2021-2022 年南非孕妇的性传播感染和 HIV 暴露前预防的即时检测：随机对照试验。

Point-of-care testing for sexually transmitted infections and HIV pre-exposure prophylaxis among pregnant women in South Africa, 2021-2022: randomised controlled trial.

机构信息

Division of Epidemiology and Biostatistics, School of Public Health, University of Cape Town Faculty of Health Sciences, Observatory, Western Cape, South Africa

Division of Epidemiology and Biostatistics, School of Public Health, University of Cape Town Faculty of Health Sciences, Observatory, Western Cape, South Africa.

出版信息

Sex Transm Infect. 2024 Feb 19;100(2):77-83. doi: 10.1136/sextrans-2023-055975.

DOI:10.1136/sextrans-2023-055975

PMID:38124133

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11106734/

Abstract

OBJECTIVE

Pregnant and postpartum women (PPW) in Southern Africa are at increased risk of acquiring HIV and curable sexually transmitted infections (STIs). Oral pre-exposure prophylaxis (PrEP) is safe and effective to use during pregnancy to reduce HIV acquisition and vertical transmission. Point-of-care (POC) STI testing can identify PPW at risk of HIV and facilitate risk-differentiated and person-centred counselling to improve PrEP initiation, persistence and adherence. We evaluated the impact of POC STI testing compared with STI syndromic management on PrEP outcomes among PPW in Cape Town, South Africa.

METHODS

The STI and PrEP in Pregnancy Study enrolled PPW without HIV and ≤34 weeks pregnant at their regular antenatal care visit with follow-up after 1 month. PPW were randomised to receive POC STI testing or STI syndromic management. PPW randomised to POC STI testing self-collected vaginal swabs for and (Cepheid GeneXpert) testing and were offered same-day treatment if diagnosed. We compared PrEP initiation at baseline, PrEP prescription refill at 1 month (persistence) and adherence through tenofovir-diphosphate detection in dried blood spots by randomisation arm. In a secondary analysis, we evaluated the association between an STI diagnosis (positive STI test or reporting STI symptoms) with PrEP outcomes.

RESULTS

We enrolled and randomised 268 pregnant women. Twenty-eight per cent of women were diagnosed with ≥1 STI. Overall, 65% of women initiated and 79% persisted on PrEP with no significant differences by randomisation arm. Secondary analysis demonstrated that an STI diagnosis (positive STI test or reporting STI symptoms) was associated with higher PrEP initiation (adjusted relative risk=1.28; 95% CI 1.08 to 1.52), controlling for arm, maternal and gestational age.

CONCLUSIONS

POC STI testing was not associated with PrEP initiation or persistence relative to syndromic management. However, improving STI diagnosis by supplementing syndromic management with POC STI testing could improve PrEP initiation among PPW.

TRIAL REGISTRATION NUMBER

NCT03902418; Clinical Trials.gov; 1 April 2019.

摘要

目的

南部非洲的孕妇和产后妇女（PPW）感染艾滋病毒和可治愈性传播感染（STI）的风险增加。在怀孕期间使用口服暴露前预防（PrEP）是安全有效的，可以降低艾滋病毒感染和垂直传播的风险。即时检测（POC）性传播感染检测可以识别有 HIV 感染风险的 PPW，并促进风险差异化和以人为本的咨询，以改善 PrEP 的启动、持续使用和坚持。我们评估了与性传播感染综合征管理相比，POC 性传播感染检测对南非开普敦的 PPW 的 PrEP 结局的影响。

方法

性传播感染和妊娠期间的 PrEP 研究纳入了在常规产前保健就诊时无 HIV 且怀孕≤34 周的 PPW，并在 1 个月后进行随访。PPW 被随机分配接受 POC STI 检测或性传播感染综合征管理。随机分配到 POC STI 检测的 PPW 自行采集阴道拭子进行和（Cepheid GeneXpert）检测，如果诊断出阳性，则提供当天治疗。我们通过随机分组比较基线时 PrEP 的启动、1 个月时 PrEP 处方的续配（持续使用）和通过随机分组的 tenofovir-二磷酸检测在干血斑中的药物依从性。在二次分析中，我们评估了 STI 诊断（阳性 STI 检测或报告 STI 症状）与 PrEP 结局之间的关联。

结果

我们共纳入并随机分配了 268 名孕妇。28%的女性被诊断出患有≥1 种 STI。总体而言，65%的女性开始使用 PrEP，79%的女性坚持使用 PrEP，随机分组组间无显著差异。二次分析表明，STI 诊断（阳性 STI 检测或报告 STI 症状）与 PrEP 的启动呈正相关（调整后的相对风险=1.28；95%CI 1.08 至 1.52），控制了手臂、产妇和胎龄的因素。