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探索南非约翰内斯堡将参与 HIV 临床试验的参与者重新融入公共卫生服务的定性研究。

Qualitative study exploring reintegration of clinical trial participants with HIV to public health services in Johannesburg, South Africa.

机构信息

School of Health Systems and Public Health, Faculty of Health Sciences, University of Pretoria, Pretoria, South Africa

Ezintsha, A Division of Wits Health Consortium, University of the Witwatersrand Faculty of Health Sciences, Johannesburg, Gauteng, South Africa.

出版信息

BMJ Open. 2024 Nov 24;14(11):e084947. doi: 10.1136/bmjopen-2024-084947.

Abstract

OBJECTIVE

People living with HIV (PLHIV) are often recruited from primary healthcare clinics (PHC) into clinical trials. On trial completion, they are transferred back to the facility for continued care and support in managing their condition, potentially leading to better health outcomes. Because transferring PLHIV back to PHCs post-clinical trials may result in decreased access to specialised care or resources that were available during the trial, this study explored insights into challenges faced during reintegration from clinical trial settings into PHCs and antiretroviral therapy (ART) adherence post-clinical trials.

DESIGN

This cross-sectional study was conducted using a qualitative research approach. Participants were recruited using purposive sampling.

SETTING

The study was conducted at the Ezintsha Research Centre in Johannesburg, South Africa, between November 2022 and February 2023.

PARTICIPANTS

The study population consisted of PLHIV who had participated in two clinical trials (DORA and ADVANCE) at the Ezintsha Research Centre in Johannesburg, South Africa.

METHODS

Using a semistructured guide, 12 in-depth interviews were conducted with PLHIV until data saturation was reached. Data were then transcribed verbatim and analysed thematically with MAXQDA software.

RESULTS

The majority (n=8, 67%) of participants were female, and the average age of all participants was 40 (SD 7.2) years. Two main themes emerged: reintegration from clinical trials to public healthcare and barriers to ART adherence. These themes were further separated into seven subthemes, namely, negative attitude of healthcare workers, poor healthcare service delivery, poor communication to patients, waiting time at healthcare facilities, lack of privacy and confidentiality, mistakes in ART dispensing and bad reception at facilities post-clinical trials.

CONCLUSION

Clinical trial sites should cultivate better stakeholder engagement with PHCs to facilitate a smoother transition of research participants, especially PLHIV, back into public healthcare for continued care.

摘要

目的

艾滋病毒感染者(PLHIV)通常从初级保健诊所(PHC)招募到临床试验中。在试验完成后,他们被转回该机构继续接受治疗和支持,以管理他们的病情,这可能会带来更好的健康结果。由于将 PLHIV 从临床试验后转回 PHC 可能会导致他们获得的专门护理或资源减少,这些资源在试验期间是可用的,因此本研究探讨了从临床试验环境重新融入 PHC 以及临床试验后抗逆转录病毒治疗(ART)依从性所面临的挑战的见解。

设计

本横断面研究采用定性研究方法进行。使用目的抽样法招募参与者。

地点

该研究在南非约翰内斯堡的 Ezintsha 研究中心进行,时间为 2022 年 11 月至 2023 年 2 月。

参与者

研究人群由在南非约翰内斯堡 Ezintsha 研究中心参加过两项临床试验(DORA 和 ADVANCE)的 PLHIV 组成。

方法

使用半结构化指南,对 12 名 PLHIV 进行了深入访谈,直到达到数据饱和。然后将数据逐字转录,并使用 MAXQDA 软件进行主题分析。

结果

大多数参与者(n=8,67%)为女性,所有参与者的平均年龄为 40(SD 7.2)岁。出现了两个主要主题:从临床试验到公共医疗保健的重新融入以及 ART 依从性的障碍。这些主题进一步分为七个子主题,即医护人员的负面态度、医疗服务提供差、与患者沟通不畅、在医疗保健设施等待时间长、缺乏隐私和保密性、ART 配药错误以及临床试验后在设施的不良接待。

结论

临床试验现场应培养与 PHC 更好的利益相关者的参与,以促进研究参与者,特别是 PLHIV,更顺利地过渡到公共医疗保健,以继续接受治疗。

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