded the Dot app 
on their phones and begun using as indicated by their having entered their period start date, 
and have specified that they want to use it for pregnancy prevention. Their risk of pregnancy 
is associated with their use of Dot rather than by participating in the study. However, there is 
some risk that participants may feel uncomfortable or embarrassed when discussing certain 
topics with an interviewer, such as family planning, whether they think they might be 
pregnant, etc. And they might feel uncomfortable entering data on their phones about having 
intercourse or using a condom. Additionally, although interviewers will be trained in 
maintaining confidentiality, there is always some risk that confidentiality will be breached. 
3.
* Describe how research-related risks will be minimized.: 
Ensuring the security and confidentiality of the research data collect is paramount. Research 
data entered into the DOT research module will be transmitted and stored in an encrypted 
fashion and be inaccessible to outside networks. Once data is entered into the module, it will 
be transmitted over a Transport Layer Security (TLS) encrypted connection to the project’s 
Research Web Portal application. 
The Research Web Portal consists of a web application and database. The web application 
will be the user-facing interface for research participants, call center staff and IRH research 

staff. Each will have a separate and role-specific interface. Research participants will have 
access to study and general information. Call center staff will be able to interact with research 
participants on an as needed basis. Call center staff will have read only access to specific and 
limited participant data in order to carry out elements of the research protocol. Authorized 
IRH research staff will be able to view built-in reports and pull down data sets as necessary. 
The research database will be setup on a separate dedicated server and isolated from the 
public Internet. Data stored on in the research database will be encrypted at the cell level. 
Direct access to the research database will be restricted to authorized IRH and HITLAB staff. 
Access to the Research Web Portal and Dot application transactions will be logged and 
monitored for unusual activity, unauthorized access attempts and to support compliance 
requirements (e.g. HIPAA). 
IRH will work with the interviewers and managing agency to ensure that they meet ethical 
compliance (CITI training) and have all necessary documentation. Study training for call 
center interviewers will include several components associated with qualitative data 
collection, DOT methodologies, and trouble-shooting the Dot app. Interviewers will be legal 
U.S. residents with experience conducting these types of interviews, as per the call center 
where they work. All interviewers will be female. 
Study training will include, in addition to the study overview, methodologies and themes, 
training about conducting research with human subjects and how to deal with situations of 
stress. Research ethics will be reviewed with the call center staff. The following ethical issues 
will be emphasized: 
• How to follow study procedures to ensure the protection of information collected from 
participants; 
• Qualitative data collection procedures; 
• What is meant by confidentiality, privacy and consent (simulated phone interviews will be 
used to clarify these ethical concepts); 
• The voluntary nature of participating in the interviews; 
• The importance of assuring participants that they can discontinue the interview without 
affecting their use of Dot; 
• The importance of obtaining and confirming informed consent; 
• Referral protocols for issues such as domestic violence, STIs, or other medical matters onto 
qualified professionals. 
Should any adverse event occur, the Principal Investigator will ensure that the adverse event 
is reported to the IRB in accordance with Georgetown University policy. 
Call center data that triggers interaction between interviewers and participants will not reveal 
personal information. Participants’ phone numbers will be stored in the remote database 
(described above) and linked to the automated dialing system within the call center. 
Interviewers will not see any participant names, phone numbers or other identifying 
information (i.e.; email addresses, street addresses, etc.). Information on the interviewer’s 
screen will reveal participant identification number and purpose of the phone call. 
Additionally, the relevant data collection tools will appear on their screen to guide the 

interview. 
All data will be entered directly into an information management system and time-stamped. 
This system will be password protected in the remote server described above. Data within the 
remote server will be managed by HitLab in compliance with HIPPA and Georgetown 
University ethical data management standards. 
Predetermined data checks will be executed daily within the database programming and 
aggregate reports sent to the IRH team for review. Additionally, the database will have a de-
identified “dashboard” through which the team can run routine data checks on factors 
including enrollment and retention. HitLab Project Coordinator, Frank Fries, will have access 
to the full database. More detail is on the data management and coordination can be found in 
the Data Management Plan. 
Study recruitment will only occur for ongoing users of the Dot app who had previously 
downloaded Dot for personal use and have been using it to prevent pregnancy for at least one 
menstrual cycle. As a requirement of initially downloading the app for personal use, all users 
must agree to routine, aggregate collection of their app usage data via Cycle Technologies 
(see Dot app Privacy Policy). However, all data collected specifically for the research study 
will be collected independently of the usage data and will not be reported to Cycle 
Technologies, the mobile carrier or to Android. This will be clarified in the consent process. 
As a requirement of initially downloading the app for personal use, all users must agree to 
routine, aggregate collection of their app usage data via Cycle Technologies Additionally, app 
download history may be collected through the mobile carrier and/or Android. However, any 
and all data collected specifically for the research study will be collected independently, 
through the app, and will not be reported (or available) to Cycle Technologies, the mobile 
carrier, or Android. 
One inclusion criterion for participation in the study is the mandatory requirement that 
participants create or use a numeric password specifically to open the app and ensure 
confidentiality of their data (section 10.0.4). When creating an app password as part of their 
study onboarding process, participants will be counseled to avoid common passwords (e.g., 
“1234”) that are easily hacked. Participants will also be reminded, as part of their informed 
consent process, that although password protecting the app substantially increases their 
privacy, a minor risk still applies and should be taken into consideration when deciding to 
participate in this study. 
To address this concern, participants will be counseled in both the Informed Consent 
document and during their study onboarding to complete their data collection in a private 
location as part of the study onboarding process. 
As part of the call center training, IRH will train the call center representatives on how to 
conduct research calls on sensitive topics (e.g., reproductive/sexual history). Additionally, all 
call center representatives will complete ethical compliance training (CITI training) prior to 

the initiation of the study. Finally, all call center representatives will be female. 
As part of the informed consent process, participants will be informed that they will be asked 
to provide information on potentially sensitive issues (such as engagement in sexual 
intercourse, pregnancy status, etc). Participants who consent to providing this information 
will be counseled that, in the future, if they find they are uncomfortable answering such study 
questions, they can choose to skip those questions or withdraw from the study at any point. 
To address data entry proficiency, all participants will be provided with a short, study 
onboarding training as part of their initial interview. This interview will provide an overview 
of how/when to enter research data in the app and who to contact in the event that the 
participant encounters a problem. All participants will be encouraged to reach out in the event 
that they have concerns or problems and will be connected to the appropriate contact (Cycle 
Technologies, study PI, etc). 
10.3 - Information for Protocol Review - Data Satefy Monitoring Plan 
1.
* Please describe how research-related risks to participants will be minimized by using (1) 
procedures which are consistent with sound research design and which do not unnecessarily 
expose study participants to risk, (2) whenever appropriate, procedures already being 
performed on the study participants, and (3) other. Such procedures might include tests that 
monitor for toxicity, close monitoring procedures, etc.: 
Ensuring the security and confidentiality of the research data collect is paramount. Research 
data entered into the DOT research module will be transmitted and stored in an encrypted 
fashion and be inaccessible to outside networks. Once data is entered into the module, it will 
be transmitted over a Transport Layer Security (TLS) encrypted connection to the project’s 
Research Web Portal application. 
The Research Web Portal consists of a web application and database. The web application will 
be the user-facing interface for research participants, call center staff and IRH research staff. 
Each will have a separate and role-specific interface. Research participants will have access to 
study and general information. Call center staff will be able to interact with research 
participants on an as needed basis. Call center staff will have read only access to specific and 
limited participant data in order to carry out elements of the research protocol. Authorized 
IRH research staff will be able to view built-in reports and pull down data sets as necessary. 
The research database will be setup on a separate dedicated server and isolated from the public 
Internet. Data stored on in the research database will be encrypted at the cell level. Direct 
access to the research database will be restricted to authorized IRH and HITLAB staff. 
Access to the Research Web Portal and Dot application transactions will be logged and 
monitored for unusual activity, unauthorized access attempts and to support compliance 
requirements (e.g. HIPAA). 
IRH will work with the interviewers and managing agency to ensure that they meet ethical 
compliance (CITI training) and have all necessary documentation. Study training for call 
center interviewers will include several components associated with qualitative data 
collection, DOT methodologies, and trouble-shooting the Dot app. Interviewers will be legal 

U.S. residents with experience conducting these types of interviews, as per the call center 
where they work. All interviewers will be female. 
Study training will include, in addition to the study overview, methodologies and themes, 
training about conducting research with human subjects and how to deal with situations of 
stress. Research ethics will be reviewed with the call center staff. The following ethical issues 
will be emphasized: 
• How to follow study procedures to ensure the protection of information collected from 
participants; 
• Qualitative data collection procedures; 
• What is meant by confidentiality, privacy and consent (simulated phone interviews will be 
used to clarify these ethical concepts); 
• The voluntary nature of participating in the interviews; 
• The importance of assuring participants that they can discontinue the interview without 
affecting their use of Dot; 
• The importance of obtaining and confirming informed consent; 
• Referral protocols for issues such as domestic violence, STIs, or other medical matters onto 
qualified professionals. 
Should any adverse event occur, the Principal Investigator will ensure that the adverse event is 
reported to the IRB in accordance with Georgetown University policy. 
Call center data that triggers interaction between interviewers and participants will not reveal 
personal information. Participants’ phone numbers will be stored in the remote database 
(described above) and linked to the automated dialing system within the call center. 
Interviewers will not see any participant names, phone numbers or other identifying 
information (i.e.; email addresses, street addresses, etc.). Information on the interviewer’s 
screen will reveal participant identification number and purpose of the phone call. 
Additionally, the relevant data collection tools will appear on their screen to guide the 
interview. 
All data will be entered directly into an information management system and time-stamped. 
This system will be password protected in the remote server described above. Data within the 
remote server will be managed by HitLab in compliance with HIPPA and Georgetown 
University ethical data management standards. 
Predetermined data checks will be executed daily within the database programming and 
aggregate reports sent to the IRH team for review. Additionally, the database will have a de-
identified “dashboard” through which the team can run routine data checks on factors 
including enrollment and retention. HitLab Project Coordinator, Frank Fries, will have access 
to the full database. More detail is on the data management and coordination can be found in 
the Data Management Plan. 
Study recruitment will only occur for ongoing users of the Dot app who had previously 
downloaded Dot for personal use and have been using it to prevent pregnancy for at least one 

menstrual cycle. As a requirement of initially downloading the app for personal use, all users 
must agree to routine, aggregate collection of their app usage data via Cycle Technologies (see 
Dot app Privacy Policy). However, all data collected specifically for the research study will be 
collected independently of the usage data and will not be reported to Cycle Technologies, the 
mobile carrier or to Android. This will be clarified in the consent process. 
As a requirement of initially downloading the app for personal use, all users must agree to 
routine, aggregate collection of their app usage data via Cycle Technologies Additionally, app 
download history may be collected through the mobile carrier and/or Android. However, any 
and all data collected specifically for the research study will be collected independently, 
through the app, and will not be reported (or available) to Cycle Technologies, the mobile 
carrier, or Android. 
One inclusion criterion for participation in the study is the mandatory requirement that 
participants create or use a numeric password specifically to open the app and ensure 
confidentiality of their data (section 10.0.4). When creating an app password as part of their 
study onboarding process, participants will be counseled to avoid common passwords (e.g., 
“1234”) that are easily hacked. Participants will also be reminded, as part of their informed 
consent process, that although password protecting the app substantially increases their 
privacy, a minor risk still applies and should be taken into consideration when deciding to 
participate in this study. 
To address this concern, participants will be counseled in both the Informed Consent 
document and during their study onboarding to complete their data collection in a private 
location as part of the study onboarding process. 
As part of the call center training, IRH will train the call center representatives on how to 
conduct research calls on sensitive topics (e.g., reproductive/sexual history). Additionally, all 
call center representatives will complete ethical compliance training (CITI training) prior to 
the initiation of the study. Finally, all call center representatives will be female. 
As part of the informed consent process, participants will be informed that they will be asked 
to provide information on potentially sensitive issues (such as engagement in sexual 
intercourse, pregnancy status, etc). Participants who consent to providing this information will 
be counseled that, in the future, if they find they are uncomfortable answering such study 
questions, they can choose to skip those questions or withdraw from the study at any point. 
To address data entry proficiency, all participants will be provided with a short, study 
onboarding training as part of their initial interview. This interview will provide an overview 
of how/when to enter research data in the app and who to contact in the event that the 
participant encounters a problem. All participants will be encouraged to reach out in the event 
that they have concerns or problems and will be connected to the appropriate contact (Cycle 
Technologies, study PI, etc). 
2.* Please describe what action(s) will be taken if any of the Adverse Events listed in the 
"Risks" section occur: 

The study call center will document the adverse event and will notify the study PI immediately 
in the case of any adverse events. The study PI will notify the Georgetown University IRB. 
3.
* Please describe how risks to participants are reasonable in relation to anticipated benefits: 
There are no physical risks to participating in the study. The only possible risks are that 
women may feel uncomfortable providing data about their menstruation or sexual activity. 
Women participating in the study will not benefit directly from their participation other than 
receiving a token reimbursement for their time. However, they will be aware that they are 
contributing to the understanding and potential improvement of a family planning method that 
is available to women worldwide. 
4.
* Will there be a Data Safety Monitoring Board/Committee to review this study? 
 
Yes 
No 
[A Data Safety and Monitoring Board, an independent group of experts, will review the data 
from this research throughout the study. Patients will be told about new information from this 
or other studies that may affect their health, welfare, or willingness to stay in this study.] 
5.If there is no DSMB/DSMC, please specify who will be responsible for monitoring the study: 
The study PI is responsible for monitoring the study. 
6.
* Please describe plans for interim analysis, monitoring the study, and the safety of 
participants: 
No interim analyses are planned for the survey data. Data will be screened periodically by the 
study team to identify issues related to discontinuation. Any adverse events will be recorded 
immediately by study staff and reported to the study PI, then to the IRB. 
The only adverse event anticipated is pregnancy. Pregnancy procedures are described in the 
study documentation. 
7.
* Please describe plans for ensuring compliance with requirements regarding the reporting of 
adverse events, including plans for reporting of adverse events to the IRB, sponsor, and/or 
regulatory agencies: 
The study PI will notify the Georgetown University IRB. 
8.
* Please describe plans for retaining subjects and ensuring follow-up visits and tests: 
Follow-up will focus on two primary pieces of information: Intercourse and Period Start Date. 
Additionally, we have a retention plan described in the study documentation as an attachment. 
Monitoring intercourse information 
The Dot research module will be programmed to provide women with brief weekly questions 
(which she will receive at approximately 9:00 a.m. or at a time of her choosing) about the 
number of times they had intercourse during the previous week, and whether it was protected 
(using a barrier method) or not. Once a woman has submitted her data, she will only be able to 
edit it by contacting the call center. She will be prompted to approve the final submission prior 
to completion. Her data will initially be stored locally on her phone, and transmitted to the 
data set as soon as the participant has a wifi or cellular connection. Once transmitted, the data 
will be deleted from her phone. Intercourse data for all days when she marked as having 
intercourse will be required in order for the woman to exit the data collection procedure. 

The participant will be able to enter data for up to seven days in the past. 
- If she does not provide this information by 9:00 p.m. on the eighth day, she will receive a 
message via push notification asking her to complete DOT information for the previous week. 
If she does not respond, she will receive the same message at 10:00 p.m. 
- For the next 4 days, she will receive a message at 9:00 a.m., followed by messages at 9:00 
p.m. and 10:00 p.m., asking her to enter her data for the previous week”. 
o On the fourth day, the message will be complemented with a notification reminding her to 
complete the data entry activity. If she does not complete it, she will receive a call from an 
interviewer. 
- On the fifth day the necessary intercourse data is missing, she will receive a message at 9:00 
a.m. asking her to enter it. If she doesn’t enter the missing data, a call will be placed by the 
call center staff. 
- The interviewer will attempt to reach the woman, up to three times over 3 consecutive days. 
- If the call center reaches her AND the participant is unable to enter or provide the 
information to the interviewer for the specified dates, the call center will ask the participant if 
she wants to remain in the study. 
o If the participant does not want to remain in the study, the call center will conduct the exit 
interview processes (see below). 
o If the participant wants to remain in the study, the call center will review her records to 
determine her retention. 
 If she has had missing sexual intercourse data for more than three seven-day periods, the 
interviewer will conduct the exit interview process 
OR 
 If she is missing more than two consecutive weeks of data on days flagged either fertile or 
non-fertile, the call center will conduct the exit interview process (see below) 
• If after three tries, the call center is unable to reach her, an automated exit questionnaire will 
be pushed to the participant’s phone. This questionnaire will ask: 
1. Why she has not entered data (wants to become pregnant, does not like Dot, wants to use 
another method, does not want to continue in the study, etc.) 
 If she responds that she wants to use another method, the participant will be asked which 
method (with methods listed in check boxes). 
2. The participant will receive this questionnaire until she responds for up to three days. If she 
does not respond after the third day, she will be considered lost to follow up. 
 If she responds, her responses will be captured and she will be exited from the study. 
Monitoring period start-date information 
The app routinely tells users when their next period is expected (a range of days). Women 
participating in the study will receive the standard Dot reminder via push notifications during 
the expected range of days. The following is a description of the process during each cycle. 
• Each time she enters the start date of her period, the participant will receive the “Period Start 
Date” message, which thanks her for participating in the study and reminds her to call the 800 
number or visit the study website if she has any questions. 

• If she does not enter her period start date before or during the range of days when Dot 
calculates that it will start, she receive the “Enter Period Start Date Reminder” for the next 5 
days. This reminder asks the participant to please enter her period date as soon as it starts. 
• If she has not entered her start date by the 41st day (because DOT is appropriate for women 
with cycles between 20 and 40 days long), she will receive the “41 Day” message (See 
Attachment E) inquiring why she has not entered her start date. She will have the options of 
stating that she thinks she is having a long cycle, stating that she did not enter her period start 
date because she no longer wants to participate in the study, entering the date her period 
started, or indicating that she thinks she might be pregnant. 
If she thinks she is having a long cycle, she will be exited from the study and be advised (via 
the routine Dot pop-up shown in Attachment B) that she should use a different method 
because Dot is not appropriate for her. It will also trigger a pop-up that asks the participant if 
she is concerned about a possible pregnancy. If the participant responds yes, then the 
Pregnancy Procedures (Attachment L) will be implemented. 
If she does not want to continue in the study, she will be exited from the study. 
Period Dates: 
- If she enters her start date and her cycle was between 20 and 40 days long, she will be 
continued in the study. 
- If the start date she enters indicates a cycle length less than 20 days or more than 40 days, or 
if it reflects 10 days or more variation in length from her previous cycle(s) in the study, she 
will be notified that Dot is not appropriate for her based on her cycle length or variability (see 
routine Dot pop-up in Attachment B), and exited from the study. 
Pregnancy Procedures 
- If she indicates on the Period Start Date form that she thinks she is pregnant, the call center 
will be notified, and an interviewer will attempt to reach her (up to five attempts). The 
interviewer will administer a questionnaire (see Attachment F, Pregnancy Questionnaire), 
asking whether and how she confirmed her pregnancy and confirming her intercourse history. 
If she had unprotected intercourse on a day flagged by Dot as fertile, she will be asked if she 
was aware that was a fertile day. 
- The interviewer will remind her that, as was explained to her when she entered the study, we 
need a photo of her pregnancy test results and that she will receive a home pregnancy test kit 
(3 tests) via express mail. The interviewer will request the best address for mailing the test kit 
and a name to include on the package. The tests/kits will be sent, along with instructions to 1) 
use her phone to take and send a photograph of the pregnancy test results (photograph of the 
completed test) to the interviewer. Note: the camera phone will be activated through an in-app 
mechanism that will facilitate the photograph and send it without linking the woman’s 
personal information to the photograph. The photograph will be sent directly to the participant 
file on the interviewer’s screen. 2) if the results of the first test are negative or ambiguous, 
wait 5 days and use the second test. Regardless of test results, she will be encouraged to 
contact her health care provider for advice. If results are negative, she will be exited from the 

study and advised to seek another method. 
If after five attempts, the call center is unable to reach her, she will receive a questionnaire on 
her phone asking her why she has not entered data (wants to become pregnant, does not like 
Dot, wants to use another method, does not want to continue in the study, whether she is 
using/plans to use another method, and which one). She will receive this questionnaire for up 
to three days. If she does not respond, she will be considered lost to follow up. If she responds, 
her responses will be captured and she will be exited from the study. 
See the Exit section below for further information about the exit process. 
The process related to completing Cycle 1 in the study is different from the above. 
When she completes Cycle 1 in the study, she will receive a message via push notification 
asking her to call the 800 number to speak with an interviewer about her experience using Dot. 
- If she calls, the interviewer will ask her questions regarding her experience with Dot, the 
opinions about Dot expressed by her partner and others with whom she has discussed it, 
whether she wants to continue using it to prevent pregnancy, and whether she wants to 
continue in the study. She also will be asked about her strategies for avoiding unprotected 
intercourse on fertile days. If she does not want to continue using Dot for pregnancy 
prevention or if she does not want to continue in the study, she will be exited from the study. 
- If she does not call within 24 hours, she will continue to receive this message for another 3 
days. If she has not responded, the call center will attempt to contact her (up to three tries) to 
administer a questionnaire. 
- If the call center is unable to reach her after three attempts, she will receive a self-
administered questionnaire on her phone asking her about her experience with Dot, what she 
thinks is her partner’s opinion of Dot, whether she has discussed Dot with anyone and if so 
their opinion about it, and whether she wants to continue to use Dot and participate in the 
study. 
- Some women may not call the number, but continue providing intercourse data. Missing data 
will be noted, and the woman will continue in the study. 
- If she does not respond to the request for an interview or complete the self-administered 
questionnaire but continues to enter intercourse data, this will be flagged as “missing data” for 
this participant and she will be considered lost to follow up. 
See the Exit section below for further information about the exit process. 
Similar procedures will be followed and similar questions asked when she completes cycles 4, 
7, and 10. However, for these cycles, she will be asked these questions via a self-administered 
phone questionnaire instead of an interview. 
The 13th cycle completion process is also different from other cycles. 
When she completes cycle 13, that is, when she enters the start date of her 14th period in the 
study, she will receive a pop up alert thanking her for completing the study and requesting that 

she call the 800 number within the next 24 hours. Alternatively, she can choose to have an 
interviewer call her by selecting a button. Whether she calls the interviewer or is called by the 
interviewer, her personal information will not be shared with the interviewer or the call center. 
This information will be automated and only information relevant to the purpose of the call 
(study ID number, purpose of interview, relevant interview questions) will appear on the 
interviewer’s computer screen. 
If she does not call, the call center will attempt to reach her (up to three attempts). If the 
interviewer reaches her and she is willing to be interviewed, she will be asked questions about 
her experience with Dot, her recommendations for any changes to Dot, and her plans to 
continue using it. If she does not plan to continue using it, she will be asked why (e.g., wants 
to become pregnant, wants to use another method). If she wants to use another method, she 
will be asked which one and why she prefers it. 
If the call center is not able to reach her after three attempts, she will receive a self-
administered questionnaire asking her about her future plans re pregnancy, using Dot, and 
using another method. 
If she does not respond to either the phone call or the self-administered questionnaire, she will 
be exited from the study and this will be considered “missing data” for this participant. 
9.* Please describe the risk categorization for your protocol: 
Minimal Risk 
10.5 - Information for Protocol Review [Unanticipated Problems and Procedures for Minimizing 
Risks] 
1.
* Who is the individual primarily responsible for reporting unanticipated problems to the 
IRB (Name and Position): 
Victoria Jennings, Study PI 
2.
* Please describe what will happen to the already collected data if subjects may decide to 
withdraw/dropout before study completion. Include examples of reasons that may prompt 
subject withdrawal/dropout. 
Note: Please describe partial withdrawal and its implications in the Informed Consent 
Document as well.  
Data will be recorded and included in the analysis. This study is centered on a mobile phone 
app. Research in mobile technologies reflects a high rate of discontinuation. If we recruit the 
upper threshold of our sample size, we could see discontinuation rates around 80%. This is, in 
part, because we are looking to retain 250 women for a maximum of 13 menstrual cycles, 
providing us with the power to test contraceptive efficacy. We understand and anticipate some 
women will drop, because mobile app retention for more than 6-8 months, in general, is 
extremely low. 
Some women will discontinue from the study due to pregnancy. This is articulated in the 
documentation and study procedures. 

3.
* Please describe potential benefits, if any, to study participants and/or society as a whole. 
Include only those benefits that may result from the research. Compensation is not considered 
a benefit. 
If there are no benefits to subjects, please state so explicitly. 
There are no benefits to study participants. However, benefits to society as a whole include: 1) 
the availability of an easily accessible, low cost method of family planning that meets the 
needs of many women/couples worldwide (pending study results); and 2) because the use of 
mobile phones for family planning is novel, and women’s ability to understand and use the 
app is unknown, the study will provide evidence of usability and assess acceptability of a 
mobile phone app to support use of this family planning method based on fertility awareness. 
4.
* Please describe the alternatives to participation in this study. If the only alternative is not 
participating (for example: survey research, observational study), please state so: 
The alternative to participation in the study is not participating in the study. 
11.0 - Recruitment Techniques 
 
1.
*  
All recruitment materials must have IRB approval and be attached to this application in 
Section 14. 
Please indicate all techniques that apply: 
Recruitment Technique 
Other 
11.1 - Recruitment Techniques - Other 
 
1.
* Please describe the "other" recruitment techniques: 
Participants will be recruited into the study using a pop-up in the Dot app, described below. 
Upon entering their second period start date, a pop-up alerts users that we are conducting a 
study to learn about how well DOT helps women prevent pregnancy over time and how it can 
be improved. The alert will provide a link to a website if they want to learn more about the 
study. The alert will ask if they would like to learn more and include three choices: “Yes”, 
“Ask me later”, and “No, don’t ask me again”. If the woman clicks “yes”, she will she be 
asked to answer 6 pre-screening questions that include: her age, desire to avoid pregnancy for 
at least one year, current sexual relationship, typical cycle length, recent hormonal method 
use, and desire to be contacted by an interviewer. Women will also be provided a phone 
number and the option to call and interviewer for recruitment. 
Women who want to be asked later will receive the opening message following their entry of 
period start dates up to two more times. After the third time, they will not receive the message 
again. 
Those who respond that they are not interested will not be contacted again. 

Advertisements: 
Although women may view advertisements for the Dot app, the only information they will 
receive about the study will come through a push notification asking if they are interested in 
participating in a study. 
Participants have two options for an initial study screening; either they can call the call center 
directly, or they can schedule a time to be contacted by a call center representative. In both 
circumstances, the call center representative will thank her for her interest in the study and 
review the screening/eligibility questions with her (See attachment B). If she is eligible, the 
interviewer will then continue with the informed consent process (See attachment C). 
11.6 - Selection of Subjects 
 
1.* Please enter the age range of the subjects: 
18-39 
2.
* Please select the gender of subjects (select all that apply): 
Female 
3.
* Please describe your source of subjects: 
Recruitment and enrollment will be determined in a multiphase process for women who are 
current Dot users, elect to participate in the research, meet pre-screening criteria, meet 
screening criteria through a phone interview, and consent to participate. 
The population of eligible participants for this study is women who 1) have begun using Dot 
for pregnancy prevention; 2) entered their second period start date (i.e., have completed one 
cycle – in whole or in part – of Dot use), and 3) have indicated that their first cycle was 20-40 
days long. Waiting for the second period date ensures that women are not pregnant at the time 
of study enrollment and allows time to recruit the woman and enroll her into the study before 
her pregnancy status for that cycle is compromised. Enrolling them when they enter their 
second period start date allows us to capture a complete sexual history from the initiation of 
that cycle moving forward. Having had a first cycle between 20 and 40 days suggests that they 
are eligible to use Dot. They will be recruited into the study using a pop-up, described below. 
Upon entering their second period start date, a pop-up alerts users that we are conducting a 
study to learn about how well DOT helps women prevent pregnancy over time and how it can 
be improved. The alert will provide a link to a website if they want to learn more about the 
study. The alert will ask if they would like to learn more and include three choices: “Yes”, 
“Ask me later”, and “No, don’t ask me again”. If the woman clicks “yes”, she will she be 
asked to answer 6 pre-screening questions that include: her age, desire to avoid pregnancy for 
at least one year, current sexual relationship, typical cycle length, recent hormonal method 
use, and desire to be contacted by an interviewer. Women will also be provided a phone 
number and the option to call and interviewer for recruitment. 
Women who want to be asked later will receive the opening message up to two more times. 
After the third time, they will not receive the message again. 

Those who respond that they are not interested will not be contacted again. 
11.7 - Safeguards for Special Populations 
 
1.
* Please select the special populations involved in the study, if any, and describe what 
additional safeguards will be in place to protect these populations from coercion or undue 
influence to participate: 
  
Special 
Population 
Safeguards 
View  
Pregnant 
Women, 
Fetuses and 
Neonates 
We are not recruiting pregnant women into this study. This is a study 
of a fertility awareness family planning method, thus we anticipate 
some women (less than 30) may become pregnant. Women who do 
get pregnant will not continue in the research study and be referred to 
seek medical care. Information about the study goals and expectations 
are clear in the consent form and women can choose to use alternative 
family planning methods if they so choose. Information about other 
family planning methods and the risks entailed in using Dot are 
present within the Apps FAQs, the participant website and consent 
form.