NCT02833922

Effectiveness and Efficacy of Dynamic Optimal Timing, a Smart Phone App for Avoiding Pregnancy: an Observational Study

Perfect- and Typical-use Effectiveness of the Dot Fertility App Over 13 Cycles: Results From a Prospective Contraceptive Effectiveness Trial

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 718 (actual)
• Sponsor: Georgetown University · Academic / Other
• Sex: Female
• Age: 18 Years – 39 Years
• Healthy volunteers: Accepted

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.

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

Interventions

Type	Name	Description
BEHAVIORAL	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.

Timeline

• Start date: 2016-09-01
• Primary completion: 2019-09-30
• Completion: 2019-09-30
• First posted: 2016-07-14
• Last updated: 2020-02-17
• Results posted: 2020-02-17