Macphail Catherine, Delany-Moretlwe Sinead, Mayaud Philippe
Wits Reproductive Health and HIV Institute, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, South Africa.
Patient Prefer Adherence. 2012;6:579-88. doi: 10.2147/PPA.S30759. Epub 2012 Aug 14.
High levels of adherence in clinical trials are essential for producing accurate intervention efficacy estimates. Adherence to clinical trial products and procedures is dependent on the motivations that drive participants. Data are presented to document reasons for trial participation and adherence to daily aciclovir for HSV-2 and HIV-1 genital shedding suppression among 300 HIV-1/HSV-2 seropositive women in South Africa. In-depth interviews after exit from the trial with 31 randomly selected women stratified by age and time since HIV diagnosis confirmed high levels of adherence measured during the trial. Main reasons for trial participation were related to seeking high-quality health care, which explains high levels of adherence in both study arms. Concerns that women would abuse reimbursements, fabricate data, and share or dump pills were not corroborated. Altruism is not a primary motivator in these settings where access to quality services is an issue. This study provides further evidence that good adherence of daily medication is possible in developing countries, particularly where study activities resonate with participants or fill an unmet need.
在临床试验中保持高水平的依从性对于准确估计干预效果至关重要。对临床试验产品和程序的依从性取决于驱动参与者的动机。本文呈现的数据记录了南非300名HIV-1/HSV-2血清阳性女性参与试验的原因以及坚持每日服用阿昔洛韦以抑制HSV-2和HIV-1生殖器病毒脱落的情况。在试验结束后,对31名按年龄和自确诊HIV以来的时间分层随机选取的女性进行深入访谈,证实了试验期间所测得的高水平依从性。参与试验的主要原因与寻求高质量医疗保健有关,这解释了两个研究组中都有较高的依从性。关于女性会滥用报销、伪造数据以及分享或丢弃药丸的担忧并未得到证实。在这些获得优质服务存在问题的环境中,利他主义并非主要动机。这项研究进一步证明,在发展中国家,尤其是研究活动能引起参与者共鸣或满足未满足需求的地方,每日药物治疗的良好依从性是可能的。