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| Name | Class |
|---|---|
| Cycle Technologies | INDUSTRY |
| EastBanc Technologies | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Women using Dot to avoid pregnancy | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 year |
| Perceived Partner Support |
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Inclusion Criteria:
Exclusion Criteria:
Women who do not meet one or more of the inclusion criteria will be excluded from the study.
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Victoria Jennings, PhD | Institute for Reproductive Health at Georgetown University | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27297611 | Background | 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. | |
| 28100441 | Background | Simmons 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Women using Dot to avoid pregnancy: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Women using Dot to avoid pregnancy: 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Count of Participants | Participants | 1 year |
|
1 year, 7 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Women using Dot to avoid pregnancy: 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Victoria Jennings | Institute for Reproductive Health | 2026871392 | Victoria.Jennings@georgetown.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 1, 2017 | Feb 12, 2020 | Prot_000.pdf |
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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.
| 1 year |
| User Acceptability of App-based, Self-reported Data Collection | 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 | 1 year |
| 30316782 | Result | Jennings 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. |
| 30880509 | Result | Jennings 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. |
| 29678802 | Derived | Shattuck 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. |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|---|
| Participants |
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| Secondary | 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. | Posted | Count of Participants | Participants | 1 year |
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| Secondary | 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. | Posted | Count of Participants | Participants | 1 year |
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| Secondary | User Acceptability of App-based, Self-reported Data Collection | Posted | Count of Participants | Participants | 1 year |
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| Secondary | 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 | Users who took the 10-month follow-up survey | Posted | Count of Participants | Participants | 1 year |
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| 0 |
| 718 |
| 0 |
| 718 |
| 0 |
| 718 |
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