title: Microbicides development programme: engaging the community in the standard of care debate in a vaginal microbicide trial in Mwanza, Tanzania.
abstract: BACKGROUND
  HIV prevention research in resource-limited countries is associated with a variety of ethical dilemmas. Key amongst these is the question of what constitutes an appropriate standard of health care (SoC) for participants in HIV prevention trials. This paper describes a community-focused approach to develop a locally-appropriate SoC in the context of a phase III vaginal microbicide trial in Mwanza City, northwest Tanzania.
  
  
  METHODS
  A mobile community-based sexual and reproductive health service for women working as informal food vendors or in traditional and modern bars, restaurants, hotels and guesthouses has been established in 10 city wards. Wards were divided into geographical clusters and community representatives elected at cluster and ward level. A city-level Community Advisory Committee (CAC) with representatives from each ward has been established. Workshops and community meetings at ward and city-level have explored project-related concerns using tools adapted from participatory learning and action techniques e.g. chapati diagrams, pair-wise ranking. Secondary stakeholders representing local public-sector and non-governmental health and social care providers have formed a trial Stakeholders' Advisory Group (SAG), which includes two CAC representatives.
  
  
  RESULTS
  Key recommendations from participatory community workshops, CAC and SAG meetings conducted in the first year of the trial relate to the quality and range of clinic services provided at study clinics as well as broader standard of care issues. Recommendations have included streamlining clinic services to reduce waiting times, expanding services to include the children and spouses of participants and providing care for common local conditions such as malaria. Participants, community representatives and stakeholders felt there was an ethical obligation to ensure effective access to antiretroviral drugs and to provide supportive community-based care for women identified as HIV positive during the trial. This obligation includes ensuring sustainable, post-trial access to these services. Post-trial access to an effective vaginal microbicide was also felt to be a moral imperative.
  
  
  CONCLUSIONS
  Participatory methodologies enabled effective partnerships between researchers, participant representatives and community stakeholders to be developed and facilitated local dialogue and consensus on what constitutes a locally-appropriate standard of care in the context of a vaginal microbicide trial in this setting.
  
  
  BACKGROUND
  Current Controlled Trials ISRCTN64716212.
authors.affiliation: London School of Hygiene & Tropical Medicine, Keppel Street, London WC1E 7HT, UK. a.vallely@uq.edu.au
authors.forename: Andrew
authors.initials: A
authors.lastname: Vallely
authors.forename: Charles
authors.initials: C
authors.lastname: Shagi
authors.forename: Shelley
authors.initials: S
authors.lastname: Lees
authors.forename: Katherine
authors.initials: K
authors.lastname: Shapiro
authors.forename: Joseph
authors.initials: J
authors.lastname: Masanja
authors.forename: Lawi
authors.initials: L
authors.lastname: Nikolau
authors.forename: Johari
authors.initials: J
authors.lastname: Kazimoto
authors.forename: Selephina
authors.initials: S
authors.lastname: Soteli
authors.forename: Claire
authors.initials: C
authors.lastname: Moffat
authors.forename: John
authors.initials: J
authors.lastname: Changalucha
authors.forename: Sheena
authors.initials: S
authors.lastname: McCormack
authors.forename: Richard J
authors.initials: RJ
authors.lastname: Hayes
mesh_terms: D000282:Administration, Intravaginal; D000293:Adolescent; D000328:Adult; D026683:Advisory Committees; D000890:Anti-Infective Agents / Q000008:administration & dosage*; D017326:Clinical Trials, Phase III as Topic; D003256:Community Participation / Q000639:trends*; D015195:Drug Design; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000517:prevention & control*; D006297:Health Services Accessibility / Q000639:trends; D006801:Humans; D011787:Quality of Health Care; D013636:Tanzania; D055815:Young Adult
chemical_list: D000890:Anti-Infective Agents