Corneli Amy L, McKenna Kevin, Perry Brian, Ahmed Khatija, Agot Kawango, Malamatsho Fulufhelo, Skhosana Joseph, Odhiambo Jacob, Van Damme Lut
*Social and Behavioral Health Sciences, FHI 360, Durham, NC; †Setshaba Research Centre, Soshanguve, South Africa; ‡Impact Research and Development Organization, Kisumu, Kenya (Lut Van Damme is now with Bill & Melinda Gates Foundation, Seattle, WA); and §Clinical Science, FHI 260, Durham, NC.
J Acquir Immune Defic Syndr. 2015 Apr 15;68(5):578-84. doi: 10.1097/QAI.0000000000000525.
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.
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.
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.
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.
由于依从性低，女性暴露前预防（FEM-PrEP）无法确定每日一次口服恩曲他滨/替诺福韦酯富马酸盐是否能降低女性感染艾滋病毒的风险。自我报告的依从性很高，药片计数数据也表明依从性良好。然而，药物浓度显示实际服药量有限。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随访研究，以了解影响依从性报告过高的因素，并了解未使用药片的去向。
对88名参与者进行了定性的半结构化访谈，并对224名参与者进行了定量的音频计算机辅助自我访谈。我们分别使用主题分析和描述性统计来分析定性和定量数据。
在音频计算机辅助自我访谈中，31%（n = 70）的人表示他们过高报告了依从性；主要原因是认为不依从会导致试验终止（69%，n = 48）。相当一部分人（35%，n = 78）承认丢弃了未使用的药片。很少有人承认把药片给了别人（4%，n = 10），甚至更少有人承认把药片给了艾滋病毒感染者（2%，n = 5）。许多参与半结构化访谈的参与者表示，其他参与者会从药瓶中数出并取出药片，以显得依从。
尽管反复告知不依从不会让工作人员不安，但参与者承认报告不依从会带来一些负面后果，这使得准确报告变得困难。在随访研究中，这种不安情绪依然存在，因为许多人表示他们在试验期间没有过高报告。改进自我报告措施的努力应包括寻找替代方法，营造支持性环境，让参与者能够自在地报告实际依从情况。
