Okello Phelix, Velloza Jennifer, Ogello Vallery, Owidi Emmah, Mogere Peter, Gakuo Stephen, Chakravarty Deepalika, Biwott Charlene, Chatterjee Purba, Mugo Nelly, Gandhi Monica, Ngure Kenneth
Partners in Health Research and Development, Center for Clinical Research, Kenya Medical Research Institute, Nairobi, Kenya.
Department of Medicine, University of California, San Franscisco (UCSF), San Franscisco, CA, USA.
AIDS Care. 2025 Feb;37(2):324-336. doi: 10.1080/09540121.2024.2444556. Epub 2024 Dec 28.
Objective measures of oral PrEP adherence - especially point-of-care (POC) measures that enable real-time assessment, intervention, and feedback - have the potential to improve adherence. Our team previously developed and validated a novel urine-based POC metric of PrEP adherence. In this study, we sought to determine whether this assay is acceptable and feasible among women taking PrEP and PrEP providers in Kenya. We conducted a trial comparing PrEP adherence counseling using the assay (intervention) versus standard-of-care counseling. We conducted in-depth interviews (IDIs) with intervention-arm participants (n = 20), and focus group discussions (n = 18) after the final (12-month) follow-up visit. We also conducted IDIs with purposively-sampled healthcare providers (HCPs) (n = 8) who administered the assay. The assay was highly acceptable among participants and HCPs as it was perceived to be accurate, could provide evidence of adherence, provides real-time results, and improves participant and provider relationship. HCPs reported that the assay facilitated counseling, seemed to increase adherence, and would be feasible to implement in routine care settings. Both participants and HCPs reported concerns about the assay related to the fear of being stigmatized for negative results, and test accessibility. Future studies should evaluate the impact of this novel test on adherence patterns over time in diverse populations.Trial registration: ClinicalTrials.gov identifier: NCT03935464.
口服暴露前预防(PrEP)依从性的客观测量方法——尤其是能够实现实时评估、干预和反馈的即时检测(POC)方法——有可能提高依从性。我们的团队之前开发并验证了一种基于尿液的新型PrEP依从性即时检测指标。在本研究中,我们试图确定该检测方法在肯尼亚服用PrEP的女性和PrEP提供者中是否可接受且可行。我们进行了一项试验,比较使用该检测方法的PrEP依从性咨询(干预组)与标准护理咨询。在最后一次(12个月)随访后,我们对干预组参与者(n = 20)进行了深入访谈(IDI),并进行了焦点小组讨论(n = 18)。我们还对有意抽样的实施该检测的医疗保健提供者(HCP)(n = 8)进行了IDI。该检测方法在参与者和HCP中高度可接受,因为他们认为其准确、能够提供依从性证据、能提供实时结果,并且改善了参与者与提供者之间的关系。HCP报告称该检测方法有助于咨询,似乎能提高依从性,并且在常规护理环境中实施是可行的。参与者和HCP都报告了对该检测方法的担忧,包括担心因检测结果为阴性而受到污名化以及检测的可及性。未来的研究应评估这种新型检测方法随时间推移对不同人群依从模式的影响。试验注册:ClinicalTrials.gov标识符:NCT03935464。
J Clin Tuberc Other Mycobact Dis. 2022-4-25
J Acquir Immune Defic Syndr. 2021-5-1