Abstract: HIV prevention research has been facing increasing ethical and operational challenges. Factors influencing the design and conduct of HIV prevention trials include a rapidly changing evidence base, new biomedical prevention methods and modalities being tested, a large diversity of countries, sites and populations affected by HIV and participating in trials, and challenges of developing and making available products that will be feasible and affordable for at-risk populations. To discuss these challenges, a meeting, Ethical considerations around novel combination prevention modalities in HIV prevention and vaccine trials in resource-limited settings, was convened by NIH/NIAID/Division of AIDS on April 22–23, 2013. Several themes emerged from the meeting: (1) because of both trial design and ethical complexities, choosing prevention packages and designing combination prevention research trials will need to be evaluated on a case by case basis in different clinical trials, countries, and health systems; (2) multilevel stakeholder engagement from the beginning is vital to a fair and transparent process and also to designing ethical and relevant trials; (3) research should generally be responsive to a host country's needs, and sponsors and stakeholders should work together to address potential barriers to future access; and finally, (4) another meeting including a broader group of stakeholders is needed to address many of the outstanding ethical issues raised by this meeting. We offer an overview of the meeting and the key discussion points and recommendations to help guide the design and conduct of future HIV prevention and vaccine research in resource-limited settings.
*HJF-DAIDS, a Division of the Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc., Contractor, NIAID, NIH, DHHS, Bethesda, MD; and
†Division of AIDS, NIAID, NIH, Bethesda, MD.
Correspondence to: Samual A. Garner, 5601 Fisher's Lane—Room 9G47, Bethesda, MD 20892, Fax: 240-627-3107, Phone: 240-292-475. (e-mail: email@example.com).
The opinions expressed are the authors' own. They do not reflect any position or policy of the National Institutes of Health, US Public Health Service, or Department of Health and Human Services.
This project has been funded in whole or in part with Federal funds from the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, under contract No. HHSN272200800014C.
The authors have no conflicts of interest to disclose.