Upfold Michele, Grobler Anneke, Suleman Fatima, Mansoor Leila E
Centre for the AIDS Programme of Research in South Africa (CAPRISA), Doris Duke Medical Research Institute, UKZN, Private bag X7, Congella, 719 Umbilo Road, 2nd Floor, Durban, 4013, South Africa.
Discipline of Pharmaceutical Sciences, University of KwaZulu-Natal, Durban, South Africa.
AIDS Behav. 2017 Feb;21(2):462-469. doi: 10.1007/s10461-016-1465-z.
Accurate and objective measurement of adherence is critical in microbicide trials. We compared two applicator tests: visual inspection of returned empty tenofovir gel applicators (VIREA) and ultraviolet light (UVL) assessment in terms of sensitivity and specificity, and for concordance. Sensitivity and specificity analysis of 24 control applicators (12 known-inserted and 12 sham-inserted) at 4-months after receipt was 75.0 and 66.7 % for VIREA and 83.3 and 91.7 % for UVL, respectively. After an additional 3 months of storage sensitivity and specificity was 100 and 58.3 % for VIREA and 100 and 66.7 % for UVL, respectively. In January 2015, 1316 empty applicators were returned as used by 115 participants enrolled at one site in a randomized controlled trial. Assessment outcomes showed 78.8 % agreement between the techniques. Methods concurred that 22.0 % of the returned empty applicators appeared unused. By UVL assessment, 40.0 % of returned empty applicators had no evidence of vaginal insertion, translating to a potential 28.0 % less product used as compared to that returned as used by women. UVL assessment may be considered a more accurate and less subjective measure of adherence as compared to VIREA.
在杀微生物剂试验中，准确客观地测量依从性至关重要。我们比较了两种涂抹器测试方法：对返还的空替诺福韦凝胶涂抹器进行目视检查（VIREA）和紫外线（UVL）评估，比较其敏感性、特异性及一致性。在收到涂抹器4个月后，对24个对照涂抹器（12个已知已插入和12个假插入）进行敏感性和特异性分析，结果显示，VIREA的敏感性和特异性分别为75.0%和66.7%，UVL的敏感性和特异性分别为83.3%和91.7%。在额外储存3个月后，VIREA的敏感性和特异性分别为100%和58.3%，UVL的敏感性和特异性分别为100%和66.7%。2015年1月，在一项随机对照试验中，一个研究点的115名参与者返还了1316个用过的空涂抹器。评估结果显示，两种技术的一致性为78.8%。两种方法都认为，返还的空涂抹器中有22.0%看起来未被使用。通过UVL评估，40.0%返还的空涂抹器没有阴道插入的迹象，这意味着与女性返还的已使用产品相比，使用的产品可能少28.0%。与VIREA相比，UVL评估可能被认为是一种更准确、主观性更低的依从性测量方法。
