Resolving Challenges in HIV Cure-Related Research: Protocol for a Modified Delphi Consensus-Building Process

Area of Science:

• Medical Ethics
• Clinical Trial Design
• Public Health

Background:

• HIV cure research faces ethical challenges, including historical underrepresentation of key populations like Black gay men and transgender women in clinical trials.
• Medical mistrust and historical mistreatment exacerbate disparities, necessitating strategies to improve engagement with affected communities in the United States.
• Building consensus is vital for designing inclusive HIV cure-related clinical trials that address the needs of populations most impacted by HIV.

Purpose of the Study:

• To describe a hybrid Delphi methodology for building consensus on engaging populations disproportionately affected by HIV in cure research.
• To identify strategies for enhancing trust and mitigating mistrust in healthcare and scientific settings to improve participation willingness.
• To develop recommendations for designing HIV cure research and analytical treatment interruption protocols that accommodate working adults.

Main Methods:

• A hybrid Delphi method with 4 iterative survey rounds, progressing from open-ended to closed-ended questions based on feedback.
• Incorporation of an independent stakeholder group using nominal group technique to review interim findings and enhance the consensus process.
• Oversampling of panelists representing diverse racial, ethnic, sex, and gender perspectives, including experts on minority issues, with recruitment via community partnerships.

Main Results:

• All 4 Delphi survey rounds and 3 nominal group technique discussions were completed by December 2024.
• The methodology facilitated a progression from broad inquiries to structured ranking and rating, refining consensus-building.
• Final data analysis and synthesis of consensus recommendations are ongoing, with results to be reported in a forthcoming paper.

Conclusions:

• The hybrid Delphi methodology proved effective in refining responses and achieving consensus on engaging priority populations in HIV cure research.
• Oversampling diverse participants and incorporating stakeholder feedback enhanced the robustness and inclusivity of the study findings.
• Future work will focus on detailed data analysis and dissemination of consensus recommendations to guide the design of more inclusive and accessible HIV cure trials.