Harrison P F, Hemmerling A, Romano J, Whaley K J, Young Holt B
Coalition for Advancing Multipurpose Innovations (CAMI)/Public Health Institute, USA ; AVAC, Global Advocacy for HIV Prevention, New York, USA.
AIDS Res Treat. 2013;2013:790154. doi: 10.1155/2013/790154. Epub 2013 Feb 28.
the need for contraception and for protection from sexually transmitted infections, importantly HIV/AIDS. While conception and infection share the same anatomical site and mode of transmission, there are no reproductive health technologies to date that simultaneously address that reality. Relevant available technologies are either contraceptive or anti-infective, are limited in number, and require different modes of administration and management. These "single-indication" technologies do not therefore fully respond to what is a substantial reproductive health need intimately linked to pivotal events in many women's lives. This paper reviews an integrated attempt to develop multipurpose prevention technologies-"MPTs"-products explicitly designed to simultaneously address the need for both contraception and protection from sexually transmitted infections. It describes an innovative and iterative MPT product development strategy with the following components: identifying different needs for such technologies and global variations in reproductive health priorities, defining "Target Product Profiles" as the framework for a research and development "roadmap," collating an integrated MPT pipeline and characterizing significant pipeline gaps, exploring anticipated regulatory requirements, prioritizing candidates for problem-solving and resource investments, and implementing an ancillary advocacy agenda to support this breadth of effort.
需要避孕以及预防性传播感染,尤其是艾滋病毒/艾滋病。虽然受孕和感染发生在相同的解剖部位且传播方式相同,但迄今为止尚无同时应对这一现实情况的生殖健康技术。现有的相关技术要么是避孕技术,要么是抗感染技术,数量有限,且需要不同的给药和管理方式。因此,这些“单一适应症”技术无法充分满足与许多女性生活中的关键事件密切相关的重大生殖健康需求。本文回顾了开发多功能预防技术(“MPTs”)的综合尝试——这些产品明确设计用于同时满足避孕和预防性传播感染的需求。它描述了一种创新且迭代的MPT产品开发策略,包括以下几个部分:确定此类技术的不同需求以及生殖健康优先事项的全球差异,将“目标产品概况”定义为研发“路线图”的框架,整理综合的MPT产品线并描述重大的产品线差距,探索预期的监管要求,对解决问题和资源投资的候选方案进行优先级排序,以及实施辅助宣传议程以支持这一广泛的努力。