title: Improving ethical and participatory practice for marginalized populations in biomedical HIV prevention trials: lessons from Thailand.
abstract: BACKGROUND
  This paper presents findings from a qualitative investigation of ethical and participatory issues related to the conduct of biomedical HIV prevention trials among marginalized populations in Thailand. This research was deemed important to conduct, as several large-scale biomedical HIV prevention trials among marginalized populations had closed prematurely in other countries, and a better understanding of how to prevent similar trial closures from occurring in the future was desired.
  
  
  METHODS
  In-depth key informant interviews were held in Bangkok and Chiang Mai, Thailand. Interviews were audio recorded, transcribed, translated and thematically analyzed. The Good Participatory Practice Guidelines for Biomedical HIV Prevention Trials (GPP) guided this work.
  
  
  RESULTS
  Fourteen interviews were conducted: 10 with policymakers, academic and community-based researchers and trial staff and four with representatives of non-governmental organizations (NGOs). Suggested ways to improve ethical and participatory practice centered on standards of HIV prevention, informed consent, communication and human rights. In particular, the need to overcome language and literacy differences was identified. Key informants felt communication was the basis of ethical understanding and trust within biomedical HIV prevention trial contexts, and thus fundamental to trial participants' ability to exercise free will.
  
  
  CONCLUSIONS
  Biomedical HIV prevention trials present opportunities for inclusive and productive ethical and participatory practice. Key informants suggested that efforts to improve practice could result in better relationships between research stakeholders and research investigative teams and by extension, better, more ethical participatory trials. This research took place in Thailand and its findings apply primarily to Thailand. However, given the universality of many ethical considerations, the results of this study can inform the improvement of ethical and participatory practice in other parts of the world where biomedical HIV prevention trials occur, and where clinical trials in marginalized populations continue.
authors.affiliation: Dalla Lana School of Public Health, University of Toronto, Toronto, Ontario, Canada; The CIHR Social Research Centre in HIV Prevention (SRC), Dalla Lana School of Public Health, University of Toronto, Toronto, Ontario, Canada.
authors.forename: Dan
authors.initials: D
authors.lastname: Allman
authors.affiliation: Sex Workers Project, Urban Justice Center, New York, New York, United States of America.
authors.forename: Melissa Hope
authors.initials: MH
authors.lastname: Ditmore
authors.affiliation: Thai AIDS Treatment Action Group (TTAG), Bangkok, Thailand.
authors.forename: Karyn
authors.initials: K
authors.lastname: Kaplan
mesh_terms: D002986:Clinical Trials as Topic / Q000941:ethics* / Q000379:methods* / Q000523:psychology; D015658:HIV Infections / Q000517:prevention & control*; D006801:Humans; D007407:Interviews as Topic; D009938:Organizations; D057766:Policy; D012108:Research Personnel; D012111:Residence Characteristics; D062487:Social Marginalization / Q000523:psychology; D013785:Thailand; D035502:Trust