title: Frontline Health Service Providers' Perspectives on HIV Vaccine Trials among Female Sex Workers and Men Who Have Sex with Men in Karnataka, South India.
abstract: BACKGROUND
  Little qualitative research is available on the role of frontline health service providers (FHSPs) in the implementation of clinical trials, particularly in developing countries. This paper presents findings from a qualitative study about the perspectives of FHSPs on future HIV vaccine trials involving female sex workers (FSWs) and men who have sex with men (MSM) in three districts of Karnataka, India. In particular, we explore FHSPs' knowledge of and views on clinical trials in general, and examine their potential willingness to play a role if such trials were introduced or implemented in the region.
  
  
  METHODS
  A field team of four researchers from Karnataka-two of whom self-identified with FSW or MSM communities ("community researchers") and two with backgrounds in social work-conducted in-depth interviews with FHSPs. Including community researchers in the study helped to build rapport with FSW and MSM participants and facilitate in-depth discussions. A coding scheme for transcribed and translated data was developed using a framework analysis approach. Data was then analysed thematically using a combination of a priori and emergent codes.
  
  
  RESULTS
  Over half of FHSPs demonstrated limited knowledge or understanding of clinical trials. Despite reported skepticism around the testing of HIV vaccines in developing countries and concerns around potential side effects, most FHSPs strongly advocated for the implementation of HIV vaccine clinical trials in Karnataka. Further, most FHSPs expressed their willingness to be involved in future HIV vaccine clinical trials in varying capacities.
  
  
  CONCLUSIONS
  Given that FHSPs are often directly involved in the promotion of health and well-being of FSWs and MSM, they are well-positioned to play leadership, ethical, and communicative roles in future HIV vaccine trials. However, our findings reveal a lack of awareness of clinical trials among FHSP participants, suggesting an important area for capacity building and staff development before viable and ethical clinical trials can be set up in the region.
authors.affiliation: Centre for Multi-Disciplinary Development Research, Dharwad, Karnataka, India; Karnataka Health Promotion Trust, Bangalore, Karnataka, India.
authors.forename: Satyanarayana
authors.initials: S
authors.lastname: Ramanaik
authors.affiliation: Centre for Global Public Health, Department of Community Health Sciences, University of Manitoba, Winnipeg, Manitoba, Canada.
authors.forename: Leigh M
authors.initials: LM
authors.lastname: McClarty
authors.affiliation: Department of Communication, University of Texas at San Antonio, San Antonio, Texas, United States of America.
authors.forename: Shamshad
authors.initials: S
authors.lastname: Khan
authors.affiliation: Karnataka Health Promotion Trust, Bangalore, Karnataka, India; Centre for Global Public Health, Department of Community Health Sciences, University of Manitoba, Winnipeg, Manitoba, Canada.
authors.forename: B M
authors.initials: BM
authors.lastname: Ramesh
authors.affiliation: Centre for Global Public Health, Department of Community Health Sciences, University of Manitoba, Winnipeg, Manitoba, Canada.
authors.forename: Monika
authors.initials: M
authors.lastname: Doshi
authors.affiliation: Centre for Global Public Health, Department of Community Health Sciences, University of Manitoba, Winnipeg, Manitoba, Canada; Department of Medical Microbiology, University of Manitoba, Winnipeg, Manitoba, Canada.
authors.forename: Marissa L
authors.initials: ML
authors.lastname: Becker
authors.affiliation: Centre for Global Public Health, Department of Community Health Sciences, University of Manitoba, Winnipeg, Manitoba, Canada.
authors.forename: Robert R
authors.initials: RR
authors.lastname: Lorway
mesh_terms: D016915:AIDS Vaccines / Q000627:therapeutic use; D000328:Adult; D002986:Clinical Trials as Topic / Q000523:psychology*; D005260:Female; D015658:HIV Infections / Q000517:prevention & control* / Q000523:psychology; D007722:Health Knowledge, Attitudes, Practice; D006282:Health Personnel / Q000193:education / Q000523:psychology*; D018451:Homosexuality, Male; D006801:Humans; D007194:India; D008297:Male; D008875:Middle Aged; D060386:Sex Workers; D014611:Vaccination / Q000523:psychology*
chemical_list: D016915:AIDS Vaccines