Effectiveness and Efficacy of Dynamic Optimal Timing, a Smart Phone App for Avoiding Pregnancy: an Observational Study
Condition: Desire to Avoid Pregnancy
Study type: Observational

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.
    

Intervention name(s): Women using Dot to avoid pregnancy
Intervention type(s): Behavioral
Intervention description(s): 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.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
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.