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A Statement on the Future of HIV Prevention Trials

From Participants in the Next-Generation Trial Design Advocates’ Academy, September 2019
Updated May 2021

As advocates for ending the HIV epidemic, we are heartened by the ever-evolving landscape of HIV prevention options. We will not stop pushing for increased access to options such as treatment and oral PrEP around the world.

But we also underscore the need for more; we need additional and improved prevention options. As we follow the HIV research and development field, we see the growing complexity of conducting clinical trials, especially to determine the efficacy of new, experimental prevention options in the midst of declining incidence.

In September 2019, a number of us—advocates from around the world who have been engaged around prevention trials, who are touched personally by HIV, and who understand the challenges of community engagement in research—gathered with AVAC and key researchers to verse ourselves in the technical concepts underlying next-generation prevention trials as well as the decision points where we as advocates can and should weigh in.

As a result of our deliberations, we provide here the following perspectives.

  • Trials must offer a standard of prevention that is ethical and grounded in Good Participatory Practice (GPP), while pursuing scientific questions with rigor. This principle is not new to our field. But testing next-generation products will require a new level of cohesion between the trial context and evolving prevention standards and programs in the “real world”. Affected communities know well whether a trial with an innovative, potentially controversial design will be acceptable and likely run smoothly. Implementing robust GPP as a central part of these new trials can speed the translation of research results into real world outcomes and public health impact.

  • We recognize the gold standard of randomized, placebo-controlled trials. Where this gold standard can be used, it should be used. Innovative designs to find participants who express preference for participating in a placebo-controlled trial over accessing available prevention programs should be carefully navigated with trial communities, national and global advocates, representative populations, normative and regulatory agencies. HIV counseling, informed consent, and prevention services should ideally be decided with advocate and community stakeholders. The work of the HVTN and Janssen to engage ethics and community stakeholders around these issues in the Mosaico vaccine trial is an example on which to build.

  • We recognize the complexity of comparator trials for new, experimental products, especially ARV-based PrEP. To ensure support for trial conduct, results dissemination and next steps, communities should be well-informed about rationale for various designs – e.g., superiority, non-inferiority, external control – in various populations and geographies. It may behoove research entities to ensure that at least a key group of community representatives understands technical complexities of these trial designs, such as calculation of a non-inferiority margin for a given trial or which data sources are being used as an external control.

  • Following the 2021 release of the revised UNAIDS/WHO Ethical Considerations in HIV Prevention Trials, it is vital to consider its practical application to trial conduct. We urge compatibility between ethical guidance at global, normative, national, institutional and local levels.

We underscore that we are a cadre of strong, committed advocates for prevention and for research into new biomedical tools. We stand ready to partner with trialists, product developers, ethicists, regulators and funders – in the global North and South – to navigate the complex and innovative solutions needed for critical research to move forward with full support of communities and advocates.

Interested to learn more, provide feedback, and engage – whether as an advocate, researcher or product developer? Please contact, and stay tuned for additional ways to collaborate.