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感染 HIV 后参与 I/II 期 HIV 疫苗试验的个人经历:来自坦桑尼亚的定性研究。

Personal experiences following acquiring HIV infection while volunteering in Phase I/II HIV vaccine trials: A qualitative study from Tanzania.

机构信息

Department of Nursing Management, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.

Department of Clinical Nursing, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.

出版信息

PLoS One. 2022 Oct 26;17(10):e0276404. doi: 10.1371/journal.pone.0276404. eCollection 2022.

Abstract

BACKGROUND

Participation in HIV vaccine trials is an essential step towards development of an effective preventive vaccine. A Phase I/II HIV vaccine trial enrolls volunteers at low risk of acquiring HIV infection, however a few may still become infected. Understanding the experiences of volunteers who acquired HIV infection while participating in such trials is essential for future research. Here, we describe experiences of HIV infected volunteers in Phase I/II HIV vaccine trials conducted in urban Tanzania.

MATERIALS AND METHODS

We used a case study design. In-depth interviews were conducted with four participants who became HIV infected during long follow-up visits after completion of vaccination schedules in a Phase I/II trial. Between 3 and 8 years after HIV positive diagnosis, each participant was interviewed at three time points within a two-year interval so as to allow for accumulation of experiences and cross-checking the emerging constructs. Data was analyzed using a qualitative data analysis framework.

RESULTS

Analysis revealed that participation in HIV vaccine trials involves balancing controversies and the spirit of informed decision. The participants declared that they did not acquire HIV from the experimental vaccine. Disclosure of HIV status within the family was gender specific. Men were hesitant to disclose their HIV status to their sexual partners fearing for the consequences. Women's attempt to disclose their HIV status yielded negative reactions from the sexual partners. The acquired knowledge from the HIV vaccine research enabled the participants to cope with the uncertainties and their health status.

CONCLUSIONS

The knowledge acquired during the Phase I/II HIV vaccine trial appears to be an essential resource to cope with uncertainties post research. The HIV vaccine trial implementers need to understand the challenges the volunteers may confront after the trial while coping with their health status. Longitudinal studies are essential to trace the effects of uncertainties to the individual participants.

摘要

背景

参与 HIV 疫苗试验是开发有效预防疫苗的重要步骤。I 期/II 期 HIV 疫苗试验招募感染 HIV 风险较低的志愿者,但仍有少数人可能会感染。了解在这些试验中感染 HIV 的志愿者的经验对于未来的研究至关重要。在这里,我们描述了在坦桑尼亚城市进行的 I 期/II 期 HIV 疫苗试验中感染 HIV 的志愿者的经验。

材料和方法

我们使用病例研究设计。对在完成疫苗接种计划后进行长时间随访期间感染 HIV 的 4 名参与者进行了深入访谈。在 HIV 阳性诊断后 3 至 8 年内,每个参与者在两年间隔内的三个时间点进行了访谈,以便积累经验并交叉检查新兴结构。使用定性数据分析框架对数据进行分析。

结果

分析显示,参与 HIV 疫苗试验涉及平衡争议和知情决策的精神。参与者声称他们没有从实验疫苗中感染 HIV。在家庭中披露 HIV 状况是性别特定的。男性担心向性伴侣透露他们的 HIV 状况会带来后果,因此犹豫不决。女性试图披露她们的 HIV 状况,却得到了性伴侣的负面反应。从 HIV 疫苗研究中获得的知识使参与者能够应对不确定性和他们的健康状况。

结论

I 期/II 期 HIV 疫苗试验中获得的知识似乎是应对研究后不确定性的重要资源。HIV 疫苗试验实施者需要了解志愿者在应对健康状况的同时可能面临的挑战。纵向研究对于跟踪不确定性对个体参与者的影响至关重要。

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