Understanding Risk-Reduction Counseling

Why is risk-reduction counseling an important part of AIDS vaccine trials?

A key component of running AIDS vaccine clinical trials is providing the volunteers with education and counseling on how they can protect themselves from HIV infection. This process begins with voluntary counseling and testing (VCT). After this, volunteers who are eligible for participation in the trial are scheduled to return to the trial site repeatedly over several months or years.

At the start of the trial volunteers are given either the vaccine candidate or an inactive substance known as a placebo. At each visit thereafter volunteers are tested for HIV infection and counseled on their behaviors. These sessions give volunteers an opportunity to talk with a counselor about how they can reduce their risk of becoming HIV infected. This process is known as risk-reduction counseling. This counseling is essential to AIDS vaccine trials as well as other HIV prevention trials because researchers do not know if the vaccine candidate will have any protective effect until large efficacy trials are completed. Also not all volunteers in the trial are receiving the vaccine.

Trained counselors can work with the participants to identify their risk behaviors and encourage them to avoid feeling any false sense of protection from the vaccine candidate. It is still very important during a clinical trial that volunteers continue practicing safer sex or injection practices and reduce behaviors that put them at risk of HIV infection as much as possible.

What is a typical risk-reduction counseling session?

During a risk-reduction counseling session the counselor will try to learn about the volunteer’s past risk behaviors. This is referred to as collecting a “history” and can include information about their sexual practices and drug use. Counselors will ask volunteers about their number of sexual partners, their use of condoms or other protective devices, and any special issues that may surround their previous behaviors, including sexual violence or domestic abuse. The type of counseling will depend on the targeted population enrolled in the study—the risk-reduction messages for injection drug users would be different from those at risk of sexual transmission.

A risk-reduction counseling session also provides volunteers with some basic information on HIV/AIDS and how it is transmitted. This may help to dispel any myths about how they can become HIV infected and can aid volunteers in identifying their true risk behaviors.

What is a risk-reduction plan?

During a risk-reduction counseling session the counselor works with each trial participant to develop an individualized plan for how to change his or her risk behaviors. Behavioral changes are often difficult for people to make so counselors should enquire about the volunteer’s attitudes and beliefs to determine how these may be contributing to their HIV risk. Counselors should also try to give volunteers several options for how to protect themselves because each volunteer is unique, even if they participate in the same risk activity. The risk-reduction plan that the counselor and volunteer create is personalized and each volunteer’s questions and concerns should be considered so that the volunteer is more likely to adhere to it. The messages should also change over the course of the study so that volunteers don’t get tired of hearing the same information.

In some studies risk-reduction counseling sessions are done with couples rather than individuals. This approach seems to work best for people who are at risk of becoming HIV infected through heterosexual transmission such as discordant couples, where only one partner is infected. Many women are still at risk of HIV infection in marriage, and for them risk-reduction counseling can be more effective if it addresses some of the power struggles or violence that occurs in the home.

The counselor should try to create an environment that allows volunteers to be comfortable discussing their personal behaviors. Risk-reduction counseling sessions require counselors to dedicate large amounts of time and effort as many participants may initially be unwilling to discuss details about their sexual activities with strangers. But the more information the volunteers provide, the more likely their risk-reduction plan will be successful. One way counselors can put volunteers at ease is to use supportive verbal and body language. They should also remain objective and avoid judging the volunteer.

Does risk-reduction counseling work?

Several clinical trials in the US have shown that individual risk-reduction counseling sessions are effective in getting people to change their behaviors and reduce their risk. But little is known about how these results translate to other cultures.

Only one efficacy trial of a preventive AIDS vaccine candidate has been completed to date. During this trial volunteers in Thailand and the US were provided with risk-reduction counseling every 3 months for the first two years and then every 6 months for the final year. Researchers have heavily studied the risk behaviors of these participants over the course of the trial and their reasons for volunteering. In some cases the risk behaviors of the volunteers actually declined among both the vaccine and placebo groups, leading to a lower incidence of HIV infection than anticipated for the study period. This is one way a vaccine trial can benefit a community even if the candidate is found ineffective. Researchers also found that several people reported joining this trial specifically to learn about reducing their risk behaviors. This observation further supports the need for intensive risk-reduction counseling in the context of AIDS vaccine trials.