评价 Malawi 地区 HIV 暴露前预防对妊娠、婴儿和母婴健康结局影响的研究方案：PrIMO 研究。

Evaluating the impact of HIV pre-exposure prophylaxis on pregnancy, infant, and maternal health outcomes in Malawi: PrIMO study protocol.

机构信息

University of North Carolina (UNC) Project Malawi, P Bag A-104, Lilongwe, Malawi.

Department of Obstetrics and Gynecology, School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.

出版信息

BMC Public Health. 2024 Sep 27;24(1):2604. doi: 10.1186/s12889-024-20029-3.

DOI:10.1186/s12889-024-20029-3

PMID:39334032

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11437625/

Abstract

BACKGROUND

Incident HIV during the perinatal period significantly impedes elimination of Mother-to-Child HIV Transmission (eMTCT) efforts. Pre-Exposure Prophylaxis (PrEP) effectively reduces HIV acquisition, and new agents like injectable Cabotegravir (CAB-LA) offer potential advantages for pregnant and breastfeeding women. The Pregnancy, Infant, and Maternal health Outcomes (PrIMO) study will compare rates of composite adverse pregnancy outcomes, and infant adverse events, growth and neurodevelopment between mother-infant dyads receiving CAB-LA and those receiving oral PrEP in Malawi.

METHODS

PrIMO is an observational cohort study involving: (1) the development of a PrEP Pregnancy Registry for longitudinal surveillance of pregnant women on PrEP in Malawi; and (2) the enrolment of a prospective safety cohort of 621 pregnant women initiating oral PrEP or CAB-LA and their subsequent infants. The registry will include all women continuing or initiating PrEP during pregnancy across targeted sites in Lilongwe and Blantyre districts. The safety cohort will enrol a subset of those women and their infants from Bwaila District Hospital in Lilongwe, Malawi. We hypothesize that CAB-LA's safety will be comparable to daily oral PrEP regarding adverse pregnancy outcomes, maternal/infant adverse events, and infant development. Participants in the cohort will choose either oral PrEP or CAB-LA and will be followed until 52 weeks post-delivery. Safety data will be collected from all mother-infant pairs and qualitative interviews will be conducted with a subset of purposively selected women (n = 50) to assess the acceptability of each PrEP modality.

DISCUSSION

The PrIMO study will provide critical data on the safety of CAB-LA in pregnant and breastfeeding women and their infants. Results will guide clinical recommendations as the Malawi Ministry of Health prepares for the rollout of CAB-LA to this population. Evaluation of Registry implementation will inform its expansion to a nationwide safety monitoring system for PrEP use during pregnancy, with implications for similar systems in the region.

TRIAL REGISTRATION NUMBER

NCT06158126. The study was prospectively registered (5 December 2023) in ClinicalTrials.gov.

摘要

背景

围产期发生的艾滋病事件严重阻碍了母婴艾滋病传播的消除（eMTCT）工作。暴露前预防（PrEP）可有效降低艾滋病感染率，而像注射用卡替拉韦（CAB-LA）这样的新药物为孕妇和哺乳期妇女提供了潜在的优势。母婴健康结局（PrIMO）研究将比较接受 CAB-LA 和口服 PrEP 的母婴对复合不良妊娠结局和婴儿不良事件、生长和神经发育的发生率。

方法

PrIMO 是一项观察性队列研究，包括：（1）为在马拉维接受 PrEP 的孕妇建立 PrEP 妊娠登记册，进行纵向监测；（2）招募 621 名开始接受口服 PrEP 或 CAB-LA 的孕妇及其随后的婴儿，组成前瞻性安全队列。该登记册将包括在利隆圭和布兰太尔地区的目标地点继续或开始 PrEP 的所有孕妇。安全队列将从马拉维利隆圭的 Bwaila 区医院招募该研究的一部分妇女及其婴儿。我们假设 CAB-LA 的安全性与每日口服 PrEP 相比，在不良妊娠结局、母婴不良事件和婴儿发育方面是可比的。队列中的参与者将选择口服 PrEP 或 CAB-LA，并将随访至产后 52 周。将从所有母婴对收集安全性数据，并对一部分有目的选择的妇女（n=50）进行定性访谈，以评估每种 PrEP 方式的可接受性。