Pregnancy Incidence and Correlates during the HVTN 503 Phambili HIV Vaccine Trial Conducted among South African Women
Pregnancy Incidence and Correlates during the HVTN 503 Phambili HIV Vaccine Trial Conducted among South African Women
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DOI：
10.1371/journal.pone.0031387
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发表时间：
2012-04-19
期刊：
影响因子：
3.7
通讯作者：
Churchyard, Gavin J.
中科院分区：
文献类型：
--
作者：
Latka, Mary H.;Fielding, Katherine;Churchyard, Gavin J.
背景：艾滋病毒预防试验越来越多地在撒哈拉以南非洲进行。有感染艾滋病毒风险的妇女也有怀孕的风险。为了最大限度地提高安全性，女性同意在试验期间避免怀孕，但还是怀孕了。使用 HVTN 503/“Phambili”疫苗试验的数据，我们报告了疫苗接种期间和疫苗接种后的怀孕发生率，并确定了筛查时测量的与意外怀孕相关的因素。方法：为了参加试验，妇女同意并支持在第三次也是最后一次疫苗接种后 1 个月（“疫苗接种期”）（相当于随访的前 7 个月）避免怀孕。对各个研究组中未绝育的女性进行了分析。泊松回归比较了疫苗接种期间和之后的妊娠率。 Cox 比例风险回归确定了与首次怀孕的关联。结果：在 352 名女性中（中位年龄 23 岁；中位随访时间 1.5 年），总体怀孕率为 9.6/100 岁女性，接种疫苗期间和之后分别为 6.8/100 周和 11.3/100 周 [比率 = 0.60 (0.32-1.14)，p = 0.10]。在多变量分析中，符合以下条件的女性怀孕率降低： 参加现场提供避孕措施的场所 [HR = 0.43，95% CI (0.22-0.86)]；作为注射避孕药使用者 [HR = 0.37 (0.21-0.67)] 或作为持续安全套使用者（趋势）[HR = 0.54 (0.28-1.04)] 进入试验。与 HIV 状况未知的单身伴侣的女性相比，具有以下情况的女性怀孕率更高： 单身伴侣 HIV 阴性 [HR = 2.34(1.16-4.73)] 和； 2 名伴侣的 HIV 状况均未知 [HR = 4.42(1.59-12.29)]。具有以上 2 个危险因素的女性：吸食大麻、大量饮酒或在性行为中吸食其中任何一种，妊娠发生率都会增加 [HR = 2.66 (1.24-5.72)]。结论：可以在试验进入时对南非女性进行妊娠风险筛查。现场免费提供注射避孕剂并支持坚持使用安全套可能会减少怀孕事件。筛查应确定夫妻双方的药物使用、伴侣关系和艾滋病毒状况，以预防怀孕和艾滋病毒。
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.