Ethical issues for late-stage trials of multipurpose prevention technologies for HIV and pregnancy

Cohen, J.A.; Mastroianni, A.C.; Macklin, R.

International Journal of Gynaecology and Obstetrics the Official Organ of the International Federation of Gynaecology and Obstetrics 127(2): 221-224

2014


ISSN/ISBN: 0020-7292
PMID: 25113651
DOI: 10.1016/j.ijgo.2014.07.012
Document Number: 636277
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.

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Ethical issues for late-stage trials of multipurpose prevention technologies for HIV and pregnancy