title: Willingness to participate in HIV vaccine trials among men who have sex with men in Chennai and Mumbai, India: a social ecological approach.
abstract: BACKGROUND
  Recruitment of low- and middle-income country volunteers from most-at-risk populations in HIV vaccine trials is essential to vaccine development. In India, men who have sex with men (MSM) are at disproportionately high risk for HIV infection and an important population for trial recruitment. Investigations of willingness to participate (WTP) in HIV vaccine trials have focused predominantly on individual-level determinants. We explored multi-level factors associated with WTP among MSM in India.
  
  
  METHODS
  We conducted 12 focus groups (n = 68) with low socioeconomic MSM in Chennai and Mumbai, and 14 key informant interviews with MSM community leaders and service providers. Focus groups/interviews were recorded, transcribed and translated into English. Two bilingual investigators conducted thematic analysis using line-by-line coding and a constant comparative method, with member-checking by community representatives.
  
  
  RESULTS
  Factors associated with WTP were evidenced across the social ecology of MSM-social-structural: poverty, HIV-, sexual- and gender non-conformity stigma, institutionalized discrimination and government sponsorship of trials; community-level: endorsement by MSM community leaders and organizations, and fear of within-group discrimination; interpersonal: anticipated family discord, partner rejection, having financially-dependent family members and disclosure of same-sex sexuality; and individual-level: HIV vaccine trial knowledge and misconceptions, safety concerns, altruism and preventive misconception.
  
  
  CONCLUSIONS
  Pervasive familial, community and social-structural factors characteristic of the Indian sociocultural context may complicate individual-focused approaches to WTP and thereby constrain the effectiveness of interventions to support recruitment and retention in HIV vaccine trials. Interventions to reduce stigma and discrimination against MSM and people living with HIV, capacity-building of MSM community organizations and transparent communications tailored to the knowledge and educational level of local communities may support meaningful engagement of MSM in HIV vaccine trials. Vigilance in providing fair but not excessive compensation and healthcare benefits and in mitigating preventive misconception are warranted to support ethical conduct of trials among MSM in India.
authors.affiliation: Centre for Sexuality and Health Research and Policy, Chennai, India.
authors.forename: Venkatesan
authors.initials: V
authors.lastname: Chakrapani
authors.forename: Peter A
authors.initials: PA
authors.lastname: Newman
authors.forename: Neeti
authors.initials: N
authors.lastname: Singhal
authors.forename: Jhalak
authors.initials: J
authors.lastname: Jerajani
authors.forename: Murali
authors.initials: M
authors.lastname: Shunmugam
mesh_terms: D016915:AIDS Vaccines / Q000009:adverse effects / Q000191:economics / Q000276:immunology*; D000328:Adult; D000533:Altruism; D002947:Cities; D002986:Clinical Trials as Topic / Q000191:economics / Q000706:statistics & numerical data*; D003710:Demography; D004192:Discrimination, Psychological; D015658:HIV Infections / Q000453:epidemiology / Q000276:immunology / Q000517:prevention & control; D006679:HIV Seropositivity; D007722:Health Knowledge, Attitudes, Practice; D018451:Homosexuality, Male / Q000706:statistics & numerical data*; D006801:Humans; D007194:India / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D010358:Patient Participation / Q000706:statistics & numerical data*; D057545:Social Stigma; D018454:Spouses; D055815:Young Adult
chemical_list: D016915:AIDS Vaccines