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

John Sauceda1, Anastasia Korolkova2, Lidia Rodriguez Garcia1

  • 1Division of Prevention Science, University of California, San Francisco, San Francisco, CA, United States.

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Summary

This study used a hybrid Delphi method to build consensus on engaging diverse populations in HIV cure research. Recommendations will improve inclusivity and trust in future HIV cure clinical trials.

Keywords:
HIV cure researchanalytical treatment interruptionconsensus buildinghybrid Delphiprotocolrecruitmentunderrepresented populations

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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.