Estimating six-cycle efficacy of the Dot app for pregnancy prevention.

OBJECTIVE: To assess six-cycle perfect and typical use efficacy of Dynamic Optimal Timing (Dot), an algorithm-based fertility app that identifies the fertile window of the menstrual cycle using a woman's period start date and provides guidance on when to avoid unprotected sex to prevent pregnancy. STUDY DESIGN: We are conducting a prospective efficacy study following a cohort of women using Dot for up to 13 cycles. Study enrollment and data collection are being conducted digitally within the app and include a daily coital diary, prospective pregnancy intentions and sociodemographic information. We used data from the first six cycles to calculate life-table failure rates. RESULTS: We enrolled 718 women age 18-39 years. Of the 629 women 18-35 years old, 15 women became pregnant during the first six cycles for a typical use failure rate of 3.5% [95% CI 1.7-5.2]. All pregnancies occurred with incorrect use, so we did not calculate a perfect use failure rate. CONCLUSIONS: These findings are promising and suggest that the 13-cycle results will demonstrate high efficacy of Dot. IMPLICATIONS: While final 13-cycle efficacy results are forthcoming, 6-cycle results suggest that Dot's guidance provides women with useful information for preventing pregnancy.

Conflict of Interest Addendum: Assessing the Efficacy of an App-Based Method of Family Planning: The Dot Study Protocol.

[This corrects the article DOI: 10.2196/resprot.6886.].

Implementation of CycleTel Family Advice: an SMS-based service to provide family planning and fertility awareness information in India.

BACKGROUND: CycleTel Family Advice (CFA), an SMS-based service designed to improve knowledge of fertility and family planning (FP), was delivered to over 100,000 people in India from April to August 2015. The goal of CFA was to increase knowledge on a range of reproductive health topics, e.g., the menstrual cycle, fertility, and FP, and to increase positive perceptions and use of FP. This paper focuses on the best practices and operational challenges for providing an SMS service based on the implementation experience of CFA. METHODS: The implementation process for CFA was well documented, specifically program design, commercial partnerships, formative research, design of messages, and recruitment of users. The impact of CFA on knowledge, attitudes, and behaviors was assessed through phone surveys before and after message delivery. RESULTS: Programmatic data and phone surveys resulted in several operational findings, particularly in the areas of user behavior, partnership management, and mHealth research. While there were improvements in knowledge, there were not significant changes in FP use and couple communication. CONCLUSIONS: The intervention yielded insights into designing an mHealth intervention as well as the opportunities and challenges of implementing a stand-alone SMS-based service with a broad audience. Lessons learned were that (I) SMS-based interventions, without other supporting systems, may not lead to high user engagement or behavior change; (II) partnerships with private sector technical platforms can help overcome the difficult problem of marketing and outreach, but they bring limitations to user interface and dependencies on a commercial structure; (III) collecting demographic data required to provide tailored content may be a barrier to user acquisition; and (IV) while phone surveys are useful for evaluation of mHealth interventions, reaching users is challenging and response rates are low.

Assessing the Efficacy of an App-Based Method of Family Planning: The Dot Study Protocol.

BACKGROUND: Some 222 million women worldwide have unmet needs for contraception; they want to avoid pregnancy, but are not using a contraceptive method, primarily because of concerns about side effects associated with most available methods. Expanding contraceptive options-particularly fertility awareness options that provide women with information about which days during their menstrual cycles they are likely to become pregnant if they have unprotected intercourse-has the potential to reduce unmet need. Making these methods available to women through their mobile phones can facilitate access. Indeed, many fertility awareness applications have been developed for smartphones, some of which are digital platforms for existing methods, requiring women to enter information about fertility signs such as basal body temperature and cervical secretions. Others are algorithms based on (unexplained) calculations of the fertile period of the menstrual cycle. Considering particularly this latter (largely untested) group, it is critical that these apps be subject to the same rigorous research as other contraceptive methods. Dynamic Optimal Timing, available via the Dot app as a free download for iPhone and Android devices, is one such method and the only one that has published the algorithm that forms its basis. It combines historical cycle data with a woman's own personal cycle history, continuing to accrue this information over time to identify her fertile period. While Dot has a theoretical failure rate of only 3 in 100 for preventing pregnancy with perfect use, its effectiveness in typical use has yet to be determined. OBJECTIVE: The study objective is to assess both perfect and typical use to determine the efficacy of the Dot app for pregnancy prevention. METHODS: To determine actual use efficacy, the Institute for Reproductive Health is partnering with Cycle Technologies, which developed the Dot app, to conduct a prospective efficacy trial, following 1200 women over the course of 13 menstrual cycles to assess pregnancy status over time. This paper outlines the protocol for this efficacy trial, following the Standard Protocol Items: Recommendations for Intervention Trials checklist, to provide an overview of the rationale, methodology, and analysis plan. Participants will be asked to provide daily sexual history data and periodically answer surveys administered through a call center or directly on their phone. RESULTS: Funding for the study was provided in 2013 under the United States Agency for International Development Fertility Awareness for Community Transformation project. Recruitment for the study will begin in January of 2017. The study is expected to last approximately 18 months, depending on recruitment. Findings on the study's primary outcomes are expected to be finalized by September 2018. CONCLUSIONS: Reproducibility and transparency, important aspects of all research, are particularly critical in developing new approaches to research design. This protocol outlines the first study to prospectively test both the efficacy (correct use) and effectiveness (actual use) of a pregnancy prevention app. This protocol and the processes it describes reflect the dynamic integration of mobile technologies, a call center, and Health Insurance Portability and Accountability Act-compliant study procedures. Future fertility app studies can build on our approaches to develop methodologies that can contribute to the evidence base around app-based methods of contraception. CLINICALTRIAL: ClinicalTrials.gov NCT02833922; https://clinicaltrials.gov/ct2/show/NCT02833922 (Archived be WebCite at http://www.webcitation.org/6nDkr0e76).

Personalised estimation of a woman's most fertile days.

OBJECTIVES: We propose a new, personalised approach of estimating a woman's most fertile days that only requires recording the first day of menses and can use a smartphone to convey this information to the user so that she can plan or prevent pregnancy. METHODS: We performed a retrospective analysis of two cohort studies (a North Carolina-based study and the Early Pregnancy Study [EPS]) and a prospective multicentre trial (World Health Organization [WHO] study). The North Carolina study consisted of 68 sexually active women with either an intrauterine device or tubal ligation. The EPS comprised 221 women who planned to become pregnant and had no known fertility problems. The WHO study consisted of 706 women from five geographically and culturally diverse settings. Bayesian statistical methods were used to design our proposed method, Dynamic Optimal Timing (DOT). Simulation studies were used to estimate the cumulative pregnancy risk. RESULTS: For the proposed method, simulation analyses indicated a 4.4% cumulative probability of pregnancy over 13 cycles with correct use. After a calibration window, this method flagged between 11 and 13 days when unprotected intercourse should be avoided per cycle. Eligible women should have cycle lengths between 20 and 40 days with a variability range less than or equal to 9 days. CONCLUSIONS: DOT can easily be implemented by computer or smartphone applications, allowing for women to make more informed decisions about their fertility. This approach is already incorporated into a patent-pending system and is available for free download on iPhones and Androids.