Joseph Davey Dvora, Fynn Lauren, Rousseau Elzette, Macdonald Pippa, Leonard Bryan, Lebelo Keitumese, Kolisa Ande, Little Francesca, Bekker Linda-Gail
Division of Infectious Diseases, Geffen School of Medicine, University of California, Los Angeles, California, USA.
Desmond Tutu HIV Centre, Institute of Infectious Diseases and Molecular Medicine, University of Cape Town, Cape Town, South Africa.
J Int AIDS Soc. 2025 May;28(5):e26488. doi: 10.1002/jia2.26488.
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.
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.
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).
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.
暴露前预防（PrEP）服务与性传播感染（STI）诊断增加有关，这可能有助于PrEP的采用。我们假设即时检验（POC）的性传播感染检测和治疗将改善PrEP的启动和持续情况。
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、非盲法的随机对照试验。参与者按1:1随机分配至标准症状性性传播感染管理（SOC）组或针对沙眼衣原体、淋病奈瑟菌、梅毒和阴道毛滴虫（仅针对女性）的POC检测组。所有参与者均接受标准的艾滋病毒预防咨询，包括提供口服PrEP。主要结局是POC性传播感染检测与症状性管理对PrEP启动的影响；次要结局包括1个月和4个月时的持续情况（PrEP处方），在随机抽取的子集中通过干血斑（DBS）中替诺福韦二磷酸（TFV-DP）的二次分析进行验证。对DBS中的TFV-DP在一个子集中进行了分析。分析采用意向性分析，对年龄和性别进行了调整。
我们招募并随机分配了900名参与者（干预组452名；SOC组448名）。平均年龄为20.4岁（标准差 = 4.2）；48%为女性。在干预组中，435人接受了POC性传播感染检测（96%）；25%（435名接受检测者中的110名）被诊断患有≥1种性传播感染；84%接受了治疗。在SOC组中，7%的参与者报告了性传播感染症状（31人）；88%接受了治疗（27人）。总体而言，SOC组64%的参与者与干预组62%的参与者启动了PrEP（风险比 = 0.98，95%置信区间 = 0.88 - 1.08）。在干预组中，41%的人在1个月时持续使用PrEP，4个月时为25%，而在SOC组中分别为46%和19%（干预组调整后风险比 = 1.39；95%置信区间 = 0.93 - 2.09；p = 0.08）。在接受性传播感染治疗或症状性治疗的参与者中，77%启动了PrEP，而未治疗/未诊断者为60%（调整后风险比 = 1.14；95%置信区间 = 1.02 - 1.27）；4个月时持续使用PrEP的比例分别为19%和14%（性传播感染/症状性治疗组调整后风险比 = 1.
