WASHINGTON (April 23, 2018) — Researchers from Georgetown University’s Institute for Reproductive Health (IRH) published a new paper detailing the process of recruiting participants for year-long prospective study to measure the efficacy of an app for avoiding unintended pregnancy.
The researchers published the paper, titled “Agile Development to Improve Recruitment and Enrollment for mHealth Research: Lessons from the Dot™ Contraceptive Efficacy Study,” in the Journal for Medical Internet Research (JMIR).
“We were in completely uncharted territory when we started this study,” said Dominick Shattuck, PhD, a Senior Research Officer for IRH and corresponding author of the paper. “Apps have enormous potential across the health sector, but they’ve proved to be difficult to research, until you better understand how to use the technology.”
IRH is assessing Dot’s efficacy in avoiding unplanned pregnancies using a protocol that allows researchers to compare the results to known efficacy rates of other family planning options. To do so, researchers needed to recruit a diverse group of women who met standard criteria for an efficacy study. Participants needed to recognize that they were part of a study, provide informed consent, and understand what was being asked of them. At the same time, study staff needed to limit contact with participants that could impact the results.
Data collection in the study is facilitated by a tool called Proofmode, which IRH developed to overlay the Dot app. Proofmode allows women to enroll in the study and enter their data in the app itself.
Study staff enrolled over 700 women in the study over a six-month period. IRH implemented a series of modifications to the recruitment process, moving from a call center-based enrollment process to a chat feature and then to self-enrollment. Study findings show that participants preferred the more automated, self-guided process.
“We hope that our study can offer lessons not just to the family planning community, but to other health researchers who are interested in analyzing apps,” Shattuck said.
The Dot efficacy study is funded by a grant from U.S. Agency for International Development (USAID). Efficacy results after six cycles have been analyzed and are expected to be published in May.
Visit www.DotStudy.org for more information.
About the Institute for Reproductive Health
The Institute for Reproductive Health at Georgetown University Medical Center has more than 30 years of experience in designing and implementing evidence-based programs that address critical needs in sexual and reproductive health. The Institute’s areas of research and program implementation include family planning, adolescents, gender equality, fertility awareness, and mobilizing technology for reproductive health. The Institute is highly respected for its focus on the introduction and scale-up of sustainable approaches to family planning and fertility awareness around the world. For more information, visit www.irh.org.
Developed by Cycle Technologies, the Dot™ app is a patent-pending technology based on Dynamic Optimal Timing™. It is designed to help women understand their pregnancy risks and use this information to prevent or plan pregnancy. To learn more about the Dot Period & Fertility Tracker, visit www.DotTheApp.com