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Novel male contraceptives have been in development for well over half a century, and despite a robust predicted global market for new methods, funding for research and development has been extremely limited. While the pharmaceutical industry previously supported male contraceptive research and development, industry partners are only spectators in the current space, awaiting a product that has been de-risked by the public sector before re-entering the field. Current male contraceptive development efforts are thus primarily funded by nonprofit, non-governmental, and government agencies who also act as the primary advocates for the field. Specific organizations include the International Consortium on Male Contraception, the Population Council, the Male Contraceptive Initiative, the World Health Organization, and the US National Institutes of Health. The funding provided by these public agencies, alongside their social and policy-based advocacy efforts such as market research, public education, and calls to action have kept the male contraceptive product development space afloat, resulting in a pipeline of potential products advancing towards market approval. However, as these products mature into more expensive clinical stages of development, they continue to face significant funding challenges, which many programs may not overcome. To fully realize the benefits of novel male contraceptive options, it is incumbent on philanthropic entities, impact investors, venture capital, and/or the pharmaceutical sector to provide significant and timely support for male contraceptive research and development.

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Multipurpose prevention technologies (MPTs) and male contraceptive methods are currently in development to address unique and critical needs facing the global reproductive health community. Currently, MPT products in development are exclusively female-focused due to the readily available nature and regulatory precedent offered by female contraceptive active pharmaceutical ingredients (APIs); however, the opportunity to explore codevelopment with male contraceptive methods, which are at a comparatively early stage of development, should not be overlooked. These fields face parallel challenges including research and development, commercialization, regulatory approval, and market uptake, and these parallels can inform strategic alignment between the fields. One challenge that precludes codevelopment, however, is the path to market and associated funding models for these innovative, yet underappreciated fields. Without candid review, reconsideration, prioritization, and innovation led by the donor and investment communities, product developers will have no compelling reason to consider accepting the added regulatory and fiscal burden associated with combining development streams.

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Globally, nearly half of all pregnancies are unplanned. Male contraceptives offer the potential to decrease unintended pregnancy and introduce contraceptive equity, but decades of research have yet to bring a novel product to market. New funding avenues from the philanthropic sector seek to stimulate research in male contraceptives through investments, grants, and support for trainees alongside other programs that encourage product development and ultimately commercialization. This Forum outlines the purpose of and funding opportunities provided by Male Contraceptive Initiative, a funding agency and non-profit focused on the advancement of non-hormonal, reversible contraceptive technologies for those who produce sperm.

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Efforts to develop a male contraceptive method beyond condoms and vasectomy have been on-going for nearly 70 years. During this time, there have been ebbs and modest flows of resources available to support product development, but not at a level sufficient to carry research efforts through to market. The small community of researchers that have continued to pursue the development of male contraceptives is comprised of dedicated scientists who have a great deal of knowledge and experience to offer. While collaboration has been an organic outcome of limited resources, competing research objectives and geographically diverse locations have made consistent and sustained progress challenging, particularly for those working in the earliest stages of developing nonhormonal, reversible male contraceptive methods. While the past decade has seen an increase in funding to the field, the levels are still modest when placed in the context of actual costs to bring products to market. In addition, there are challenges still to be identified given that there is no regulatory precedent for these products. These challenges present an excellent use case for the application of design-thinking or human centered design, as a means of generating novel solutions. By engaging those with deep technical expertise in the field of male contraception as well as thought leaders from other fields of practice, design-thinking offers an opportunity to identify potential strategies, including nontraditional approaches, capable of driving the product development process forward, in a faster and more efficient manner.

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OBJECTIVE: To evaluate the acceptability, information access, and potential behavioral impact of providing contraception information via text message on mobile phones to young people in Kenya. METHODS: Three methods of data collection were implemented during the 17-month pilot period for the Mobile for Reproductive Health (m4RH) program in Kenya: automatic logging of all queries to the m4RH system; demographic and behavior change questions sent via short message service protocol (SMS) to everyone who used m4RH during the pilot period; and telephone interviews with a subset of m4RH users. RESULTS: During the pilot period, 4817 unique users accessed m4RH in Kenya. Of these, 82% were 29 years of age and younger, and 36% were male. Condom and natural family-planning information was accessed most frequently, although users queried all methods. One in 5 used the m4RH system to locate nearby clinics. Respondents liked the simple language and confidentiality of receiving health information via mobile phone, and reported increased contraceptive knowledge and use after using m4RH. CONCLUSION: Providing contraception information via mobile phone is an effective strategy for reaching young people. More research is needed to learn how to link young people to youth-friendly services effectively.

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BACKGROUND: The objective of this research was to evaluate the feasibility, reach and potential behavioral impact of providing automated family planning information via mobile phones to the general public in Tanzania. STUDY DESIGN: Data from users of the Mobile for Reproductive Health (m4RH) program were collected during the 10-month pilot period. First, contraceptive methods queried by each user were electronically logged by the mobile phone system. Second, four text questions assessing gender, age, promotion point and potential family planning impact were sent to every user. RESULTS: During the pilot period, 2870 unique users accessed m4RH in Tanzania, resulting in 4813 queries about specific contraceptive methods. Among those responding to text questions, 56% were female and approximately 60% were 29 or younger years in age. A variety of changes in family planning use were mentioned after using m4RH, with reported changes consistent with where users are in their reproductive life cycle. CONCLUSIONS: Reaching younger people, women and men of reproductive age with family planning information delivered via mobile phone is recommended.

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Uterine leiomyomata (fibroids) are the leading cause of hysterectomy in the United States. Black women have a greater fibroid burden than whites, yet no study has systematically evaluated the growth of fibroids in blacks and whites. We prospectively tracked growth for 262 fibroids (size range: 1-13 cm in diameter) from 72 premenopausal participants (38 blacks and 34 whites). Fibroid volume was measured by computerized analysis of up to four MRI scans over 12 months. We used mixed effects models to identify factors that are associated with growth, and results were converted to percent change per 6 months for clinical relevance. The median growth rate was 9% (range: -89% to +138%). Seven percent of fibroids regressed (>20% shrinkage). Tumors from the same woman grew at different rates (within-woman component of variation was twice the component among women; both were significant, P < 0.001). Black and white women less than 35 years of age had similar fibroid growth rates. However, growth rates declined with age for whites but not for blacks (P = 0.05). The odds of a tumor growing more than 20% in 6 months also decreased with age for whites but not for blacks (P < 0.01). Growth rates were not influenced by tumor size, location, body mass index, or parity. We conclude that (i) spontaneous regression of fibroids occurs; (ii) fibroids from the same woman grow at different rates, despite a uniform hormonal milieu; (iii) fibroid size does not predict growth rate; and (iv) age-related differences in fibroid growth between blacks and whites may contribute to the higher symptom burden for black women.

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The National Institute of Environmental Health Sciences is establishing a DNA repository named the Environmental Polymorphisms Registry (EPR). The goal is to recruit 20,000 subjects from the greater Research Triangle Park region of North Carolina and collect a sample of each subject's DNA for genetic study. Personal information is obtained from each EPR subject and linked to their sample in coded form. Once individuals with the genotypes of interest are identified, their samples are decoded, and their names and contact information are given to scientists for follow-up studies in which genotype is important. "Recruit-by-genotype" resources such as the EPR require a transparent consent process and rigorous human subjects protection measures. Unlike the EPR, most US DNA resources are anonymous. Once scientists identify potentially significant genetic variants, they must screen new populations to find individuals with the variants of interest to study. The EPR eliminates this time consuming and expensive step. In designing the EPR, consideration was given to achieving high response rates, minimizing attrition and maximizing usefulness for future research studies. Subjects are recruited from outpatient clinics in area medical centers as well as from the general population to ascertain individuals in diverse states of health. Data are collected on race, ethnicity, gender and age, and are monitored for demographic diversity. As of November 2007, 7,788 individuals have been recruited into the EPR and their DNA samples have been used in numerous genetic studies. EPR subjects have also been solicited for several follow-up studies with high response rates (>90%). The success of the EPR based on the number of subjects recruited and genetic studies underway, suggests that it will be a model for future DNA resources.

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