Assessing microbicide acceptability: a comprehensive and integrated approach.
A safe, effective, and acceptable microbicide is needed in order to decisively impact the global AIDS pandemic. As such, microbicide acceptability research is of paramount importance. In order to best utilize limited financial resources and save precious development time, acceptability studies should be fully integrated into preclinical and clinical trial contexts where candidate products are being developed and tested. An integrated approach for examining theoretically valid and relevant variables is needed so that data across studies and products can more effectively advance the field. We propose an approach for measuring factors related to microbicide acceptability in each phase of product development, and dependent on what product-specific knowledge is already established in the field. We discuss the roles that behavioral and social science methodologies should play in all phases of microbicide development, as well as the challenges faced when conducting acceptability research in the context of preclinical and clinical trial settings.
Morrow
Kathleen M
KM
Centers for Behavioral and Preventive Medicine, Department of Psychiatry & Human Behavior, The Miriam Hospital and the Warren Alpert Medical School of Brown University, Coro West, One Hoppin Street, Providence, RI, USA. kmorrow@lifespan.org
Ruiz
Monica S
MS
D000163:Acquired Immunodeficiency Syndrome; D000890:Anti-Infective Agents / Q000627:therapeutic use; D044966:Anti-Retroviral Agents / Q000008:administration & dosage / Q000494:pharmacology / Q000627:therapeutic use*; D002986:Clinical Trials as Topic; D003258:Consumer Behavior; D003268:Contraception Behavior / Q000523:psychology*; D015195:Drug Design; D004347:Drug Interactions; D015658:HIV Infections / Q000517:prevention & control* / Q000635:transmission / Q000821:virology; D006302:Health Services Research / Q000639:trends; D010342:Patient Acceptance of Health Care; D012749:Sexually Transmitted Diseases / Q000517:prevention & control; D012942:Social Sciences
D000890:Anti-Infective Agents; D044966:Anti-Retroviral Agents