Marissa Chmiola

Female condoms. Photo: PATH/Patrick McKernTake a stroll through any pharmacy and you’ll see shelves stacked with male condoms of many varieties, but look for a female condom and you aren't likely to find one for sale. Though first introduced more than 20 years ago, female condoms are remain an unknown or inaccessible option for many women. But thanks to the efforts of dedicated product developers, public health professionals, and female condom advocates, that’s changing, as a slew of new female condom products are emerging and expanding the market. Today, in celebration of Global Female Condom Day, we look back at the history of the female condom and look ahead at what’s next for this female-initiated prevention tool.A game changing product with a slow start When the first female condom—known as the FC1—was introduced on the US market in 1993 by Wisconsin Pharmaceuticals (now the Female Health Company), it was hailed as a game-changer in sexual health. It checked off all the requirements for what product developers had heard women wanted—it had comparable effectiveness to male condoms, it could be inserted prior to sex allowing for less disruptive love-making, it was less physically restrictive for male partners, and most importantly, it was female-initiated. FC2 female condom. Photo: Female Health Company In spite of these advantages, the female condom never really caught on among American consumers. Many women were hesitant to try it because of its unfamiliar size and shape—it is larger than a male condom and doesn’t come neatly rolled up in a small package. Among those women who did try a female condom, many found it was difficult to insert and uncomfortable or noisy during sex. The FC1 was also many times more expensive than a male condom, which deterred some women and couples from trying it out.While the product received a tepid reception in the United States, women’s health and rights groups in middle- and low-income countries—where rates of unplanned pregnancy and STIs/HIV are alarmingly high and women may have few options to negotiate protection—saw the female condom as an important new tool to save women’s lives. Pilot introduction programs took off in countries including Brazil, Ghana, South Africa, and Zimbabwe. In response, the Female Health Company optimized the product, changing the material from polyurethane to nitrile to reduce production costs, and introduced the world to FC1’s successor—you guessed it: the FC2. In 2007, the FC2 was prequalified by the World Health Organization (WHO) making it eligible for bulk procurement. Today, the FC2 is available in 144 nations. Expanding choice in the female condom market Cupid Female Condom. Photo: Female Condom Market IntelligenceSpurred by increased advocacy to expand options for female-initiated prevention, researchers and product developers went to work on new female condom designs. In recent years, consumers have begun to see the fruits of this labor, as several new female condoms, each with different design variations, have emerged on the market. In 2012, the Cupid female condom—which uses a foam sponge on one end rather than a ring to provide stability—joined the FC2 as the second female condom to receive WHO prequalification.The female condom market is on the cusp of further diversification, as additional female condoms are awaiting WHO prequalification decision or soon to be submitted for review. Phoenurse female condom. Photo: Female Condom Market Intelligence Each of these options offers a different approach to addressing the drawbacks of the FC1. For example, the Air female condom contains an air bubble to help keep the product stable during sex, while the Phoenurse comes packaged with an insertion stick for optional use when inserting the product. The Velvet condom is similar to the FC2 design but made of natural rubber latex, while the VA w.o.w, like the Cupid, contains a sponge for internal stability, but instead has a rounded triangular outer ring to keep it secure.Another second generation female condom in early introduction is the Woman’s Condom, developed by GHTC member PATH. As a nonprofit product developer focused on user-centered design, PATH set out in the late 1990s to create a female condom that would be easy to use and comfortable for both partners. The product development team began by examining acceptability studies of existing female condoms and hosting focus groups with men and woman in several countries to better understand what users wanted from a product. Their design objectives became clear: “create a product that would be easy to handle, easy to insert, stay stable in the vagina during sex…[and] provide good sensation for both the male and female partner,” explained Maggie Kilbourne-Brook, program officer at PATH, adding “and if possible, users wanted it be more aesthetically pleasing.” The Women's Condom. Photo: PATH/Glenn Austin  PATH developed and tested more than 50 prototypes before freezing design development. To increase the ease of insertion, the Women’s Condom’ main pouch is compressed into a narrow, rounded capsule which women insert like a tampon. Within 30-60 seconds, this capsule dissolves, allowing the condom to expand within the vagina. To provide stability, four small foam pieces are used which adhere gently to the interior of the vagina. And unlike other female condoms, the Woman’s Condom is not pre-lubricated; instead it is packaged with separate lubricant users can apply following insertion.New designs under development The Origami Condom. Photo: Female Condom Market IntelligenceAs these aforementioned female condoms are introduced and vie for market share, additional female condoms are advancing through the research and development (R&D) process. Next to market will likely be the Origami Condom, which is moving into phase 2 clinical trials. The Origami female condom is quite a dramatic reimagining of the female condom. It’s a conical shaped device that is folded during insertion and expands like an accordion during sex. It’s made of a durable, flexible silicon material designed for wash and reuse. The Bill & Melinda Gates Foundation is also giving a boost to female condom development. Last year as part of its initiative to develop “next generation condoms,” the Gates Foundation announced grant funding for three early-stage female condom development projects. Researchers from Indiana University received funding to advance their “female pleasure condom” which has ribbed siding to increase stimulation and enhance sexual experience, while another grantee is developing an “air-infused female condom” that is “inflated and positioned using air pressure” to enable easier and quicker insertion. The third grant recipient is approaching the insertion challenge in an entirely different way, designing a sliding, easy to use, re-usable applicator for female condoms that works like a tampon applicator.The many challenges of female condom development and access  A woman demonstrates use of a female condom at a community meeting in Kenya. Photo: PATH/Eric Becker Studies have shown that including female condoms in condom promotion programs leads to increased levels of protected sex, meaning certain men and women are using female condoms in circumstances where male condoms would have otherwise not been used. And qualitative studies have found that having female condoms available as an option can help some women negotiate condom use with their partners. “It can shift the conversation,” explains Kilbourne-Brook, “It’s not male condom or nothing—it’s male condom, female condom, or nothing.” Even though female condoms deliver improved health outcomes, they are still a challenging value proposition for global procurers who purchase over 90 percent of female condoms. While prices are expected to drop as new products come to market and production volumes increase, female condoms will always cost more because of their design. Today, at bulk procurement prices, a buyer can purchase roughly 17 male condoms for the price of one FC2 female condom. And the fact that demand is so driven by price-sensitive bulk procurers changes the nature of the market, discouraging developers and manufacturers from investing in R&D to enhance consumer-experience or spending on marketing to increase appeal. Instead, it encourages companies to focus on developing the lowest cost product possible that meets the health need.Developers hoping to bring a new female condom into the US market also face an additional hurdle. Because female condoms were a new product category at the time the FC1 underwent regulatory review, the US Food and Drug Administration (FDA) decided to regulate female condoms as Class III medical devices—a classification typically reserved for higher risk medical products (male condoms are classified as Class II devices). Because Class III devices require more data and evidence for approval, it creates a more costly and lengthy process for developers. Most other regulatory authorities classify female condoms as Class II devices, and female condom advocates are calling on the FDA to down classify female condoms to pave the way for expanded choice. The path forward  Many advocates argue that for female condoms to make the leap from niche product to a staple in the bedroom worldwide, concerted marketing, education, and awareness campaigns are needed to demystify and destigmatize female condoms and boost their consumer appeal. To build momentum, Global Female Condom Day was launched in 2012 as an international day of action focused on increasing knowledge, availability, and use of female condoms. And this year, advocates will Dance4Demand to urge policymakers, donors, and health providers to increase their support for female condoms. While the female condom may have been slow to catch on, its supporters believe it can make such a leap. After all, many people forget that male condoms were at one point stigmatized as products used only by people engaged in morally questionable activity. It took a concerted effort from public health professionals, governments, and the private sector to bring them into the mainstream and make them the ubiquitous, widely-used product they are today. If the hopes of female advocates are realized, pharmacies everywhere may soon have to make some extra room on their shelves. ReferencesHoke TH, Feldblum PJ, Van Damme K, et al. Temporal trends in sexually transmitted infection prevalence and condom use following introduction of the female condom to Madagascar sex workers. International Journal of STD and AIDS. 2007; 18(7):461–466. Latka M, Gollub E, French P, Stein Z. Male-condom and female-condom use among women after counseling in risk-reduction hierarchy for STD prevention. Sexually Transmitted Diseases. 2000;27(8):431–437. Barbosa RM, Berquo E, Kalckmann S. Acceptability of the Female Condom in Different Social Contexts: Final Research Report. Brasilia, Brazil: Ministry of Health, Secretariat for Health Policies, National STD/AIDS Coordinating Office; 2000. Artz L, Macaluso M, Brill I, et al. Effectiveness of an intervention promoting the female condom to patients at sexually transmitted disease clinics. American Journal of Public Health. 2000;90(2):237–244. Macaluso M, Demand M, Artz L, et al. Female condom use among women at high risk of sexually transmitted disease. Family Planning Perspectives. 2000;32(3):138–144. Musaba E, Morrison CS, Sunkutu MR, Wong EL. Long-term use of the female condom among couples at high risk of human immunodeficiency virus infection in Zambia. Sexually Transmitted Diseases. 1998;25(5):260–264. Gollub EL, French P, Latka M, Rogers C, Stein Z. Achieving safer sex with choice: studying a woman’s sexual risk reduction hierarchy in an STD clinic. Journal of Women’s Health & Gender-Based Medicine. 2001;10(8):771–783.

An injectable HIV and AIDS treatment that could offer HIV-positive individuals an option other than taking daily pills is entering late-stage clinical-trials. In previous studies, the drug—PRO140—was shown to be successfully in suppressing viral loads to an undetectable level for at least one month in 98 percent of patients. Most HIV-positive patients take nearly 30 antiretroviral pills every week. In some patients, these pills cause kidney and liver damage as well as resistance to further treatment. The developers of this new treatment hope PRO140 could become available in once-a-week, two-dose treatments by 2017, pending success of clinical trials. Former US Treasury Secretary Lawrence Summers and Lancet Commission member Gavin Yamey write in a Huffington Post op-ed that the development of game-changing health technologies will be critical to reaching the health goal in the Sustainable Development Goals (SDGs). They argue that reaching the SDG health targets is not possible with today’s health tools and that new medicines, vaccines, diagnostics, and other innovations will be required. To spur such innovation, they call for increased investment in global health research and development from all nations. A new observational study suggests that taking daily pills to prevent HIV infection—known as pre-exposure prophylaxis (PrEP)—is working to prevent HIV infection in the real world. Kaiser Permanente of San Francisco announced last week that none of its 657 clients receiving PrEP have become infected over a period of more than two years. When PrEP was introduced, many critics predicted that it could decrease condom use, in turn leading to more HIV infections. Advocates of PrEP say this study shows that such concerns were unwarranted, as PrEP is proving effective in nonclinical settings. CNN reports in-depth on the global spread of Dengue and efforts to control and treat the disease. While Dengue fever was once a problem only in pockets of South America and Southeast Asia, today more than 100 countries harbor risk of infection. Currently, there is no treatment or vaccine against for the disease and no effective prevention options; because the mosquitoes that carry Dengue bite during the day, bed nets that have been critical in preventing malaria are not effective for Dengue prevention. New mosquito control interventions, drugs, and vaccines are needed to tackle the disease.

Many infants have difficulty breastfeeding and must rely on cup feeding. Photo: PATH/Amy MacIver Breast milk is the perfect first food for newborns; it provides nutrients and energy that infants need and contains substances that strengthen their immune systems. Ideally, newborns are breastfed within their first hour of life with breastfeeding continuing for their first several months of life. However, some babies are not able to breastfeed—preterm babies often do not have the fine motor skills and babies born with facial anomalies like cleft palates cannot breastfeed. And in some cases, babies who are orphaned or have mothers too sick to breastfeed who must be fed with donor milk. In high-resource settings, these infants could have breast milk fed to them through feeding tubes or specially-designed bottles, but in low-resource settings these solutions are impractical and often unsafe in areas where reliable clean water is not available. Tubes must be inserted by a trained medical professional and are often not available in low-resource settings; while bottles are expensive—particularly those that adapted for use by infants with cleft palates— and difficult for mothers to keep free of bacteria due to their crevices. For infants in low-resource settings who cannot breastfeed, the World Health Organization recommends hand expression of breast milk and use of a small cup to feed newborns. Cups are easier to clean so reduce the risk of infection, and cup feeding has been shown in some studies to improve the transition of preterm infants to exclusive breastfeeding. The problem? There is no cup designed specifically for the job, and the household cups many mothers use have some serious drawbacks that can put their baby’s health at risk. A solution? A group of innovators from the University of Washington, Seattle Children’s Hospital Craniofacial Center, and PATH have invented the NIFTY™ cup—a simple-to-use, easy-to-clean, inexpensive cup designed specifically for delivering breast milk to infants. Your average cup won’t do for breastfeeding Because there is no standard cup designed for the purpose, mothers who need to cup feed typically use whatever small cups or devices they have on hand. For example, in India mothers typically use a miniature gravy-boat like device called a paladai—originally used to burn oil during religious ceremonies—that have sharp-edged metal spouts and can cause oral cuts or injuries to an infant. A young infant being cup fed with a mug in Kenya. Photo: PATH/Evelyn Hockstein In other areas of the world, mothers use coffee mugs, shot glasses, medicines cups, or whatever small cups they can find. Unfortunately, the relatively wide rims of these cups can make it difficult for a mother to maintain a consistent flow of milk to her newborn which can be problematic and even dangerous. Too much milk too fast can cause a newborn to aspirate, while too little milk can mean the baby does not get sufficient nutrition. “These infants are getting an erratic, inconsistent, sometimes too rapid flow [of milk] or not enough access to milk while they are feeding,” explained Christy McKinney, PhD, MPH, a clinical assistant professor at the University of Washington who helped design the NIFTY™ cup, “So the infants don’t get enough nutrients within the short amount of time to grow and fight infection.” During lengthy cup feedings, an infant can actually expend more energy trying to feed than it takes in, which can lead to a rapid decline in health. Another problem with standard cups is spillage. “About a third of milk is spilled at each feeding, said McKinney, “If you are trying to feed and hand expressing your breast milk, it’s a pretty painful experience to have a third of that spilled and wasted every time you are feeding, which can be 12 times a day for a newborn.” The NIFTY™ cup: a game changer for cup feeding A demonstration of feeding using the NIFTY cup. Photo: Marissa Chmiola/GHTC McKinney and her collaborators kept these drawbacks in mind as they set out to create the perfect cup for cup feeding. The NIFTY™ cup was designed with a unique reservoir that can hold a bolus of milk at its end. McKinney called this reservoir a “game changer.” It reduces spillage and allows the milk to be constantly available to the infant. McKinney explained that unlike a spout which only allows milk to be poured into an infant’s mouth, the unique reservoir of the NIFTY™ cup enables cup feeding to become a two-way street just like traditional breastfeeding or bottle feeding. “The mother is making sure that the reservoir is filled and then the infant gets to help pace the feed,” said McKinney, “That pacing results in a much calmer infant. They don’t run the risk of aspirating from too much milk poured into their mouth; instead, they can get the milk they need at the rate they want it, which allows for a calmer, integrated feeding experience between mother and infant.” The NIFTY™ cup inventors also made the cup out of silicone, which offers several advantages: The cup is soft and easy to squeeze, it prevents mouth injuries, it’s durable, and it can be boiled, which makes it easy to sterilize. Because the NIFTY™ has a reservoir that controls the flow of milk, the cup can be sized much larger than other cups used for cup feeding. This allow mothers to directly hand express the milk into the NIFTY™ cup rather than using multiple cups which in turn reduces spillage and opportunities for contamination. In addition, the NIFTY™ cup contains tracking markers on the side to monitor milk intake, it’s ergonomically designed for comfort, and it can be affordably produced at less than $1.00 per cup. In short, the NIFTY™ cup offers more advantages for mothers and infants than any other available cup. The long road to innovation For McKinney it has been over a five-year odyssey to turn the NIFTY™ cup from idea to reality. Inspired by her time as a Peace Corp volunteer in Ethiopia and having just completed her PhD studying craniofacial anomalies and beginning her new post-doctoral position, McKinney was looking for ways she could help children in low-resource settings with oral clefts. She saw feeding as the most problematic area and an area most in need of innovation. “So I just thought it would be nice to come up with an idea to feed these infants with,” said McKinney. With this concept in mind, McKinney began searching for a partner who could help make such an idea possible. She discussed the idea with Dr. Michael Cunningham, the director of the Seattle Children’s Hospital Craniofacial Center, where she completed her PhD, and they approached GHTC member PATH, based in Seattle. “We reached out to PATH…and there was sufficient interest to say let’s try and make this work,” said McKinney. Together they developed a design team which included McKinney (an epidemiologist); Dr. Cunningham (a craniofacial pediatrician); a social scientist, engineer, and commercialization officer from PATH; and an occupational therapist/lactation consultant from Seattle Children’s Hospital. Together, with funding from PATH and the Seattle Children’s Hospital Craniofacial Center, the team designed their first prototype cup. A product can only have impact if it meets end-user needs and people are actually interested in obtaining it. To make sure both applied to the NIFTY™ cup prototype, the team set out to test drive the cup in low-resource settings. With support from a nonprofit Transforming Faces—which supports care for children with oral clefts in South India—and additional funding from the University of Washington CoMotion, McKinney and the team took the NIFTY™ cup to Sri Ramachandra University in South India to do formative design work in both the cleft center and the Neonatal Intensive Care Unit. They introduced the cup to mothers and health providers including lactation consultants, watched the product in use, and conducted surveys to gauge interest in the product and to inform design. The NIFTY™ cup was a big hit. “I was really excited that they liked it more than what they were using,” said McKinney, “I didn’t quite know what to expect on that, but they are really excited to get it commercialized.” Armed with valuable feedback from South India, McKinney and the team regrouped and are doing a minor redesign of the product which will be complete this summer. Last month, the team won a grant from the Saving Lives at Birth Challenge. With this funding, the NIFTY™ cup developers plan to conduct a clinical study in Ethiopia to evaluate the product’s effectiveness compared to standard cups being used, and also develop a market shaping strategy for introducing the product. While it could still be some time before the product is widely available to those who need it, McKinney and the rest of the team are energized by the NIFTY™ cup’s lifesaving potential and the support they are receiving to continue development and introduction. “I’m so excited. This little idea has percolated so long, and people have finally seen the value it can bring,” said McKinney.

In this guest post, the HIV Vaccines & Microbicides Resource Tracking Working Group—comprised of AVAC as secretariat, the International AIDS Vaccine Initiative , and UNAIDS—discusses its new report examining investment in research and development (R&D) for HIV prevention options. Investment in R&D for HIV prevention fell slightly, from US$1.26 billion to $1.25 billion, between 2013 and 2014 and has largely been stagnant for nearly a decade, according to a new report from the HIV Vaccines & Microbicides Resource Tracking Working Group which looks at year-over-year spending on HIV prevention R&D and trends spanning the last 15 years. The report, HIV Prevention Research & Development Funding Trends 2000–2014: Investment Priorities to Fund Innovation in an Evolving Global Health and Development Landscape, provides detailed information on funding for R&D on HIV prevention options—including preventive HIV and AIDS vaccines, microbicides, pre-exposure prophylaxis (PrEP), the use of AIDS treatment by people living with HIV to reduce transmission, the use of AIDS treatment to prevent infections in infants born to women living with HIV, voluntary medical male circumcision, and female condoms. In addition to funding information for R&D for HIV prevention options, the report also provides an update on investment in HIV cures, therapeutic vaccines, herpes (HSV-2) vaccines, and multipurpose prevention technology research. Despite the slight decline in funding, HIV prevention R&D is still delivering important advances. The 8th International AIDS Society Conference on HIV Pathogenesis, Treatment and Prevention held in Vancouver from July 20-22, showcased results for a range of groundbreaking research that has been supported over the past several years, including the Strategic Timing of Antiretroviral Treatment (START) trial, the HPTN 052 antiretroviral (ARV) treatment as prevention trial, and several groundbreaking oral PrEP trials. Results from studies of a vaginal ring containing the ARV dapivirine are expected in the next 12 months. Several different HIV and AIDS vaccine candidates, neutralizing antibodies, and long-acting injectable ARVs are currently in studies that could lead to multiple efficacy trials starting over the next two years. Robust ongoing investment will be critical to advancing these promising products through the R&D process. Through their research and analysis, the Working Group identified four key findings about the state of funding for HIV prevention R&D which are highlighted in the report: R&D investment is expanding beyond research to rollout: Since the Working Group began tracking investments in HIV prevention, a number of options have moved through the pipeline from research to rollout. The importance of investing in products beyond bench science and clinical trials is shown through the recent rollout and scale-up of options such as voluntary medical male circumcision and female condoms, and—in the demonstration project phase—PrEP. Majority of investment is from several large funders: The United States remained the largest public-sector funder of HIV prevention R&D, spending a total of $868 million in 2014—66 percent of the total investment. Combined, the US government and the Bill & Melinda Gates Foundation accounted for 83 percent of all HIV prevention R&D funding. Expanding and diversifying this investment base could bring in new perspectives and capacity and better assure sustained and consistent funding, reducing the potential negative impact of reductions by one or two primary funders. Increasingly important to HIV prevention is research into how to deliver HIV prevention products and ensure that those products meet the needs of, and reach, end users. Early investment to ensure the uptake of products is a growing part of HIV prevention R&D. Decrease in number of philanthropic funders engaged: While the total amount of philanthropic funding increased in 2014, the number of philanthropic funders engaged in HIV prevention research has been steadily declining since 2010. In 2014, 16 philanthropic funders invested in HIV prevention research, down from 30 in 2010. Development funding priorities are changing: The Millennium Development Goals and the United Nations Declaration of Commitment on HIV and AIDS galvanized increased investment in HIV and AIDS. This in turn led to greater overall HIV prevention R&D investment—an increase of threefold between 2001 and 2014. With the new Sustainable Development Goals set to be decided in September and global financing and development also in a period of transition, it remains to be seen whether HIV prevention R&D, and global health R&D as a whole, will receive a prominent place in the new international development agenda. For further analysis of HIV prevention funding trends, visit the Working Group's website at www.hivresourcetracking.org to download HIV Prevention Research & Development Funding Trends 2000–2014: Investing in innovation in an evolving global health and development landscape and to view additional Working Group reports, as well as graphics and PowerPoint slides.

Wendy Taylor of USAID introducing the other event partners. Photo: Marissa Chmiola/GHTC Last Wednesday 53 teams of innovators gathered at the International Trade Center in Washington, DC, for the Saving Lives at Birth DevelopmentXChange—an event resembling a cross between a science fair and an episode of Shark Tank. There were no baking soda volcanoes or smiley sponges to be found, rather innovative ideas to advance the health of pregnant women and newborns in poor communities around the world. And at stake was not a blue ribbon or a chance to take home Mr. Wonderful’s money, but something much more important—the chance to save the lives of mothers and their babies. Saving lives at birth through innovation This DevelopmentXChange served as the final stage of competition in the 5th annual Saving Lives at Birth Grand Challenges Program, a contest sponsored by the US Agency for International Development (USAID), the government of Norway, Grand Challenges Canada, and the UK Department of International Development, which aims to identify and advance groundbreaking and cost-effective solutions to improve maternal and newborn health. Innovators from around the world compete for grants to develop, test, and bring their ideas to scale. The competition covers three areas—technology development, service delivery, and demand creation. The program started in 2011 as a way to “leapfrog” solutions in the underserved area of research. “We recognized that the area of maternal and neonatal health is an area that had really not seen the type of innovation we need to save the lives of mothers and newborn around the time of birth and in the hardest to reach areas,” said Wendy Taylor, director of the Center for Accelerating Innovation and Impact at USAID. “So we put together the Saving Lives at Birth Grand Challenge…and called on the brightest minds across the world, engineers and entrepreneurs, scientists and students, to come up with new, groundbreaking ideas, new ways to prevent and treat mothers and newborns and save their lives in the most risky time—the 48 hours around the time of birth.” The response to this call has been tremendous. Since 2011, the program has provided over US$47 million in funding to 81 innovative tools and approaches, and many of the program’s successes are already having an impact as they begin to scale. To date, Saving Lives at Birth–supported innovations have been delivered to over 1.5 million women and newborns, saving at least 4,000 lives. This year the Saving Lives at Birth competition received more than 750 submissions, over half of which came from low-and middle-income countries (LMICs). Fifty-three teams were chosen to compete as finalists at the DevelopmentXChange. At the conclusion of the event, 17 award nominees were selected with additional nominees in the transition-to-scale category to be announced later this year. GHTC member projects featured as finalists Among the 53 finalists were 10 projects from GHTC member organizations: Validation of low-cost, user-friendly strip test for preeclampsia/eclampsia screening PATH Brandon Troy Leader showcases his team's innovation. Photo: GHTC/Courtney Carson Dr. Brandon Troy Leader and his team at PATH are developing a low-cost, easy-to-use strip to test for proteinuria—a key indicator of preeclampsia/eclampsia—during pregnancy. Preeclampsia is a serious health risk to both mothers and infants and accounts for at least 16 percent of maternal deaths in low-resource settings. Current diagnostics are either time-consuming and expensive—requiring 24 hour urine analysis—or inaccurate—relying on analysis of protein levels in urine which can fluctuate with fluid intake. Both of these tools are impractical for use in secondary health centers, where most women in LMICs receive treatment. The team’s innovative dipstick promises to deliver a quick, low-cost, and highly accurate test that will allow more women in low-resource settings to be diagnosed and appropriately monitored for preeclampsia/eclampsia. The strip tests for a new protein-to-creatinine (PR/CR) marker and uses a product specifically designed for this single application. It is available at less than $0.10 a strip—the current cost of the inaccurate protein-urine analysis diagnostic. In lab tests, the PR/CR strips showed 85 percent sensitivity, indicating that with appropriate clinical trials, the product could be quickly rolled out to communities in need. The team was seeking a Saving Lives at Birth validation award to test the PR/CR strips in a clinical trial with over 20,000 women and accelerate the product’s introduction into low-resource settings. Advancing introduction of new screening test for preeclampsia PATH To address the unmet need for effective screening and treatment of preeclampsia in low-resource settings, PATH is preparing for a large-scale evaluation of its innovative glycosylated fibronectin (GlyFN) test. The test targets the GlyFN biomarker, which occurs at higher concentration in the blood than other preeclampsia biomarkers and offers excellent sensitivity and specificity. Small scale tests indicate that the GlyFN test predicts preeclampsia in the third trimester of pregnancy with a sensitivity of 97 percent and specificity of 93 percent. The GlyFN test is innovative not only for its use of an easier to detect biomarker, but also for its accuracy and sensitivity in diagnosis. The PATH team was seeking a Saving Lives at Birth award to perform the first operational evaluations of the GlyFN test, refine training materials with users in the field, and implement a prospective-cohort study in Karnataka, India. Developing a model for national scale-up of the Pratt Pouch to prevent mother-to-child HIV transmission Elizabeth Glaser Pediatric AIDS Foundation (EGPAF) A syringe typically used to measure ARV dosage and the Pratt Pouch which could replace it. Photo: GHTC/Marissa Chmiola Dr. Edward Bitarakwate and his team at EGPAF Uganda are seeking to develop a model for the national scale-up of an innovative product to prevent mother-to-child HIV transmission known as the Pratt Pouch. About 1.5 million HIV positive women give birth each year. It’s possible to prevent mother-to-child HIV transmission if antiretrovirals (ARVs) are administered during labor and for several weeks following delivery. Unfortunately, many mothers don’t give birth in health facilities so their infants fail to receive ARVs during this critical period, and those who do are currently sent home with bottles of liquid ARVs and a syringe to measure appropriate doses to administer to their child. Keeping these syringes clean can prove difficult for new moms in low-resource settings, and the viscosity of the liquid ARVs makes it challenging to measure accurate doses. The Pratt Pouch addresses these challenges—it’s an easy to tear open package containing a premeasured dose of ARVs which can be stored safely for up to 12 months at any temperature. Dr. Bitarakwate described the pouch as a “ketchup packet” for ARVs, noting that the pouch is an adaptation of technology used in the food industry to package ketchup. The pouch was developed by a team of engineers at Duke University with support from a previous Saving Lives at Birth grant. Small pilot tests of the product in individual health care settings have demonstrated promise, so Dr. Bitarakwate is seeking funding to work with the Ugandan government to integrate the product into the country’s health system and create an effective model for national scale-up of the product. Reducing birth complications by increasing access to noninvasive, cloud-connected anemia screening diagnostic device PATH Masimo's Pronto-7 anemia screening device. Photo: PATH/Patrick McKern Iron-deficiency anemia affects half of all pregnant women in LMICs and can lead to poor pregnancy outcomes including preterm births, low birth weight, and maternal mortality, contributing to one-fifth of maternal deaths. However, anemia often goes undetected, as methods commonly used throughout sub-Saharan Africa require a blood draw, which can be prohibitive to patients and must be administered by highly-trained health professionals. PATH consulted more than 100 nurses, doctors, and other health professionals in sub-Saharan Africa, hearing repeatedly “noninvasive is the future” of diagnostics. PATH has partnered with California-based diagnostic manufacturer Masimo to create a noninvasive, easy-to-use, cloud-connected diagnostic device, using the “FDA-approved guts” of Masimo’s Pronto-7 hemoglobin test. Rather than drawing blood, the health worker merely asks the patient to place their finger on the sensor (see photo) and the results are available within a minute. PATH will use Masimo’s equipment and technology, but will develop a device that is more durable and even easier to read—enabling use by lower-skilled professionals. Andy Beddoe, a product development officer at PATH, explained that diagnostics that require disposable parts are more dependent on a robust supply chain. This device, however, will require no such disposables, and will use cloud-enabled software, allowing the manufacturer to “sell tests like you would cell phone minutes,” troubleshoot, or calibrate it remotely. Beddoe believes each device could last three to four years, administering more than 50,000 tests. The software could also be used for data collection and could be adapted for use in other diagnostics. A pediatric-friendly ARV dosage form: validation of palatability, flexibility, and accurate dosing of LPV/r PATH “[We’re] targeting the most vulnerable population infected with HIV,” explains Dr. Manjari Lal, senior research officer in Vaccine and Pharmaceutical Technologies at PATH, in discussing her project. Less than a quarter of HIV-positive children in LMICs are receiving ARVs, and for most families, the current treatment method involves breaking adult doses into two, crushing up one half, and mixing it with food. Lal’s team is working to transform lopinavir/ritonavir (LPV/r)—the first-line treatment for pediatric HIV—into a product that is palatable, heat-stable, and that allows for flexible dosing. The team is developing a freeze-dried, fast-dissolving tablet, which allows a parent to mix the medicine with water—as children often struggle with pills that must be swallowed. According to Lal, palatability is a major consideration for pediatric treatments, as infants won’t hesitate to spit out bitter medicines. The treatment is currently in the preclinical phase, and must go through animal studies and clinical trials with human adults before it is ready for use in children. Scaling an Integrated Human Milk Bank and Breastfeeding promotion program in Kenya PATH Human milk provides important nutritional and disease-preventing properties for infants and is particularly critical for those who are born preterm or have low birth weight. Unfortunately, some mothers are unable to produce milk or do so in the quantity needed to feed their newborn. While it’s preferable for infants to receive their own mother’s fresh milk through breastfeeding or hand expression, in cases when that is not possible, the World Health Organization recommends the administration of human donor milk. The idea of milk banks were developed to meet this need. These banks accept donor milk, screen and process it for safety, and disseminate it to mothers in need. PATH was seeking a grant to scale-up and evaluate the impact of an innovative and integrated human milking banking approach known as Mother and Baby Friendly Initiative Plus (MBFI+). Unlike stand-alone milk banks, the MBFI+ approach creates “hubs” that provide both lactation support and milk banking at the same facility. Kimberly Amundson—program officer on PATH’s Maternal and Child Health and Nutrition Team which is leading the project—describes MBFI+ as a “self-reinforcing cycle of supporting breastfeeding for all infants.” Mothers come into the facilities for lactation support, and are then able to donate any excess milk they may produce to those who need it, and those infants who receive donor milk often go on to be able to breastfeed just fine with their own mother. The team hopes to introduce the approach at two hospitals in Kenya, evaluate its effectiveness and potential cost savings, and position the approach for national adoption. Clinical validation of a novel, affordable uterine balloon tamponade, developed in Africa, to reduce maternal deaths due to postpartum hemorrhage. PATH Postpartum hemorrhage, or severe bleeding after childbirth, is the leading cause of maternal mortality, resulting in 125,000 deaths annually. However, with just a condom and a catheter—materials readily found in health clinics—the risk can be drastically reduced. The condom—connected to the catheter—is inserted into the uterus and slowly filled with water, inducing uterine contractions and ultimately slowing or stopping the bleeding. While such a device, known as a uterine balloon tamponade, is readily available in high-income countries, it can be used just once and can cost as much as $400. PATH and partners have worked to develop a device—designed and manufactured in Sou Africa with input from health professionals—that costs just a few dollars. While condoms work well, they vary greatly and the thickness of  a condom can impact the pressure exerted by the device. This uterine balloon tamponade involves a reusable bag that is filled with water and held at a certain height—depending on how much pressure is needed—connected to a reusable catheter which is in turn connected to the disposable, standardized balloon. The device has been successfully tested and with widespread introduction, an estimated 169,000 deaths could be prevented over the next fifteen years. PATH was seeking funding to conduct a clinical validation study of the product and develop a commercialization strategy to increase access to the product in LMICs. Use of a low-cost simulation model to expand postpartum intrauterine device services Jhpiego The Mama-U simulator at the Jhpiego display. Photo: GHTC/Marissa Chmiola Over 90,000 maternal deaths can be prevented each year through family planning use. Yet, many women who have just given birth don’t receive access to long-acting family planning methods like intrauterine contraceptive devices (IUCDs) because there are not enough health providers trained to properly administer IUCDs to women with postpartum bodies; and many women incorrectly believe the product may not stay in place given the changes to their bodies resulting from birth. Under a previous grant, Jhpiego found that using a postpartum body simulator called the Mama-U was effective for training workers and improving service delivery. According to Dr. Fauzia Assad, a medical doctor working with Jhpiego Pakistan, the Mama-U offers benefits over existing approaches to training for postpartum IUCD training. “It’s cost-effective, just $50 versus $600 for the usual model, culturally appropriate, easy to take along, very portable, easy to understand, and it offers the same level of difficulty one would experience with an actual patient because it has a similar feel and tension.” In earlier testing, Jhpiego found the product was not only helpful in training providers, but counselors found it helpful in educating patients, dispelling patient concerns, and increasing client use of IUCDs. Jhpiego was seeking a grant to build on past learning and show that the Mama-U can improve quality of services and patient uptake and change the way postpartum IUCD training, counseling, and services are delivered. Projecting Health India PATH People typically find it easier to learn a process if they see it demonstrated, rather than just hearing or reading about it. This is why the Projecting Health India program is using video as a medium through which to promote health behaviors. Projecting Health India a community-based, video education project, which trains communities in India to create and produce videos addressing a variety of health topics—including birth preparedness, breastfeeding, and family planning—which are shown at community mothers’ groups and village health days. The videos feature local actors and health workers and aren’t distributed outside the district for which they were produced. Michelle Desmond, a monitoring and evaluation officer at PATH involved with the program, described the approach “as hyperlocal” which is key to the program’s effectiveness. “Literature on behavior change shows that if you can empathize with a person you see practicing a healthy behavior, you are more likely to practice it yourself,” said Desmond. “So in these videos women are seeing people who sound like them, who look like them, who are in the same situation as them practicing these health behaviors.” After realizing that the videos were so popular that women were finding ways to transfer them onto their mobile phones to rewatch and share, Projecting Health partnered with mobile phone vendors in India to allow the videos to be easily loaded onto phones, providing an additional way for these videos to be distributed to harder to reach mothers. PATH was seeking a Saving Lives at Birth grant to scale up this project in government systems throughout the state of Uttar Pradesh. NIFTY: A Neonatal Intuitive Feeding Technology for preterm infants who have difficulty breastfeeding PATH A demonstration of feeding using the NIFTY cup. Photo: GHTC/Marissa Chmiola In high-resource settings, infants who struggle with breastfeeding can be fed with breast milk through tubes or bottles, however such technologies can be expensive, difficult-to-use, or unsanitary in low-resource settings. In LMICs, the World Health Organization recommends the use of small cups for infants with feeding difficulties, including preterm infants, infants who have lost their mother due to complications in pregnancy or childbirth, and children with cleft palates. There is currently no product on the market specifically designed for this purpose, and the metal or glass cups that are often used can be inefficient, or can cause injury to the infant’s mouth including cuts. To address these limitations, PATH and its partners created the NIFTY™ cup which is made of silicone, making it soft and durable. The cup can also be boiled without causing any damage—making it easy to sterilize. The cup also has a reservoir on the lip of the cup, making it easy to control the amount of milk delivered and prevent waste. The NIFTY™ cup costs just $1.25 to produce. This innovation was chosen as one of the 17 competition award nominees. The team at PATH will use the funding to test the NIFTY™ cup in hospital settings in Ethiopia and work with private-sector partners throughout the sub-Saharan market to commercialize the cup. Innovation is happening around the world In visiting the DevelopmentXChange, it was clear that innovation is happening in all corners of the globe and lifesaving ideas can come from anywhere and anyone. Saving Lives at Birth demonstrates the power of bringing governments, foundations, academic institutions, and for-profit companies together to address our most pressing health challenges. GHTC congratulates both our members and the other teams who were selected as finalists and award nominees—your work continues to inspire us. Authored by Marissa Chmiola, GHTC’s communications officer with support from Courtney Carson, senior policy and advocacy associate, and Kat Kelley, senior program assistant.

This Independence Day, GHTC is taking a break from our cookouts and parades to celebrate America’s extraordinary contributions to advancing innovation to save lives around the world. The US government has long played a leading role in the development of new technologies to diagnose, treat, and prevent diseases and conditions impacting people living in the world’s poorest places. US leadership in global health research and development (R&D) is a testament to our nation’s character, our ingenuity and entrepreneurial spirit, and our dedication to improving human lives worldwide. Below GHTC takes a look at America’s contributions to global health innovation: The US government is the largest funder of global health R&D in the world. The US government is by far the largest funder of global health R&D—contributing around 45 percent of total investment and 70 percent of all government investment each year. Even when measured as a proportion of gross domestic product (GDP), the US government remains the largest funder of global health R&D. Between 2000-2013, the US government invested over US$18 billion in global health R&D. While this may sound like an extraordinary amount of money, annual US investment in global health R&D represents only a tiny fraction of overall US government spending—less than one-tenth of one percent of our GDP. While US investment in global health R&D nearly doubled between 2000 and 2009, funding has been largely stagnant, or on the decline, since then. A sustained and robust US investment in R&D by the United States is critical to delivering the next generation of health technologies to address both existing and emerging diseases and conditions. The US government contributes more than just funding to advance global health R&D. Five federal agencies that are engaged in global health R&D—the US Agency for International Development, National Institutes of Health, Centers for Disease Control and Prevention, Department of Defense, and the Food and Drug Administration—contribute much more than just funding. The US government has been involved in the development of many breakthrough technologies that are transforming global health. Between 2000 and 2010, the US government was involved in the development of over half (25) of the 45 global health products. The US government has been involved in the development of lifesaving innovations, including: Antiretroviral treatments, which have dramatically extended the lives of those living with HIV and AIDS. A vaccine that protects against meningitis A, costing less than $.50 per dose, which been delivered to more than 251 million people in Africa’s meningitis belt since its launch in 2010. A pediatric antimalarial drug, which has had 300 million treatments delivered to children suffering from malaria in 50 endemic countries since 2009. US investment is fueling a robust pipeline of global health products with the promise to save and improve lives. As of 2012, the US government was involved in the development of 200 of the 365 global health products in the development pipeline. Promising innovations under development receiving support from the US government include: A preventative HIV and AIDS vaccine that could dramatically reduce new infections. New tools to prevent and treat malaria, including medicines that will both protect against the disease and prevent its transmission. Vaccines to prevent tuberculosis (TB), which are in various phases of clinical trials. New cost-effective diagnostics for malaria, TB, and neglected tropical diseases (NTDs). New vaccines for NTDs—such as dengue fever, Chagas disease, and leishmaniasis. US contributions to global health R&D are having a ripple effect beyond saving and improving lives. US contributions to global health innovation not only saves lives, but also produce direct benefits for Americans by creating jobs, strengthening US competitiveness in research and technology, improving US relations abroad, and enhancing our health and national security. US investments also drive economic progress and reduce poverty in low- and middle-income countries (LMICs). Between 2000 and 2011, health improvements accounted for about 11 percent of economic growth in LMICs. The development of new health technologies will ultimately provide LMICs with the solutions they need to tackle their most pressing health challenges and chart a course for self-sustainment. So this Fourth of July, as you enjoy your burger and watch fireworks light up the sky, take a moment to celebrate America’s contributions to global health. While there is much more to be done, Americans should take pride in our nation’s efforts to advance innovation to save lives worldwide.