title: Community and research staff collaboration for development of materials to inform microbicide study participants in Africa.
abstract: BACKGROUND
  Clinical trials of new vaginal products require careful communication with participants about trial requirements. Most microbicide trials have been multi-site studies conducted among women in sub-Saharan Africa, where literacy levels and understanding of scientific methods differ from those designing and conducting the trials. Microbicide trials require women to insert objects in their vagina and ensure they are present in the vagina during sex. For many women, this is a novel behaviour. These behaviours take place within the context of clinical trial participation, which is an additional novelty. Research teams must develop informational materials to help participants understand the clinical trial and input from local research staff and community members can improve the content and format of these materials.
  
  
  METHODS
  This paper discusses the development of illustrated materials developed for microbicide trial participants, presenting examples from two studies. In both studies, research staff and community advisory groups collaborated to review and revise materials.
  
  
  RESULTS
  Collaborative efforts revealed insights about how to convey information about clinical trial participation and microbicide use. These insights highlighted realities of the local context, details that might be misunderstood, illustrations of a sensitive nature and concerns about blood testing. In particular, information about blood testing and product use instructions required careful consideration. Although the research team anticipated needing advice on how best to convey information on these topics to participants, some aspects of potential participant concerns about these topics were also new to the research team. Community advisors and local research staff suggested better ways to convey this information, and provided guidance on how to use the materials.
  
  
  CONCLUSIONS
  The collaboration served to develop informational materials for microbicide trial participants. Furthermore, staff gained a better understanding of issues and concerns that could influence trial participation. A collaborative engagement process can provide important insights into local culture and knowledge beyond what is needed for development of clinical trial participant information materials. Research teams should be sensitive to this possibility, avail themselves of information and take appropriate action.
authors.affiliation: International Partnership for Microbicides, Silver Spring, MD, USA; cwoodsong@ipmglobal.org.
authors.forename: Cynthia
authors.initials: C
authors.lastname: Woodsong
authors.affiliation: Community Engagement Consultant, Cape Town, South Africa.
authors.forename: John Michael
authors.initials: JM
authors.lastname: Mutsambi
authors.affiliation: International Partnership for Microbicides, Paarl, South Africa.
authors.forename: Smangalisa
authors.initials: S
authors.lastname: Ntshele
authors.affiliation: TB/HIV Care Association, Cape Town, South Africa.
authors.forename: Peggy
authors.initials: P
authors.lastname: Modikoe
mesh_terms: D000282:Administration, Intravaginal; D000349:Africa; D017954:Africa South of the Sahara; D000891:Anti-Infective Agents, Local / Q000008:administration & dosage*; D044966:Anti-Retroviral Agents / Q000008:administration & dosage*; D018890:Chemoprevention / Q000379:methods*; D003299:Cooperative Behavior; D018562:Disease Transmission, Infectious / Q000517:prevention & control*; D005260:Female; D015658:HIV Infections / Q000517:prevention & control*; D058015:Health Communication / Q000379:methods*; D006801:Humans; D065129:Pre-Exposure Prophylaxis / Q000379:methods*; D012108:Research Personnel; D012111:Residence Characteristics
chemical_list: D000891:Anti-Infective Agents, Local; D044966:Anti-Retroviral Agents
keywords: community collaboration; microbicide trials; participant information materials