Humphrey John M, Chepkemoi Audrey, Brown Steven, Carlucci James G, McPheron Molly, Kerich Caroline, Matelong Winnie, Kooreman Harold, McHenry Megan S, Bernard Caitlin, Kiano Marylydia, Musick Beverly S, Yiannoutsos Constantin T, Wools-Kaloustian Kara, Patel Rena C, Were Edwin
Department of Medicine, Indiana University School of Medicine, Indianapolis, Indiana, USA
Department of Pediatrics, Moi Teaching and Referral Hospital, Eldoret, Kenya.
BMJ Open. 2025 Apr 30;15(4):e092430. doi: 10.1136/bmjopen-2024-092430.
Pharmacovigilance (PV) systems to assess the safety of antiretroviral treatment used periconception and during pregnancy are lacking in low-resource settings with high HIV burdens, and strategies to guide their implementation are limited. We implemented the Measuring Adverse Pregnancy and Newborn Congenital Outcomes (MANGO) study in Kenya to address these gaps.
In MANGO, we ascertained delivery outcomes for pregnant women living with HIV (WLH) and not living with HIV (WNLH) enrolled in care at Moi Teaching and Referral Hospital (MTRH) through two cohorts: C1, a prospective cohort of 1:1 matched WLH and WNLH attending antenatal clinic; and C2, a cross-sectional cohort of all deliveries, including among those who did not attend antenatal clinic at MTRH.
24 205 deliveries were recorded from October 2020 to September 2023 (853 in C1 and 23 352 in C2). Median maternal age was 32 years, 4.5% were WLH and 2.6% of deliveries were stillbirths. Among liveborn infants, 17.2% were preterm (<37 weeks), and 15.1% were low birth weight (<2.5 kg). Prevalence of ≥1 major congenital abnormality was 73.9/10 000 births (47.7 in C1 and 76.1 in C2). Assessing implementation barriers/facilitators, lack of national PV policy was a barrier overcome through establishing partnerships with the Kenya Ministry of Health. The facility's size and complexity were barriers to newborn surface exam coverage overcome through staff training and cocreation of a standardised form for newborn surface exam documentation. High staff turnover was addressed by involving head nurses to champion implementation and incentivising staff participation with medical education credits. Use of audit/feedback cycles and focusing on PV as a way to improve care quality facilitated PV institutionalisation at MTRH.
The MANGO model is a multifaceted strategy with replicative potential in other settings. Research is needed to understand the model's opportunities for implementation in other settings.
在艾滋病毒负担高的资源匮乏地区，缺乏用于评估受孕期间和怀孕期间使用的抗逆转录病毒治疗安全性的药物警戒（PV）系统，且指导其实施的策略有限。我们在肯尼亚开展了测量不良妊娠和新生儿先天性结局（MANGO）研究，以填补这些空白。
在MANGO研究中，我们通过两个队列确定了在莫伊教学与转诊医院（MTRH）接受护理的感染艾滋病毒的孕妇（WLH）和未感染艾滋病毒的孕妇（WNLH）的分娩结局：队列C1，是1:1匹配的参加产前诊所的WLH和WNLH的前瞻性队列；队列C2，是所有分娩的横断面队列，包括那些未在MTRH参加产前诊所的产妇。
2020年10月至2023年9月记录了24205例分娩（C1中有853例，C2中有23352例）。产妇中位年龄为32岁，4.5%为WLH，2.6%的分娩为死产。在活产婴儿中，17.2%为早产（<37周），15.1%为低出生体重（<2.5千克）。≥1种主要先天性异常的发生率为73.9/10000例出生（C1中为47.7，C2中为76.1）。在评估实施障碍/促进因素时，缺乏国家PV政策是一个障碍，通过与肯尼亚卫生部建立伙伴关系得以克服。该机构的规模和复杂性是新生儿体表检查覆盖范围的障碍，通过工作人员培训和共同创建新生儿体表检查文件的标准化表格得以克服。通过让护士长带头实施并以医学教育学分激励工作人员参与，解决了工作人员流动率高的问题。使用审核/反馈循环并将PV作为提高护理质量的一种方式，促进了MTRH的PV制度化。
MANGO模式是一种多方面的策略，在其他环境中具有复制潜力。需要开展研究以了解该模式在其他环境中的实施机会。
