Sauceda John, Korolkova Anastasia, Rodriguez Garcia Lidia, Picou Bridgette, Ahmed Ali, Dubé Karine
Division of Prevention Science, University of California, San Francisco, San Francisco, CA, United States.
University of California, San Diego, San Diego, CA, United States.
JMIR Res Protoc. 2025 Aug 6;14:e67123. doi: 10.2196/67123.
HIV cure-related research is expanding rapidly, bringing both new opportunities and ethical challenges. Historically, clinical trials for novel HIV treatments have underrepresented populations most affected by HIV, such as Black gay men and transgender women. This disparity is compounded by medical mistrust and historical mistreatment of racially and ethnically diverse individuals in the United States. Addressing these issues is crucial as we plan HIV cure-related clinical trials. We aim to build consensus on how to increase representation of groups most affected by HIV in cure-related trials in the United States.
We aimed to describe a protocol using a hybrid Delphi consensus-building methodology to build consensus on 3 key research questions: how to better engage populations in HIV cure research who carry the greatest burden of HIV (ie, racial, ethnic, sex, and gender minority groups); how to enhance trust and diminish mistrust in health care and scientific settings that influence willingness to participate; and how to design HIV cure research and analytical treatment interruption protocols that do not limit participation of working adults.
We used a hybrid Delphi method, involving 4 iterative survey rounds. Initial surveys were open-ended and broad, refining over subsequent rounds into more specific, closed-ended questions based on previous feedback. Between rounds, an independent stakeholder group reviewed interim findings, incorporating a nominal group technique to enhance the process. Panelists represented diverse racial, ethnic, sex, and gender perspectives, including an intentional oversampling of experts on racial and ethnic minority issues. Recruitment was facilitated through partnerships with community-based organizations, such as The Well Project, National Minority AIDS Council, and TruEvolution.
As of December 2024, all 4 Delphi survey rounds and 3 nominal group technique discussions have been completed. The process progressed from broad, open-ended questions in round 1 to structured ranking and rating in rounds 3 and 4. Iterative feedback informed survey refinement between rounds. The final data analysis and synthesis of consensus recommendations are underway and will be reported in a forthcoming results paper.
The hybrid Delphi methodology effectively refined responses and built consensus on engaging priority populations in HIV cure research. Oversampling of diverse participants and the inclusion of independent stakeholder feedback added robustness and inclusivity to the findings. Future steps include detailed data analysis and data dissemination. Consensus recommendations will be reported in subsequent manuscripts to inform more inclusive, trust-centered, and accessible HIV cure trial design.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/67123.
与治愈艾滋病病毒相关的研究正在迅速扩展，带来了新的机遇和伦理挑战。从历史上看，新型艾滋病病毒治疗方法的临床试验中，受艾滋病病毒影响最严重的人群，如黑人男同性恋者和跨性别女性，代表性不足。在美国，医疗不信任以及对不同种族和族裔人群的历史虐待加剧了这种差异。在规划与治愈艾滋病病毒相关的临床试验时，解决这些问题至关重要。我们旨在就如何提高美国受艾滋病病毒影响最严重群体在治愈相关试验中的代表性达成共识。
我们旨在描述一种使用混合德尔菲共识构建方法的方案，就三个关键研究问题达成共识：如何更好地让承担最大艾滋病病毒负担的人群（即种族、族裔、性别和性少数群体）参与艾滋病病毒治愈研究；如何增强对影响参与意愿的医疗保健和科学环境的信任并减少不信任；以及如何设计不限制在职成年人参与的艾滋病病毒治愈研究和分析性治疗中断方案。
我们使用了混合德尔菲方法，包括四轮迭代调查。初始调查是开放式且广泛的，在后续轮次中根据先前的反馈细化为更具体的封闭式问题。在各轮之间，一个独立的利益相关者小组审查中期结果，并采用名义小组技术来改进这一过程。小组成员代表了不同的种族、族裔、性别和性取向观点，包括有意对种族和族裔少数群体问题专家进行过度抽样。通过与基于社区的组织（如健康项目、全国少数族裔艾滋病委员会和真实进化组织）合作来促进招募。
截至2024年12月，德尔菲调查的四轮以及名义小组技术讨论均已完成。过程从第一轮的广泛开放式问题发展到第三轮和第四轮的结构化排序和评分。迭代反馈为各轮之间的调查细化提供了依据。最终的数据分析和共识建议的综合正在进行中，将在即将发表的结果论文中报告。
混合德尔菲方法有效地完善了回答，并就吸引优先人群参与艾滋病病毒治愈研究达成了共识。对不同参与者的过度抽样以及纳入独立利益相关者的反馈增强了研究结果的稳健性和包容性。未来的步骤包括详细的数据分析和数据传播。共识建议将在后续稿件中报告，以为更具包容性、以信任为中心且易于参与的艾滋病病毒治愈试验设计提供参考。
国际注册报告识别码（IRRID）：DERR1-10.2196/67123
