The Science of Being a Study Participant: FEM-PrEP Participants' Explanations for Overreporting Adherence to the Study Pills and for the Whereabouts of Unused Pills
The Science of Being a Study Participant: FEM-PrEP Participants' Explanations for Overreporting Adherence to the Study Pills and for the Whereabouts of Unused Pills
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DOI：
10.1097/qai.0000000000000525
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发表时间：
2015-04-15
影响因子：
3.6
通讯作者：
Van Damme, Lut
中科院分区：
文献类型：
--
作者：
Corneli, Amy L.;McKenna, Kevin;Van Damme, Lut
背景：由于依从性低，FEM-PrEP无法确定每天一次口服恩曲他滨/替诺福韦富马酸二异丙酯是否降低女性感染艾滋病毒的风险。自我报告的依从性很高，药片计数数据表明依从性很好。然而，药物浓度显示出避孕药的使用有限。我们对肯尼亚邦多和南非比勒陀利亚的前参与者进行了一项跟踪研究，以了解影响过度报告依从性的因素，并了解未使用药物的下落。方法：对88名参与者进行定性、半结构化访谈，对224名参与者进行定量、音频计算机辅助自访。结果：在音频计算机辅助自访中，31%(n=70)的人表示他们多报了服药依从性，主要原因是相信不服药会导致试验终止(69%，n=48)。相当大的比例(35%，n=78)承认丢弃了未使用的药片。很少有人承认把他们的药给了别人(4%，n=10)，更少的人承认给了艾滋病毒携带者(2%，n=5)。参与半结构化访谈的许多人表示，其他参与者曾数过药片，并从瓶子里取出药片，以示遵守。结论：尽管反复传达不遵守规定不会让员工不安的信息，但参与者承认报告不遵守规定的几个负面后果，这使得准确报告变得困难。在后续研究中，不安情绪仍在继续，因为许多人表示，他们在试验过程中没有过度报告。改进自我报告措施的努力应包括确定创造支持性环境的替代方法，使参与者能够放心地报告实际遵守情况。
Background: FEM-PrEP was unable to determine whether once-daily, oral emtricitabine/tenofovir disoproxil fumarate reduces the risk of HIV acquisition among women because of low adherence. Self-reported adherence was high, and pill-count data suggested good adherence. Yet, drug concentrations revealed limited pill use. We conducted a follow-up study with former participants in Bondo, Kenya, and Pretoria, South Africa, to understand factors that had influenced overreporting of adherence and to learn the whereabouts of unused pills.Methods: Qualitative, semistructured interviews were conducted with 88 participants, and quantitative, audio computer-assisted self-interviews were conducted with 224 participants. We used thematic analysis and descriptive statistics to analyze the qualitative and quantitative data, respectively.Results: In audio computer-assisted self-interviews, 31% (n = 70) said they had overreported adherence; the main reason was the belief that nonadherence would result in trial termination (69%, n = 48). A considerable percentage (35%, n = 78) acknowledged discarding unused pills. Few acknowledged giving their pills to someone else (4%, n = 10), and even fewer acknowledged giving them to someone with HIV (2%, n = 5). Many participants in the semistructured interviews said other participants had counted and removed pills from their bottles to appear adherent.Conclusions: Despite repeated messages that nonadherence would not upset staff, participants acknowledged several perceived negative consequences of reporting nonadherence, which made it difficult to report accurately. Uneasiness continued in the follow-up study, as many said they had not overreported during the trial. Efforts to improve self-reported measures should include identifying alternative methods for creating supportive environments that allow participants to feel comfortable reporting actual adherence.