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VAX-3(8)-August-2005

Vol. 03, No. 08 - August 2005

SPOTLIGHT:

International Conference highlights need for simultaneous treatment and prevention efforts

SPOTLIGHT:

The US government's funding of the research and development of candidate microbicides to prevent transmission of HIV will increase by more than US$12 million next year. The US Agency for International Development (USAID) will devote $42 million annually to microbicides as part of the government's overall funding for HIV/AIDS initiatives, which totals more than $2 billion.

Microbicides are creams or gels that can be applied topically in the vagina or rectum to block transmission of HIV. They are seen as an important preventive technology, particularly for women because they can be used without a partner's consent. The 2006 budget for microbicides is meant to fund research into new candidates and to support the testing of these candidates in clinical trials. The money will also be used to provide antiretrovirals (ARVs) to people in microbicide trials who happen to become HIV infected through exposure in the community.

The National Institutes of Allergies and Infectious Diseases (NIAID), part of the US National Institutes of Health, will also form a partnership with a non-governmental organization to develop vaginal microbicides. The International Partnership for Microbicides (IPM) will focus on candidates that are further along in development while NIAID will be more involved in the basic science and research of new microbicides. There are currently 5 candidates in various stages of clinical trials at sites in Africa and North America and 2 of them are already sponsored by NIAID. Emphasis has been placed recently on the need for collaborative partnerships between public and private organizations to speed the development of an effective microbicide and vaccine to prevent the spread of the pandemic.

GLOBAL NEWS

The World Health Organization (WHO) has returned seven ARVs manufactured by Indian drug companies to the approved list of medicines for use in developing countries. The WHO removed 3 of the generic or copied drugs from this list last year and 4 others were withdrawn by the companies after tests failed to prove that the ARVs were equivalent to those manufactured by European and US companies.

WHO also added 3 new drugs produced by the Indian company Aurobindo Pharma Ltd. The approval of these drugs allows them to be purchased and used by several international treatment programs and increases the options available to people in developing countries.

GLOBAL NEWS

The Global Fund to Fight AIDS, Tuberculosis, and Malaria funds 316 programs in 127 countries aimed at combating these life-threatening diseases. According to its annual progress report issued recently, these programs are providing 220,000 people with ARVs, far exceeding the target set for this year.

Within the report the Global Fund announced that it is suspending several of its grants to both Uganda and Myanmar. All 5 of the grants to Uganda, including 2 for HIV/AIDS, were temporarily stopped until the country’s finance ministry can ensure that the approximately $200 million will be handled effectively. The suspension of these grants should not interrupt treatment services or prevention programs in the country.

he Global Fund also chose to close its programs in Myanmar because of difficulty in delivering medicines and supplies. The grant was supposed to provide the Southeast Asian country with $98 million over 5 years and officials are now trying to convince the non-profit organization to reconsider its decision. The United Nations is now considering how to fill the gap in financial support to Myanmar.

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All articles written by Kristen Jill Kresge

PRIMER

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.