The challenge of defining standards of prevention in HIV prevention trials
- Sean Philpott1,2,
- Lori Heise1,3,
- Elizabeth McGrory4,
- Lynn Paxton5,
- Catherine Hankins6,
- the participants in the 2009 GCM/CDC/UNAIDS Consultation on Standards of Prevention in HIV Prevention Trials*
- 1Global Campaign for Microbicides (GCM), PATH, Washington, DC, USA
- 2Union Graduate College-Mt Sinai School of Medicine Bioethics Program, Schenectady, New York, USA
- 3Gender Violence and Health Centre, London School of Hygiene and Tropical Medicine, London, UK
- 4Nyack, New York, USA
- 5United States Centers for Disease Control and Prevention (CDC), Atlanta, Georgia, USA
- 6Joint United Nations Programme on HIV/AIDS (UNAIDS), Geneva, Switzerland
- Correspondence to Sean Philpott, The Bioethics Program, Union Graduate College, 80 Nott Terrace, Schenectady, NY 12308, USA;
Contributors SP, LH, EM, LP and CH participated in developing the conceptual framework, organisation and facilitation of the March 2009 meeting. SP wrote and LH, EM, LP and CH reviewed and approved the final version of this report.
- Received 8 April 2010
- Revised 18 October 2010
- Accepted 31 October 2010
- Published Online First 24 December 2010
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.
- Clinical trials
- foreign nationals
- HIV infection and AIDS
- policy guidelines/institutional review boards/review committees
- position statements (of organisations/groups)
↵* For list of participants see appendix 1 at the end of this article.
Funding Funding for this project was provided by the generous support of the American people through USAID under the terms of the HealthTech IV Cooperative Agreement no. GPH-A-00-01-00005-00. Additional financial support was provided by the Joint United Nations Programme on HIV/AIDS.
Competing interests None.
Provenance and peer review Not commissioned; externally peer reviewed.