Overview of the Oral HIV/AIDS Research Alliance (OHARA) Programme

Background and Objectives: The Oral HIV/AIDS Research Alliance (OHARA) is part of the AIDS Clinical Trials Group (ACTG), the largest HIV clinical trials organization in the world. OHARA’s main objective is to investigate the oral complications associated with HIV/AIDS as the epidemic is evolving, in particular the effects of potent antiretrovirals on the development of oral mucosal lesions and associated fungal and viral pathogens.

Methods: We present an overview of OHARA’s infrastructure within the ACTG, its scientific agenda, and updated case definitions of oral mucosal disease outcomes explored as part of OHARA protocols. We also present an outline of ongoing and developing OHARA study protocols.

Results: The OHARA infrastructure comprises three units: the Epidemiological Research Unit (based at the University of California San Francisco), the Medical Mycology Unit (based at Case Western Reserve University), and the Virology and Specimen Banking Unit (based at the University of North Carolina). The OHARA team of investigators includes clinical scientists (both dentists specialized in oral medicine and physicians specialized in infectious diseases), basic scientists (virologists, mycologists, and immunologists), epidemiologists and statisticians. Observational studies and clinical trials are implemented at ACTG-affiliated clinical research sites in the US and in resource-poor countries. Many of these studies have shared end-points, which include oral mucosal diseases that are known to be associated with HIV/AIDS and that are measured by trained and calibrated ACTG study nurses. To-date, comprehensive training modules have been developed and case definitions updated. OHARA has two ongoing studies (focusing on oral HPV), and five protocols in development. Several protocols pertain to the use of oral fluid to monitor HIV RNA, KSHV DNA (and other herpes viruses), and HPV DNA oral shedding in relation to specific HIV-related covariates.

Conclusion: In addition to investigating the oral complications associated with HIV/AIDS, OHARA will permit the development of a comprehensive oral infection and disease database and an HIV/AIDS oral specimen bank that will provide valuable material for future epidemiologic and biological research questions.

Supported by NIH/NIDCR/NIAID U01 AI 68636