Desire to Avoid PregnancyNCT02833922
Effectiveness and Efficacy of Dynamic Optimal Timing, a Smart Phone App for Avoiding Pregnancy: an Observational Study
An observational study of Desire to Avoid Pregnancy, run by Georgetown University.
Trial summary
The purpose of this study is to assess the effectiveness and efficacy of Dynamic Optimal Timing (DOT), an app-based method of family planning that can be used via Android devices, for women who use the method to avoid pregnancy. Read more about this study
- Who is it for?
- Ages 18 to 39 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Desire to Avoid Pregnancy
- What is being tested?
- Women using Dot to avoid pregnancy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 718 participants
- Where
- No sites listed yet
- Study dates
- Sep 2016to 30 Sep 2019
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: 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.
Who may be able to join
- Have downloaded the Android app and selected to use it for pregnancy prevention and have indicated that they are interested in participating in the study;
- Have provided contact information to learn more about the study or called the call center;
- Are between 18 and 39 at the time of admission;
- Have menstrual cycles between 20-40 days at the time of enrollment
- Are sexually active with a male partner;
- Have not been pregnant or using any hormonal method of family planning within the past three months
- Are willing to install a password or biometric protection on their phone to ensure the confidentiality of their study data; and
- Live in the U.S.
Who cannot join
- Women who do not meet one or more of the inclusion criteria will be excluded from the study.
About this study
Official title: Perfect- and Typical-use Effectiveness of the Dot Fertility App Over 13 Cycles: Results From a Prospective Contraceptive Effectiveness Trial
The purpose of this study is to assess the effectiveness and efficacy of Dynamic Optimal Timing (DOT), an app-based method of family planning that can be used via Android devices, for women who use the method to avoid pregnancy.
Read the detailed description
This is a prospective, efficacy study of the Dynamic Optimal Timing (Dot), an app-based method of family planning that provides the user with information about her daily probability of pregnancy based on the length of her menstrual cycles over time. To use the app, women enter the first day of their menstrual period. Women are then provided information about their daily risk of pregnancy for that day, which they can then use to avoid having unprotected sex. The study is being conducted by the Institute for Reproductive Health (IRH) at Georgetown University.
The study will examine the relationship between women's use of the Dot method (both perfect and typical use) and their pregnancy outcomes at the end of the study. The study will also look at several additional secondary outcomes, such as perceived partner support for the method, coital frequency during the fertile time, and intention to continue using the method after study discontinuation, as well as several other variables around the acceptability of conducting an efficacy study via an app.
The study will recruit women who have already downloaded the DOT app on their Android phones. The study will only recruit women who have previously set their intent in the Dot app as "avoid pregnancy" and entered their second period start date into the app. Eligible women will be: between 18 and 39 years old, have not been pregnant or used hormonal contraception in the last 3 months, are sexually active in a relationship with a male partner, and desire to avoid pregnancy for at least one year.
Women who are consented and entered into the study will activate a "research module" within the Dot app. This module is essentially an "overlay" to the DOT app. It does not change the app itself in any way, but provides a data platform for researchers to obtain self-reported data from study participants about their daily sexual history and to collect periodic surveys from participants on topics pertaining to the study primary and secondary outcomes. Women who report pregnancy, or who fail to enter a new cycle start date within the 40-day window allowed by the Dot method, will be contacted and sent urine pregnancy tests, to confirm their pregnancy status. Participants will complete a maximum of 13 menstrual cycles (approximately 1 year) in the study.
- Conditions
- Desire to Avoid Pregnancy
- Being tested
- Women using Dot to avoid pregnancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Women using Dot to avoid pregnancyBehavioural
Women who have chosen to use Dot to prevent pregnancy will be followed for 13 cycles to assess perfect and typical use of the Dynamic Optimal Timing method.
| Study group | Role | What they receive |
|---|---|---|
| Women using Dot to avoid pregnancy | Women living in the United States, ages 18-39 who have not used hormonal birth control or been pregnant in the last three months, who are in a relationship with a male sexual partner, and who wish to use the Dot app to avoid pregnancy for at least one year. Receives: Behavioral: Women using Dot to avoid pregnancy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy Rates
Pregnancy rates during perfect and typical use of the Dynamic Optimal Timing method to avoid pregnancy in a way directly comparable to the approach used in recent family planning effectiveness studies
Measured: 1 year
Secondary outcomes (4)
Intent to Continue Using the Method at Study Completion
46.8% of women reported on their 13th cycle that they intend to keep using Dot to prevent pregnancy.
Measured: 1 year
Perceived Partner Support
687 out of 718 women completed the survey where we asked about perceived partner support. The survey was not mandatory and some women did not complete the study or exited the study prior to its administration.
Measured: 1 year
User Acceptability of App-based, Self-reported Data Collection
Measured: 1 year
User Perceived Impact of the Dot App
The Dot app has increased my awareness of the importance of knowing my fertile window, in order to prevent pregnancy
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2016 (estimated)
- Study startSep 2016
- Primary completion30 Sep 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Desire to Avoid PregnancyStudies of the same condition, open and under way.
- More trials run by Georgetown UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 718 participants (actual)
Sponsor and investigators
- Lead sponsor
- Georgetown University
- Sponsor type
- University, hospital or other
- Collaborators
- Cycle Technologies, EastBanc Technologies
- Responsible party
- Principal investigator, Victoria Jennings, PhD, Georgetown University
- Investigators
- Victoria Jennings, PhD, Principal investigator, Institute for Reproductive Health at Georgetown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02833922
- Sponsor's protocol ID
- GR409775
- Status last verified
- Feb 2020
- First submitted
- 11 Jul 2016
- Last updated
- 17 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Li D, Heyer L, Jennings VH, Smith CA, Dunson DB. Personalised estimation of a woman's most fertile days. Eur J Contracept Reprod Health Care. 2016 Aug;21(4):323-8. doi: 10.1080/13625187.2016.1196485. Epub 2016 Jun 14.
PubMed 27297611Simmons RG, Shattuck DC, Jennings VH. Assessing the Efficacy of an App-Based Method of Family Planning: The Dot Study Protocol. JMIR Res Protoc. 2017 Jan 18;6(1):e5. doi: 10.2196/resprot.6886.
PubMed 28100441Jennings VH, Haile LT, Simmons RG, Fultz HM, Shattuck D. Estimating six-cycle efficacy of the Dot app for pregnancy prevention. Contraception. 2019 Jan;99(1):52-55. doi: 10.1016/j.contraception.2018.10.002. Epub 2018 Oct 11.
PubMed 30316782Jennings V, Haile LT, Simmons RG, Spieler J, Shattuck D. Perfect- and typical-use effectiveness of the Dot fertility app over 13 cycles: results from a prospective contraceptive effectiveness trial. Eur J Contracept Reprod Health Care. 2019 Apr;24(2):148-153. doi: 10.1080/13625187.2019.1581164. Epub 2019 Mar 18.
PubMed 30880509Shattuck D, Haile LT, Simmons RG. Lessons From the Dot Contraceptive Efficacy Study: Analysis of the Use of Agile Development to Improve Recruitment and Enrollment for mHealth Research. JMIR Mhealth Uhealth. 2018 Apr 20;6(4):e99. doi: 10.2196/mhealth.9661.
PubMed 29678802
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perfect- and Typical-use Effectiveness of the Dot Fertility App Over 13 Cycles: Results From a Prospective Contraceptive Effectiveness Trial
- ClinicalTrials.gov ID
- NCT02833922
- Acronym / sponsor ID
- GR409775
- Conditions
- Desire to Avoid Pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 718 participants (actual)
- Lead sponsor
- Georgetown UniversityUniversity, hospital or other
- Collaborators
- Cycle Technologies, EastBanc Technologies
- Study start
- Sep 2016
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 14 Jul 2016 (estimated)
- Results
- Posted 17 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the effectiveness and efficacy of Dynamic Optimal Timing (DOT), an app-based method of family planning that can be used via Android devices, for women who use the method to avoid pregnancy.
Detailed description
This is a prospective, efficacy study of the Dynamic Optimal Timing (Dot), an app-based method of family planning that provides the user with information about her daily probability of pregnancy based on the length of her menstrual cycles over time. To use the app, women enter the first day of their menstrual period. Women are then provided information about their daily risk of pregnancy for that day, which they can then use to avoid having unprotected sex. The study is being conducted by the Institute for Reproductive Health (IRH) at Georgetown University.
The study will examine the relationship between women's use of the Dot method (both perfect and typical use) and their pregnancy outcomes at the end of the study. The study will also look at several additional secondary outcomes, such as perceived partner support for the method, coital frequency during the fertile time, and intention to continue using the method after study discontinuation, as well as several other variables around the acceptability of conducting an efficacy study via an app.
The study will recruit women who have already downloaded the DOT app on their Android phones. The study will only recruit women who have previously set their intent in the Dot app as "avoid pregnancy" and entered their second period start date into the app. Eligible women will be: between 18 and 39 years old, have not been pregnant or used hormonal contraception in the last 3 months, are sexually active in a relationship with a male partner, and desire to avoid pregnancy for at least one year.
Women who are consented and entered into the study will activate a "research module" within the Dot app. This module is essentially an "overlay" to the DOT app. It does not change the app itself in any way, but provides a data platform for researchers to obtain self-reported data from study participants about their daily sexual history and to collect periodic surveys from participants on topics pertaining to the study primary and secondary outcomes. Women who report pregnancy, or who fail to enter a new cycle start date within the 40-day window allowed by the Dot method, will be contacted and sent urine pregnancy tests, to confirm their pregnancy status. Participants will complete a maximum of 13 menstrual cycles (approximately 1 year) in the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women using Dot to avoid pregnancy | – | Behavioral: Women using Dot to avoid pregnancyWomen living in the United States, ages 18-39 who have not used hormonal birth control or been pregnant in the last three months, who are in a relationship with a male sexual partner, and who wish to use the Dot app to avoid pregnancy for at least one year. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 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.
Key inclusion criteria (8 listed)
- Have downloaded the Android app and selected to use it for pregnancy prevention and have indicated that they are interested in participating in the study;
- Have provided contact information to learn more about the study or called the call center;
- Are between 18 and 39 at the time of admission;
- Have menstrual cycles between 20-40 days at the time of enrollment
- Are sexually active with a male partner;
Key exclusion criteria (1 listed)
- Women who do not meet one or more of the inclusion criteria will be excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Women using Dot to avoid pregnancyWomen who have chosen to use Dot to prevent pregnancy will be followed for 13 cycles to assess perfect and typical use of the Dynamic Optimal Timing method. | Behavioural | Women using Dot to avoid pregnancy |
Primary outcome
Pregnancy Rates
Time frame: 1 year
Pregnancy rates during perfect and typical use of the Dynamic Optimal Timing method to avoid pregnancy in a way directly comparable to the approach used in recent family planning effectiveness studies
4 secondary outcomes
Intent to Continue Using the Method at Study Completion
Time frame: 1 year
Perceived Partner Support
Time frame: 1 year
User Acceptability of App-based, Self-reported Data Collection
Time frame: 1 year
User Perceived Impact of the Dot App
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 27297611Li D, Heyer L, Jennings VH, Smith CA, Dunson DB. Personalised estimation of a woman's most fertile days. Eur J Contracept Reprod Health Care. 2016 Aug;21(4):323-8. doi: 10.1080/13625187.2016.1196485. Epub 2016 Jun 14.
- Background: PubMed 28100441Simmons RG, Shattuck DC, Jennings VH. Assessing the Efficacy of an App-Based Method of Family Planning: The Dot Study Protocol. JMIR Res Protoc. 2017 Jan 18;6(1):e5. doi: 10.2196/resprot.6886.
- Results publication: PubMed 30316782Jennings VH, Haile LT, Simmons RG, Fultz HM, Shattuck D. Estimating six-cycle efficacy of the Dot app for pregnancy prevention. Contraception. 2019 Jan;99(1):52-55. doi: 10.1016/j.contraception.2018.10.002. Epub 2018 Oct 11.
- Results publication: PubMed 30880509Jennings V, Haile LT, Simmons RG, Spieler J, Shattuck D. Perfect- and typical-use effectiveness of the Dot fertility app over 13 cycles: results from a prospective contraceptive effectiveness trial. Eur J Contracept Reprod Health Care. 2019 Apr;24(2):148-153. doi: 10.1080/13625187.2019.1581164. Epub 2019 Mar 18.
- Derived from this study: PubMed 29678802Shattuck D, Haile LT, Simmons RG. Lessons From the Dot Contraceptive Efficacy Study: Analysis of the Use of Agile Development to Improve Recruitment and Enrollment for mHealth Research. JMIR Mhealth Uhealth. 2018 Apr 20;6(4):e99. doi: 10.2196/mhealth.9661.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Victoria Jennings, PhD principal investigator
Institute for Reproductive Health at Georgetown University
Questions about this trial
What is this clinical trial studying?
An observational study of Desire to Avoid Pregnancy, run by Georgetown University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pregnancy Rates (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02833922, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2020.