Designing research in vulnerable populations: lessons from HIV prevention trials that stopped early

doi:10.1136/bmj.331.7529.1403

BMJ 2005;331:1403-1406 (10 December), doi:10.1136/bmj.331.7529.1403

Education and debate

Designing research in vulnerable populations: lessons from HIV prevention trials that stopped early

Edward J Mills, fellow¹, 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

¹ Department of Clinical Epidemiology and Biostatistics, McMaster University, HSC-2C12, 1200 Main Street West, Hamilton, ON, Canada L8N 3Z5, ² Department of Medicine, Wake Forest University, North Carolina, USA, ³ Centre for the AIDS Programme of Research in South Africa and Howard College School of Law, University of KwaZulu-Natal, Durban, South Africa, ⁴ St Michael's Hospital, University of Toronto, Toronto, Canada, ⁵ AIDS Vaccine Advocacy Coalition, New York, USA, ⁶ Joint Centre for Bioethics, University of Toronto, Toronto, Canada

Correspondence to: E J Mills millsej@mcmaster.ca

Activist groups have been successful in promoting research andbetter treatment for people with HIV infection, but they canalso stop trials if their views are not considered

The first 150 words of the full text of this article appear below.

Introduction

Methods to prevent HIV infection are one of the most urgentglobal public health needs.¹ One novel method in clinical trialsis 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 communityinvolvement.² This opposition and media coverage has stoppedtwo trials in Cambodia and Cameroon and threatens the stabilityof planned and recruiting trials among intravenous drug usersin Thailand and other developing nations. The issues raisedby activists, academics, and the research community highlightthe poor communication between these stakeholders and the needfor mutual understanding of values. The differences threatento undermine the progress of prevention trials and ultimatelyaffect the most important stakeholders, those who are at risk.³