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

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.

Women and ARV‐based HIV prevention – challenges and opportunities

“…WHO guidelines play a critical role in the introduction of new products within national health ministries. The last paper in the supplement by Lusti-Narasimhan [ 25 ] considers the relevance of gender norms in developing guidelines for microbicide or PrEP services. The proactive consideration of the influence of gender norms in the use of ARV-based technologies can help policymakers and programme managers facilitate women's full access to their use by considering issues such as protection of privacy and confidentiality in service delivery and reducing barriers such as parental consent that may keep adolescents at risk from using them.…”

Historical development of vaginal microbicides to prevent sexual transmission of HIV in women: from past failures to future hopes

“…Although the results obtained in recent years with gels containing reverse transcriptase inhibitors increase the hope of developing a microbicide that will significantly reduce HIV transmission, the creation of an effective vaginal microbicide also implies knowledge of the circumstances of the target population, and transmission prevention strategies must be adapted accordingly. 125 This is why much of the current effort focuses on understanding the aspects that govern the effectiveness of microbicides, among which a key factor is considered to be adherence in trials. Strategies must, therefore, be designed to improve adherence and the factors that influence it.…”