The need for better protection

Working to develop new prevention technologies means acknowledging the limitations of current means to control the epidemic. This may be seen as challenging the idea that more should be done to make effective use of the strategies we already have. This threatens more than is seen at first sight, and so it needs to be considered before looking at any of those new technologies.

Existing valid strategies may include: education for knowledge and skills; challenging or reinforcing traditional patterns of behaviour; selectively promoting condoms, clean needles and better use of medical treatment.

Along with preventing HIV and AIDS, much HIV prevention work has other goals. These may include changing gender relations, to increase boys' respect for girls and women and the confidence of girls and women in their ability to achieve their ambitions. Campaigners seek to increase the self-respect and social standing of people who have been marginalised in many societies, such as men who have sex with men and injecting drug users. Above all, people with HIV are becoming central to HIV prevention. It is essential to address their needs and secure their involvement to counter the stigma which prevents people finding out their status and/or taking action to protect other people.

These aims are important and worthwhile. They should be advanced, not threatened, by giving people better means to protect themselves against HIV and AIDS. However, when people think of new technologies as a magic bullet, an alternative to existing methods of prevention rather than a way of strengthening them, those other aims and the values that underpin them may seem to be under threat.

It is important that advocates for new prevention technologies understand, anticipate and address such concerns, to secure community support both for the evaluation and the future adoption of successful products.

Adding not replacing

None of the prevention technologies discussed in this chapter are likely to remove the need for existing strategies in the foreseeable future.

This means that the evaluation of these technologies must always be undertaken alongside and in combination with existing approaches.

Even the most enthusiastic advocates of antiviral treatment to prevent sexual transmission would see it as a back-up to other methods for use in extreme circumstances, when condoms fail or to protect victims of sexual assault, or to cover limited periods in a person's life when they are at greatest risk of HIV infection.

In relation to microbicides and vaccines, advocates sometimes express concern that condom use, or antiviral treatment could make the evaluation of other options difficult or even impossible. In practice, as more experience is gained with Phase III trials of vaccines and microbicides, this concern seems likely to disappear.

The COL-1492 microbicide trial, discussed later on, was an impressive demonstration that it is possible to show the superiority of one product over another (even if it was the placebo that came out ahead), despite a successful campaign to promote increased condom use among trial participants.

Similarly, the VaxGen trials showed that it was possible to recruit, motivate and retain a large group of volunteers at continuing high risk of HIV without adding to their risk-taking. (Reported risk-taking behaviour declined during the course of the trial and HIV infection rates were stable.)

This highlights the importance of feasibility studies, to identify populations in which there is continuing HIV risk despite the wholehearted promotion of the best available means of HIV prevention.

It may also point to the need for multi-agency as well as multi-disciplinary projects, in which some or all of the prevention education can be provided independently of the researchers.

Community engagement

Organising prevention research as a clinical trial opens the way to formal review by ethical committees, providing important safeguards to trial participants. Increasingly, those organising prevention trials have seen the need for and value of a Community Advisory Board.

Most of the work that has been done on Community Advisory Boards has been in the context of preventive vaccine trials, and this is reflected in the UNAIDS ethical guidelines.

Here, the main point to make is that the same considerations apply to all of the prevention research discussed here. Most of the ethical guidance set out by UNAIDS for vaccine trials is equally applicable to microbicide trials or trials of antiretrovirals used to prevent HIV infection.

One of the critical roles of the Community Advisory Board should be, to decide on the nature of the HIV prevention efforts that should be directed at all trial participants, aside from the use of the product that is being evaluated.

It is also vital that the standard of care to be provided to any trial participant who becomes HIV- positive should be discussed and agreed in advance of the trial.

Multidisciplinary evaluation

It may seem obvious, that the ultimate goal of clinical trials of an antiviral drug, a microbicide or a vaccine should be to find out if that product works to prevent HIV or AIDS and save lives. Or, as stated later on in relation to HIV vaccines, to reduce the burden of the disease and of its treatment.

However, in the context of adding an antiviral, a microbicide, a vaccine or another option to a range of strategies that people are already using in response to HIV, there are more questions that need to be asked.

How do people understand the role of this new technology? How can they integrate it into their other strategies? Does it open up new strategies to them? Does it change the way they perceive the epidemic, and their own and other people's relationship to it?

To answer such questions requires the active involvement of social researchers in evaluating new biomedical technologies. When it comes to HIV prevention, medicine is far too important to be left only to medical scientists.