From the *Albert Einstein College of Medicine and Montefiore Medical Center, Bronx, NY; †The Population Council, New York, NY; ‡Albert Einstein Cancer Center, Bronx, NY; and §National Cancer Institute, National Institutes of Health, Bethesda, MD.
Sex Transm Dis. 2013 Dec;40(12):939-43. doi: 10.1097/OLQ.0000000000000040.
Applicator dye staining and ultraviolet (UV) light have been used in trials to measure adherence, but not in the setting of before and after sex gel dosing (BAT-24). This study was designed to determine if semen or presex gel dosing impacts the sensitivity and specificity of a dye stain assay (DSA) for measuring vaginal insertion of placebo-filled applicators with BAT-24 dosing.
Healthy monogamous couples received Microlax-type applicators (Tectubes, Åstorp, Sweden) filled with hydroxyethylcelluose placebo gel. Women were instructed to vaginally insert 1 dose of gel before and a second dose after sex and to return applicators within 48 hours after sex. Applicators were stained to detect semen, followed by UV then DSA, and scored by 2 readers. Positive and negative controls were randomly included in applicator batches.
Fifteen couples completed the study. Each woman returned at least 6 applicators over a 30-day period. The sensitivity for insertion of postsex applicators was higher for UV (97%) compared with DSA (90%), and the specificity was similar (≥96%). For presex applicators, the sensitivity and specificity were higher for DSA (100%) compared with UV testing (87% sensitivity, 96% specificity). Among returned postsex applicators, 95% tested positive by UV compared with 87% by DSA. Agreement between readers was significantly better on the presex applicators for DSA than for UV, and for postsex readings, agreement was less than half that for UV, although the results were not statistically significant.
Applicator tests are feasible for measuring adherence in trials with gel dosing before and after sex.
在评估药物依从性的临床试验中，常使用染剂染色和紫外光照射法，但在阴道凝胶用药前后（BAT-24）的研究中并未应用。本研究旨在评估在阴道凝胶用药前后，染剂染色法（DSA）测量安慰剂填充阴道给药器插入阴道的准确性，及其是否受精液或性交前阴道凝胶用药的影响。
健康、一夫一妻制的夫妇使用含有羟乙基纤维素的安慰剂凝胶，对 Tectubes（瑞典Åstorp）型 Microlax 给药器进行阴道给药。每位女性在性交前阴道给药 1 次，性交后阴道给药 2 次，并在性交后 48 小时内将给药器交回。使用染剂检测精液后，使用紫外光和 DSA 对给药器进行检测，由 2 名读者进行评分。阳性和阴性对照品随机加入到给药器批次中。
15 对夫妇完成了研究。每位女性在 30 天内至少交回 6 个给药器。对于插入性交后给药器的敏感性，紫外光（97%）优于 DSA（90%），特异性则相似（≥96%）。对于性交前给药器，DSA 的敏感性和特异性均高于紫外光检测（100%敏感，96%特异）。在交回的性交后给药器中，95%用紫外光检测阳性，87%用 DSA 检测阳性。对于 DSA，读者间的一致性明显优于 UV 检测，而对于性交后读数，其一致性不到 UV 检测的一半，尽管这一结果没有统计学意义。
在阴道凝胶用药前后的临床试验中，使用给药器检测法测量药物依从性是可行的。
