Optimizing Pre-Exposure Antiretroviral Prophylaxis Adherence in Men Who Have Sex with Men: Results of a Pilot Randomized Controlled Trial of "Life-Steps for PrEP"
Optimizing Pre-Exposure Antiretroviral Prophylaxis Adherence in Men Who Have Sex with Men: Results of a Pilot Randomized Controlled Trial of "Life-Steps for PrEP"
复制标题
DOI：
10.1007/s10461-016-1606-4
复制
发表时间：
2017-05-01
影响因子：
4.4
通讯作者：
Mimiaga, Matthew J.
中科院分区：
文献类型：
--
作者：
Mayer, Kenneth H.;Safren, Steven A.;Mimiaga, Matthew J.
在多个疗效试验中，抗逆转录病毒暴露前预防（PrEP）已被证明可以减少HIV感染，但药物依从性至关重要，在一些研究中并未达到最佳效果。50名未感染艾滋病毒的高危男男性行为者（MSM）被随机分配到认知行为干预组或时间和会话匹配的比较咨询干预组。实验干预包括四个护士提供的初始阶段和两个基于Life-Steps的强化阶段，这是一种抗逆转录病毒治疗依从性干预。比较条件提供信息和支持性咨询。初步分析比较了3个月和6个月的依从性（Wisepill和替诺福韦的血浆水平）。对58名男男性行为者进行筛选，招募50名参与者。中位年龄38.2岁，86%为白人；64%的人完成了大学学业。两组的Wisepill依从性都很高，没有统计学差异。使用平均替代分析（即计算缺失变量），干预组6个月时血浆替诺福韦水平显著较高（p = 0.037），然而，在完整分析（即仅使用完成所有研究访问的人）中，随机化条件之间没有统计学上的显著差异。在认知行为（Life-Steps）和时间匹配的PrEP依从性咨询干预中，药物依从性很高，一些证据表明Life-Steps在该试点RCT中具有优势。有必要在一项完全有效的疗效试验中进行进一步评估，以评估该干预措施的稳健性。
Antiretroviral pre-exposure prophylaxis (PrEP) has been demonstrated to decrease HIV acquisition in multiple efficacy trials, but medication adherence is critical, and was suboptimal in several studies. Fifty HIV-uninfected at risk men who have sex with men (MSM) were randomized to a cognitive behavioral intervention condition or a time and session-matched comparison counseling intervention. The experimental intervention entailed four nurse-delivered initial and two booster sessions based on Life-Steps, an ART treatment adherence intervention. The comparison condition provided information and supportive counseling. The primary analyses compared adherence (Wisepill and tenofovir plasma levels) at 3 and 6 months. Fifty-eight MSM were screened to enroll 50 participants. Median age was 38.2 years old, 86% were white; 64% had completed college. Wisepill adherence was high in both groups, and not statistically different. Plasma tenofovir levels were significantly higher in the intervention group at 6 months using mean substitution analysis (i.e., computing missing variables) (p = 0.037), however, in the completer analyses (i.e., using only those completing all study visits), there were no statistically significant differences between randomization conditions. Medication adherence was high across a cognitive-behavioral (Life-Steps) and time-matched counseling intervention for PrEP adherence, with some evidence suggesting superiority of Life-Steps in this pilot RCT. Further evaluation in a fully powered efficacy trial is warranted to assess the robustness of this intervention.