Literature DB >> 25113651

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

Jessica A Cohen1, Anna C Mastroianni2, Ruth Macklin3.   

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.
Copyright © 2014. Published by Elsevier Ireland Ltd.

Entities:  

Keywords:  Ethics; HIV prevention; Multipurpose prevention technologies; Pregnancy prevention

Mesh:

Substances:

Year:  2014        PMID: 25113651      PMCID: PMC4219999          DOI: 10.1016/j.ijgo.2014.07.012

Source DB:  PubMed          Journal:  Int J Gynaecol Obstet        ISSN: 0020-7292            Impact factor:   3.561


  12 in total

1.  The ancillary-care responsibilities of medical researchers. An ethical framework for thinking about the clinical care that researchers owe their subjects.

Authors:  Henry S Richardson; Leah Belsky
Journal:  Hastings Cent Rep       Date:  2004 Jan-Feb       Impact factor: 2.683

Review 2.  Recent advances in antiretroviral treatment and prevention in HIV-infected patients.

Authors:  Fernando Maltêz; Manuela Doroana; Teresa Branco; Cristina Valente
Journal:  Curr Opin HIV AIDS       Date:  2011-12       Impact factor: 4.283

3.  The challenge of defining standards of prevention in HIV prevention trials.

Authors:  Sean Philpott; Lori Heise; Elizabeth McGrory; Lynn Paxton; Catherine Hankins
Journal:  J Med Ethics       Date:  2010-12-24       Impact factor: 2.903

4.  Multipurpose prevention technologies for sexual and reproductive health: gaining momentum and promise.

Authors:  Bethany Young Holt; Maggie Kilbourne-Brook; Alan Stone; Polly Harrison; Wayne C Shields
Journal:  Contraception       Date:  2010-01-04       Impact factor: 3.375

5.  Enrolling pregnant women in biomedical research.

Authors:  Ruth Macklin
Journal:  Lancet       Date:  2010-02-20       Impact factor: 79.321

Review 6.  Contraception technology: past, present and future.

Authors:  Regine Sitruk-Ware; Anita Nath; Daniel R Mishell
Journal:  Contraception       Date:  2012-09-17       Impact factor: 3.375

7.  Predictors of pregnancy in microbicide trials.

Authors:  Vera Halpern; Che-Chin Lie; Paul Feldblum; Lut Van Damme
Journal:  Contraception       Date:  2010-10-08       Impact factor: 3.375

Review 8.  Use of hormonal contraceptives and HIV acquisition in women: a systematic review of the epidemiological evidence.

Authors:  Chelsea B Polis; Kathryn M Curtis
Journal:  Lancet Infect Dis       Date:  2013-07-19       Impact factor: 25.071

9.  Ethics of medical care and clinical research: a qualitative study of principal investigators in biomedical HIV prevention research.

Authors:  Bridget G Haire
Journal:  J Med Ethics       Date:  2012-11-22       Impact factor: 2.903

10.  Developing multipurpose reproductive health technologies: an integrated strategy.

Authors:  P F Harrison; A Hemmerling; J Romano; K J Whaley; B Young Holt
Journal:  AIDS Res Treat       Date:  2013-02-28
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