Deficiencies in research design have held back progress in identifying HIV prevention interventions, say Stephen W. Lagakos and Alicia R. Gable in the New England Journal of Medicine.
Shortcomings have included inadequate pre-trial research and sample size, poor site preparation and lack of community engagement.
The authors say the research community should increase investment in the development of safe, easy-to-use biomedical interventions because, in the 15–20 years it may take to achieve an efficacious vaccine, 20–60 million new HIV infections could occur.
Preclinical and early-stage clinical testing, and prioritisation of products for later-stage testing should be improved to maximise use of research resources, and reduce further testing of unsafe or ineffective products.
Better methods for assessing and improving adherence to intervention trials and risk-taking behaviour should also be prioritised.
Because young women are disproportionately affected by the epidemic in many regions, Lagakos and Gable urge sponsors and researchers to take steps to evaluate the safety and efficacy of preventive products in pregnant women.
They also say sponsors should reconsider the usual financial and time constraints placed on investigators conducting HIV-prevention trials.