Book 5: HIV risk-reduction interventions

The most appropriate risk-reduction counselling and access to preventive methods should be provided to all trial participants, with new methods being added as they are discovered and validated.

14.1 Reducing the risk of HIV infection among participants is an essential ethical component of HIV preventive vaccine trials (see Points 9 and 10).

14.1.1 This is especially critical given that phase III efficacy trials rest on some exposure to HIV infection. In order to manage the perceived conflict of interest between risk reduction and scientific goals of the research, and to promote the welfare of participating individuals, investigators are morally compelled to provide optimal risk-reduction measures to participants. This is clearly captured in Book 1, 3.1.3 x, which states that research objectives are subordinate to the principle that human beings should be treated with respect.

14.2 It is recommended that before the start of a trial, a process of consultation between community representatives, investigators, host government and sponsors be used to design an effective risk-reduction strategy and its parameters. The local research ethics committee should approve the risk-reduction strategy.

14.3 The most suitable parties to be risk-reduction counsellors should be considered.

14.3.1 This should take into account factors such as real or perceived conflicts of interest for trial counsellors, local capacity building and sustainability, and protection of participant confidentiality regarding participation.

14.3.1.1 In order to provide a contribution of lasting benefit to the participating community, consideration could be given to developing the capacity of community members to provide counselling. To prevent any real or perceived conflict of interest, consideration could be given to utilising counsellors from an independent organisation.

14.3.1.2 All risk-reduction counsellors should be provided with appropriate training, supervision and support, including ethical responsibilities, lines of accountability and, if necessary, anticipated personal and professional conflicts.

14.4 All trial participants should receive comprehensive risk-reduction counselling and methods to decrease risk of HIV infection. As new methods of prevention are discovered and validated, these must be added to the preventive methods offered to trial participants. Preventive methods should include, but not necessarily be limited to:

1. Basic principles of risk-free and safer sexual practices;
2. Education concerning general health and identification and prevention of sexually transmitted infections (STIs);
3. Appropriate access to barrier methods, such as condoms, during every counselling session and on every other contact with the trial site, and participants should be informed where barrier methods are locally available between visits;
4. Treatment of STIs. Simultaneously, participants should be informed how to obtain treatment for their partners; and
5. Counselling around the potential benefits and risks of post-exposure prophylaxis with antiretroviral medication, and how it can be accessed.

14.5 HIV prevention counselling can be a most effective mechanism through which to facilitate personal behaviour change. Counselling should be:

1. Conducted in accordance with recognised national counselling guidelines;
2. Appropriate to participants' culture, language, gender and age; and
3. Based on reliable information about the prevailing social and behavioural characteristics of the research population.

14.6 Theoretical behaviour-change principles should be used to assist participants to identify and modify personal behaviour that places them at risk of acquiring or transmitting HIV infection.

14.6.1 While the standard approach to voluntary counselling and testing (VCT) in South Africa is the single pre-test and post-test counselling session, trial counsellors are encouraged to offer enhanced counselling encounters, which are likely to be more effective in encouraging safer sex behaviours.

14.6.2 While a directive, educative, health-advising orientation pre-dominates in current HIV/ AIDS counselling, trial counsellors are encouraged to adopt an interactive, facilitative approach to assist participants to make a range of decisions in their own best interests (see Point 12).

14.6.3 After consideration for the autonomous choice of participants, and protection of their welfare and privacy, counsellors might adopt flexible alternatives to individual counselling, such as couples' counselling, based on the influence of interpersonal relationships on individual behaviour.

14.6.4 Counselling should aim to assist at-risk participants to avoid infection, and assist participants who become infected to modify their behaviour so as to minimise the risk of HIV transmission. Counselling should also assist infected participants to maximise their quality of life and their psychosocial well-being.

14.6.5 Trial participants should be counselled about the dangers of presuming that an experimental vaccine can prevent HIV infection, and about the potential for a false sense of security and increased risk behaviour (see Points 9.5 and 12.4).

14.6.6 Every effort must be made to ensure that counsellors involved in risk-reduction procedures understand the potentially harmful consequences of participants falsely believing that they are protected from HIV infection (see Point 9.5.3).