Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, 3535 Market St, 3rdFloor, Philadelphia, PA, 19104, USA.
Division of Men's Health, Desmond Tutu HIV Centre, University of Cape Town, Cape Town, South Africa.
Trials. 2022 May 24;23(1):441. doi: 10.1186/s13063-022-06400-y.
Sexually transmitted infections (STIs) during pregnancy are associated with adverse birth outcomes, including preterm birth, low birth weight, perinatal death, and congenital infections such as increased mother-to-child HIV transmission. Prevalence of STIs among pregnant women in South Africa remains high, with most women being asymptomatic for their infection(s). Unfortunately, most STIs remain undetected and untreated due to standard practice syndromic management in accordance with World Health Organization (WHO) guidelines. Although lab-based and point-of-care molecular tests are available, optimal screening strategies during pregnancy, their health impact, and cost-effectiveness are unknown.
We will implement a 3-arm (1:1:1) type-1 hybrid effectiveness-implementation randomized-controlled trial (RCT). We will enroll 2500 pregnant women attending their first antenatal care (ANC) visit for their current pregnancy at participating health facilities in Buffalo City Metro District, Eastern Cape Province, South Africa. Participants allocated to arms 1 and 2 (intervention) will receive GeneXpert® point-of-care diagnostic testing for Neisseria gonorrhoeae, Chlamydia trachomatis, and Trichomonas vaginalis, with same-day treatment for detected infection(s). Arm 1 will additionally receive a test-of-cure 3 weeks post-treatment, while Arm 2 will receive a repeat test at 30-34 weeks' gestation. Those allocated to Arm 3 will receive syndromic management (standard-of-care). The RE-AIM framework will be used to guide collection of implementation indicators to inform potential future scale up. Primary outcome measures include (1) frequency of adverse birth outcomes among study arms, defined by a composite measure of low birth weight and pre-term delivery, and (2) change in STI prevalence between baseline and birth outcome among intervention arms and compared to standard-of-care. Estimates and comparative costs of the different screening strategies relative to standard-of-care and the costs of managing adverse birth outcomes will be calculated. Cost-effectiveness will be assessed per STI and disability-adjusted life year averted.
This trial is the first RCT designed to identify optimal, cost-effective screening strategies that decrease the burden of STIs during pregnancy and reduce adverse birth outcomes. Demonstrating the impact of diagnostic screening and treatment, compared to syndromic management, on birth outcomes will provide critical evidence to inform changes to WHO guidelines for syndromic management of STIs during pregnancy.
ClinicalTrials.gov NCT04446611 . Registered on 25 June 2020.
性传播感染（STIs）在妊娠期间与不良出生结局相关，包括早产、低出生体重、围产期死亡和先天性感染，如母婴 HIV 传播增加。南非孕妇的 STI 患病率仍然很高，大多数感染无症状。不幸的是，由于根据世界卫生组织（WHO）指南进行的标准实践综合征管理，大多数 STI 仍然未被发现和未得到治疗。虽然有基于实验室和即时检测的分子检测，但在怀孕期间的最佳筛查策略、它们的健康影响和成本效益尚不清楚。
我们将实施一项 3 臂（1:1:1）1 型混合有效性实施随机对照试验（RCT）。我们将在南非东开普省布法罗城市都会区的参与卫生机构招募 2500 名参加当前妊娠第一次产前保健（ANC）就诊的孕妇。分配到臂 1 和 2（干预）的参与者将接受 GeneXpert®即时检测淋病奈瑟菌、沙眼衣原体和阴道毛滴虫，并对检测到的感染进行当日治疗。臂 1 将额外进行 3 周后的治愈测试，而臂 2 将在 30-34 周妊娠时进行重复测试。分配到臂 3 的参与者将接受综合征管理（标准护理）。RE-AIM 框架将用于指导实施指标的收集，以提供未来可能扩大规模的信息。主要结局指标包括（1）研究臂中不良出生结局的频率，定义为低出生体重和早产的复合指标，以及（2）干预臂中 STI 患病率在基线和出生结局之间的变化，并与标准护理进行比较。将计算不同筛查策略相对于标准护理的估计和相对成本以及管理不良出生结局的成本。将按每例 STI 和避免的残疾调整生命年来评估成本效益。
这项试验是首个旨在确定最佳、具有成本效益的筛查策略的 RCT，这些策略可降低妊娠期间 STI 的负担并减少不良出生结局。与综合征管理相比，证明诊断筛查和治疗对出生结局的影响将为 WHO 妊娠期间 STI 综合征管理指南的改变提供关键证据。
ClinicalTrials.gov NCT04446611。于 2020 年 6 月 25 日注册。
