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A qualitative study of participant adherence in a randomized controlled trial of herpes suppressive therapy for HIV prevention in Tanzania.

机译:坦桑尼亚在一项针对HIV预防的疱疹抑制性疗法的随机对照试验中,参加者依从性的定性研究。

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摘要

Poor participant adherence to treatment may contribute to lack of impact in some biomedical HIV prevention trials. This qualitative study explored adherence in a randomized controlled trial of herpes suppressive therapy to reduce HIV acquisition and infectivity among 1305 Tanzanian women. The trial found participants completed 72% of visits on treatment; 52-56% of women on treatment had > or = 90% adherence by pill count estimate; and between six and nine months 30/86 (35%) of urine samples from acyclovir recipients tested acyclovir negative, and 7/86 (8%) from placebo recipients tested acyclovir positive. Twenty in-depth interviews (IDIs) were conducted after 30 months with respondents randomly selected from "acyclovir negative" acyclovir recipients and "acyclovir positive" placebo recipients, or by preliminary pill count adherence categories ("under users," "good users," and "over users"). Almost all respondents reported appropriate adherence and positive trial attitudes, e.g., trusting staff, appreciating services, perceiving pills as beneficial. Fourteen understood placebo use, and six understood the trial purpose. Notably, 5/9 acyclovir recipients and 1/11 placebo recipients believed their pills had treated pre-existing sexually transmitted infections. Limited understanding did not negatively affect reported adherence. Reported adherence problems usually related to illness, travel, and/or family obligations (e.g., husband's disapproval). Acyclovir positive The IDIs also did not resolve discrepant reports of pill loss or theft. Biomedical HIV interventions often have strong behavioral components that require close attention during intervention development, trial design, and process and impact evaluation. This study identified topics which warrant further consideration, including: information reinforcement and comprehension assessment throughout a trial for long-term participant understanding; involving partners in adherence promotion activities; strategizing with participants to maintain adherence during familial illnesses or other crises; and close monitoring, identification, and follow-up of (1) individuals with discrepant biological tests, and (2) other sources of the treatment in the trial area. Methodological research is also needed to improve adherence measures.
机译:参与者对治疗的依从性差可能导致在某些生物医学艾滋病毒预防试验中缺乏影响。这项定性研究探索了一项随机对照试验,即采用疱疹抑制疗法以减少1305名坦桑尼亚妇女的HIV感染率和感染率。该试验发现参与者完成了72%的就诊访问;根据药丸计数估计,接受治疗的妇女中有52-56%的患者依从性 = 90%;在6到9个月之间,来自阿昔洛韦接受者的30/86(35%)尿液样本检测出阿昔洛韦阴性,而来自安慰剂接受者的7/86(8%)则检测出阿昔洛韦阳性。 30个月后进行了20次深度访谈(IDI),对从“无环鸟苷阴性”的阿昔洛韦接受者和“无环鸟苷阳性”的安慰剂接受者中随机选择的受访者,或者按初步的药丸计数依从性类别(“在使用者中”,“良好使用者”和“过度用户”)。几乎所有受访者都报告了适当的依从性和积极的试用态度,例如,信任员工,赞赏服务,认为药丸有益。十四位了解安慰剂的用法,六位了解试验目的。值得注意的是,有5/9的阿昔洛韦接受者和1/11的安慰剂接受者认为他们的药已治疗了先前存在的性传播感染。有限的理解不会对报告的依从性产生负面影响。报告的依从性问题通常与疾病,旅行和/或家庭义务有关(例如,丈夫的不赞成)。阿昔洛韦呈阳性IDIs也没有解决有关药丸丢失或失窃的不同报道。生物医学HIV干预通常具有强大的行为成分,在干预开发,试验设计以及过程和影响评估期间需要密切关注。这项研究确定了需要进一步考虑的主题,包括:在整个试验过程中的信息增强和理解评估,以使长期的参与者了解。让合作伙伴参与遵守促进活动;与参与者制定策略,以在家族性疾病或其他危机期间保持坚持;并密切监视,识别和跟踪(1)具有不同生物学测试的个体,以及(2)试验地区的其他治疗来源。还需要进行方法学研究以改善依从性措施。

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