title: Implementation of pre-exposure prophylaxis for human immunodeficiency virus infection: progress and emerging issues in research and policy.
abstract: In this article, we present recent evidence from studies focused on the implementation, effectiveness and cost-effectiveness of pre-exposure prophylaxis (PrEP) for HIV infection; discuss PrEP scale-up to date, including the observed levels of access and policy development; and elaborate on key emerging policy and research issues to consider for further scale-up, with a special focus on lower-middle income countries.
  
  
  
  The 2015 WHO Early Release Guidelines for HIV Treatment and Prevention reflect both scientific evidence and new policy perspectives. Those guidelines present a timely challenge to health systems for the scaling up of not only treatment for every person living with HIV infection but also the offer of PrEP to those at substantial risk. Delivery and uptake of both universal antiretroviral therapy (ART) and PrEP will require nation-wide commitment and could reinvigorate health systems to develop more comprehensive "combination prevention" programmes and support wider testing linked to both treatments and other prevention options for populations at highest risk who are currently not accessing services. Various gaps in current health systems will need to be addressed to achieve strategic scale-up of PrEP, including developing prioritization strategies, strengthening drug regulations, determining cost and funding sources, training health providers, supporting user adherence and creating demand.
  
  
  
  The initial steps in the scale-up of PrEP globally suggest feasibility, acceptability and likely impact. However, to prevent setbacks in less well-resourced settings, countries will need to anticipate and address challenges such as operational and health systems barriers, drug cost and regulatory policies, health providers' openness to prescribing PrEP to populations at substantial risk, demand and legal and human rights issues. Emerging problems will require creative solutions and will continue to illustrate the complexity of PrEP implementation.
authors.affiliation: Center for Interdisciplinary Studies in Sexuality, AIDS and Society, Universidad Peruana Cayetano Heredia, Lima, Peru; Carlos.caceres@upch.pe.
authors.forename: Carlos F
authors.initials: CF
authors.lastname: Cáceres
authors.affiliation: Division of Global Public Health, University of California, San Diego, CA, USA.
authors.forename: Annick
authors.initials: A
authors.lastname: Borquez
authors.affiliation: David Geffen School of Medicine, University of California, Los Angeles, CA, USA.|Fielding School of Public Health, University of California, Los Angeles, CA, USA.
authors.forename: Jeffrey D
authors.initials: JD
authors.lastname: Klausner
authors.affiliation: HIV Department, World Health Organization, Geneva, Switzerland.
authors.forename: Rachel
authors.initials: R
authors.lastname: Baggaley
authors.affiliation: Center for Public Health and Human Rights, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MA, USA.
authors.forename: Chris
authors.initials: C
authors.lastname: Beyrer
mesh_terms: D019380:Anti-HIV Agents / Q000627:therapeutic use*; D035843:Biomedical Research; D003362:Cost-Benefit Analysis; D005260:Female; D006078:Government Programs; D015658:HIV Infections / Q000188:drug therapy / Q000517:prevention & control*; D006291:Health Policy; D006801:Humans; D008297:Male; D011203:Poverty; D065129:Pre-Exposure Prophylaxis
chemical_list: D019380:Anti-HIV Agents
keywords: HIV; acceptability; combination prevention; health systems; implementation science; pre-exposure prophylaxis; program cost; scale-up