JMIR Publications

ABSTRACT

Background:

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 U.S. Addressing these issues is crucial as we plan HIV cure-related clinical trials. Our study aims to build consensus on how to increase representation of groups most affected by HIV in cure-related trials in the U.S.

Objective:

The primary objective was to utilize a hybrid Delphi consensus-building methodology to address three key research questions: (1) strategies for better engaging high-burden populations in HIV cure research; (2) approaches to enhance trust and reduce mistrust in healthcare settings; and (3) designing inclusive HIV cure research protocols that can accommodate working adults.

Methods:

We employed a hybrid Delphi method, involving four iterative survey rounds. Initial surveys were open-ended and broad, refining over subsequent rounds into more specific, closed-ended questions based on prior feedback. Between rounds, an independent stakeholder group reviewed interim findings, incorporating a Nominal Group Technique (NGT) 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.

Results:

Of the 85 panelists invited, 58 accepted, and 57 remained active after one withdrawal. Response rates were high throughout, with 93% completing round 1, 82.1% round 2, and 85.7% each for rounds 3 and 4. Participants were predominantly female, White/Caucasian, and highly educated, with an average of 8 years of involvement in HIV cure research. The NGT component included 8 participants (6 cisgender women and 2 transgender women). Delphi surveys evolved from broad questions in round 1 to specific ranking questions in round 3, and final assessments of importance and urgency in round 4. Feedback from 23 panelists indicated overall satisfaction with the process, though some suggested improvements.

Conclusions:

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. Our findings aim to enhance the design and execution of HIV cure trials, contributing to more equitable and effective research practices. Clinical Trial: N/A