Factors Associated with Adherence and Concordance Between Measurement Strategies in an HIV Daily Oral Tenofovir/Emtricitibine as Pre-exposure Prophylaxis (Prep) Clinical Trial, Botswana, 2007-2010
Factors Associated with Adherence and Concordance Between Measurement Strategies in an HIV Daily Oral Tenofovir/Emtricitibine as Pre-exposure Prophylaxis (Prep) Clinical Trial, Botswana, 2007-2010
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DOI：
10.1007/s10461-014-0891-z
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发表时间：
2015-05-01
影响因子：
4.4
通讯作者：
Paxton, Lynn A.
中科院分区：
文献类型：
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作者：
Kebaabetswe, Poloko M.;Stirratt, Michael J.;Paxton, Lynn A.
本研究在博茨瓦纳口服暴露前预防疗效试验中检验了研究产品的依从性及其决定因素。在 1,219 名参与者中，根据服药数量和 3 天自我报告得出的平均依从率为 94%。在多变量模型中，服药计数依从性与不良事件（恶心、头晕、呕吐）（RR 0.98 95 % CI 0.98-1.00；p = 0.03）和副作用问题（RR 0.98 95 % CI 0.96-0.99；p = 0.01）显着相关。自我报告的依从性与 HIV 阳性伴侣（RR 1.02 95 % CI 1.00-1.04；p = 0.02）和弗朗西斯敦居住地（RR 0.98 95 % CI 0.96, 0.99；p = 0.0001）显着相关。可检测到的药物浓度与自我报告和药丸计数依从性显示出适度的关联，自我报告 100% 依从性的人的药物水平高于那些报告 < 100% 的人。最常见的遵守障碍包括补充延迟和其他物流挑战；手机闹钟提醒的使用是最常见的促进因素。
This study examined study product adherence and its determinants in the Botswana oral pre-exposure prophylaxis efficacy trial. Among the 1,219 participants, the mean adherence by pill count and 3-day self-report was 94 % for each. In multivariable models, pill count adherence was significantly associated with adverse events (nausea, dizziness, vomiting) (RR 0.98 95 % CI 0.98-1.00; p = 0.03) and side effect concerns (RR 0.98 95 % CI 0.96-0.99; p = 0.01). Self-reported adherence was significantly associated with having an HIV-positive partner (RR 1.02 95 % CI 1.00-1.04; p = 0.02) and Francistown residence (RR 0.98 95 % CI 0.96, 0.99; p = 0.0001). Detectable drug concentrations showed modest associations with self-report and pill count adherence, and drug levels were higher among those self-reporting 100 % adherence than those reporting < 100 %. Most common adherence barriers involved refill delays and other logistic challenges; cellphone alarm reminder use was the most common facilitator.