title: WHO guidance grounded in a comprehensive approach to sexual and reproductive health and human rights: topical pre-exposure prophylaxis.
abstract: BACKGROUND
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Reproductive Health and Research, World Health Organization, Geneva, Switzerland; lustinarasimhanm@who.int.
authors.forename: Manjula
authors.initials: M
authors.lastname: Lusti-Narasimhan
authors.affiliation: Department of Reproductive Health and Research, World Health Organization, Geneva, Switzerland.
authors.forename: Rajat
authors.initials: R
authors.lastname: Khosla
authors.affiliation: Department of HIV/AIDS, World Health Organization, Geneva, Switzerland.
authors.forename: Rachel
authors.initials: R
authors.lastname: Baggaley
authors.affiliation: Department of Reproductive Health and Research, World Health Organization, Geneva, Switzerland.
authors.forename: Marleen
authors.initials: M
authors.lastname: Temmerman
authors.affiliation: Consultant, New York, NY, USA.
authors.forename: Elizabeth
authors.initials: E
authors.lastname: McGrory
authors.affiliation: Sigma 3 Services SÀRL, Nyon, Switzerland.
authors.forename: Tim
authors.initials: T
authors.lastname: Farley
mesh_terms: D000282:Administration, Intravaginal; D000293:Adolescent; D000891:Anti-Infective Agents, Local / Q000627:therapeutic use*; D044966:Anti-Retroviral Agents / Q000627:therapeutic use*; D018562:Disease Transmission, Infectious / Q000517:prevention & control*; D005260:Female; D014943:Global Health; D017408:Guidelines as Topic; D015658:HIV Infections / Q000517:prevention & control*; D006806:Human Rights; D006801:Humans; D065129:Pre-Exposure Prophylaxis / Q000379:methods*; D060728:Reproductive Health; D014944:World Health Organization; D055815:Young Adult
chemical_list: D000891:Anti-Infective Agents, Local; D044966:Anti-Retroviral Agents
keywords: HIV; human rights; microbicide; pre-exposure prophylaxis; prevention; sexual and reproductive health