Abstract
IntroductionTwo 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.DiscussionGiven 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.ConclusionsHuman 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.
Highlights
Two new microbicide products based on topical application of antiretroviral drugs for HIV prevention Á 1% tenofovir gel and the dapivirine intravaginal ring Á are currently in late-stage clinical testing and results on their safety and efficacy are expected to become available in early 2015
A significant challenge to designing and implementing programmes to deliver new HIV prevention methods is to ensure that they are made available to, and used by, women at high risk of HIV infection who are not using existing methods. Many such women visit family planning and other reproductive health services to obtain contraceptive advice and supplies, or to seek treatment for sexually transmitted infections (STIs). These family planning and reproductive health services have a key role to play in providing information on the new HIV prevention methods, even if a woman can only obtain the products from a limited number of facilities
Given the continued high rate of new infections among women, especially young women in generalized HIV epidemics, it is critical to determine how best to ensure that effective HIV prevention products, including topical PrEP, can be delivered appropriately and sustainably
Summary
Two new microbicide products based on topical (vaginal) application of antiretroviral drugs Á 1% tenofovir gel and the dapivirine ring Á are currently in late-stage clinical testing, and results on their safety and effectiveness are expected to become available in early 2015. Two new microbicide products based on topical (vaginal) application of antiretroviral drugs for HIV prevention Á 1% tenofovir gel and the dapivirine intravaginal ring Á are currently in late-stage clinical testing and results on their safety and efficacy are expected to become available in early 2015 To ensure that these products are able to reach women and young girls most at risk of HIV acquisition, their launch must be accompanied by WHO guidelines on the use of topical preexposure prophylaxis (topical PrEP). These guidelines must be evidence-based and integrate human rights standards and principles with recommendations taking into account policy, programmatic and community considerations. This advice addresses, for example, whether and how it should be prioritized to certain segments of the population or risk groups, and how to deliver the new product in an efficient and cost-effective manner with due consideration to other priority health interventions
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