P14-07. Offering new prevention modalities in HIV vaccine trials: experience with male circumcision in the Phambili trial

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dc.contributor.authorde Bruyn, Gen_ZA
dc.contributor.authorMlisana, Ken_ZA
dc.contributor.authorMetch, Ben_ZA
dc.contributor.authorChurchyard, Gen_ZA
dc.contributor.authorNchabeleng, Men_ZA
dc.contributor.authorBekker, Len_ZA
dc.contributor.authorRoux, Sen_ZA
dc.contributor.authorNaicker, Nen_ZA
dc.contributor.authorLatka, Men_ZA
dc.contributor.authorCorey, Len_ZA
dc.contributor.authorKublin, Jen_ZA
dc.contributor.authorGray, Gen_ZA
dc.date.accessioned2015-11-04T11:46:45Z
dc.date.available2015-11-04T11:46:45Z
dc.date.issued2009en_ZA
dc.description.abstractBackground: New prevention options will be added to the 'standard of prevention' offered in HIV vaccine efficacy trials as new methods prove effective. The HVTN503/Phambili trial was initiated in January 2007, shortly after results from 3 randomized controlled trials of male circumcision (MC) demonstrated that MC reduces the risk of HIV acquisition. Thus, HVTN503 investigators made plans to offer MC at no cost to enrolled male participants. Methods: All participants were informed of the benefits of MC as a component of HIV risk reduction counseling, including how and where MC could be accessed. One site offered on-site MC and the others provided referral to local services for men who requested MC. We present data on uptake of MC post-enrollment. Results: Prior to discontinuation of enrolment, 441 men joined the trial, of whom 312 (70.7%) were uncircumcised. Of these, 82 (26.3% of uncircumcised men) requested MC after enrolment. Uptake varied by site, being lower (70%) at the eThekwini site, the site with lowest baseline MC prevalence. Among 3 sites with intermediate baseline MC prevalence, uptake varied from 3.3 to 37.6%, being highest at the site providing MC on site. Uptake was similar in vaccine and placebo arms of the trial [42 (26.1%) vs. 40 (26.5%)]. There was no significant difference by arm in the timing of circumcision relative to randomization assignment being provided to participants following release of the STEP trial results [post-unblinding, vaccine 18 (42.9%) vs. placebo 13 (32.5%), p = 0.37]. Conclusion: MC, a new prevention modality, was offered as part of HIV prevention services in HVTN503. Uptake varied by provision of care model and inversely with baseline MC prevalence, but did not differ between treatment arms, and remained similar even after provision of treatment.en_ZA
dc.identifier.apacitationde Bruyn, G., Mlisana, K., Metch, B., Churchyard, G., Nchabeleng, M., Bekker, L., ... Gray, G. (2009). P14-07. Offering new prevention modalities in HIV vaccine trials: experience with male circumcision in the Phambili trial. <i>Retrovirology</i>, http://hdl.handle.net/11427/14660en_ZA
dc.identifier.chicagocitationde Bruyn, G, K Mlisana, B Metch, G Churchyard, M Nchabeleng, L Bekker, S Roux, et al "P14-07. Offering new prevention modalities in HIV vaccine trials: experience with male circumcision in the Phambili trial." <i>Retrovirology</i> (2009) http://hdl.handle.net/11427/14660en_ZA
dc.identifier.citationde Bruyn, G., Mlisana, K., Metch, B., Churchyard, G., Nchabeleng, M., Bekker, L., ... & Gray, G. (2009). P14-07. Offering new prevention modalities in HIV vaccine trials: experience with male circumcision in the Phambili trial. Retrovirology, 6(Suppl 3), 1-1.en_ZA
dc.identifier.ris TY - Journal Article AU - de Bruyn, G AU - Mlisana, K AU - Metch, B AU - Churchyard, G AU - Nchabeleng, M AU - Bekker, L AU - Roux, S AU - Naicker, N AU - Latka, M AU - Corey, L AU - Kublin, J AU - Gray, G AB - Background: New prevention options will be added to the 'standard of prevention' offered in HIV vaccine efficacy trials as new methods prove effective. The HVTN503/Phambili trial was initiated in January 2007, shortly after results from 3 randomized controlled trials of male circumcision (MC) demonstrated that MC reduces the risk of HIV acquisition. Thus, HVTN503 investigators made plans to offer MC at no cost to enrolled male participants. Methods: All participants were informed of the benefits of MC as a component of HIV risk reduction counseling, including how and where MC could be accessed. One site offered on-site MC and the others provided referral to local services for men who requested MC. We present data on uptake of MC post-enrollment. Results: Prior to discontinuation of enrolment, 441 men joined the trial, of whom 312 (70.7%) were uncircumcised. Of these, 82 (26.3% of uncircumcised men) requested MC after enrolment. Uptake varied by site, being lower (70%) at the eThekwini site, the site with lowest baseline MC prevalence. Among 3 sites with intermediate baseline MC prevalence, uptake varied from 3.3 to 37.6%, being highest at the site providing MC on site. Uptake was similar in vaccine and placebo arms of the trial [42 (26.1%) vs. 40 (26.5%)]. There was no significant difference by arm in the timing of circumcision relative to randomization assignment being provided to participants following release of the STEP trial results [post-unblinding, vaccine 18 (42.9%) vs. placebo 13 (32.5%), p = 0.37]. Conclusion: MC, a new prevention modality, was offered as part of HIV prevention services in HVTN503. Uptake varied by provision of care model and inversely with baseline MC prevalence, but did not differ between treatment arms, and remained similar even after provision of treatment. DA - 2009 DB - OpenUCT DO - 10.1186/1742-4690-6-S3-P195 DP - University of Cape Town J1 - Retrovirology LK - https://open.uct.ac.za PB - University of Cape Town PY - 2009 T1 - P14-07. Offering new prevention modalities in HIV vaccine trials: experience with male circumcision in the Phambili trial TI - P14-07. Offering new prevention modalities in HIV vaccine trials: experience with male circumcision in the Phambili trial UR - http://hdl.handle.net/11427/14660 ER - en_ZA
dc.identifier.urihttp://hdl.handle.net/11427/14660
dc.identifier.urihttp://dx.doi.org/10.1186/1742-4690-6-S3-P195
dc.identifier.vancouvercitationde Bruyn G, Mlisana K, Metch B, Churchyard G, Nchabeleng M, Bekker L, et al. P14-07. Offering new prevention modalities in HIV vaccine trials: experience with male circumcision in the Phambili trial. Retrovirology. 2009; http://hdl.handle.net/11427/14660.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 de Bruyn 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.otherMC Prevalenceen_ZA
dc.subject.otherHIV Vaccine Efficacy Trialen_ZA
dc.subject.otherMale Circumcisionen_ZA
dc.subject.otherHIV Risk Reductionen_ZA
dc.subject.otherHIV Prevention Serviceen_ZA
dc.subject.otherUncircumcised Manen_ZA
dc.subject.otherRisk Reduction Counselingen_ZA
dc.subject.otherHIV Acquisitionen_ZA
dc.titleP14-07. Offering new prevention modalities in HIV vaccine trials: experience with male circumcision in the Phambili trialen_ZA
dc.typeJournal Articleen_ZA
uct.type.filetypeText
uct.type.filetypeImage
uct.type.publicationResearchen_ZA
uct.type.resourceArticleen_ZA
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