title: Reasons for declining to enroll in a phase I and II HIV vaccine trial after randomization among eligible volunteers in Dar es Salaam, Tanzania.
abstract: BACKGROUND
  Recruitment, enrollment and retention of volunteers in an HIV vaccine trial is important in the efforts to ultimately develop a vaccine that can prevent new HIV infections. Following recruitment, some randomized individuals decline to be enrolled in an HIV vaccine trial. The reasons for such a decision are not well known. This article describes why individuals who were randomized in a phase I and II HIV vaccine trial in Dar es Salaam, Tanzania declined to be enrolled.
  
  
  METHODS
  Face-to-face interviews were conducted with 14 individuals (7 men and 7 women). Repeated readings of the 14 interview transcripts to look for reasons for declining to enroll in the trial were performed. Data was analyzed using the content analysis approach.
  
  
  RESULTS
  Informants expressed fear of the outcome of an experimental HIV vaccine in their lives. Unlike women, some men were concerned over the effect of the vaccine on their reproduction intentions. Women were concerned about the unknown effects of the vaccine in their bodies. Also, to a large extent, informants faced resistance from significant others such as fiancées, parents, relatives, and friends. Women were influenced by their potential intimate sexual partners; men were forbidden by their parents, and mothers had the most influential opinion.
  
  
  CONCLUSIONS
  Fear of the negative outcome of an experimental vaccine and resistance from significant others are the main reasons for declining to enroll in the HIV vaccine trial among eligible volunteers after randomization. The resistance from the significant others provides valuable guidance for designing future trials in Tanzania; for example, expanding the HIV vaccine trial education to the general population from the onset of the trial design.
authors.affiliation: Division of Global Health, Department of Public Health Sciences, Karolinska Institutet, Stockholm, Sweden. etarimo54@yahoo.co.uk
authors.forename: Edith A M
authors.initials: EA
authors.lastname: Tarimo
authors.forename: Anna
authors.initials: A
authors.lastname: Thorson
authors.forename: Thecla W
authors.initials: TW
authors.lastname: Kohi
authors.forename: Muhammad
authors.initials: M
authors.lastname: Bakari
authors.forename: Fred
authors.initials: F
authors.lastname: Mhalu
authors.forename: Asli
authors.initials: A
authors.lastname: Kulane
mesh_terms: D016915:AIDS Vaccines / Q000627:therapeutic use*; D000328:Adult; D000465:Algorithms; D015984:Causality; D017321:Clinical Trials, Phase I as Topic / Q000523:psychology / Q000706:statistics & numerical data; D017322:Clinical Trials, Phase II as Topic / Q000523:psychology / Q000706:statistics & numerical data; D005260:Female; D015658:HIV Infections / Q000453:epidemiology / Q000517:prevention & control* / Q000523:psychology; D006805:Human Experimentation / Q000706:statistics & numerical data; D006801:Humans; D007407:Interviews as Topic; D008297:Male; D016032:Randomized Controlled Trials as Topic / Q000523:psychology / Q000706:statistics & numerical data; D045808:Refusal to Participate / Q000523:psychology / Q000706:statistics & numerical data; D013636:Tanzania / Q000453:epidemiology; D016312:Treatment Refusal / Q000523:psychology / Q000706:statistics & numerical data; D055815:Young Adult
chemical_list: D016915:AIDS Vaccines