Preparing for microbicide introduction, rollout, and sustained access.

Two topical vaginal microbicide candidates for HIV prevention are at an advanced stage of clinical testing, with efficacy results from three clinical trials expected within the next 2 years. Therefore, preparations for introducing and ensuring access to these products in the event that they are proven safe and effective now require increased attention. Microbicides are expected to fill an important global public health need for HIV prevention options for women. They have been developed almost exclusively with public and private funding through academic and nongovernmental institutions and minimal involvement of commercial pharmaceutical partners. Efficient and rapid introduction of a new public health technology requires a broad range of expertise and collaborations, some of which are new to the microbicide field as products are at last completing late-stage pivotal licensure studies. Strong leadership, political commitment, and considerable financial investments will be required to ensure successful distribution as well as uptake and continued access to this new product class. This paper highlights work conducted since 2000 by scientists, advocates, and public health officials to prepare for microbicide introduction, and discusses some of the needed actions to ensure that products will become readily accessible to the women who need them.

The challenge of defining standards of prevention in HIV prevention trials.

As new HIV prevention tools are developed, researchers face a number of ethical and logistic questions about how and when to include novel HIV prevention strategies and tools in the standard prevention package of ongoing and future HIV prevention trials. Current Joint United Nations Programme on HIV/AIDS (UNAIDS)/World Health Organization (WHO) guidance recommends that participants in prevention trials receive 'access to all state of the art HIV risk reduction methods', and that decisions about adding new tools to the prevention package be made in consultation with 'all relevant stakeholders'. The guidance, however, leaves open questions of both process and implementation. In March 2009, the Global Campaign for Microbicides, UNAIDS and the Centers for Disease Control and Prevention convened a consultation to develop practical answers to these questions. Fifty-nine diverse participants, including researchers, ethicists, advocates and policymakers, worked to develop consensus criteria on when to include new HIV prevention tools in future trials. Participants developed a set of questions to guide decision-making, including: whether the method has been recommended by international bodies or adopted at a national level; the size of the effect and weight of the evidence; relevance to the trial population; whether the tool has been approved or introduced in the trial country; whether adding the tool might lead to trial futility; outstanding safety issues and status of the trial. Further work is needed to develop, implement and evaluate approaches to facilitate meaningful stakeholder participation in this deliberative process.

Challenges to microbicide introduction in South Africa.

Qualitative research was conducted in South Africa to determine perceptions about intra-vaginal microbicides in order to better understand the socioeconomic, cultural and structural contexts for the support of future introduction of this new HIV prevention method. Focus group discussions and in-depth interviews were conducted at community, health service, and policy levels of inquiry. The main study site was a black working class urban area close to Cape Town. "Desperation" in response to the HIV/AIDS epidemic, rape, sexual coercion and unplanned consensual sex emerged as major reasons to support microbicides, while concerns about the partial effectiveness of microbicide protection and its hypothetical nature elicited a more cautious approach. Other key findings included the likelihood that microbicides would be "mainstream", the possible impact on sexual practices and gender norms, issues of condom substitution/migration and potential avenues for education and distribution. We found that microbicides have the potential to meet diverse needs beyond that suggested by prior research. This included a desire for products that could protect against HIV infection following rape, sexual coercion and unplanned sex, and the finding that a wider range of people than previously suggested would potentially use microbicides. The challenge for microbicide introduction will be to develop products that can meet diverse needs not only in South Africa, but also in the broader global context.

WHO guidance grounded in a comprehensive approach to sexual and reproductive health and human rights: topical pre-exposure prophylaxis.

INTRODUCTION: Two new microbicide products based on topical (vaginal) application of antiretroviral drugs - 1% tenofovir gel and the dapivirine ring - are currently in late-stage clinical testing, and results on their safety and effectiveness are expected to become available in early 2015. WHO guidelines on the use of topical pre-exposure prophylaxis (topical PrEP) are important in order to ensure that these new prevention products are optimally used. DISCUSSION: Given that these new topical PrEP products are designed to be woman initiated and will likely be delivered in reproductive health settings, it is important to ensure that the guidance be framed in the context of comprehensive sexual and reproductive health and human rights. In addition to the safety and effectiveness data resulting from clinical trials, and the regulatory approval required for new products, the WHO normative guidelines on the use of topical PrEP will be essential for rapid roll-out in countries. CONCLUSIONS: Human rights standards and principles provide a framework for the provision of woman-initiated HIV prevention products. These include addressing issues related to the gender inequities which are linked to the provision of HIV-prevention, treatment and care for young girls and women. Effective programming for women and girls must therefore be based on understanding the local, social and community contexts of the AIDS epidemic in the country, and adapting HIV strategies and programmes accordingly. Such a framework therefore is needed not only to ensure optimal uptake of these new products by women and girls but also to address sociocultural barriers to women's and girls' access to these products.

Prioritizing multipurpose prevention technology development and investments using a target product profile.

Multipurpose prevention technologies (MPTs) represent a powerful opportunity to address the unmet sexual and reproductive health needs of women in at-risk populations around the world in an efficient and cost-effective manner. The development of MPT products for the combination prevention of pregnancy and sexually transmitted infections (including HIV) is a high-risk/high-gain, expensive process. The associated challenges are compounded by limitations in available resources for the development, evaluation, and delivery of such products. Consequently, an objective process for identifying MPT products with the highest public health impact potential is necessary to serve as the basis of coordinated investment of supporting agencies in the development of such products. Moreover, this process would serve as a framework for product development organizations, guiding their product development strategies. The Scientific Agenda Working Group of the Initiative for Multipurpose Prevention Technologies conducted an MPT pipeline evaluation exercise for the purpose of defining specific MPT product priorities, and to identify MPT technology gaps which need to be addressed in order to achieve development of optimal products. Through a formal and objective process, a set of MPT priority product recommendations emerged, along with several priority MPT gaps. Further, specific MPT development process priorities were identified. The detailed process and summary findings of this exercise are presented here. This article is based on a presentation at the "Product Development Workshop 2013: HIV and Multipurpose Prevention Technologies," held in Arlington, Virginia on February 21-22, 2013. It forms part of a special supplement to Antiviral Research.