title: A Systematic Review of the Inclusion (or Exclusion) of Women in HIV Research: From Clinical Studies of Antiretrovirals and Vaccines to Cure Strategies.
abstract: BACKGROUND
  The effect of clinical interventions can differ because of sex/gender. Studies have shown that women are often under-represented in medical research. The aim of this systematic literature review was to characterize women's participation in HIV clinical studies of antiretroviral drugs (ARV), prophylactic vaccines (VAX), and curative strategies (CURE).
  
  
  METHODS
  Systematic PubMed searches were conducted to identify ARV, VAX, and CURE studies. Data were extracted on the number of women, date of publication, sources of funding, country of study, and trial phase. Correlates of female participation were assessed.
  
  
  RESULTS
  Women represented a median of 19.2% participants in ARV studies (387), 38.1% in VAX studies (53), and 11.1% in CURE studies (104). Funding source was not correlated with the proportion of female participants in VAX and CURE studies but was for ARV studies (P = 0.03). ARV trials funded by private noncommercial sources had the highest proportion of women, whereas publicly funded trials had the lowest female participation (median 16.7%). The median proportion of women in ARV trials that were fully or partially funded by the National Institutes of Health was significantly lower than the median in trials funded by other sources (19.6% vs. 22.3%, P = 0.001).
  
  
  CONCLUSIONS
  Although women comprise nearly half of people living with HIV, they continue to be under-represented in clinical studies. Despite federal policies that have been established to address this, our study shows that publicly funded ARV trials recruit even fewer women than other trials. There is an urgent need to ensure that HIV clinical studies consider sex/gender dimensions.
authors.affiliation: *Formerly International AIDS Society, Geneva, Switzerland; †Frontiers, Lausanne, Switzerland; ‡Krebsregister Bern, University of Bern, Switzerland; §World Health Organization, Geneva, Switzerland; ‖The Foundation for AIDS Research, New York, NY; ¶International AIDS Vaccine Initiative, New York, NY; #Department of Epidemiology & Biostatistics, University of California San Francisco, San Francisco, CA; and **Inforia, Geneva, Switzerland.
authors.forename: Mirjam J
authors.initials: MJ
authors.lastname: Curno
authors.forename: Samuela
authors.initials: S
authors.lastname: Rossi
authors.forename: Ioannis
authors.initials: I
authors.lastname: Hodges-Mameletzis
authors.forename: Rowena
authors.initials: R
authors.lastname: Johnston
authors.forename: Matt A
authors.initials: MA
authors.lastname: Price
authors.forename: Shirin
authors.initials: S
authors.lastname: Heidari
mesh_terms: D016915:AIDS Vaccines; D044966:Anti-Retroviral Agents / Q000627:therapeutic use*; D035843:Biomedical Research; D002986:Clinical Trials as Topic; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000517:prevention & control; D006801:Humans; D014481:United States
chemical_list: D016915:AIDS Vaccines; D044966:Anti-Retroviral Agents