This presentation provides an overview of MPTs and the IMPT MPTs, also known as Multipurpose Prevention Technologies, have potential impacts and benefits on numerous global health priorities, particularly in the areas of reproductive health. The Initiative for MPTs (IMPT) is a product neutral, global collaboration that is working to advance a new product development paradigm that prioritizes the needs and feedback of women and girls, so that once available, MPTs reflect the realities of women’s daily lives. Comprehensive Sexual & Reproductive Health Prevention: The Promise of MPTs Initiative for MPTs [IMPT]

Women’s Sexual & Reproductive Health Risks are Interlinked Unintended Pregnancy HIV Women need better protection Other Sexually Transmitted Infections (STIs) The SRH risks of women and adolescent girls are interlinked. Women at risk for unintended pregnancy are simultaneously at risk for STIs, including HIV. [Some risk stats that can be replaced with regionally relevant stats as needed] Half of all pregnancies are unintended - globally and in the US. Every minute a young woman is infected with HIV, and HIV is the leading killer of women of reproductive age globally. 1 million people acquire a sexually transmitted infection, or STI, every day. STIs are the most commonly reported infections in the US. These can cause cervical cancer, infertility, and even death. Women don’t have the tools they need to simultaneously protect themselves against these risks. Additional options and more choices are needed when it comes to prevention. Women need better protection.

Global Need 222 million women have an unmet need for family planning. Each day, 830 women die from preventable causes related to pregnancy and childbirth. In 2016, 1 million people died from AIDS related causes and 1.8 million became newly infected with HIV. Every 60 seconds a young woman is newly infected with HIV. 1 million people contract a sexually transmitted infection every day. Global Need: [Please add relevant local statistics here or on a separate slide] HIV/AIDS, other STIs, and unintended pregnancies remain critical public health issues across the globe, impacting developing countries as well as more developed nations and having devastating impacts on women and their families. 222 million women have an unmet need for family planning [1] Each day, 830 women die from preventable causes related to pregnancy and childbirth [2] In 2016, 1 million people died from AIDS related causes and 1.8 million became newly infected with HIV [3] Every 60 seconds a young woman is newly infected with HIV [4] 1 million people contract a sexually transmitted infection every day [5] [1] Gribble, J. (2012). Fact Sheet: Unmet Need for Family Planning. [2] WHO. (November 2015) Maternal Mortality: Fact Sheet No. 348: Women’s Health. Media Centre. [3] WHO. (July 2017) HIV/AIDS: Fact Sheet. Media Centre <http://www.who.int/mediacentre/factsheets/fs360/en/>. [4] UNAIDS. (June 2012) Resources <http://www.unaids.org/en/resources/infographics/20120608gendereveryminute>. [5] World Health Organization. (2016). Sexually Transmitted Infections (STIs): Fact Sheet No. 110. Media Centre.

Interlinked SRH Risks and Unmet Need for Modern Contraception among Women An analysis published in Contraception in 2016 highlights regions of the world with the greatest epidemiological need for contraception and prevention of HIV, HSV-2, and HPV. While epidemiological data for these health risks is inconsistently available in different parts of the world, based on available data, the overlap between these risks is high in many parts of the world, including parts of sub Saharan Africa, SE Asia and Europe and the LAC region - as illustrated in this figure. Source: Schelar, et al. http://www.contraceptionjournal.org/article/S0010-7824%2815%2900577-6/

Contraceptive Method Mix There are a wide range of contraceptive methods currently available and millions of women are using them, BUT only the condom provides protection from STIs, including HIV. As millions of women are currently using contraception (and many who have an unmet need for contraception), there is viable market for MPT products that offer a contraceptive component. Similar to the method mix touted within the field of family planning, the MPT field aims to offer a suite of MPT products to better meet women's sexual and reproductive health needs. Daroch and Singh, Lancet, Vol 381, May 2013

Multipurpose Prevention Technologies MPTs combine protection against: Unintended pregnancy HIV Other STIs The ideal MPT would be: Extremely safe Affordable Easy-to-use MPTs are innovative, breakthrough solutions because they deliver simultaneous prevention of at least two health risks: Unintended pregnancy, HIV, and other STIs. Women’s needs vary depending on her stage of life and the region and culture in which she lives. The ideal MPT products would be extremely safe, affordable, and easy-to use.

MPTs in the R&D Pipeline Vaginal rings Innovative vaginal delivery products Injectables and implant technologies New male and female condom designs Other novel technologies and platforms An array of MPTs are in development. No single solution will meet the needs of all women. That is why there are numerous MPT designs in the development pipeline. In addition to rings, there are fast-dissolving vaginal films, which is like the “Listerine” film that dissolves upon contact, vaginal and rectal inserts (similar to suppositories), and vaginal and rectal gels that can address multiple risks. Some combine contraception with HIV prevention. Some combine contraception with protection against other sexually transmitted infections. Others prevent HIV and other sexually transmitted infections while allowing for conception. In many areas of the world, women often prioritize their need for modern contraception over their need for HIV prevention. HIV stigma can be a big issue and can create a barrier for many women who need HIV prevention. Combining HIV prevention with STI prevention and contraception and delivering it in a family planning setting could increase the uptake of HIV prevention.

Online MPT Product Development Database Learn more at http://mpts101.org/mpt-database To learn more about what is in the MPT pipeline, visit the MPT Product Development Database housed on the IMPT’s website. We track the MPTs in development and provide information and links to learn more about each product.

Options for MPTs + Co-formulated: Multiple API formulated into a single dose Co-administered: Two independent products used together Co-packaged: Two different doses packaged together in a single product for simultaneous co-use + There are three delivery options for MPTs: Co-formulated methods – which are a single product or dose that combines multiple APIs – like vaginal rings that combine contraception with HIV prevention. Co-administered methods, like combining a diaphragm with a gel or co-administration of a contraceptive injectable with an injectable anti-HIV drug is an option for multipurpose prevention. Co-packaging two different doses together in a single product, like oral Truvada (i.e., PrEP) with a contraceptive pill in a single pack.

Initiative for MPTs Funder Collaboration Science Product launch and introduction Women’s voices and access The MPT field is complex. There are different disciplines being united and a wide array of scientific and technical challenges that must be overcome to achieve a successful MPT. The Initiative for MPTs was formed at the onset of the formal launching of the MPT field in 2009 to help address the inherent complexities in developing MPTs and uniting the fields of HIV prevention, Contraception and STI prevention. As a product neutral platform, the IMPT works to tap upon the expertise of a multidisciplinary cadre of experts, working in areas of contraception, prevention of HIV and other STIs, social behavioral and market researchers, advocates, and funders to inform clinical and social/behavioral decisions and next steps to ensure the value potential of MPTs is achieved. With a long-term, strategic vision for the field, the IMPT Secretariat facilitates collaboration among MPT stakeholders to optimize product development and introduction efforts, ensuring that work is complementary rather than duplicative and aligns with identified research priorities. Drawing from the application of the collective impact collaborations applied in other fields, the IMPT has developed a base strategy to achieve the necessary coordination of the diverse stakeholders involved. As such, the IMPT has shaped the growth of the field by approaching the development of MPTs in a very strategic way by identifying critical field-wide issues and gaps and convening experts to address these – the evolution of the field has truly been a collaborative and iterative process. Advocacy & Market Development

How the IMPT works Convene experts to address priority areas and gaps in the field Implement task force activities Strategically coordinate the MPT field Assess end-user and acceptability issues in priority regions Modeling public health impact of potential indication combinations among target populations As the neutral convener for the MPT field, the IMPT: Convenes experts to address priority areas and gaps in the field Implements and oversees task force activities Strategically coordinates the MPT field from a product neutral perspective Assesses critical end-user and acceptability issues in priority regions Modeling public health impact of potential indication combinations among target populations

IMPT Priority Areas Understand hormonal contraceptive (HC) knowledge gaps in the context of MPT development. Assess challenges and other issues related to MPT clinical trial design. Develop a process for achieving a more robust product development pathway for non-HIV STI MPTs. Assess the gaps in social-behavioral knowledge for MPT development and MPT commercialization potential. Engage modeling efforts to robustly assess public health impact and cost effectiveness of MPT product options in specific target populations. Through a robust stakeholder review and survey process in 2015, the IMPT identified 5 MPT Field-wide priorities: Understanding hormonal contraceptive (HC) knowledge gaps in the context of MPT development. There are a number of critical knowledge gaps that are essential to consider when combining hormonal contraceptives and STI and HIV prevention active ingredients in a single product and the IMPT has been leading efforts to assess these gaps and identify next steps. Assessing challenges and other issues related to MPT clinical trial design. It is important for MPT funders, product developers, and researchers to understand feasibility and risk around clinical trial design issues to guide investment decisions, particularly in the wake of the challenges experienced during recent microbicide trials. The IMPT has been facilitating collaborations to assess these challenges. Developing a process for achieving a more robust product development pathway for non-HIV STI MPTs. Critical gaps include the development of non-ARV MPTs, identification of candidate STI indications through products shelved due to non-efficacious non-STI primary indications, and additional data on STI epidemiology. Assessing the gaps in social-behavioral knowledge for MPT development and MPT commercialization potential. Engaging modeling efforts to robustly assess public health impact and cost effectiveness of MPT product options in specific target populations. In order to address these priority areas, the IMPT has been engaging in an iterative process of enabling multidisciplinary collaborations, promoting technical advocacy, and defining next steps for research.

IMPT Resource Center http://www.theimpt.org/resources To access a comprehensive inventory of resources on MPTs and the IMPT, visit the IMPT’s resource center where you can find reports, articles and other technical resources on MPTs.

Women and adolescent girls need better options The promise of MPTs is great The IMPT has fortified the MPT field Continued field-wide guidance and collaboration will be necessary to see impactful MPT products In the past 8 years the IMPT has provided a platform in which multidisciplinary experts from across the globe have truly come together to work towards MPTs. The promise of MPTs is great – but we cannot get there unless we work together.

The Health and Social benefits of MPTs are numerous and can improve the health and lives of women and their families across the globe.

Join the IMPT Network of Experts (NoE) at http://mpts101