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Reasons for participating in a randomised clinical trial: The volunteers' voices in the COSTOP trial in Uganda

机译:参加随机临床试验的原因:乌干达COSTOP试验中志愿者的声音

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Introduction The reasons why research participants join clinical trials remains an area of inquiry especially in low and middle income countries. Methods We conducted exit interviews with participants who took part in a trial which aimed to evaluate whether long term prophylaxis with cotrimoxazole can be safely discontinued among adults who have been stabilised on antiretroviral therapy (ART). Participants were all reported to be stable on ART and had been participating in the trial for between 12 and 36 months; at the end of the trial participants were interviewed using a semi-structured questionnaire. One of the objectives of the exit interview was to find out what motivated the participants to join the research. Results Participants gave personal reasons for joining the trial, frequently linked to their health and well-being as well as reduction of pill burden. Conclusion We conclude that underlying reasons for joining clinical trials may extend beyond or can be different from the rationale given to the participants before enrolment by the research team. The reasons that motivate enrolment to clinical trials and research in general require further investigation in different settings. Trial registration number ISRCTN44723643.
机译:引言研究参与者参加临床试验的原因仍然是一个需要研究的领域,尤其是在中低收入国家。方法我们对参加一项试验的参与者进行了退出访谈,该试验旨在评估在接受抗逆转录病毒治疗(ART)稳定的成年人中,是否可以安全地终止使用cotrimoxazole的长期预防。据报道,所有参与者对ART的病情稳定,并且已经参加了12到36个月的试验;在试验结束时,参与者使用半结构化问卷进行了访谈。退出面试的目的之一是找出促使参与者加入研究的动机。结果参与者给出了参加试验的个人原因,这些原因经常与他们的健康和福祉以及减轻药丸负担有关。结论我们得出结论,参加临床试验的根本原因可能超出或可能不同于研究小组入组前给予参与者的理由。一般而言,促使其加入临床试验和研究的原因需要在不同环境中进行进一步调查。试用注册号ISRCTN44723643。

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