Sithole Nsika, Govender Indira, Spinelli Matthew, Smit Theresa, Cibane Siyabonga, Zwane Mlungisi, Phakathi Njabulo, Krows Meighan, Nkosi Busisiwe, Seeley Janet, Barnabas Ruanne V, Siedner Mark J, Moshabela Mosa, Celum Connie, Grant Alison, Gandhi Monica, Shapiro Adrienne E
Africa Health Research Institute, Somkhele, South Africa.
London School of Hygiene & Tropical Medicine, London, UK.
J Int AIDS Soc. 2025 Jun;28(6):e26515. doi: 10.1002/jia2.26515.
Differentiated service delivery (DSD) models for HIV and tuberculosis (TB) care prioritize efficient resource allocation and targeted interventions, and benefit from accurate assessment of patients' antiretroviral therapy (ART) pill-taking status. Accurate ART use identification is essential for ensuring proper care transition services rather than unnecessary initiation. A point-of-care urine tenofovir (TFV) assay may identify undisclosed ART use in settings with high rates of TB and HIV coinfection.
A cohort of people living with HIV (PWH) presenting for routine care, including newly diagnosed and those returning to care, and reporting no ART use within 90 days, was enrolled in a clinic-based cross-sectional study of TB prevalence which tested for TB using sputum and urine-based TB tests in two clinics in KwaZulu-Natal, South Africa. CD4 counts were determined at the time of ART initiation, per national guidelines. A novel urine-based lateral flow assay (LFA) which detects TFV ingested within the past 4-7 days was used to assess ART use from thawed urine samples, which were collected concurrently with the self-report assessment. Conditional logistic regression models assessed predictors of ART non-disclosure.
Between 12/2021 and 5/2024, 404 PWH (40% male) reporting no recent ART use presented for ART initiation. TB testing identified 14 (3%) PWH with undiagnosed TB. Seventy-nine (20%) had detectable TFV in urine indicating undisclosed ART use, with a median CD4 count of 466 cells/mm (IQR 277-625) compared to 322 cells/mm (IQR 175-490, p = 0.001) in those without undisclosed ART use. In a multivariable model, undisclosed ART use was associated with older age, rural clinic site, higher CD4 count and having active TB, but not with gender, education or employment.
Among people presenting for HIV treatment initiation, 20% had evidence of ART use within 4-7 days by TFV urine LFA testing. Integration of point-of-care urine TFV assays into DSD models of HIV care may support providers to engage PWH about treatment challenges, address potential barriers to disclosure and facilitate seamless transfers between clinics. If successful, this strategy may reduce duplicative care entries and promote more efficient use of resources.
用于艾滋病病毒（HIV）和结核病（TB）治疗的差异化服务提供（DSD）模式优先考虑高效的资源分配和有针对性的干预措施，并受益于对患者抗逆转录病毒疗法（ART）服药状况的准确评估。准确识别ART的使用情况对于确保适当的护理过渡服务而非不必要的启动至关重要。即时检验尿液替诺福韦（TFV）检测可能会在TB和HIV合并感染率高的环境中识别出未披露的ART使用情况。
一组前来接受常规护理的HIV感染者（PWH），包括新诊断的患者和复诊患者，且报告在90天内未使用ART，被纳入一项基于诊所的TB患病率横断面研究，该研究在南非夸祖鲁-纳塔尔省的两家诊所使用痰液和尿液TB检测方法检测TB。根据国家指南，在开始ART时测定CD4细胞计数。一种新型的基于尿液的侧向流动分析（LFA）方法，用于检测过去4至7天内摄入的TFV，以评估解冻尿液样本中的ART使用情况，这些样本是在自我报告评估的同时收集的。条件逻辑回归模型评估了未披露ART使用情况的预测因素。
在2021年12月至2024年5月期间，404名报告近期未使用ART的PWH前来开始接受ART治疗。TB检测发现14名（3%）PWH患有未确诊的TB。79名（20%）尿液中可检测到TFV，表明存在未披露的ART使用情况，其CD4细胞计数中位数为466个细胞/mm³（四分位间距277 - 625），而未使用未披露ART的患者为322个细胞/mm³（四分位间距175 - 490，p = 0.001）。在多变量模型中，未披露的ART使用情况与年龄较大、农村诊所地点、较高的CD4细胞计数以及患有活动性TB有关，但与性别、教育程度或就业情况无关。
在前来开始接受HIV治疗的人群中，20%的人通过TFV尿液LFA检测显示在4至7天内有ART使用的证据。将即时检验尿液TFV检测纳入HIV护理的DSD模式可能会帮助医疗服务提供者与PWH讨论治疗挑战，解决披露的潜在障碍，并促进诊所之间的无缝转诊。如果成功，这一策略可能会减少重复的护理登记，并促进资源的更有效利用。
