Botswana-Harvard AIDS Institute Partnership, Gaborone, Botswana
Department of Clinical Research, London School of Hygiene and Tropical Medicine, London, UK.
BMJ Open. 2021 Apr 5;11(4):e039191. doi: 10.1136/bmjopen-2020-039191.
Individuals recruited into clinical trials for life-threatening illnesses are particularly vulnerable. This is especially true in low-income settings. The decision to enrol may be influenced by existing inequalities, poor healthcare infrastructure and fear of death. Where patients are confused or unconscious the responsibility for this decision falls to relatives. This qualitative study is nested in the ongoing AMBIsome Therapy Induction OptimisatioN (AMBITION) Trial. AMBITION is recruiting participants from five countries in sub-Saharan Africa and is trialling a novel treatment approach for HIV-associated cryptococcal meningitis, an infection known to affect brain function. We aim to learn from the experiences of participants, relatives and researchers involved in AMBITION.
We will collect data through in-depth interviews with trial participants and the next of kin of participants who were confused at enrolment and therefore provided surrogate consent. Data will be collected in Gaborone, Botswana; Kampala, Uganda and Harare, Zimbabwe. Interviews will follow a narrative approach including participatory drawing of participation timelines. This will be supplemented by direct observation of the research process at each of the three recruiting hospitals. Interviews will also take place with researchers from the African and European institutions that form the partnership through which the trial is administered. Interviews will be transcribed verbatim, translated (if necessary) and organised thematically for narrative analysis.
This study has been approved by the Health Research Development Committee, Gaborone (Reference: HPDME:13/18/1); Makerere School of Health Sciences Institutional Review Board, Kampala (Reference: 2019-061); University of Zimbabwe Joint Research Ethics Committee, Harare (Reference: 219/19), and the London School of Hygiene and Tropical Medicine (Reference: 17957). Study findings will be shared with research participants from the sites, key stakeholders at each research institution and ministries of health to help inform the development and implementation of future trials. The findings of this study will be published in journals and presented at academic meetings.
Registered at www.clinicaltrials.gov:NCT04296292.
招募到危及生命的疾病临床试验中的个体特别脆弱。在低收入环境中尤其如此。参加试验的决定可能受到现有不平等、医疗保健基础设施差和对死亡的恐惧的影响。当患者感到困惑或失去意识时，决策责任落在亲属身上。本定性研究嵌套在正在进行的 AMBIsome 治疗诱导优化（AMBITION）试验中。AMBITION 正在从撒哈拉以南非洲的五个国家招募参与者，该试验正在测试一种治疗 HIV 相关隐球菌性脑膜炎的新方法，这种感染已知会影响大脑功能。我们旨在从参与 AMBITION 的参与者、亲属和研究人员的经验中学习。
我们将通过对试验参与者和在登记时感到困惑并因此提供代理同意的参与者的近亲进行深入访谈来收集数据。数据将在博茨瓦纳的哈博罗内、乌干达的坎帕拉和津巴布韦的哈拉雷收集。访谈将采用叙事方法进行，包括参与时间表的参与性绘图。这将通过对三个招募医院的研究过程进行直接观察来补充。还将与通过该试验管理的合作伙伴关系中的非洲和欧洲机构的研究人员进行访谈。访谈将逐字记录、翻译（如果需要）并进行主题组织，以便进行叙事分析。
该研究已获得博茨瓦纳卫生研究发展委员会（参考号：HPDME:13/18/1）、坎帕拉的马凯雷雷大学健康科学学院机构审查委员会（参考号：2019-061）、哈拉雷的津巴布韦大学联合研究伦理委员会（参考号：219/19）和伦敦卫生与热带医学学院（参考号：17957）的批准。研究结果将与来自这些地点的研究参与者、每个研究机构的主要利益攸关者以及卫生部共享，以帮助为未来试验的制定和实施提供信息。本研究的结果将发表在期刊上，并在学术会议上展示。
在 www.clinicaltrials.gov 上注册：NCT04296292。
