Evaluation of point-of-care diagnostics for sexually transmitted infection on oral PrEP initiation and persistence among young people in South Africa: a randomized controlled study

IF 4.6 1区医学 Q2 IMMUNOLOGY

Journal of the International AIDS Society Pub Date : 2025-05-12 DOI:10.1002/jia2.26488

Dvora Joseph Davey, Lauren Fynn, Elzette Rousseau, Pippa Macdonald, Bryan Leonard, Keitumese Lebelo, Ande Kolisa, Francesca Little, Linda-Gail Bekker

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Abstract

Introduction

Pre-exposure prophylaxis (PrEP) services are linked to increased sexually transmitted infection (STI) diagnoses, which may facilitate PrEP uptake. We hypothesized that point-of-care (POC) STI testing and treatment would improve PrEP initiation and persistence.

Methods

Between September 2023 and November 2024, we conducted a single-centre, open-label, unblinded, randomized controlled trial among adolescent girls and young women (15−29 years old) or male partners (any age). Participants were randomized 1:1 to standard syndromic STI management (SOC) or POC testing for C. trachomatis, N. gonorrhoeae, syphilis and T. vaginalis (women only). All participants received standard HIV prevention counselling, including the offer of oral PrEP. The primary outcome was effect of POC STI testing versus syndromic management on PrEP initiation; secondary outcomes included persistence at 1 and 4 months (PrEP prescription), verified in the secondary analysis of tenofovir diphosphate (TFV-DP) in dried blood spots (DBS) in a random subset. TFV-DP in DBS was analysed in a subset. Analysis was intention-to-treat, adjusted for age and sex.

Results

We enrolled and randomized 900 participants (452 in intervention; 448 in SOC). The mean age was 20.4 years (SD = 4.2); 48% were female. In the intervention arm, 435 received POC STI testing (96%); 25% (110 of 435 tested) were diagnosed with =>1 STIs; 84% were treated. In SOC, 7% of participants reported symptoms of STIs (31); 88% were treated (27). Overall, 64% of participants in SOC versus 62% in intervention-initiated PrEP (RR = 0.98, 95% CI = 0.88ng women and partners1.08). In the intervention, 41% persisted on PrEP at 1 month and 25% through 4 months, compared to 46% and 19%, respectively, in SOC (aRR intervention = 1.39; 95% CI = 0.93−2.09; p = 0.08). In participants treated for STIs or syndromically, 77% initiated PrEP versus 60% untreated/diagnosed (aRR = 1.14; 95% CI = 1.02−1.27); 19% versus 14% persisted on PrEP at 4 months (aRR STI/syndrome treated = 1.41; 95% CI = 0.79−2.51). Overall, 30% of 64 DBS had any TFV-DP levels present with no difference by study arm (RR = 0.74; 95% CI: 0.38−1.41).

Conclusions

POC STI testing did not increase PrEP initiation or 1-month persistence but showed a moderate association with 4-month persistence. STI treatment (syndromic or confirmed) was linked to higher PrEP uptake and persistence. Integrating STI management may improve PrEP persistence among youth.

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评价南非年轻人口服PrEP开始和持续的性传播感染的即时诊断：一项随机对照研究

暴露前预防（PrEP）服务与性传播感染（STI）诊断增加有关，这可能促进PrEP的吸收。我们假设护理点（POC）性传播感染检测和治疗将改善PrEP的启动和持久性。方法在2023年9月至2024年11月期间，我们在青春期女孩和年轻女性（15 - 29岁）或男性伴侣（任何年龄）中进行了一项单中心、开放标签、非盲、随机对照试验。参与者按1:1随机分为沙眼原体、淋病奈索菌、梅毒和阴道原索菌（仅限女性）的标准综合征性传播感染管理（SOC）或POC检测。所有参与者都接受了标准的艾滋病毒预防咨询，包括提供口服PrEP。主要结果是POC STI检测与综合征管理对PrEP启动的影响；次要结局包括1个月和4个月的持续时间（PrEP处方），在随机子集的干血斑（DBS）中进行替诺福韦二磷酸（ttfv - dp）的二次分析中得到证实。在一个子集中分析DBS患者的ttv - dp。分析是意向治疗，根据年龄和性别进行调整。结果我们招募并随机分配了900名参与者(干预组452人；448 （SOC）。平均年龄20.4岁（SD = 4.2）；48%是女性。在干预组，435人接受了POC STI检测（96%）；25%（435名测试者中的110名）被诊断为1性传播感染；84%得到了治疗。在SOC中，7%的参与者报告了性传播感染症状（31）；88%的患者得到治疗（27例）。总体而言，64%的SOC参与者与62%的干预启动PrEP参与者（RR = 0.98, 95% CI = 0.88，女性和伴侣1.08）。在干预中，41%的人在1个月时坚持PrEP， 25%坚持4个月，而在SOC中分别为46%和19% (aRR干预= 1.39；95% ci = 0.93−2.09；P = 0.08)。在接受性传播感染或综合征性治疗的参与者中，77%的人开始了PrEP，而60%的人未接受治疗/诊断(aRR = 1.14；95% ci = 1.02−1.27)；4个月时持续服用PrEP的比例分别为19%和14%(治疗后的aRR = 1.41；95% ci = 0.79−2.51)。总体而言，64名DBS患者中有30%存在ttv - dp水平，各研究组间无差异(RR = 0.74；95% ci: 0.38−1.41)。结论POC STI检测不会增加PrEP的开始或持续1个月，但与持续4个月有中等程度的关联。性传播感染治疗（综合征性或确诊性）与较高的PrEP摄取和持久性有关。整合性传播感染管理可提高青少年预防措施的持久性。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Journal of the International AIDS Society IMMUNOLOGY-INFECTIOUS DISEASES

CiteScore

8.60

自引率

10.00%

发文量

186

审稿时长

>12 weeks

期刊介绍： The Journal of the International AIDS Society (JIAS) is a peer-reviewed and Open Access journal for the generation and dissemination of evidence from a wide range of disciplines: basic and biomedical sciences; behavioural sciences; epidemiology; clinical sciences; health economics and health policy; operations research and implementation sciences; and social sciences and humanities. Submission of HIV research carried out in low- and middle-income countries is strongly encouraged.