Ethical considerations in determining standard of prevention packages for HIV prevention trials: Examining PrEP

Developing World Bioethics

Volumn 13, Issue 2, 2013, Pages 87-94

  Haire, Bridget ^a   Folayan, Morenike Oluwatoyin ^b   Hankins, Catherine ^c,d   Sugarman, Jeremy ^e   Mccormack, Sheena ^f   Ramjee, Gita ^g   Warren, Mitchell ^h  

^a UNIVERSITY OF SYDNEY   (Australia)

^b OBAFEMI AWOLOWO UNIVERSITY   (Nigeria)

^c AMSTERDAM INSTITUTE FOR GLOBAL HEALTH AND DEVELOPMENT   (Netherlands)

^d LONDON SCHOOL OF HYGIENE AND TROPICAL MEDICINE   (United Kingdom)

^e JOHNS HOPKINS UNIVERSITY   (United States)

^f CHELSEA AND WESTMINSTER HOSPITAL   (United Kingdom)

^g SOUTH AFRICAN MEDICAL RESEARCH COUNCIL   (South Africa)

^h Global Advocacy for HIV Prevention   (United States)

Author keywords

Antiretroviral therapy; Developing world bioethics; Guidelines; HIV AIDS; International justice; Research ethics

Indexed keywords

HUMAN IMMUNODEFICIENCY VIRUS;

EID: 84880703461     PISSN: 14718731     EISSN: 14718847     Source Type: Journal    
DOI: 10.1111/dewb.12032     Document Type: Article

References (67)

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57. For an example of effective community consultation, see A. Vallely etal. The Benefits of Participatory Methodologies to Develop Effective Community Dialogue in the Context of a Microbicide Trial Feasibility Study in Mwanza, Tanzania. BMC Public Health 2007; 7: 133.
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59. Low literacy does not mean that people lack the capacity to understand research concepts, but it can pose communication challenges that require commitment to overcome. See P. Ndebele, D. Wassenaar, E. Munalula & F. Masiye. Improving understanding of clinical trial procedures among low literacy populations: an intervention within a microbicide trial in Malawi. BMC Medical Ethics 2012; 13: 29.
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61. Ukpong. op. cit. note 33.
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63. M. Ukpong, op. cit. note 33.
64. At the time of writing, this issue was under review with regard to the French trial PrEP Ipergay. Ipergay tests episodic PrEP against a placebo comparator in men who have sex with men (MSM), and is being reviewed to determine whether this is ethically appropriate, given the evidence for PrEP efficacy and the FDA approval. http://www.ipergay.fr.
65. World Health Organisation. Guidance on oral pre-exposure prophylaxis (PrEP) for serodiscordant couples, men and transgender women who have sex with men at high risk of HIV: Recommendations for use in the context of demonstration projects. July, 2012. Geneva, Switzerland: WHO. Available at: http://www.who.int/hiv/pub/guidance_prep/en/index.html [Accessed 18 Feb 2013].
66. The HIV Vaccine Trials Network (HVTN) 505 Study currently taking place in the US is not yet providing oral TDF/FTC for PrEP to participants, but is offering information about it and monitoring drug levels. See HVTN 505: Expansion in Response to an Evolving Field. Seattle, WA: HVTN Available at: http://hvtnews.wordpress.com/2011/09/13/hvtn-505-expansion-in-response-to-an-evolving-field/ [Accessed 18 Feb 2013].
67. B. Haire. op. cit. note 1.