P15-13. HVTN 503(Phambili) trial discontinuation of enrolment/vaccination: the impact on trial participant attitudes to vaccine trials and scientific research

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dc.contributor.authorMark, Den_ZA
dc.contributor.authorMiddelkoop, Ken_ZA
dc.contributor.authorRoux, Sen_ZA
dc.contributor.authorGray, Gen_ZA
dc.contributor.authorMlisana, Ken_ZA
dc.contributor.authorNchabaleng, Men_ZA
dc.contributor.authorChurchyard, Gen_ZA
dc.contributor.authorDe Bruyn, Gen_ZA
dc.contributor.authorLatka, Men_ZA
dc.contributor.authorMagagula, Den_ZA
dc.contributor.authorKublin, Jen_ZA
dc.contributor.authorAllen, Men_ZA
dc.contributor.authorBekker, Len_ZA
dc.contributor.authort NIAID HIV Vaccine Trials Networken_ZA
dc.date.accessioned2015-11-04T11:46:42Z
dc.date.available2015-11-04T11:46:42Z
dc.date.issued2009en_ZA
dc.description.abstractBackground: The HVTN 503/Phambili trial, a phase IIB study of the Merck Ad-5 HIV vaccine, suspended enrollment and vaccinations following results of the HVTN502/STEP study. Participants were notified of their treatment allocation and continue to be followed. We investigated the impact of the suspension on trial participants' attitudes towards HIV vaccine trials and scientific research. Methods: A self-administered questionnaire investigating knowledge and attitudes utilising a five-point likert scale, was administered 12–18 months post suspension at the 4 Phambili trial sites implementing the latest protocol. Results: Of 544 participants enrolled at 4 sites, 490 completed the questionnaire. 51% understood that vaccination, and 31% that enrolment had been permanently discontinued. Although 85% knew Phambili DSMB recommendations were based on results of the STEP study, only 51% knew that the results showed more infections in the vaccine arm. Although 90% knew they should continue protecting themselves against HIV, only 33% acknowledged trialists' concerns that the vaccine may make them more susceptible to HIV. Knowledge was similar across sites. 12% had tested for HIV antibodies outside of the trial before unblinding to establish their treatment allocation. 46% felt disappointed, angry or afraid, primarily because the vaccine would not prevent HIV in their community. 79% said they would engage in less risk behaviour. 94% thought the study team had made the correct decision by unblinding them and 96% thought site-participant communication was appropriate. 91% felt they made the right decision to enrol in Phambili and 91% planned to continue attending scheduled visits. 86% support scientific research and 80% would want to participate in future HIV vaccine. Conclusion: Despite site communications, knowledge levels were low. Importantly, most knew they should continue to protect themselves against HIV. Although almost half of participants reported negative feelings, most attitudes towards trial sites, scientific research and HIV vaccine trials were positive.en_ZA
dc.identifier.apacitationMark, D., Middelkoop, K., Roux, S., Gray, G., Mlisana, K., Nchabaleng, M., ... (2009). P15-13. HVTN 503(Phambili) trial discontinuation of enrolment/vaccination: the impact on trial participant attitudes to vaccine trials and scientific research. <i>Retrovirology</i>, http://hdl.handle.net/11427/14659en_ZA
dc.identifier.chicagocitationMark, D, K Middelkoop, S Roux, G Gray, K Mlisana, M Nchabaleng, G Churchyard, et al "P15-13. HVTN 503(Phambili) trial discontinuation of enrolment/vaccination: the impact on trial participant attitudes to vaccine trials and scientific research." <i>Retrovirology</i> (2009) http://hdl.handle.net/11427/14659en_ZA
dc.identifier.citationMark, D., Middelkoop, K., Roux, S., Gray, G., Mlisana, K., Nchabaleng, M., ... & Bekker, L. (2009). P15-13. HVTN 503 (Phambili) trial discontinuation of enrolment/vaccination: the impact on trial participant attitudes to vaccine trials and scientific research. Retrovirology, 6(Suppl 3), P214.en_ZA
dc.identifier.ris TY - Journal Article AU - Mark, D AU - Middelkoop, K AU - Roux, S AU - Gray, G AU - Mlisana, K AU - Nchabaleng, M AU - Churchyard, G AU - De Bruyn, G AU - Latka, M AU - Magagula, D AU - Kublin, J AU - Allen, M AU - Bekker, L AU - t NIAID HIV Vaccine Trials Network AB - Background: The HVTN 503/Phambili trial, a phase IIB study of the Merck Ad-5 HIV vaccine, suspended enrollment and vaccinations following results of the HVTN502/STEP study. Participants were notified of their treatment allocation and continue to be followed. We investigated the impact of the suspension on trial participants' attitudes towards HIV vaccine trials and scientific research. Methods: A self-administered questionnaire investigating knowledge and attitudes utilising a five-point likert scale, was administered 12–18 months post suspension at the 4 Phambili trial sites implementing the latest protocol. Results: Of 544 participants enrolled at 4 sites, 490 completed the questionnaire. 51% understood that vaccination, and 31% that enrolment had been permanently discontinued. Although 85% knew Phambili DSMB recommendations were based on results of the STEP study, only 51% knew that the results showed more infections in the vaccine arm. Although 90% knew they should continue protecting themselves against HIV, only 33% acknowledged trialists' concerns that the vaccine may make them more susceptible to HIV. Knowledge was similar across sites. 12% had tested for HIV antibodies outside of the trial before unblinding to establish their treatment allocation. 46% felt disappointed, angry or afraid, primarily because the vaccine would not prevent HIV in their community. 79% said they would engage in less risk behaviour. 94% thought the study team had made the correct decision by unblinding them and 96% thought site-participant communication was appropriate. 91% felt they made the right decision to enrol in Phambili and 91% planned to continue attending scheduled visits. 86% support scientific research and 80% would want to participate in future HIV vaccine. Conclusion: Despite site communications, knowledge levels were low. Importantly, most knew they should continue to protect themselves against HIV. Although almost half of participants reported negative feelings, most attitudes towards trial sites, scientific research and HIV vaccine trials were positive. DA - 2009 DB - OpenUCT DO - 10.1186/1742-4690-6-S3-P214 DP - University of Cape Town J1 - Retrovirology LK - https://open.uct.ac.za PB - University of Cape Town PY - 2009 T1 - P15-13. HVTN 503(Phambili) trial discontinuation of enrolment/vaccination: the impact on trial participant attitudes to vaccine trials and scientific research TI - P15-13. HVTN 503(Phambili) trial discontinuation of enrolment/vaccination: the impact on trial participant attitudes to vaccine trials and scientific research UR - http://hdl.handle.net/11427/14659 ER - en_ZA
dc.identifier.urihttp://hdl.handle.net/11427/14659
dc.identifier.urihttp://dx.doi.org/10.1186/1742-4690-6-S3-P214
dc.identifier.vancouvercitationMark D, Middelkoop K, Roux S, Gray G, Mlisana K, Nchabaleng M, et al. P15-13. HVTN 503(Phambili) trial discontinuation of enrolment/vaccination: the impact on trial participant attitudes to vaccine trials and scientific research. Retrovirology. 2009; http://hdl.handle.net/11427/14659.en_ZA
dc.language.isoengen_ZA
dc.publisherBioMed Central Ltden_ZA
dc.publisher.departmentDesmond Tutu HIV Centreen_ZA
dc.publisher.facultyFaculty of Health Sciencesen_ZA
dc.publisher.institutionUniversity of Cape Town
dc.rightsThis is an Open Access article distributed under the terms of the Creative Commons Attribution Licenseen_ZA
dc.rights.holder2009 Mark et al; licensee BioMed Central Ltd.en_ZA
dc.rights.urihttp://creativecommons.org/licenses/by/2.0en_ZA
dc.sourceRetrovirologyen_ZA
dc.source.urihttp://www.retrovirology.com/en_ZA
dc.subject.otherHIVen_ZA
dc.subject.otherVaccine Trialen_ZA
dc.subject.otherFuture HIV Vaccineen_ZA
dc.titleP15-13. HVTN 503(Phambili) trial discontinuation of enrolment/vaccination: the impact on trial participant attitudes to vaccine trials and scientific researchen_ZA
dc.typeJournal Articleen_ZA
uct.type.filetypeText
uct.type.filetypeImage
uct.type.publicationResearchen_ZA
uct.type.resourceArticleen_ZA
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