title: Fostering community understanding of sufficient benefit and early stopping for a phase 2B HIV prevention clinical trial in Africa.
abstract: BACKGROUND
  Most trials of interventions are designed to address the traditional null hypothesis of no benefit. VOICE, a phase 2B HIV prevention trial funded by NIH and conducted in Africa, is designed to assess if the intervention will prevent a substantial fraction of infections. Planned interim analysis may provide conclusive evidence against the traditional null hypothesis without establishing substantial benefit. At this interim point, the Data and Safety Monitoring Board would then face the dilemma of knowing the product has some positive effect, but perhaps not as great an effect as the protocol has declared necessary.
  
  
  OBJECTIVE
  In March 2008, NIH program staff recommended that the VOICE protocol team discuss the stopping rules with stakeholders prior to initiating the protocol. The goals of the workshop were to inform community representatives about the potential ethical dilemma associated with stopping rules and engage in dialogue about these issues. We describe the resulting community consultation and summarize the outcomes.
  
  
  METHODS
  A 2-day workshop was convened with the goal of having a clear and transparent consultation with the stakeholders around the question, 'Given emerging evidence that a product could prevent some infections, would the community support a decision to continue accruing to the trial?' Participants included research staff and community stakeholders. Lectures with visual aids, discussions, and exercises using interactive learning tasks were used, with a focus on statistics and interpreting data from trials, particularly interim data.
  
  
  RESULTS
  Results of oral and written evaluations by participants were reviewed. The feedback was mostly positive, with some residual confusion regarding statistical concepts. However, discussions with attendees later revealed that not all felt prepared to engage fully in the workshop.
  
  
  CONCLUSIONS
  This was the presenters' first experience facilitating a formal discussion with an audience that had no advanced science, research, or mathematics training. Community representatives' concern regarding speaking for their communities without consulting them also created a challenge for the workshop.
  
  
  CONCLUSIONS
  Open discussion around trial stopping rules requires that all discussants have an understanding of trial design concepts and feel a sense of empowerment to ask and answer questions. The VOICE CWG workshop was a first step toward the goal of open discussion regarding trial stopping rules and interim results for the study; however, ongoing education and dialogue must occur to ensure that all stakeholders fully participate in the process.
authors.affiliation: FHI, Research Triangle Park, Durham, NC, USA. rwhite@fhi.org
authors.forename: Rhonda
authors.initials: R
authors.lastname: White
authors.forename: Modesta
authors.initials: M
authors.lastname: Chileshe
authors.forename: Liza
authors.initials: L
authors.lastname: Dawson
authors.forename: Deborah
authors.initials: D
authors.lastname: Donnell
authors.forename: Sharon
authors.initials: S
authors.lastname: Hillier
authors.forename: Neetha
authors.initials: N
authors.lastname: Morar
authors.forename: Lisa
authors.initials: L
authors.lastname: Noguchi
authors.forename: Dennis
authors.initials: D
authors.lastname: Dixon
mesh_terms: D000349:Africa; D019380:Anti-HIV Agents / Q000627:therapeutic use; D017322:Clinical Trials, Phase II as Topic; D057239:Early Termination of Clinical Trials / Q000523:psychology*; D004493:Education; D015658:HIV Infections / Q000188:drug therapy / Q000517:prevention & control*; D006266:Health Education; D007722:Health Knowledge, Attitudes, Practice; D006293:Health Promotion; D006801:Humans; D009316:National Institutes of Health (U.S.); D012111:Residence Characteristics; D040241:Social Marketing; D057212:Therapeutic Equipoise; D013995:Time; D014481:United States
chemical_list: D019380:Anti-HIV Agents