Division of Clinical Pharmacology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, 21287, USA.
Departments of Pathology and Medicine, Johns Hopkins University School of Medicine, 1800 Orleans St., Sheikh Zayed Tower, B1020-F, Baltimore, MD, 21287, USA.
AIDS Behav. 2019 Jan;23(1):252-258. doi: 10.1007/s10461-018-2211-5.
Evaluating the efficacy of any HIV prevention strategy is dependent on ensuring and objectively monitoring adherence to the intervention. Medicated rectal enemas are a potential method for providing topical, episodic HIV prophylaxis during receptive anal intercourse. Assessing adherence to recommended enema dosing regimens is essential in evaluating the utility of this strategy. We utilized fecal coliform bacteria on used enema tips as a marker for enema use. Enema tip coliforms were tested by repurposing a microtiter plate-based water quality test designed to detect fecal contamination of water. Coliform detection occurred with 100% sensitivity and specificity when tips were assayed on day of use. The assay performed well post-7 day sample storage at room temperature, yielding a sensitivity of 80% and specificity of 93%. All (n = 64) samples collected in a subset of the DREAM-01 rectal microbicide enema clinical trial tested positive, even when tips were evaluated > 7 days post-reported use. The coliform-based enema tip assay allows monitoring of adherence in interventions involving rectal enemas in a sensitive, specific and inexpensive manner. The test performs well in clinical trial settings.
评估任何 HIV 预防策略的疗效都取决于确保并客观监测对干预措施的依从性。经药物处理的直肠灌肠是在接受性肛交期间提供局部、间歇性 HIV 预防的一种潜在方法。评估对推荐的灌肠剂量方案的依从性对于评估该策略的实用性至关重要。我们利用用过的灌肠尖端上的粪便大肠菌群细菌作为灌肠使用的标志物。通过重新利用旨在检测水样粪便污染的基于微量滴定板的水质测试来测试灌肠尖端的大肠菌群。当在使用当天进行分析时，尖端的大肠菌群检测具有 100%的敏感性和特异性。在室温下储存 7 天后的样本进行检测，该检测的敏感性为 80%，特异性为 93%。在 DREAM-01 直肠杀微生物剂灌肠临床试验的一个亚组中收集的所有（n=64）样本均呈阳性，即使在报告使用后 7 天以上评估尖端也是如此。基于大肠菌群的灌肠尖端检测法以敏感、特异和廉价的方式监测直肠灌肠干预措施的依从性。该检测在临床试验环境中表现良好。
