Matthews Lynn T, Bruxvoort Katia J, Jaggernath Manjeetha, Kriel Yolandie, Smith Patricia M, Haberer Jessica E, Bassler John, Bennett Kara, Psaros Christina, Bangsberg David R, Hurwitz Kathleen Wirth, Smit Jennifer A
Division of Infectious Diseases, University of Alabama at Birmingham Heersink School of Medicine.
University of Alabama at Birmingham, School of Public Health, Birmingham, AL, USA.
AIDS. 2025 Apr 1;39(5):508-518. doi: 10.1097/QAD.0000000000004090. Epub 2024 Dec 20.
We developed Healthy Families-PrEP to support perinatal women to use HIV prevention strategies.
Single-arm study to evaluate PrEP use among pregnant women exposed to the intervention.
We offered safer conception counselling, including TDF/FTC as PrEP with adherence support (Healthy Families-PrEP) for women planning for pregnancy in South Africa with a partner with HIV or unknown serostatus. Women completed pregnancy and HIV testing quarterly and were followed for 1 year or until pregnancy end. For those initiating PrEP, electronic pillcap data and plasma were collected. We described PrEP adherence by proportion of days with pillcap openings and proportion of women with detected (≥10ng/ml) plasma tenofovir.
From November 2017 to January 2020, 326 women with median age 24 years [interquartile range (IQR) 22-27] enrolled. Partner HIV-serostatus was unknown by 316 (97%). Over 3204 person-months of follow-up, 56 women became pregnant. Twenty-six women used PrEP during pregnancy and opened pillcaps on a mean of 53.1% [95% confidence interval (CI) 46.9-59.3%] of days. Plasma tenofovir was detected among 25, 15.4, and 12.5% of women providing samples during months 0-3, 4-6, and 7-9. No HIV seroconversions were observed.
We observed low-pregnancy incidence. Counselling may have encouraged delayed pregnancy plans; some women may have exaggerated pregnancy plans to enroll. About half of pregnant women used PrEP and took over half of doses by pillcap. Fewer than 25% had tenofovir detected, likely reflecting pregnancy-related pharmacokinetics and adherence challenges. High interest in pregnancy PrEP use highlights the need to optimize adherence support and prevention choice.
我们开发了“健康家庭-暴露前预防(PrEP)”项目,以支持围产期女性采用艾滋病病毒(HIV)预防策略。
单臂研究,评估接受干预的孕妇中PrEP的使用情况。
我们为南非有感染HIV或血清学状态不明伴侣且计划怀孕的女性提供更安全受孕咨询,包括将替诺福韦二吡呋酯(TDF)/恩曲他滨(FTC)作为PrEP并提供依从性支持(“健康家庭- PrEP”)。女性每季度进行妊娠和HIV检测,并随访1年或直至妊娠结束。对于开始使用PrEP的女性,收集电子药瓶盖数据和血浆。我们通过药瓶盖打开天数的比例以及血浆中替诺福韦检测到(≥10ng/ml)的女性比例来描述PrEP依从性。
2017年11月至2020年1月,326名年龄中位数为24岁[四分位间距(IQR)22 - 27]的女性入组。316名(97%)女性伴侣的HIV血清学状态不明。在超过3204人月的随访中,56名女性怀孕。26名女性在孕期使用PrEP,药瓶盖打开天数的平均值为53.1%[95%置信区间(CI)46.9 - 59.3%]。在第0 - 3个月、4 - 6个月和7 - 9个月提供样本的女性中,分别有25%、15.4%和12.5%检测到血浆替诺福韦。未观察到HIV血清转化。
我们观察到妊娠发生率较低。咨询可能促使妊娠计划推迟;一些女性可能夸大妊娠计划以入组。约一半的孕妇使用PrEP,且通过药瓶盖服用了超过一半的剂量。不到25%的人检测到替诺福韦,这可能反映了与妊娠相关的药代动力学和依从性挑战。对孕期使用PrEP的高度关注凸显了优化依从性支持和预防选择的必要性。