AEGiS-14IAC: Recruiting gay men into phase III HIV vaccine trials: is it feasible?

14th International AIDS Conference

Barcelona, Spain - July 7-12, 2002

Recruiting gay men into phase III HIV vaccine trials: is it feasible?

Int Conf AIDS 2002 Jul 7-12; 14:(abstract no. LbPeC9031)

Bolding G, Sherr L, Elford J
City University, London, United Kingdom

BACKGROUND: As clinical trials enter phase III, will high-risk HIV negative gay men volunteer to take part?

METHODS: 506 HIV negative gay men were surveyed at community venues in central London in February 2002. They were asked about the likelihood of their volunteering for an HIV vaccine trial, attitudes to HIV vaccines and sexual risk behaviour.

RESULTS: Men were divided according to sexual risk-taking in the previous 3 months. Men reporting unprotected anal intercourse (UAI) with a man of HIV positive or unknown HIV status were classified as high-risk (n=94, 18.6%). The remainder who reported no UAI or UAI only with another man they knew to be HIV negative were low-risk (n=412, 81.4%). High-risk men were more likely to say they would volunteer for an HIV vaccine trial than low-risk men ('quite likely' 28.7% v 18.0%; 'very likely' 8.5% v 2.2%, p<0.001). Hence of the HIV negative men who were high-risk (18.6% of the sample), between 8.5% and 37.2% were willing to volunteer. That is to say, between 1.6% and 6.9% of all HIV negative gay men surveyed were both high-risk and willing to take part in a trial. High-risk men were more likely to agree that: they would participate in an HIV vaccine trial even if they thought the vaccine might not work (46.8% v 29.9%, p<0.01); that an effective vaccine will make safe sex less important (45.7% v 31.3%, p=0.01); that if they were in an HIV vaccine trial they would be more likely to have unprotected sex (23.4% v 7.8%, p<0.001).

CONCLUSIONS: Based on the responses of gay men in London, UK, this study suggests that to recruit 1000 high-risk HIV negative gay men in the community to participate in an HIV vaccine trial, between 15,000 and 62,000 may need to be approached. Of those who agreed to take part, around one-in-four believed they would be more likely to have unprotected sex as a result. Only strict randomisation will ensure that such men are equally distributed between the intervention and placebo groups.

Keywords: AEGIS, Homosexuality, Male, AIDS Vaccines, Homosexuality, Safe Sex, Risk-Taking, Sex Behavior, Clinical Trials, HIV Infections, HIV Seropositivity, Attitude, London, Human, Male

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