HIV Center for Clinical and Behavioral Studies, Psychiatric Institute, Columbia University, New York, NY, USA.
Division of Gender, Sexuality and Health, New York State Psychiatric Institute, 1051 Riverside Drive, New York, NY, 10032, USA.
AIDS Behav. 2023 Oct;27(10):3478-3486. doi: 10.1007/s10461-023-04063-7. Epub 2023 Apr 12.
Tenofovir diphosphate (TFV-DP) concentrations in dried blood spots (DBS) predict viral breakthrough, but their use remains understudied in real-world clinic settings. This pilot study examined acceptability, feasibility, and initial adherence outcomes of providing adherence feedback using TFV-DP concentrations on patient- and provider-levels in Cape Town, South Africa. We enrolled 60 persons with HIV (PWH) receiving tenofovir-containing ART attending a primary health clinic. They were randomized 1:1 to an intervention receiving TFV-DP concentration feedback by research staff vs. no feedback at monthly visits for 4 months. Acceptability among medical providers and level of clinical follow-up of TFV-DP results was examined. Patient acceptability was assessed descriptively. Mean electronic adherence (EA), as measured by WisePill device, and TFV-DP in DBS were compared between the two arms. All participants in the intervention group (100%) reported finding TFV-DP feedback helpful and 86% reported changing adherence behaviors. Medical providers indicated high acceptability of incorporating TFV-DP concentration feedback into the clinic, yet among 29 results < 1000 fmol/punch, only 2 were reviewed with no follow-up actions performed. In the intervention arm, mean TFV-DP concentrations were significantly higher (t = 2.5, p < .01) during follow-up and EA in upper quartile (96-100%) was greater compared to controls (x = 7.8, p ≤ .05). This study found high acceptability among patients for receiving adherence feedback based on TFV-DP concentrations. TFV-DP and EA data demonstrated greater adherence in the intervention group. Providers indicated high acceptability of incorporating TFV-DP feedback into the clinic, but few providers reviewed results, which could impact clinic-level feasibility.
替诺福韦二磷酸酯(TFV-DP)在干血斑(DBS)中的浓度可预测病毒突破,但在真实临床环境中,其应用仍研究不足。本研究通过在南非开普敦的一个初级保健诊所,从患者和医护人员两个层面评估了基于 TFV-DP 浓度为患者提供依从性反馈的可接受性、可行性和初步依从性结果。我们纳入了 60 名正在接受含替诺福韦的抗逆转录病毒治疗(ART)的艾滋病毒感染者(PWH)。他们被随机分为 1:1 组,在每月就诊时,干预组接受 TFV-DP 浓度反馈,对照组不接受反馈,持续 4 个月。我们评估了医护人员的接受程度和对 TFV-DP 结果的临床随访水平。患者的可接受性采用描述性评估。用 WisePill 设备测量的电子依从性(EA)和 DBS 中的 TFV-DP 进行了比较。干预组的所有参与者(100%)都表示发现 TFV-DP 反馈很有帮助,86%的参与者表示改变了依从行为。医护人员表示非常愿意将 TFV-DP 浓度反馈纳入诊所,但在 29 个结果<1000 fmol/打孔的情况下,只有 2 个进行了检查,但没有采取后续行动。在干预组中,在随访期间 TFV-DP 浓度明显更高(t=2.5,p<0.01),且依从性处于四分位上限(96-100%)的患者比例大于对照组(x=7.8,p≤0.05)。本研究发现,患者对基于 TFV-DP 浓度的依从性反馈的接受程度很高。TFV-DP 和 EA 数据表明,干预组的依从性更高。医护人员表示非常愿意将 TFV-DP 反馈纳入诊所,但很少有医护人员检查结果,这可能会影响诊所层面的可行性。