Division of Infectious Diseases, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, CA, USA; Division of Epidemiology and Biostatistics, School of Public Health, University of Cape Town, Cape Town, South Africa; Department of Epidemiology, Fielding School of Public Health, University of California Los Angeles, Los Angeles, CA, USA.
Division of Epidemiology and Biostatistics, School of Public Health, University of Cape Town, Cape Town, South Africa.
Lancet HIV. 2024 Nov;11(11):e746-e755. doi: 10.1016/S2352-3018(24)00240-6.
When used effectively, oral pre-exposure prophylaxis (PrEP; tenofovir disoproxil fumarate and emtricitabine) prevents maternal HIV acquisition and reduces the risk of vertical transmission. Our study aimed to better understand PrEP initiation, continued use, and adherence in pregnant and postpartum women.
The PrEP in Pregnancy and Postpartum (PrEP-PP) study is a demonstration cohort study that enrolled pregnant women aged 16 years and older without HIV attending their first antenatal care visit in Cape Town, South Africa, between Aug 29, 2019, and Oct 10, 2021. Eligible, consenting women were followed up quarterly up to 12 months postpartum with regular HIV testing and offer of PrEP with ongoing adherence counselling. The primary outcome was distribution of women across the PrEP cascade (ie, initiation and continuation up to 12 months postpartum) with crude and adjusted hazard ratios (HRs). We also report on HIV incidence by pregnancy and postpartum status.
Overall, 1195 pregnant women were recruited and followed up (median age 26 years, IQR 23-31; median gestational age 21 weeks, IQR 15-31); 1009 (84·4%) started PrEP at enrolment. Among women who initiated PrEP at enrolment, 668 (67·5%) of 990 continued PrEP at the 1-month follow-up, 485 (49·9%) of 972 continued at 3 months, 392 (39·4%) of 994 at 6 months, and 275 (27·4%) of 1005 at 12 months. Of 186 women who did not accept PrEP at enrolment, 70 (37·6%) of 186 subsequently initiated PrEP. Overall, 200 (18·6%) of 1076 women continued PrEP at 12 months postpartum. Of 186 women who did not initiate PrEP at baseline, 70 (37·6%) subsequently initiated PrEP during the study. Factors associated with PrEP discontinuation up to 12 months postpartum included being married or cohabiting (adjusted HR 1·32, 95% CI 1·16-1·50), condomless sex since last visit (1·43, 1·23-1·65), reporting intimate partner violence (2·03, 1·59-2·59), or depression in the past 12 months (1·53, 1·14-2·05). Overall, 16 women seroconverted over 1673·8 woman-years (HIV incidence rate 0·96 per 100 woman-years, 95% CI 0·49-1·42); 14 discontinued PrEP use and two never initiated PrEP. HIV incidence was 0·28 per 100 woman-years during pregnancy (95% CI 0·22-0·33), and the incidence rate ratio was 1·77 per 100 woman-years (0·53-5·90) 0-6 months postpartum and 2·19 per 100 woman-years (0·61-7·83) 6-12 months postpartum compared with pregnant women.
There is an urgent need for the integration of PrEP into antenatal and postnatal care and interventions that address barriers to continued use, including targeted counselling during pregnancy and postpartum to reduce PrEP discontinuation.
National Institute of Mental Health and Fogarty International, US National Institutes of Health.
For the French translation of the abstract see Supplementary Materials section.
当有效使用时，口服暴露前预防（PrEP；富马酸替诺福韦二吡呋酯和恩曲他滨）可预防母婴艾滋病毒感染，并降低垂直传播的风险。我们的研究旨在更好地了解孕妇和产后妇女中 PrEP 的起始、持续使用和依从性。
PrEP 在妊娠和产后（PrEP-PP）研究是一项演示队列研究，招募了年龄在 16 岁及以上且没有艾滋病毒的孕妇，他们在 2019 年 8 月 29 日至 2021 年 10 月 10 日期间在南非开普敦首次接受产前护理。符合条件并同意的妇女每季度随访一次，直至产后 12 个月，定期进行 HIV 检测，并提供 PrEP 以及持续的依从性咨询。主要结局是 PrEP 级联中女性的分布（即开始和持续使用至产后 12 个月），采用粗和调整后的危险比（HR）进行报告。我们还报告了按妊娠和产后状况划分的 HIV 发病率。
总体而言，招募并随访了 1195 名孕妇（中位年龄 26 岁，IQR 23-31；中位妊娠周数 21 周，IQR 15-31）；1009 名（84.4%）在入组时开始 PrEP。在入组时开始 PrEP 的妇女中，668 名（67.5%）在 1 个月随访时继续使用 PrEP，972 名（49.9%）在 3 个月时继续使用，994 名（39.4%）在 6 个月时继续使用，1005 名（27.4%）在 12 个月时继续使用。在 186 名不接受入组时 PrEP 的妇女中，70 名（37.6%）随后开始使用 PrEP。总体而言，1076 名妇女中有 200 名（18.6%）在产后 12 个月时继续使用 PrEP。在 186 名基线时未开始 PrEP 的妇女中，70 名（37.6%）随后在研究期间开始使用 PrEP。与产后 12 个月时 PrEP 停药相关的因素包括已婚或同居（调整后的 HR 1.32，95%CI 1.16-1.50）、上次就诊后无保护性行为（1.43，1.23-1.65）、报告亲密伴侣暴力（2.03，1.59-2.59）或过去 12 个月抑郁（1.53，1.14-2.05）。总体而言，在 1673.8 名女性年中，有 16 名女性血清转化（HIV 发病率为 0.96/100 女性年，95%CI 0.49-1.42）；14 名妇女停止使用 PrEP，2 名妇女从未开始使用 PrEP。妊娠期间 HIV 发病率为 0.28/100 女性年（95%CI 0.22-0.33），发病率比值比为 1.77/100 女性年（0.53-5.90），产后 0-6 个月为 2.19/100 女性年（0.61-7.83），与孕妇相比。
迫切需要将 PrEP 纳入产前和产后护理，并采取措施解决持续使用的障碍，包括在妊娠和产后期间进行有针对性的咨询，以减少 PrEP 的停药。
美国国立心理健康研究所和福格蒂国际，美国国立卫生研究院。
