Background

To test efficacy, HIV cure-related trials often require a period of intensively monitored interruption of antiretroviral therapy (ART) (analytical treatment interruption or ATI). As individuals who started ART during primary HIV-1 infection (PHI) are often recruited, we have asked people already enrolled into an observational PHI study about their willingness and concerns around participating in cure-related studies involving ATIs.

Methods

People who were diagnosed with PHI and started ART, attending two London HIV clinics, provided informed consent to complete a digital survey in clinic between 21/07/21 to October 31, 2023. Questions comprised sociodemographics, motivations, concerns and practical considerations influencing willingness to participate in studies involving ATIs. Hierarchical clustering of responses was performed using the ‘pheatmap’ R statistical package and ranked from most to least concerned. Responses were cross-referenced with enrolment into an ATI study which recruited from this cohort.

Results

Of 352 eligible participants, 75 completed the survey. The majority were white, cisgender men who have sex with men, 34/75 (45 %) were born outside the UK. 29 (39 %) expressed interest in joining ATI studies. Participants who were interested or unsure in joining ATI studies were primarily motivated (53/65, 82 % very or moderately interested) by an altruistic desire to help scientific research. Across all participants, onward HIV transmission was the predominant concern (67/75, 89 % very or moderately concerned), and similar levels of concerns reported if the HIV-1 viral load threshold to restarting ART was increased from 500 to 50 000 copies/mL. Most participants preferred weekly (23/65, 35 %) or fortnightly (11/65, 17 %) viral load monitoring during an ATI. Before taking part in a study involving an ATI, participants stated they would prefer to discuss this with their HIV doctor (55/65, 85 %).

Conclusion

In this small survey, 39 % of respondents expressed interest in joining studies involving ATIs, primarily for altruistic reasons. Participants were more interested in joining a potential ATI study if a novel intervention was included than simply an ATI alone. The main concern expressed was risk of viral transmission. To inform practical and study design considerations for future ATI studies, unrestricted access for mitigation of transmission risk should be included, and regular, frequent viral load monitoring is preferred.

中文翻译：

---

了解参与者对英国涉及抗逆转录病毒分析治疗中断的 HIV-1 治愈相关研究的看法

背景

为了测试疗效，HIV 治愈相关试验通常需要一段时间的抗逆转录病毒治疗 (ART) 中断（分析治疗中断或 ATI）的密切监测。由于经常招募在原发性 HIV-1 感染 (PHI) 期间开始 ART 的个体，我们询问了已经参加观察性 PHI 研究的人，了解他们参与涉及 ATI 的治疗相关研究的意愿和担忧。

方法

被诊断患有 PHI 并开始 ART 并就诊于伦敦两家 HIV 诊所的患者提供知情同意书，以在 2021 年 7 月 21 日至 2023 年 10 月 31 日期间在诊所完成一项数字调查。问题包括社会人口统计学、动机、担忧和影响意愿的实际考虑因素参与涉及 ATI 的研究。使用“pheatmap”R 统计包对响应进行分层聚类，并从最关心到最不关心进行排名。答复与从该队列中招募的 ATI 研究的入组情况进行了交叉引用。

结果

在 352 名符合资格的参与者中，75 人完成了调查。大多数是与男性发生性行为的白人顺性别男性，其中 34/75 (45%) 出生在英国境外。29 人 (39%) 表示有兴趣加入 ATI 研究。对参加 ATI 研究感兴趣或不确定的参与者主要是出于帮助科学研究的利他愿望（53/65，82% 非常或中等兴趣）。在所有参与者中，HIV 继续传播是主要担忧（67/75，89% 非常或中度担忧），如果重新启动 ART 的 HIV-1 病毒载量阈值从 500 份增加到 50 000 份/，则报告的担忧程度相似。毫升。大多数参与者更喜欢在 ATI 期间每周（23/65，35％）或每两周（11/65，17％）进行病毒载量监测。在参加涉及 ATI 的研究之前，参与者表示他们更愿意与艾滋病毒医生讨论这个问题（55/65，85%）。

结论

在这项小型调查中，39% 的受访者表示有兴趣加入涉及 ATI 的研究，主要是出于利他的原因。如果包含新颖的干预措施，参与者比单纯的 ATI 更愿意加入潜在的 ATI 研究。人们表达的主要担忧是病毒传播的风险。为了为未来 ATI 研究提供实际和研究设计考虑因素，应包括不受限制的访问以减轻传播风险，并且最好定期、频繁地进行病毒载量监测。