CMAJ • February 15, 2005; 172 (4). doi:10.1503/cmaj.1031785.
© 2005 Canadian Medical Association or its licensors
All editorial matter in CMAJ represents the opinions of the authors and not necessarily those of the Canadian Medical Association.
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Research
Recherche

Sexual risk behaviour of Canadian participants in the first efficacy trial of a preventive HIV-1 vaccine

Thomas M. Lampinen, Keith Chan, Robert S. Remis, Maraki Fikre Merid, Melanie Rusch, Jean Vincelette, Ken Logue, Vladimir Popovic, Michel Alary, Martin T. Schechter and Robert S. Hogg

From the British Columbia Centre for Excellence in HIV/AIDS, Vancouver, BC (Lampinen, Chan, Rusch, Schechter, Hogg); the Department of Health Care and Epidemiology, University of British Columbia, Vancouver, BC (Lampinen, Rusch, Schechter, Hogg); the Department of Public Health Science, University of Toronto, Toronto, Ont. (Remis, Merid); Hôpital Saint-Luc du Centre hospitalier de l'Université de Montréal (CHUM), Montréal, Que. (Vincelette); University Health Network, Toronto General Hospital, Toronto, Ont. (Logue); Vaxgen Inc., Brisbane, Calif. (Popovic); and the Population Health Research Unit, Centre hospitalier affilié universitaire de Québec and Université Laval, Québec, Que. (Alary). Robert Remis is coordinator of CANVAC Project 1.5 (Behavioural and Epidemiological Aspects of HIV Vaccine Trials), and Robert Remis, Jean Vincelette and Michel Alary are coinvestigators with the project.

Correspondence to: Dr. Thomas M. Lampinen, BC Centre for Excellence in HIV/AIDS, 608–1081 Burrard St., Vancouver BC V6Z 1Y6; fax 604 806-9044; tlampinen{at}cfenet.ubc.ca

Background: Phase I and phase II HIV-1 vaccine trials have revealed increases in risky sexual activity among study subjects during the trials, perhaps because the subjects believe that the vaccine being tested is efficacious; subjects may thus suffer harm from their participation. We evaluated the sexual behaviour of Canadian men who have sex with men (MSM) who participated in the phase III Vax004 trial of an HIV-1 vaccine.

Methods: Using self-reports of sexual behaviours during the 6 months before trial entry as a baseline, we determined changes in reported sexual behaviour after 6, 12 and 18 months of participation in the trial.

Results: Of 291 HIV-seronegative MSM enrolled from July to October 1999, 260 (89%) completed 18 months of follow-up, 19 (7%) experienced seroconversion, and 12 (4%) did not complete follow-up. Unprotected receptive anal intercourse during the previous 6 months with partners whose HIV-1 serostatus was positive or unknown was reported by 21% of men at enrolment and by 27% at any point during 18 months of follow-up. No increase in this behaviour from baseline was reported by participants, including among men who were motivated to enrol because of expected protection from HIV-1 infection, men who believed they had received the vaccine, men who believed that the vaccine had greater than 50% efficacy, or men who believed that they had received the vaccine and that vaccine efficacy was greater than 50%.

Interpretation: MSM can be successfully enrolled in HIV-1 vaccine efficacy trials without evident increases in those sexual behaviours most associated with HIV-1 risk.