TY - JOUR
T1 - The challenge of defining standards of prevention in HIV prevention trials
AU - Philpott, Sean
AU - Heise, Lori
AU - McGrory, Elizabeth
AU - Paxton, Lynn
AU - Hankins, Catherine
AU - AUTHOR GROUP
AU - Alexander, Lorraine
AU - Apuuli, David Kihumuro
AU - Baeten, Jared
AU - Birx, Deborah
AU - de Bruyn, Guy
AU - Bukusi, Elizabeth
AU - Burns, David
AU - Calazans, Gabriela
AU - Campbell, James
AU - Caswell, Georgina
AU - Coutinho, Alex
AU - Dawson, Liza
AU - Dhai, Amaboo
AU - Dube, Samukeliso
AU - Ecuru, Julius
AU - Essack, Zaynab
AU - Farley, Timothy
AU - Gafos, Mitzy
AU - Irungu, Pauline
AU - Kaleebu, Pontiano
AU - Kamali, Anatoli
AU - Kestelyn, Evelyne
AU - Kublin, James
AU - Lohse, Nicolai
AU - Lutalo, Tom
AU - Macklin, Ruth
AU - Mâsse, Benôıt
AU - Mauney, Chris
AU - McCormack, Sheena
AU - Miller, Lori
AU - Mfutso-Bengo, Joseph
AU - Misra, Rajender
AU - Muganwa, Margaret
AU - Ndase, Patrick
AU - Nel, Annalene
AU - Nielsen, Leslie
AU - Nkala, Busisiwe
AU - O'Reilly, Kevin
AU - Okware, Sam
AU - Paicheler, Geneviève
AU - Rees, Helen
AU - Rerks-Ngarm, Supachai
AU - Ridzon, Renee
AU - Rosenberg, Zeda
AU - Singh, Jerome
PY - 2011
Y1 - 2011
N2 - As new HIV prevention tools are developed, researchers face a number of ethical and logistic questions about how and when to include novel HIV prevention strategies and tools in the standard prevention package of ongoing and future HIV prevention trials. Current Joint United Nations Programme on HIV/AIDS (UNAIDS)/World Health Organization (WHO) guidance recommends that participants in prevention trials receive 'access to all state of the art HIV risk reduction methods', and that decisions about adding new tools to the prevention package be made in consultation with 'all relevant stakeholders'. The guidance, however, leaves open questions of both process and implementation. In March 2009, the Global Campaign for Microbicides, UNAIDS and the Centers for Disease Control and Prevention convened a consultation to develop practical answers to these questions. Fifty-nine diverse participants, including researchers, ethicists, advocates and policymakers, worked to develop consensus criteria on when to include new HIV prevention tools in future trials. Participants developed a set of questions to guide decision-making, including: whether the method has been recommended by international bodies or adopted at a national level; the size of the effect and weight of the evidence; relevance to the trial population; whether the tool has been approved or introduced in the trial country; whether adding the tool might lead to trial futility; outstanding safety issues and status of the trial. Further work is needed to develop, implement and evaluate approaches to facilitate meaningful stakeholder participation in this deliberative process
AB - As new HIV prevention tools are developed, researchers face a number of ethical and logistic questions about how and when to include novel HIV prevention strategies and tools in the standard prevention package of ongoing and future HIV prevention trials. Current Joint United Nations Programme on HIV/AIDS (UNAIDS)/World Health Organization (WHO) guidance recommends that participants in prevention trials receive 'access to all state of the art HIV risk reduction methods', and that decisions about adding new tools to the prevention package be made in consultation with 'all relevant stakeholders'. The guidance, however, leaves open questions of both process and implementation. In March 2009, the Global Campaign for Microbicides, UNAIDS and the Centers for Disease Control and Prevention convened a consultation to develop practical answers to these questions. Fifty-nine diverse participants, including researchers, ethicists, advocates and policymakers, worked to develop consensus criteria on when to include new HIV prevention tools in future trials. Participants developed a set of questions to guide decision-making, including: whether the method has been recommended by international bodies or adopted at a national level; the size of the effect and weight of the evidence; relevance to the trial population; whether the tool has been approved or introduced in the trial country; whether adding the tool might lead to trial futility; outstanding safety issues and status of the trial. Further work is needed to develop, implement and evaluate approaches to facilitate meaningful stakeholder participation in this deliberative process
U2 - https://doi.org/10.1136/jme.2010.037176
DO - https://doi.org/10.1136/jme.2010.037176
M3 - Article
C2 - 21186207
SN - 0306-6800
VL - 37
SP - 244
EP - 248
JO - Journal of medical ethics
JF - Journal of medical ethics
IS - 4
ER -