Designing research in vulnerable populations: lessons from HIV prevention trials that stopped early
BMJ 2005; 331 doi: https://doi.org/10.1136/bmj.331.7529.1403 (Published 08 December 2005) Cite this as: BMJ 2005;331:1403
- Edward J Mills, fellow (millsej@mcmaster.ca)1,
- Sonal Singh, assistant professor2,
- Jerome A Singh, head of bioethics and health law programme3,
- James J Orbinski, associate professor4,
- Mitchell Warren, executive director5,
- Ross E Upshur, associate professor6
- 1Department of Clinical Epidemiology and Biostatistics, McMaster University, HSC-2C12, 1200 Main Street West, Hamilton, ON, Canada L8N 3Z5
- 2Department of Medicine, Wake Forest University, North Carolina, USA
- 3Centre for the AIDS Programme of Research in South Africa and Howard College School of Law, University of KwaZulu-Natal, Durban, South Africa
- 4St Michael's Hospital, University of Toronto, Toronto, Canada
- 5AIDS Vaccine Advocacy Coalition, New York, USA
- 6Joint Centre for Bioethics, University of Toronto, Toronto, Canada
- Correspondence to: E J Mills
- Accepted 2 September 2005
Activist groups have been successful in promoting research and better treatment for people with HIV infection, but they can also stop trials if their views are not considered
Introduction
Methods to prevent HIV infection are one of the most urgent global public health needs.1 One novel method in clinical trials is pre-exposure prophylaxis with the antiretroviral drug tenofovir. The trials have, however, been criticised by activist groups, citing human rights, ethical concerns, and a lack of community involvement.2 This opposition and media coverage has stopped two trials in Cambodia and Cameroon and threatens the stability of planned and recruiting trials among intravenous drug users in Thailand and other developing nations. The issues raised by activists, academics, and the research community highlight the poor communication between these stakeholders and the need for mutual understanding of values. The differences threaten to undermine the progress of prevention trials and ultimately affect the most important stakeholders, those who are at risk.3
This protest at the 2004 International AIDS Society Conference helped stop the Cambodian tenofovir trialCredit: STR/AFP/GETTY IMAGES
Trials stopped early
Cambodia
The first randomised trial planned to assess the safety and efficacy of prophylactic tenofovir was in Phnom Penh, Cambodia. The study, funded by the US National Institutes of Health and the Bill and Melinda Gates Foundation, planned to recruit 960 sex workers and was led by researchers from the United States and Australia.3 In July 2004, activists mounted the first large demonstration against the trial at the Gilead booth at the International AIDS Society conference in Bangkok, a protest that captured the world's media attention.4 This protest, as well as local remonstration to the Ministry of Health in Cambodia, resulted in the Cambodian prime minister closing the trial before recruitment.
The government has provided no official reasons for its decision. The primary …
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