Baseline Predictors of High Adherence to a Coitally Dependent Microbicide Gel Based on an Objective Marker of Use: Findings from the Carraguard Phase 3 Trial
Baseline Predictors of High Adherence to a Coitally Dependent Microbicide Gel Based on an Objective Marker of Use: Findings from the Carraguard Phase 3 Trial
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DOI：
10.1007/s10461-015-1123-x
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发表时间：
2016-11-01
影响因子：
4.4
通讯作者：
Lahteenmaki，Pekka
中科院分区：
文献类型：
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作者：
Friedland，Barbara A.;Stoner，Marie;Lahteenmaki，Pekka
一项随机、安慰剂对照的Carraguard疗效试验无法证明女性感染艾滋病毒的风险降低，这可能部分是由于依从性低（平均42%的阴道性行为使用凝胶）。进行二次分析以了解与高依从性相关的基线因素（≥ 85%的性行为使用凝胶）。纳入了报告≥1次阴道性行为、返还≥1个打开的施源器和≥1次确定性入组后HIV检测的女性（N= 5990）。依从性估计为平均每周施用器插入（基于指示阴道插入的染料染色试验）/平均每周性行为（通过自我报告）的比率。多因素Logistic回归分析表明，性交频率、地点、避孕方法和性伴年龄差异对依从性有显著影响。平均而言，每周报告>1次且≤2次阴道性行为的女性的依从性是每周报告1次或更少阴道性行为的女性的一半[校正比值比（AOR）：0.48; 95% CI 0.38-0.61];来自西开普省的女性的依从性是来自KZN的女性的三分之一（AOR：0.31; 95% CI 0.23-0.41）;与使用注射避孕药的女性相比，使用任何其他方法或未使用任何方法的女性更有可能依从（AOR：1.30; 95% CI 1.04-1.63）;与伴侣年龄差距较大的女性更有可能遵守（AOR：1.03; 95% CI 1.01-1.05; p = 0.001）。尽管依从性较低，但总体而言，13%的参与者达到了近乎完美的依从性，这表明了一种依赖于性交的杀微生物剂的潜在利基。需要对性行为模式和艾滋病毒风险认知对产品可接受性和依从性的影响进行更多的研究，以改善正在进行的试验和最终推出产品时的咨询。
A randomized, placebo-controlled, efficacy trial of Carraguard was unable to demonstrate a reduction in women’s risk of HIV infection, which may have been due, in part, to low adherence (gel used in 42 % of vaginal sex acts, on average). A secondary analysis was undertaken to understand baseline factors associated with high adherence (gel used in ≥85 % of sex acts). Women who reported ≥1 vaginal sex act, returned ≥1 opened applicator, and had ≥1 conclusive post-enrollment HIV test (N= 5990) were included. Adherence was estimated as the ratio of average weekly applicator insertions (based on a dye stain assay indicating vaginal insertion)/average weekly sex acts (by self-report). Multivariate logistic regression modeling indicated that coital frequency, site, contraception, and partner age difference had a significant impact on adherence. Women reporting >1 and ≤2 vaginal sex acts per week, on average, were half as likely to be adherent as those reporting 1 vaginal sex act per week or less [adjusted odds ratio (AOR): 0.48; 95 % CI 0.38–0.61]; women from the Western Cape had one-third the odds of being adherent compared to women from KZN (AOR: 0.31; 95 % CI 0.23–0.41); compared to women using injectable contraception, women using any other or no method were more likely to be adherent (AOR: 1.30; 95 % CI 1.04–1.63); and women who had a larger age gap from their partners were more likely to be adherent (AOR: 1.03; 95 % CI 1.01–1.05; p = 0.001). Despite low adherence, overall, 13 % of participants achieved nearly perfect adherence, indicating a potential niche for a coitally dependent microbicide. More research is needed on the impact of sexual patterns and HIV risk perception on product acceptability and adherence to improve counseling in ongoing trials and when products are eventually introduced.