Funding Source and Period: amfAR 106765-41, 1/1/07/6/30/07

HIV Center Key Personnel

Investigator:  Alex Carballo-Dieguez, Ph.D.

Project Overview
(from abstract of research plan)

Development of a Standard Rectal Microbicide Delivery Device Topical rectal microbicides are compounds under development that could be applied inside the rectum to decrease the chances of HIV transmission. Whether people will use rectal microbicides consistently and correctly depends, to a great extent, on the rectal applicator or microbicide delivery device (MDD). The wrong MDD may result in difficulties with product administration, irritation or damage to the fragile rectal mucosa, discomfort, and poor acceptability. Dr. Carballo-Diéguez received support from the American Foundation for AIDS Research to conduct a study in collaboration with PATH (www.path.org). PATH is an international, nonprofit organization that creates sustainable, culturally relevant solutions to improve the health of people around the world by advancing technologies, strengthening systems, and encouraging healthy behaviors. The goal of this study was to develop a prototype of an inexpensive standard rectal MDD that could be used across rectal microbicide trials to ensure ease of use, comfort, and effective delivery of microbicide gel across a wide range of dose volumes to both men and women who have anal intercourse. Following interviews with the nine experts in the field of rectal microbicide development, specifications of a MDD were developed and sent to prospective manufacturers for bidding. HTI Plastics, the company that produces the vaginal applicators used in most vaginal microbicide trials, was the selected as the manufacturer for the rectal MDD. At the time of this writing, the company was producing the molds to manufacture the initial batches of the first rectal specific MDD.