Addressing men's own specific health concerns in the context of sexual and reproductive health (SRH) remains a largely neglected topic, despite growing levels of unmet SRH needs among men and the broader benefits of engaging men in the SRH of women and others. A comprehensive policy analysis explored how men are currently addressed and characterized within 37 key global and regional SRH-focused policies. Men's own SRH was found to be a significantly neglected policy issue. Less than half (43%) of the policies provided reference to men's SRH, and only 16% purposefully outlined steps to address men's own SRH needs. This contrasted with 78% of policies addressing women's SRH. Policies rarely provided sex disaggregated data nor targets on men's SRH outcomes. The inclusion of men was typically for solely instrumental reasons—in order to improve women's SRH. Men's SRH was best addressed within language on HIV and sexuality transmitted infections (STIs), particularly for men who have sex with men. Policy coverage was poor on men's SRH needs and roles in relation to contraception, fertility, sexual dysfunction, reproductive cancers, sexual pleasure, healthy relationships. and SRH-related discrimination. Only a quarter (24%) of the policies included a focus on one or more vulnerable male sub-group, with inadequate policy attention to the specific SRH needs of older men, disabled men, men living with serious health conditions, transgender people, and heterosexual men. An absence of focus on men's distinct SRH needs, alongside that of women, limits global understanding and visibility of SRH challenges particular to men, impeding the formulation of policies, programs, and funding priorities that sufficiently address men's needs. It also reinforces SRH as a women's sole burden and entrenches gender inequalities. Health policies should prioritize men's increased access to SRH information and care and better frame SRH as a critical part of men's lives.

BACKGROUND: Vasectomy utilization has historically been very low in Bolivia, constituting just 0.1% of the contraceptive method-mix. To address one of the perceived barriers to vasectomy utilization—cost—MSI Reproductive Choices Bolivia partnered with World Vasectomy Day, No-Scalpel Vasectomy International, and Laval University in 2021 to train in-house providers, and reduced the previous cost of contracting private urologists by half. Demand for procedures during the training campaign was considerably higher than expected; although just 77 vasectomies were provided in 2019, 882 men contacted MSI Bolivia in 2021 to request appointments in the one-month campaign. METHODS: A cross-sectional survey of vasectomy clients was implemented post-procedure to capture demographic characteristics as well as to assess motivations for getting a vasectomy. RESULTS: Among the 262 vasectomy clients who completed the survey, the average age was 31, and half (50.4%) of respondents had one or two children, 3.1% had four or more, and 30.5% had none. Motivations varied by client type with most clients reporting “wanted only the number of children they had”, while higher percentages of young clients who were often without children reported the “costs of children”, “overpopulation and the environment”, and “violence and social unrest” as their top motivations. CONCLUSIONS: The results of this study and the related vasectomy campaign reflected a high unmet demand for affordable vasectomy services in Bolivia. The relatively high proportion of single and/or childless men under 30 years old in the sample may also reflect a larger societal shift in pregnancy intention among younger generations and merit further investigation. These results have implications for demand-generation strategies and pre-vasectomy counseling, and may reflect a market for reversible male contraceptive technologies still in development.

Poor mental health can negatively impact health outcomes across diverse health areas, including in the first year postpartum. Yet, the intersection of postpartum mental health and postpartum family planning (FP) is understudied. Cognitive Behavioral Therapy (CBT) is an evidence-based practice that has proven helpful for improving mental health and supporting positive behavior change across health areas, including in low-resource settings. Drawing on existing CBT tools, we created and piloted an intervention called Mothers Time, designed to be delivered in three sessions by a community health worker (CHW) to small groups of postpartum women experiencing depression or anxiety symptoms and an unmet need for FP. Our objective was to assess the feasibility and acceptability of Mothers Time in rural Amhara, Ethiopia. We recruited and trained four CHWs to deliver the intervention. We recruited 16 postpartum women experiencing mild to moderate anxiety and depressive symptoms to participate. We conducted in-depth interviews with women and CHWs before, during and after the intervention. We used a framework approach to analyze data. To assess acceptability, we analyzed data from mothers, probing to understand whether they found the intervention accessible, engaging, and relevant for the challenges they were experiencing postpartum. To assess feasibility, we explored CHWs ability to deliver the intervention and analyzed their capacity to deliver it at consistent quality. Interviews with CHWs and other health actors provided additional data on the feasibility of adding simplified CBT to CHWs' current package of services. Mothers perceived Mothers Time to be acceptable and to provide helpful tools for navigating the postpartum period. Prior to the intervention, many women felt isolated, and the group sessions supported social connection. Vignettes demonstrating simple CBT concepts engaged mothers, provoking reflection on how anxious or sad thoughts can impact behaviors that are important for informed FP use (such as care seeking, spousal communication and planning for the future) and sparked discussions on how mothers can support their own mental and physical health. Homework (explained by CHW in sessions and completed independently between sessions) helped women prioritize caring for themselves and social connection. Overall, we found that it was feasible for CHW to learn and deliver Mothers Time. CHW understood that mental health could create challenges for mothers and were able to use the simplified materials to share information about basic mental health concepts. Limited time was the biggest challenge; CHWs would benefit from additional training, and women would likely benefit from additional sessions. This research may be useful to practitioners looking to integrate mental health and postpartum FP in low-resource settings. These findings can be used as a foundation for future research and pilot interventions to support all women to meet their postpartum and FP needs, including those living with symptoms of depression and anxiety.

Depression and anxiety symptoms are associated with increased unmet need for family planning (FP) postpartum, yet solutions promoting the integration of mental health into FP service settings remain scarce. The aims of this study were to quantitatively examine the immediate and longer term effects of participation in a group-based cognitive behavioral therapy (CBT) intervention called Mothers Time on (1) symptoms of depression and anxiety, (2) the use of a modern family planning method, and (3) intermediate FP-related factors among postpartum women in Ethiopia. Building from lessons learned during a feasibility study, we implemented a cluster randomized controlled design, with structured interviews delivered before (baseline), immediately following (endline), and fourxst months after implementation of the intervention (follow-up). A total of 302 postpartum women were recruited from 10 health clusters in northwest Ethiopia. In comparison to control clusters where participants received standard of care, intervention clusters showed significantly greater reductions in symptoms for both depression and anxiety from baseline to follow-up. Modern FP use also increased significantly more in intervention clusters as compared to control clusters from baseline to follow-up. Results suggest that more holistic FP services that consider postpartum mental health can both reduce postpartum depression and anxiety and support women in fulfilling their reproductive intentions.

Background Male sterilization, or vasectomy, is 99.9% effective at preventing pregnancy with less than a 2% risk of complications. Despite the high efficacy, low risk, low cost, and gender equity benefits of vasectomy, just 2% of women reported that they and their partners relied on vasectomy as their contraceptive method globally in 2019. Health care providers can be both a facilitator and a barrier in men’s health generally, and may be in vasectomy provision as well. This study sought to describe the decision-making rationales of experienced vasectomy providers when evaluating patient candidacy in complex cases. Methods Fifteen vasectomy providers belonging to the global Vasectomy Network google group from seven countries participated in online interviews using a semi-structured in-depth interview guide. Providers were asked about their vasectomy training, their reasons for vasectomy provision, challenging cases they have faced, and approaches used to manage challenging cases. Vignettes were used to further elicit decision-making rationale. Thematic analysis was conducted using MAXQDA20. Results Provider decision-making was predicated on ensuring patients were well-informed, able to consent, and certain about their choice to have a vasectomy. Once those foundational conditions were met, providers filtered patient characteristics through their training, laws and policies, sociocultural norms, experience, and peer influence to produce a cost-benefit breakdown. Based on the cost-benefit analysis, providers determined whether to weigh autonomy or non-maleficence more heavily when determining vasectomy patient candidacy. Conclusions Despite clinical best practices that promote prioritizing patient autonomy over non-maleficence, some providers continued to weigh non-maleficence over autonomy in vasectomy patient candidacy evaluations. Non-maleficence was particularly prioritized in cases providers deemed to be at higher risk of regret. The findings of this study suggest vasectomy provider training should emphasize evidence-based best practices in shared decision-making and patient-centered care to facilitate vasectomy provision that honors patient autonomy and rights.

Background Male sterilization, or vasectomy, is 99.9% effective at preventing pregnancy with less than a 2% risk of complications. Despite the high efficacy, low risk, low cost, and gender equity benefits of vasectomy, just 2% of women reported that they and their partners relied on vasectomy as their contraceptive method globally in 2019. Health care providers can be both a facilitator and a barrier in men’s health generally, and may be in vasectomy provision as well. This study sought to describe the decision-making rationales of experienced vasectomy providers when evaluating patient candidacy in complex cases. Methods Fifteen vasectomy providers belonging to the global Vasectomy Network Google Group from seven countries participated in online interviews using a semi-structured in-depth interview guide. Providers were asked about their vasectomy training, their reasons for vasectomy provision, challenging cases they have faced, and approaches used to manage challenging cases. Vignettes were used to further elicit decision-making rationale. Thematic analysis was conducted using MAXQDA20. Results Provider decision-making was predicated on ensuring patients were well-informed, able to consent, and certain about their choice to have a vasectomy. Once those foundational conditions were met, providers filtered patient characteristics through their training, laws and policies, sociocultural norms, experience, and peer influence to produce a cost-benefit breakdown. Based on the cost-benefit analysis, providers determined whether to weigh autonomy or non-maleficence more heavily when determining vasectomy patient candidacy. Conclusions Despite clinical best practices that promote prioritizing patient autonomy over non-maleficence, some providers continued to weigh non-maleficence over autonomy in vasectomy patient candidacy evaluations. Non-maleficence was particularly prioritized in cases providers deemed to be at higher risk of regret. The findings of this study suggest vasectomy provider training should emphasize evidence-based best practices in shared decision-making and patient-centered care to facilitate vasectomy provision that honors patient autonomy and rights.

Correspondence to Dr Ann Gottert; agottert@ popcouncil. org © Author(s) (or their employer(s)) 2022. Reuse permitted under CC BYNC. No commercial reuse. See rights and permissions. Published by BMJ. The COVID19 pandemic has produced a global mental health crisis whose scope and severity are becoming increasingly apparent. 2 While women and girls, men and boys, are all affected, we argue that the crisis among men warrants close attention given potential impacts on global public health, as well as the unique and gendered responses required to meet men’s needs. As researchers focused on men and masculinities, we have seen how men’s mental health and wellbeing can affect outcomes across the areas of genderbased violence (GBV), sexual and reproductive health (SRH), HIV and AIDS, and maternal and child health. Men’s mental health issues and illnesses contribute to poverty and the stress of poverty, and unhealthy coping mechanisms—especially substance abuse and violence—have cascading consequences for men themselves and the people around them. 5 These factors, in turn, cause poor SRH, family planning, maternal mental health and child nutrition. Moreover, men are less likely than women to seek help for mental health concerns, which can also be more difficult to detect. Our analysis of data from the COVID19 Trends and Impact Survey paints an alarming picture of the scale of the problem among men worldwide. Online serial crosssectional surveys were conducted with over 12 million Facebook users aged 18 years and older in 115 countries (with sampling weights applied to increase representativeness of the adult population in each country), from May 2021 to September 2021. Results showed that on average across countries, 36·8% of men reported feelings of depression (figure 1), and 33·8% reported feelings of anxiety. In addition, 43·9% and 67·5% reported worrying about food insecurity and household finances, respectively. For each indicator, prevalence was markedly higher among younger men and steadily decreased among successively older age groups. For example, 44·0% of 18–24yearold men worldwide reported feelings of anxiety, compared with 22·8% among ages 55 years and older. Prevalence also varied substantially between countries—reported feelings of depression, for instance, ranged from 18·2% in Denmark to 64·2% in Turkey (figure 1). Of note, women also experienced a high (and similar) prevalence for each indicator. The data further suggest that many men consider mental health a priority and are asking for support. Men ranked ‘How to maintain my mental health’ among the top COVID19related topics they wanted more information about (global mean 30·2%; 12·6%–46·1% across countries)—alongside COVID19 variants (37·0%) and treatment (35·9%). Recognition of the burgeoning crisis among men—and gaps in available resources—is Summary box

Policy and communication responses to COVID-19 can benefit from better understanding of people’s baseline and resulting beliefs, behaviours and norms. From July 2020 to March 2021, we fielded a global survey on these topics in 67 countries yielding over 2 million responses. This paper provides an overview of the motivation behind the survey design, details the sampling and weighting designed to make the results representative of populations of interest and presents some insights learned from the survey. Several studies have already used the survey data to analyse risk perception, attitudes towards mask wearing and other preventive behaviours, as well as trust in information sources across communities worldwide. This resource can open new areas of enquiry in public health, communication and economic policy by leveraging large-scale, rich survey datasets on beliefs, behaviours and norms during a global pandemic.

Objectives The purpose of this study was to identify predictors of COVID-19 vaccine intention among Bangladeshi adults. Methods Secondary data from the COVID-19 Beliefs, Behaviors & Norms Survey conducted by the Massachusetts Institute of Technology (MIT) and Facebook were analyzed. Data were collected from 2,669 adult Facebook users in Bangladesh and was collected between February 15 and February 28, 2021. Binomial logistic regression examined the relationship between COVID-19 vaccination intent and demographic variables, risk perception, preventive behaviors, COVID-19 knowledge, and likelihood of future actions. Results Seventy-nine percent of respondents reported intent to get the COVID-19 vaccine when it becomes available. Intent to get vaccinated was highest among females, adults aged 71-80, individuals with college or graduate-level degrees, city dwellers, and individuals who perceived that they were in excellent health. Results of the binomial logistic regression indicated that predictors of vaccination intent include age (OR = 1.39), high risk perception of COVID-19 (OR = 1.47), and intent to practice social distancing (OR = 1.22). Discussion Findings suggest that age, perceived COVID-19 risk, and non-pharmaceutical COVID-19 interventions may predict COVID-19 vaccination intent among Bangladeshi adults. Findings can be used to create targeted messaging to increase demand for and uptake of COVID-19 vaccines in Bangladesh.

Handwashing is essential for respiratory virus prevention, but uptake of handwashing in the context of the SARS-CoV-2 pandemic remains under-explored. This study examines trends in and determinants of handwashing practices for COVID-19 prevention in 10 countries in West, East, and Southern Africa. Data are derived from an online global Facebook survey assessing COVID-19 knowledge, attitudes, and practices, fielded in July (Round 1) and November 2020 (Round 2). Adults ≥18 years (N = 29,964) were asked if they practiced handwashing with soap and water in the past week to prevent COVID-19. Design-corrected F-statistics compared knowledge and practice of handwashing, at country and regional levels, between survey rounds. A country-level fixed-effects logistic regression model then identified socio-demographic and ideational correlates of handwashing at Round 2. Most participants were >30 years-old, men, post-secondary educated, and urban residents. Between survey rounds, handwashing prevalence declined significantly across regions and in each country, from a 14% decline (Δ84%–70%) in Tanzania to a 3% decline (Δ92%–89%) in South Africa. Handwashing was higher among participants aged >30 years (Adjusted Odds Ratio [aOR] = 1.25, 95% confidence interval [95%CI]: 1.15–1.35) and with post-secondary education (aOR = 1.62, 95%CI: 1.49–1.77) but lower among men (aOR = 0.71, 95%CI: 0.64–0.78). Ideational factors associated with handwashing included perceived effectiveness of handwashing (aOR = 2.17, 95%CI: 2.00–2.36), knowing someone diagnosed with COVID-19 (aOR = 1.28, 95%CI: 1.18–1.40), and perceived importance of personal action for COVID-19 prevention (aOR = 2.93; 95%CI: 2.60–3.31). Adjusting for socio-demographic and ideational factors, country-level marginal probabilities of handwashing ranged from 67% in Tanzania to 91% in South Africa in Round 2. COVID-19 prevention messages should stress the importance of handwashing, coupled with mask use and physical distancing, for mitigating respiratory disease transmission. Behaviour change communications should be sensitive to resource heterogeneities in African countries, which shape opportunities for sustainable handwashing behaviours.

In this commentary, the authors point out that there are important gender determinants to both men's and women's vulnerabilities to COVID-19, and call on the global health community to unpack and address these early in the COVID-19 pandemic response. They point to best practices and tools from two decades of engaging men in research and programming in the sexual and reproductive health field.

Nepali migration is longstanding, and increased from 2.3% of the total population in 2001 to 7.2% in 2011. The estimated 1.92 million migrants are predominantly men. Consequently, 32% of married women have husbands working abroad. Social structures are complicated as many married women live with their in-laws who typically assume decision-making power, including access to health services. This study compares access to reproductive health services, fertility awareness, and decision-making power among a sample of married women aged 15–24 years (n = 1123) with migrant husbands (n = 485), and with resident husbands (n = 638). Predictably, women with migrant husbands had significantly lower contraceptive use than other married women (9.3% vs 30.3%, respectively), and expressed a higher intention to become pregnant in the next year. Despite their intentions, women with migrant husbands scored lower on a fertility awareness index, were less likely to discuss pregnancy planning with their spouse, and less likely to describe their relationships positively. Decision-making for both groups of married women was dominated by both husbands and in-laws in different ways. Yet, across multiple normative scales, fewer women with migrant husbands felt pressure to conform to existing social norms. Married women with migrant husbands reflect a subset of women, with unique fertility issues and desires. Interventions that increase knowledge of fertility among this subset of women, promote healthy preconception behaviours. Linking women for counselling opportunities throughout the pre and postnatal periods may help improve health outcomes for mothers and children.

Objective: Dynamic Optimal Timing (Dot) is a smartphone application (app) that estimates the menstrual cycle fertile window based on the user's menstrual period start dates. Dot uses machine learning to adapt to cycles over time and informs users of 'low' and 'high' fertility days. We investigated Dot's effectiveness, calculating perfect- and typical-use failure rates. Methods: This prospective, 13 cycle observational study (ClinicalTrials.gov NCT02833922) followed 718 women who were using Dot to prevent pregnancy. Participants contributed 6616 cycles between February 2017 and October 2018, providing data on menstrual period start dates, daily sexual activity and prospective intent to prevent pregnancy. We determined pregnancy through participant-administered urine pregnancy tests and/or written or verbal confirmation. We calculated perfect- and typical-use failure rates using multi-censoring, single-decrement life-table analysis, and conducted sensitivity, attrition and survival analyses. Results: The perfect-use failure rate was calculated to be 1.0% (95% confidence interval [CI]: 0.9%, 2.9%) and the typical-use failure rate was 5.0% (95% CI: 3.4%, 6.6%) for women aged 18-39 (n = 718). Survival analyses identified no significant differences among age or racial/ethnic groups or women in different types of relationships. Attrition analyses revealed no significant sociodemographic differences, except in age, between women completing 13 cycles and those exiting the study earlier. Conclusion: Dot's effectiveness is within the range of other user-initiated contraceptive methods.

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)

Background Rigorous evidence of the effectiveness of male engagement interventions, particularly on how these interventions impact relationship power dynamics and women’s decision-making, remains limited. This study assessed the impact of the Bandebereho gender-transformative couples’ intervention on impact on multiple behavioral and health-related outcomes influenced by gender norms and power relations. Methods We conducted a multi-site randomised controlled trial in four Rwandan districts with expectant/current fathers and their partners, who were randomised to the intervention (n = 575 couples) or control group (n = 624 couples). Primary outcomes include women’s experience of physical and sexual IPV, women’s attendance and men’s accompaniment at ANC, modern contraceptive use, and partner support during pregnancy. At 21-months post-baseline, 1123 men and 1162 partners were included in intention to treat analysis. Generalized estimating equations with robust standard errors were used to fit the models. Findings The Bandebereho intervention led to substantial improvements in multiple reported outcomes. Compared to the control group, women in the intervention group reported: less past-year physical (OR 0.37, p<0.001) and sexual IPV (OR 0.34, p<0.001); and greater attendance (IRR 1.09, p<0.001) and male accompaniment at antenatal care (IRR 1.50, p<0.001); and women and men in the intervention group reported: less child physical punishment (women: OR 0.56, p = 0.001; men: OR 0.66, p = 0.005); greater modern contraceptive use (women: OR 1.53, p = 0.004; men: OR 1.65, p = 0.001); higher levels of men’s participation in childcare and household tasks (women: beta 0.39, p<0.001; men: beta 0.33, p<0.001); and less dominance of men in decision-making. Conclusions Our study strengthens the existing evidence on male engagement approaches; together with earlier studies our findings suggest that culturally adapted gender-transformative interventions with men and couples can be effective at changing deeply entrenched gender inequalities and a range of health-related behavioral outcomes. Trial registration ClinicalTrials.gov NCT02694627

Given widespread misunderstanding of pregnancy risk, awareness of one’s fertility has the potential to influence sexual and reproductive health behaviors. This mixed-methods study examined the impact of a serial radio drama in Rwanda, Impano n’Impamba, on fertility awareness and other factors related to family planning uptake by comparing listeners and non-listeners in a nationally representative household survey (n = 1477) and analyzing in-depth interviews with 32 listeners. Listeners had higher fertility awareness than non-listeners for key concepts, including the menstrual cycle, onset of fertility, and postpartum pregnancy risk. Qualitative interviews suggest discussion groups provided an invaluable opportunity to ask questions to a knowledgeable facilitator and clarify the fertility awareness information. No significant differences in modern family planning use or intention to use were found between listeners and non-listeners, but listeners reported greater supportive norms, self-efficacy, and discussion of family planning. Qualitative interviews suggest that increased discussion about family planning occurred because the drama emboldened people to talk about uncomfortable and taboo topics. Post-broadcast, listeners of Impano n’Impamba had greater fertility awareness then non-listeners and were more likely to experience intermediate outcomes related to family planning such as perception of positive family planning norms, a feeling of self-efficacy, and increased communication with others related to family planning. The study provides lessons for future interventions with the aim of increasing fertility awareness to improve sexual and reproductive health.

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. (C) 2018 The Authors. Published by Elsevier Inc.

Smartphone apps that provide women with information about their daily fertility status during their menstrual cycles can contribute to the contraceptive method mix. However, if these apps claim to help a user prevent pregnancy, they must undergo similar rigorous research required for other contraceptive methods. Georgetown University’s Institute for Reproductive Health is conducting a prospective longitudinal efficacy trial on Dot (Dynamic Optimal Timing), an algorithm-based fertility app designed to help women prevent pregnancy. The aim of this paper was to highlight decision points during the recruitment-enrollment process and the effect of modifications on enrollment numbers and demographics. Recruiting eligible research participants for a contraceptive efficacy study and enrolling an adequate number to statistically assess the effectiveness of Dot is critical. Recruiting and enrolling participants for the Dot study involved making decisions based on research and analytic data, constant process modification, and close monitoring and evaluation of the effect of these modifications. Originally, the only option for women to enroll in the study was to do so over the phone with a study representative. On noticing low enrollment numbers, we examined the 7 steps from the time a woman received the recruitment message until she completed enrollment and made modifications accordingly. In modification 1, we added call-back and voicemail procedures to increase the number of completed calls. Modification 2 involved using a chat and instant message (IM) features to facilitate study enrollment. In modification 3, the process was fully automated to allow participants to enroll in the study without the aid of study representatives. After these modifications were implemented, 719 women were enrolled in the study over a 6-month period. The majority of participants (494/719, 68.7%) were enrolled during modification 3, in which they had the option to enroll via phone, chat, or the fully automated process. Overall, 29.2% (210/719) of the participants were enrolled via a phone call, 19.9% (143/719) via chat/IM, and 50.9% (366/719) directly through the fully automated process. With respect to the demographic profile of our study sample, we found a significant statistical difference in education level across all modifications (P<.05) but not in age or race or ethnicity (P>.05). Our findings show that agile and consistent modifications to the recruitment and enrollment process were necessary to yield an appropriate sample size. An automated process resulted in significantly higher enrollment rates than one that required phone interaction with study representatives. Although there were some differences in demographic characteristics of enrollees as the process was modified, in general, our study population is diverse and reflects the overall United States population in terms of race/ethnicity, age, and education. Additional research is proposed to identify how differences in mode of enrollment and demographic characteristics may affect participants’ performance in the study. ClinicalTrials.gov NCT02833922; http://clinicaltrials.gov/ct2/show/NCT02833922 (Archived by WebCite at http://www.webcitation.org/6yj5FHrBh)