title: Formulating the Future Research Agenda for Postexposure Prophylaxis for HIV: Methodological Challenges and Potential Approaches.
abstract: BACKGROUND
  During a World Health Organization-convened Guideline Development Group meeting, recommendations for postexposure prophylaxis (PEP) for human immunodeficiency virus were made and research gaps identified.
  
  
  METHODS
  We used the PEP clinical management pathway and the Grading of Evidence, Assessment, Development and Evaluation (GRADE) system as a framework to formulate future research questions, describe the most feasible study design, and identify potential biases.
  
  
  RESULTS
  Three key study design formats were identified to address 12 research questions: (1) survey- and interview-driven research to identify barriers to access to PEP and related clinical care; (2) establishment of a global PEP registry to generate data to inform the choice of an optimal PEP drug regimen, record drug toxicities arising from specific PEP regimens, and track follow-up and linkage to care (including transition from PEP to preexposure prophylaxis); and (3) randomized controlled trials to determine the optimal adherence promotion strategies necessary for successful outcomes following PEP.
  
  
  CONCLUSIONS
  Positioning key clinical and programmatic research questions within the GRADE framework facilitates the formulation of an evidence-based research agenda and future revisions of guidelines.
authors.affiliation: Centre for Infectious Disease Epidemiology and Research, University of Cape Town, South Africa Department of Epidemiology and Biostatistics, University of California, San Francisco.
authors.forename: Nandi
authors.initials: N
authors.lastname: Siegfried
authors.affiliation: Department of HIV/AIDS, World Health Organization, Geneva, Switzerland.
authors.forename: Rachel L
authors.initials: RL
authors.lastname: Beanland
authors.affiliation: Centre for Infectious Disease Epidemiology and Research, University of Cape Town, South Africa Department of HIV/AIDS, World Health Organization, Geneva, Switzerland.
authors.forename: Nathan
authors.initials: N
authors.lastname: Ford
authors.affiliation: The Fenway Institute, Fenway Health Beth Israel Deaconess Medical Center, Boston, Massachusetts.
authors.forename: Kenneth H
authors.initials: KH
authors.lastname: Mayer
mesh_terms: D019380:Anti-HIV Agents / Q000627:therapeutic use*; D035843:Biomedical Research; D017408:Guidelines as Topic; D015658:HIV Infections / Q000517:prevention & control*; D006801:Humans; D056990:Post-Exposure Prophylaxis; D014944:World Health Organization
chemical_list: D019380:Anti-HIV Agents
keywords: GRADE; HIV; guidelines; postexposure prophylaxis; research agenda