Pregnancy incidence and correlates during the HVTN 503 Phambili HIV vaccine trial conducted among South African women

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dc.contributor.authorLatka, Mary Hen_ZA
dc.contributor.authorFielding, Katherineen_ZA
dc.contributor.authorGray, Glenda Een_ZA
dc.contributor.authorBekker, Linda-Gailen_ZA
dc.contributor.authorNchabeleng, Maphoshaneen_ZA
dc.contributor.authorMlisana, Kolekaen_ZA
dc.contributor.authorNielson, Tanyaen_ZA
dc.contributor.authorRoux, Suritaen_ZA
dc.contributor.authorMkhize, Baningien_ZA
dc.contributor.authorMathebula, Matsontsoen_ZA
dc.date.accessioned2015-11-23T12:28:30Z
dc.date.available2015-11-23T12:28:30Z
dc.date.issued2012en_ZA
dc.description.abstractBACKGROUND: HIV prevention trials are increasingly being conducted in sub-Saharan Africa. Women at risk for HIV are also at risk of pregnancy. To maximize safety, women agree to avoid pregnancy during trials, yet pregnancies occur. Using data from the HVTN 503/"Phambili" vaccine trial, we report pregnancy incidence during and after the vaccination period and identify factors, measured at screening, associated with incident pregnancy. METHODS: To enrol in the trial, women agreed and were supported to avoid pregnancy until 1 month after their third and final vaccination ("vaccination period"), corresponding to the first 7 months of follow-up. Unsterilized women, pooled across study arms, were analyzed. Poisson regression compared pregnancy rates during and after the vaccination period. Cox proportional hazards regression identified associations with first pregnancy. RESULTS: Among 352 women (median age 23 yrs; median follow-up 1.5 yrs), pregnancy incidence was 9.6/100 women-years overall and 6.8/100 w-yrs and 11.3/100 w-yrs during and after the vaccination period, respectively [Rate Ratio = 0.60 (0.32-1.14), p = 0.10]. In multivariable analysis, pregnancy was reduced among women who: enrolled at sites providing contraception on-site [HR = 0.43, 95% CI (0.22-0.86)]; entered the trial as injectable contraceptive users [HR = 0.37 (0.21-0.67)] or as consistent condom users (trend) [HR = 0.54 (0.28-1.04)]. Compared with women with a single partner of HIV-unknown status, pregnancy rates were increased among women with: a single partner whose status was HIV-negative [HR = 2.34(1.16-4.73)] and; 2 partners both of HIV-unknown status [HR = 4.42(1.59-12.29)]. Women with 2 more of these risk factors: marijuana use, heavy drinking, or use of either during sex, had increased pregnancy incidence [HR = 2.66 (1.24-5.72)]. CONCLUSIONS: It is possible to screen South African women for pregnancy risk at trial entry. Providing injectable contraception for free on-site and supporting consistent condom use may reduce incident pregnancy. Screening should determine the substance use, partnering, and HIV status of both members of the couple for both pregnancy and HIV prevention. Trial Registration SA National Health Research Database DOH-27-0207-1539; Clinicaltrials.gov NCT00413725en_ZA
dc.identifier.apacitationLatka, M. H., Fielding, K., Gray, G. E., Bekker, L., Nchabeleng, M., Mlisana, K., ... Mathebula, M. (2012). Pregnancy incidence and correlates during the HVTN 503 Phambili HIV vaccine trial conducted among South African women. <i>PLoS One</i>, http://hdl.handle.net/11427/15288en_ZA
dc.identifier.chicagocitationLatka, Mary H, Katherine Fielding, Glenda E Gray, Linda-Gail Bekker, Maphoshane Nchabeleng, Koleka Mlisana, Tanya Nielson, Surita Roux, Baningi Mkhize, and Matsontso Mathebula "Pregnancy incidence and correlates during the HVTN 503 Phambili HIV vaccine trial conducted among South African women." <i>PLoS One</i> (2012) http://hdl.handle.net/11427/15288en_ZA
dc.identifier.citationLatka, M. H., Fielding, K., Gray, G. E., Bekker, L. G., Nchabeleng, M., Mlisana, K., ... & Churchyard, G. J. (2012). Pregnancy incidence and correlates during the HVTN 503 Phambili HIV vaccine trial conducted among South African women. PloS one, 7(4), e31387. doi:10.1371/journal.pone.0031387en_ZA
dc.identifier.ris TY - Journal Article AU - Latka, Mary H AU - Fielding, Katherine AU - Gray, Glenda E AU - Bekker, Linda-Gail AU - Nchabeleng, Maphoshane AU - Mlisana, Koleka AU - Nielson, Tanya AU - Roux, Surita AU - Mkhize, Baningi AU - Mathebula, Matsontso AB - BACKGROUND: HIV prevention trials are increasingly being conducted in sub-Saharan Africa. Women at risk for HIV are also at risk of pregnancy. To maximize safety, women agree to avoid pregnancy during trials, yet pregnancies occur. Using data from the HVTN 503/"Phambili" vaccine trial, we report pregnancy incidence during and after the vaccination period and identify factors, measured at screening, associated with incident pregnancy. METHODS: To enrol in the trial, women agreed and were supported to avoid pregnancy until 1 month after their third and final vaccination ("vaccination period"), corresponding to the first 7 months of follow-up. Unsterilized women, pooled across study arms, were analyzed. Poisson regression compared pregnancy rates during and after the vaccination period. Cox proportional hazards regression identified associations with first pregnancy. RESULTS: Among 352 women (median age 23 yrs; median follow-up 1.5 yrs), pregnancy incidence was 9.6/100 women-years overall and 6.8/100 w-yrs and 11.3/100 w-yrs during and after the vaccination period, respectively [Rate Ratio = 0.60 (0.32-1.14), p = 0.10]. In multivariable analysis, pregnancy was reduced among women who: enrolled at sites providing contraception on-site [HR = 0.43, 95% CI (0.22-0.86)]; entered the trial as injectable contraceptive users [HR = 0.37 (0.21-0.67)] or as consistent condom users (trend) [HR = 0.54 (0.28-1.04)]. Compared with women with a single partner of HIV-unknown status, pregnancy rates were increased among women with: a single partner whose status was HIV-negative [HR = 2.34(1.16-4.73)] and; 2 partners both of HIV-unknown status [HR = 4.42(1.59-12.29)]. Women with 2 more of these risk factors: marijuana use, heavy drinking, or use of either during sex, had increased pregnancy incidence [HR = 2.66 (1.24-5.72)]. CONCLUSIONS: It is possible to screen South African women for pregnancy risk at trial entry. Providing injectable contraception for free on-site and supporting consistent condom use may reduce incident pregnancy. Screening should determine the substance use, partnering, and HIV status of both members of the couple for both pregnancy and HIV prevention. Trial Registration SA National Health Research Database DOH-27-0207-1539; Clinicaltrials.gov NCT00413725 DA - 2012 DB - OpenUCT DO - 10.1371/journal.pone.0031387 DP - University of Cape Town J1 - PLoS One LK - https://open.uct.ac.za PB - University of Cape Town PY - 2012 T1 - Pregnancy incidence and correlates during the HVTN 503 Phambili HIV vaccine trial conducted among South African women TI - Pregnancy incidence and correlates during the HVTN 503 Phambili HIV vaccine trial conducted among South African women UR - http://hdl.handle.net/11427/15288 ER - en_ZA
dc.identifier.urihttp://hdl.handle.net/11427/15288
dc.identifier.urihttp://dx.doi.org/10.1371/journal.pone.0031387
dc.identifier.vancouvercitationLatka MH, Fielding K, Gray GE, Bekker L, Nchabeleng M, Mlisana K, et al. Pregnancy incidence and correlates during the HVTN 503 Phambili HIV vaccine trial conducted among South African women. PLoS One. 2012; http://hdl.handle.net/11427/15288.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© 2012 Latka 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.otherPregnancyen_ZA
dc.subject.otherFemale contraceptionen_ZA
dc.subject.otherVaccination and immunizationen_ZA
dc.subject.otherHIVen_ZA
dc.subject.otherVaccinesen_ZA
dc.subject.otherHIV preventionen_ZA
dc.subject.otherOral contraceptive therapyen_ZA
dc.subject.otherManagement of high-risk pregnanciesen_ZA
dc.titlePregnancy incidence and correlates during the HVTN 503 Phambili HIV vaccine trial conducted among South African womenen_ZA
dc.typeJournal Articleen_ZA
uct.type.filetypeText
uct.type.filetypeImage
uct.type.publicationResearchen_ZA
uct.type.resourceArticleen_ZA
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