We sat down with our research partners from the Institute for Reproductive Health (IRH) at Georgetown University to discuss the fundamental aspects of Dot's ongoing efficacy study. Together, we aimed to answer questions that current, as well as prospective, Dot users may have regarding the who, what, when where, why and how of the study.
Below you will see a couple of transcribed questions and answers from Leslie Heyer (CT's CEO), Dr. Victoria Jennings (Director and Principal Investigator at the IRH), Dominick Shattuck, PhD (Senior Research Officer at the IRH), and Liya Haile (Research Officer at the IRH).
Q: Why did Cycle Technologies ask an outside research group to conduct this study?
A: (Leslie H) Doing a contraceptive efficacy study is a really technical and specific capability. And it’s something that developers would have in-house. So it was important for us to partner with someone who had experience and credibility in this space.
Q: Why is it important that the Dot Fertility App undergo a contraceptive efficacy study?
A: (VJ) Dot is a new fertility awareness based method. Just like any other method of family planning (hormonal birth control, condoms, IUDs, etc.) it’s critical that Dot undergo a contraceptive efficacy study. If someone is considering using Dot or any other family planning method, they need to know how well it’s likely to work for them. And that’s what a contraceptive efficacy study can do.
Q: How were women recruited into the study (and who was determined to be eligible)?
A: (Liya H) Women using the app to prevent pregnancy received a pop message in the app asking if they were interested in participating in the Dot study. Once screened and determined eligible, women went through an informed consent process and then were enrolled into the study.
(VJ) One of the things we screened was age. We limited the study participants for our primary analysis to women between the ages of 18 and 35 because those are known to be prime ages for women to get pregnant.
Q: How is the Dot study different from a traditional contraceptive efficacy study?
A: (DS) The biggest difference between the two types of studies are that we didn’t have a face to face interaction with the participants which is what you typically have in a traditional study site. This also did give us opportunities to create new ways to assess pregnancy. And also using the mobile technology we got real-time data collection and we were able to assess activities in real-time rather than on a monthly basis. Not only did we have to take into consideration the traditional recruitment and retention issues, but we had technology involved here and a technology that people are intimately aware of, technology that sits in their pocket all day everyday.
Q: What are you looking at other than the efficacy of Dot?
A: (Liya H) I think that we’re very interested in learning what participants are doing during their fertile time. And what type of methods they are utilizing to manage these high risk days.
(VJ) But also how well did they use it? What is their perception of it? What do they think about this app? Have they discussed it with their partner? How does it affect couple communication? What kind of partner support might there be? We’re also very interested in women’s motivation to avoid pregnancy.
Q: What lessons may be applied to other digital health research?
A: (Liya H) One of the biggest lessons that we’ve learned so far is that we’ve had to be agile and develop a contingency plan throughout the study. Whether it started from the recruitment phase or implementation of the study, it’s important that we can learn from our mistakes so that things can run more smoothly in the future.
Want to hear the full discussion? Dot Efficacy Study: Q&A with the Research Team and Cycle Technologies.