title: Motivations and concerns about adolescent tuberculosis vaccine trial participation in rural Uganda: a qualitative study.
abstract: BACKGROUND
  Research is being carried out to develop and test new potentially more effective tuberculosis vaccines. Among the vaccines being developed are those that target adolescents. This study explored the stakeholders' perceptions about adolescent participation in a hypothetical tuberculosis vaccine trial in Ugandan adolescents.
  
  
  METHODS
  Focus group discussions with adolescents, parents of infants and adolescents, and key informant interviews with community leaders and traditional healers were conducted.
  
  
  RESULTS
  The majority of the respondents expressed potential willingness to allow their children participate in a tuberculosis vaccine trial. Main motivations for potential participation would be being able to learn about health-related issues. Hesitations included the notion that trial participation would distract the youths from their studies, fear of possible side effects of an investigational product, and potential for being sexually exploited by researchers. In addition, bad experiences from participation in previous research and doubts about the importance of research were mentioned. Suggested ways to motivate participation included: improved clarity on study purpose, risks, benefits and better scheduling of study procedures to minimize disruption to participants' academic schedules.
  
  
  CONCLUSIONS
  Findings from this study suggest that the community is open to potential participation of adolescents in a tuberculosis vaccine trial. However, there is a need to communicate more effectively with the community about the purpose of the trial and its effects, including safety data, in a low-literacy, readily understood format. This raises a challenge to researchers, who cannot know all the potential effects of a trial product before it is tested.
authors.affiliation: Makerere University School of Public Health, Kampala, Uganda.
authors.forename: Esther
authors.initials: E
authors.lastname: Buregyeya
authors.affiliation: Institute of Global Health, Department of Public Health Sciences, Karolinska Institutet, Stockholm, Sweden.
authors.forename: Asli
authors.initials: A
authors.lastname: Kulane
authors.affiliation: Makerere University School of Public Health, Kampala, Uganda.
authors.forename: Juliet
authors.initials: J
authors.lastname: Kiguli
authors.affiliation: Makerere University School of Medicine, Kampala, Uganda.
authors.forename: Phillipa
authors.initials: P
authors.lastname: Musoke
authors.affiliation: Makerere University School of Medicine, Kampala, Uganda.
authors.forename: Harriet
authors.initials: H
authors.lastname: Mayanja
authors.affiliation: KNCV Tuberculosis Foundation. The Hague, Netherlands; Department of Global Health, Academic Medical Center, Amsterdam Institute of Global Health and Development, Amsterdam, Netherlands.
authors.forename: Ellen Maeve Hanlon
authors.initials: EM
authors.lastname: Mitchell
mesh_terms: D000293:Adolescent; D000328:Adult; D002986:Clinical Trials as Topic; D005260:Female; D017144:Focus Groups; D007722:Health Knowledge, Attitudes, Practice; D064368:Healthy Volunteers / Q000523:psychology*; D006801:Humans; D008297:Male; D009042:Motivation; D010290:Parents / Q000523:psychology; D010342:Patient Acceptance of Health Care; D012424:Rural Population; D014376:Tuberculosis / Q000517:prevention & control*; D032581:Tuberculosis Vaccines / Q000008:administration & dosage*; D014454:Uganda
chemical_list: D032581:Tuberculosis Vaccines
keywords: Uganda; Willingness to participate; adolescents; hypothetical tuberculosis vaccine; qualitative study; trial
references.citation: Int J Tuberc Lung Dis. 2004 Jan;8(1):151-5
references.pmid: 14974759
references.citation: IRB. 2006 May-Jun;28(3):1-6
references.pmid: 17036437
references.citation: Ann Trop Paediatr. 2000 Mar;20(1):5-10
references.pmid: 10824206
references.citation: Clin Infect Dis. 2000 Jun;30 Suppl 3:S271-5
references.pmid: 10875798
references.citation: BMC Pregnancy Childbirth. 2010;10:9
references.pmid: 20178626
references.citation: J Clin Invest. 2005 Jul;115(7):1681-7
references.pmid: 16007244
references.citation: AIDS Res Hum Retroviruses. 2006 Jun;22(6):491-5
references.pmid: 16796522
references.citation: Am J Respir Crit Care Med. 2010 Jun 15;181(12):1407-17
references.pmid: 20167847
references.citation: Public Health Action. 2013 Mar 21;3(1):31-7
references.pmid: 26392993
references.citation: Vaccine. 2008 Aug 26;26(36):4725-30
references.pmid: 18620015
references.citation: Trop Med Int Health. 2009 Feb;14(2):196-203
references.pmid: 19207177
references.citation: Int J Tuberc Lung Dis. 2011 Jul;15(7):938-42
references.pmid: 21682968
references.citation: Proc Natl Acad Sci U S A. 2009 Feb 17;106(7):2301-6
references.pmid: 19188599
references.citation: Subst Use Misuse. 2008;43(11):1640-52
references.pmid: 18752165
references.citation: Nat Med. 2004 Nov;10(11):1240-4
references.pmid: 15502839
references.citation: Vaccine. 2009 May 18;27(23):3063-71
references.pmid: 19428920
references.citation: J Gen Intern Med. 1999 Sep;14(9):537-46
references.pmid: 10491242
references.citation: Indian J Med Res. 2006 Dec;124(6):631-40
references.pmid: 17287550
references.citation: Nurse Educ Today. 2004 Feb;24(2):105-12
references.pmid: 14769454
references.citation: Am J Public Health. 2005 Mar;95(3):412-9
references.pmid: 15727968
references.citation: Br Med J (Clin Res Ed). 1986 Oct 25;293(6554):1065-8
references.pmid: 3094776
references.citation: Vaccine. 2005 Feb 3;23(11):1351-8
references.pmid: 15661383
references.citation: Clin Infect Dis. 2010 May 15;50 Suppl 3:S178-83
references.pmid: 20397946
references.citation: JAMA. 2004 Oct 6;292(13):1593-601
references.pmid: 15467062
references.citation: Malar J. 2010;9:86
references.pmid: 20346126
references.citation: JAMA. 1994 Mar 2;271(9):698-702
references.pmid: 8309034
references.citation: Cancer. 2001 Jan 1;91(1 Suppl):233-6
references.pmid: 11148585
references.citation: Fam Pract. 2004 Dec;21(6):636-42
references.pmid: 15528290