Hidden heterogeneity: Uncovering patterns of adherence in microbicide trials for HIV prevention.
Hidden heterogeneity: Uncovering patterns of adherence in microbicide trials for HIV prevention.
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DOI：
10.1371/journal.pone.0267011
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发表时间：
2022
期刊：
影响因子：
3.7
通讯作者：
Hayes, Richard
中科院分区：
文献类型：
--
作者：
Miller, Lori;Prieto Merino, David;Baisley, Kathy;Hayes, Richard
对阴道杀微生物剂凝胶预防艾滋病毒临床试验结果的解释取决于参与者的依从性。在抗逆转录病毒药物时代之前，杀微生物剂试验通过自我报告收集依从性数据，试验通常在主要结果手稿中报告试验人群的总体平均依从性。本研究首先试图确定是否可以从三个阴道杀微生物剂凝胶试验中识别出不同的粘附模式，使用自我报告的数据，如果可以，这些模式如何在试验中进行比较。第二个目标是探索哪些个人层面的因素与不同的依从性模式有关。本研究使用了以下三个阴道杀微生物剂临床试验的数据：HIV预防试验网络（HPTN） 035测试PRO 2000和Buffergel，杀微生物剂开发计划（MDP） 301测试PRO 2000，以及人口委员会的Carraguard研究，测试Carraguard凝胶。使用潜在类别分析（LCA）来识别使用凝胶的自我报告数据的依从性纵向模式。使用多项多变量逻辑回归来估计每个试验中与不同潜在依从性轨迹独立相关的因素的相对风险比，并在试验之间进行比较。该分析包括来自HPTN 035的2,282名女性（17-56岁），来自MDP 301的6238名女性（16-75岁）和来自Carraguard的6039名女性（16-73岁）。使用LCA，在每个试验中确定了3-4种不同的凝胶粘附模式；这些模式在所有试验中都是相似的。在所有试验中都确定了与依从性模式相关的因素。在三个试验中，年龄越大与凝胶使用的依从性轨迹一致。在两项试验中，参与者报告的伴侣对凝胶的负面反应与报告的不一致依从性的轨迹有关。在一些试验中，更多的基线报告的性伴侣或性行为与报告的不一致的依从性轨迹有关。试验地点的位置与所有试验中轨迹的隶属关系有关。LCA能够在使用自我报告数据的临床试验中识别杀微生物剂凝胶粘附模式。在这项研究中，与依从性模式相关的关键因素是参与者年龄、临床试验地点和伴侣对研究凝胶的反应。这些发现，特别是年龄和感知到的伴侣对该方法的反应，与非洲妇女的其他临床试验和规划推出的生物医学艾滋病毒预防方法的结果一致。这项研究提供了大量证据，表明女性需要更多的支持来驾驭她们与男性关系中的权力动态，以便她们能够成功地使用艾滋病毒预防方法。
Interpretation of clinical trial results testing vaginal microbicide gels for HIV prevention depends on participant adherence. Prior to the era of antiretrovirals, microbicide trials collected adherence data via self-report, and trials typically reported trial population adherence as overall averages in primary results manuscripts. This study first sought to determine if different patterns of adherence from three trials of vaginal microbicide gels could be identified, using self-reported data and if so, how those patterns compare across trials. The second objective was to explore which individual-level factors were associated with different adherence patterns. Data from the following three clinical trials of vaginal microbicides were used for this study: HIV Prevention Trials Network (HPTN) 035 testing PRO 2000 and Buffergel, the Microbicides Development Programme (MDP) 301 testing PRO 2000, and the Population Council’s Carraguard study, testing Carraguard gel. Latent Class Analysis (LCA) was used to identify longitudinal patterns of adherence using self-reported data about gel use. Multinomial multivariable logistic regression was used to estimate relative risk-ratios for factors which were independently associated with different latent adherence trajectories within each trial, and compared across trials. Included in this analysis are 2,282 women from HPTN 035 (age 17–56 years), 6238 women from MDP 301 (age 16–75 years), and 6039 women from Carraguard (age 16–73 years). Using LCA, 3–4 different patterns of gel adherence were identified in each trial; these patterns were similar across the trials. Factors associated with adherence patterns were identified in all trials. Older age was associated with the adherence trajectory that consistently reported gel use in three trials. Participant-reported negative reaction of partners to the gel was associated with trajectories that reported less consistent adherence in two trials. A greater number of baseline-reported sex partners or sex acts was associated with trajectories which reported less consistent adherence in some trials. Trial site location was associated with membership of trajectories in all trials. LCA was able to identify patterns of microbicide gel adherence in clinical trials that used self-reported data. Key factors associated with patterns of adherence in this study were participant age, clinical trial site location, and partner reaction to the study gel. These findings, in particular, age and perceived partner reaction to the method, are consistent with results from other clinical trials and programmatic rollout of biomedical HIV prevention methods for women in Africa. This study contributes to the body of evidence that women need more support to navigate power dynamics within their relationships with men so that they can successfully use HIV prevention methods.
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DOI：
10.1097/qai.0b013e3182a6b0be
发表时间：
2013-12-01
影响因子：
3.6
作者：
Kacanek, Deborah;Bostrom, Alan;van der Straten, Ariane
通讯作者：
van der Straten, Ariane
DOI：
10.1097/qad.0b013e32834541d9
发表时间：
2011-04-24
期刊：
AIDS (London, England)
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HIV Prevention Trials Network (HPTN) 035 Study Team
影响因子：
10.5
作者：
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通讯作者：
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DOI：
10.1097/qai.0000000000000525
发表时间：
2015-04-15
影响因子：
3.6
作者：
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通讯作者：
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影响因子：
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作者：
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