title: How informed is consent in vulnerable populations? Experience using a continuous consent process during the MDP301 vaginal microbicide trial in Mwanza, Tanzania.
abstract: BACKGROUND
  HIV prevention trials conducted among disadvantaged vulnerable at-risk populations in developing countries present unique ethical dilemmas. A key concern in bioethics is the validity of informed consent for trial participation obtained from research subjects in such settings. The purpose of this study was to investigate the effectiveness of a continuous informed consent process adopted during the MDP301 phase III vaginal microbicide trial in Mwanza, Tanzania.
  
  
  METHODS
  A total of 1146 women at increased risk of HIV acquisition working as alcohol and food vendors or in bars, restaurants, hotels and guesthouses have been recruited into the MDP301 phase III efficacy and safety trial in Mwanza. During preparations for the trial, participatory community research methods were used to develop a locally-appropriate pictorial flipchart in order to convey key messages about the trial to potential participants. Pre-recorded audio tapes were also developed to facilitate understanding and compliance with gel-use instructions. A comprehension checklist is administered by clinical staff to all participants at screening, enrolment, 12, 24, 40 and 50 week follow-up visits during the trial. To investigate women's perceptions and experiences of the trial, including how well participants internalize and retain key messages provided through a continuous informed consent process, a random sub-sample of 102 women were invited to participate in in-depth interviews (IDIs) conducted immediately after their 4, 24 and 52 week follow-up visits.
  
  
  RESULTS
  99 women completed interviews at 4-weeks, 83 at 24-weeks, and 74 at 52 weeks (a total of 256 interviews). In all interviews there was evidence of good comprehension and retention of key trial messages including that the gel is not currently know to be effective against HIV; that this is the key reason for conducting the trial; and that women should stop using gel in the event of pregnancy.
  
  
  CONCLUSIONS
  Providing information to trial participants in a focussed, locally-appropriate manner, using methods developed in consultation with the community, and within a continuous informed-consent framework resulted in high levels of comprehension and message retention in this setting. This approach may represent a model for researchers conducting HIV prevention trials among other vulnerable populations in resource-poor settings.
  
  
  BACKGROUND
  Current Controlled Trials ISRCTN64716212.
authors.affiliation: London School of Hygiene & Tropical Medicine, London, UK. a.vallely@uq.edu.au
authors.forename: Andrew
authors.initials: A
authors.lastname: Vallely
authors.forename: Shelley
authors.initials: S
authors.lastname: Lees
authors.forename: Charles
authors.initials: C
authors.lastname: Shagi
authors.forename: Stella
authors.initials: S
authors.lastname: Kasindi
authors.forename: Selephina
authors.initials: S
authors.lastname: Soteli
authors.forename: Natujwa
authors.initials: N
authors.lastname: Kavit
authors.forename: Lisa
authors.initials: L
authors.lastname: Vallely
authors.forename: Sheena
authors.initials: S
authors.lastname: McCormack
authors.forename: Robert
authors.initials: R
authors.lastname: Pool
authors.forename: Richard J
authors.initials: RJ
authors.lastname: Hayes
mesh_terms: D000282:Administration, Intravaginal; D000293:Adolescent; D000328:Adult; D019380:Anti-HIV Agents / Q000008:administration & dosage*; D000890:Anti-Infective Agents / Q000008:administration & dosage; D032882:Comprehension; D032984:Ethics, Research; D005260:Female; D005782:Gels; D015658:HIV Infections / Q000517:prevention & control*; D006801:Humans; D007258:Informed Consent / Q000941:ethics*; D011939:Mental Recall; D008698:Mesylates / Q000008:administration & dosage / Q000627:therapeutic use*; D008875:Middle Aged; D011795:Surveys and Questionnaires; D013636:Tanzania; D036302:Therapeutic Human Experimentation / Q000941:ethics*; D013997:Time Factors; D016896:Treatment Outcome; D035862:Vulnerable Populations; D055815:Young Adult
chemical_list: D019380:Anti-HIV Agents; D000890:Anti-Infective Agents; D005782:Gels; D008698:Mesylates; C011011:naphthalenesulfonic acid, polymer with formaldehyde