We stand at a unique moment in the evolution of women’s reproductive health programs and in the development of new health technologies for women. The global health community has recognized the need for an integrated approach to women’s sexual and reproductive health (SRH) to meet women’s multiple and diverse needs. And 21st-century health programs have embraced the integration of family planning, reproductive health, and HIV services. Now is the time to embrace the development of new health technologies that could provide simultaneous protection for the multiple health risks many women face.
Every year an estimated 87 million women become pregnant when they did not plan or want to.
Every day nearly 500,000 young people, mostly women, contract a curable sexually transmitted infection (STI), placing them at an increased risk for HIV, cervical cancer, and infertility.
Every minute a woman is newly infected with HIV, making it the leading cause of death and disease among women of reproductive age worldwide.
New technologies that could provide simultaneous protection against pregnancy and STIs, including HIV, could contribute substantially to the health of women and girls around the globe.
Thankfully, these products may not be too far off. Referred to as multipurpose prevention technologies, or MPTs, they are the result of collaboration among reproductive health, contraceptive, and HIV researchers. Donors and product developers are working together to create new technologies that offer simultaneous protection from these key SRH risks.
While the existing MPTs (male and female condoms) are effective when used correctly and consistently, many women simply are not able to negotiate condom use with their partners. New MPTs in development include vaginal gels, long-acting intravaginal rings, new and improved barrier devices, vaginal tablets, and films. Once developed and approved, MPTs will be a major advance for global public health and will provide millions of women with new means to protect them. But to get the products from the lab into the hands of the women who need them, key challenges must be addressed:
Understanding women’s preferences, choices, and needs. We know that many women want and need technologies that prevent pregnancy and STIs, including HIV. But finding the right delivery system is crucial. Data from several studies indicate that women don’t use products consistently for a variety of reasons. A recent example of this is the VOICE (Vaginal and Oral Interventions to Control the Epidemic) study. VOICE was a large-scale trial conducted in South Africa, Uganda, and Zimbabwe from 2009 to 2012 to test whether the daily use of a product containing the antiviral tenofovir (oral tablet or vaginal gel) could prevent the sexual transmission of HIV in women. The results showed that many women did not use the study products as directed. While low adherence prevented the study from being able to get an answer about the effectiveness of tenofovir to prevent sexual transmission of HIV among women, it did confirm that women have different needs, preferences, motivations, and barriers to use.
To design effective products that women can use, product developers must understand the challenges women face in accessing and using new technologies. The role that gender norms and power asymmetry play in women’s ability to access and use technologies cannot be underestimated. In, addition, preferences for specific MPT product characteristics (such as formulation, duration of action, and presence and magnitude of side effects) must be taken into account early on in the product-development process. For example, a long-acting product may be easier for some women to use than one that must be taken or used on a daily basis (like those in VOICE) or around the time of sex.
Overcoming technical challenges. Developing MPTs is complicated. Researchers work with active ingredients that have vastly different properties and are designing technologies that will be effective for anywhere from one hour to 90 days. For example, the active ingredients in the MPTs being developed by the Population Council include MIV-150 to prevent HIV; zinc acetate to protect against HIV and herpes; carrageenan to block human papillomavirus (HPV) and strengthen the effectiveness of zinc acetate (which may have protective effects against HIV and herpes); and levonorgestrel to prevent pregnancy. Council researchers are developing delivery mechanisms that release these drugs in a controlled manner for the lifetime of the product—for instance in a slow-release vaginal ring. Too much or too little of one compound can prevent the product from providing maximum protective benefit. Researchers have successfully tested a gel and a vaginal ring that contain three of these drugs and are beginning to design technologies that incorporate all four. More information about the Population Council’s microbicides pipeline is available here.
Bolstering and sustaining funding for R&D. Candidate products must go through a series of preliminary tests before ever reaching the large-scale effectiveness studies needed for product approval. It is the nature of research that many of these candidate products will never make it out of the lab and into effectiveness studies. And by their nature, first-generation products can usually be improved upon with additional study and refinement. That is why investment in MPT R&D is vital. Maintaining an active and robust product pipeline increases the chances that a handful of products will prove promising enough to move on to large-scale studies. Donors and others must recognize the importance of this research and consider MPT R&D a priority. And, when the first generation of new MPTs becomes available we must ensure that health systems are ready to deliver them and that financing mechanisms are in place to support their procurement and introduction.
Navigating complex regulatory issues. Because MPTs combine different components, they do not fit neatly into the discrete categories of “drug, device, or biologic” typically used by the U.S. Food and Drug Administration—the body charged with approving medical drugs and devices for use in the United States. The unique nature of MPTs poses challenges for regulatory bodies in other parts of the world, making their entry to the market complex. The good news is that efforts are underway to identify regulatory pathways for MPTs, and to clarify the regulatory requirements at different stages of product development. We are working now to engage regulators in the emerging MPT field so that the regulatory process is efficient, timely, cost-effective, and ultimately successful.
With continued effort, MPTs could address the major reproductive and sexual health challenges that women worldwide face. While momentum is growing, the public health, medical, and scientific communities must continue to move forward with a sense of urgency and clarity to accelerate the development of these potentially lifesaving technologies for girls and women around the globe.