Uptake of genital mucosal sampling in HVTN 097, a phase 1b HIV vaccine trial in South Africa

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dc.contributor.authorLazarus, Erica Maxineen_ZA
dc.contributor.authorOtwombe, Kennedyen_ZA
dc.contributor.authorAdonis, Taniaen_ZA
dc.contributor.authorSebastian, Elaineen_ZA
dc.contributor.authorGray, Glendaen_ZA
dc.contributor.authorGrunenberg, Nicoleen_ZA
dc.contributor.authorRoux, Suritaen_ZA
dc.contributor.authorChurchyard, Gavinen_ZA
dc.contributor.authorInnes, Craigen_ZA
dc.contributor.authorLaher, Fatimaen_ZA
dc.date.accessioned2015-11-23T12:25:47Z
dc.date.available2015-11-23T12:25:47Z
dc.date.issued2014en_ZA
dc.description.abstractBecause sexual transmission of HIV occurs across mucosal membranes, understanding the immune responses of the genital mucosa to vaccines may contribute knowledge to finding an effective candidate HIV vaccine. We describe the uptake of rectal secretion, cervical secretion and seminal mucosal secretion sampling amongst volunteers in a Phase 1b HIV vaccine trial. Age at screening, gender, study site and the designation of the person conducting the informed consent procedure were collected for volunteers who screened for the HVTN 097 study. A total of 211 volunteers (54% female) were screened at three sites in South Africa: Soweto (n = 70, 33%), Cape Town (n = 68, 32%) and Klerksdorp (n = 73, 35%). Overall uptake of optional mucosal sampling amongst trial volunteers was 71% (n = 149). Compared to Cape Town, volunteers from Soweto and Klerksdorp were less likely to consent to sampling (Soweto OR 0.08 CI: 0.03-0.25 p<0.001 and Klerksdorp OR 0.13 CI: 0.04-0.41 p = 0.001). In contrast, volunteers over 25 years of age were 2.39 times more likely to consent than younger volunteers (CI: 1.13-5.08, p = 0.02). Further studies are required to better understand the cultural, demographic and sociobehavioral factors which influence willingness to participate in mucosal sampling in HIV prevention studies. Trial Registration ClinicalTrials.gov: NCT02109354en_ZA
dc.identifier.apacitationLazarus, E. M., Otwombe, K., Adonis, T., Sebastian, E., Gray, G., Grunenberg, N., ... Laher, F. (2014). Uptake of genital mucosal sampling in HVTN 097, a phase 1b HIV vaccine trial in South Africa. <i>PLoS One</i>, http://hdl.handle.net/11427/15286en_ZA
dc.identifier.chicagocitationLazarus, Erica Maxine, Kennedy Otwombe, Tania Adonis, Elaine Sebastian, Glenda Gray, Nicole Grunenberg, Surita Roux, Gavin Churchyard, Craig Innes, and Fatima Laher "Uptake of genital mucosal sampling in HVTN 097, a phase 1b HIV vaccine trial in South Africa." <i>PLoS One</i> (2014) http://hdl.handle.net/11427/15286en_ZA
dc.identifier.citationLazarus, E. M., Otwombe, K., Adonis, T., Sebastian, E., Gray, G., Grunenberg, N., ... & Laher, F. (2013). Uptake of genital mucosal sampling in HVTN 097, a phase 1b HIV vaccine trial in South Africa. PloS one, 9(11), e112303. doi:10.1371/journal.pone.0112303en_ZA
dc.identifier.ris TY - Journal Article AU - Lazarus, Erica Maxine AU - Otwombe, Kennedy AU - Adonis, Tania AU - Sebastian, Elaine AU - Gray, Glenda AU - Grunenberg, Nicole AU - Roux, Surita AU - Churchyard, Gavin AU - Innes, Craig AU - Laher, Fatima AB - Because sexual transmission of HIV occurs across mucosal membranes, understanding the immune responses of the genital mucosa to vaccines may contribute knowledge to finding an effective candidate HIV vaccine. We describe the uptake of rectal secretion, cervical secretion and seminal mucosal secretion sampling amongst volunteers in a Phase 1b HIV vaccine trial. Age at screening, gender, study site and the designation of the person conducting the informed consent procedure were collected for volunteers who screened for the HVTN 097 study. A total of 211 volunteers (54% female) were screened at three sites in South Africa: Soweto (n = 70, 33%), Cape Town (n = 68, 32%) and Klerksdorp (n = 73, 35%). Overall uptake of optional mucosal sampling amongst trial volunteers was 71% (n = 149). Compared to Cape Town, volunteers from Soweto and Klerksdorp were less likely to consent to sampling (Soweto OR 0.08 CI: 0.03-0.25 p<0.001 and Klerksdorp OR 0.13 CI: 0.04-0.41 p = 0.001). In contrast, volunteers over 25 years of age were 2.39 times more likely to consent than younger volunteers (CI: 1.13-5.08, p = 0.02). Further studies are required to better understand the cultural, demographic and sociobehavioral factors which influence willingness to participate in mucosal sampling in HIV prevention studies. Trial Registration ClinicalTrials.gov: NCT02109354 DA - 2014 DB - OpenUCT DO - 10.1371/journal.pone.0112303 DP - University of Cape Town J1 - PLoS One LK - https://open.uct.ac.za PB - University of Cape Town PY - 2014 T1 - Uptake of genital mucosal sampling in HVTN 097, a phase 1b HIV vaccine trial in South Africa TI - Uptake of genital mucosal sampling in HVTN 097, a phase 1b HIV vaccine trial in South Africa UR - http://hdl.handle.net/11427/15286 ER - en_ZA
dc.identifier.urihttp://hdl.handle.net/11427/15286
dc.identifier.urihttp://dx.doi.org/10.1371/journal.pone.0112303
dc.identifier.vancouvercitationLazarus EM, Otwombe K, Adonis T, Sebastian E, Gray G, Grunenberg N, et al. Uptake of genital mucosal sampling in HVTN 097, a phase 1b HIV vaccine trial in South Africa. PLoS One. 2014; http://hdl.handle.net/11427/15286.en_ZA
dc.language.isoengen_ZA
dc.publisherPublic Library of Scienceen_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 License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.en_ZA
dc.rights.holder© 2014 Lazarus et alen_ZA
dc.rights.urihttp://creativecommons.org/licenses/by/4.0en_ZA
dc.sourcePLoS Oneen_ZA
dc.source.urihttp://journals.plos.org/plosoneen_ZA
dc.subject.otherSecretionen_ZA
dc.subject.otherHIV vaccinesen_ZA
dc.subject.otherHIVen_ZA
dc.subject.otherSemenen_ZA
dc.subject.otherVaccinesen_ZA
dc.subject.otherHIV preventionen_ZA
dc.subject.otherImmune responseen_ZA
dc.subject.otherSouth Africaen_ZA
dc.titleUptake of genital mucosal sampling in HVTN 097, a phase 1b HIV vaccine trial in South Africaen_ZA
dc.typeJournal Articleen_ZA
uct.type.filetypeText
uct.type.filetypeImage
uct.type.publicationResearchen_ZA
uct.type.resourceArticleen_ZA
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