title: Ethical issues for late-stage trials of multipurpose prevention technologies for HIV and pregnancy.
abstract: Multipurpose prevention technologies (MPTs) designed to simultaneously prevent pregnancy and HIV could provide urgently needed tools to address unmet sexual and reproductive health needs of women worldwide. Late-stage clinical trials will be complex given the need to demonstrate efficacy for HIV and contraceptive indications simultaneously from a single product. Currently, HIV and pregnancy prevention trials have distinctive design features that will need to be reconciled in MPT trials. This article identifies several ethical issues uniquely associated with this research that will benefit from future deliberation and guidance to ensure that this globally important research can proceed efficiently and expeditiously.
authors.affiliation: PATH, Seattle, WA, USA. Electronic address: jcohen@path.org.
authors.forename: Jessica A
authors.initials: JA
authors.lastname: Cohen
authors.affiliation: University of Washington School of Law, Seattle, WA, USA.
authors.forename: Anna C
authors.initials: AC
authors.lastname: Mastroianni
authors.affiliation: Department of Epidemiology and Population Health, Albert Einstein College of Medicine, New York, NY, USA.
authors.forename: Ruth
authors.initials: R
authors.lastname: Macklin
mesh_terms: D000890:Anti-Infective Agents / Q000627:therapeutic use; D044966:Anti-Retroviral Agents / Q000627:therapeutic use; D002986:Clinical Trials as Topic / Q000941:ethics*; D003267:Contraception / Q000941:ethics*; D005260:Female; D015658:HIV Infections / Q000517:prevention & control*; D006801:Humans; D008297:Male; D011247:Pregnancy; D011322:Primary Prevention / Q000941:ethics* / Q000592:standards
chemical_list: D000890:Anti-Infective Agents; D044966:Anti-Retroviral Agents
keywords: Ethics; HIV prevention; Multipurpose prevention technologies; Pregnancy prevention
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