The US government has reversed its decision to force all international recipients of funding from the Global Fund to Fight AIDS, Tuberculosis, and Malaria to accept a policy saying they condemn commercial sex work.
Countries that receive money directly from the US government will still need to adhere to this pledge but Randall Tobias, director of the President's Emergency Plan for AIDS Relief, rejected the plan to extend the policy to the 128 countries that receive grants from the Global Fund.
The US contributed a third of the money currently available through the Global Fund, which has committed US$3 billion to more than 3,000 AIDS organizations throughout the world. Organizations like the Global Fund had the right to refuse restrictions from donor countries until the US Justice Department amended the Bush Administration's global AIDS initiative last year.
The announcement from Tobias comes just weeks after Brazil refused millions of dollars in grants from the US government because of its reluctance to denounce commercial sex work. This decision was based on the need to work closely with affected, and often stigmatized, groups like sex workers as an essential part of the country's successful HIV prevention strategy. Brazil's decision will not be affected by the change in US policy since the funds were not administered through the Global Fund.
The HIV Vaccine Trials Network is launching another arm of its HVTN 059 trial in Botswana and will begin enrolling volunteers next month to receive an experimental AIDS vaccine candidate. This trial is being run in cooperation with the Botswana Harvard AIDS Institute Partnership and will involve 24 HIV-uninfected people in Gaborone. Other sites in the US and South Africa are already testing the vaccine candidate, known as AVX101.
Participants in the trial will receive three injections of the candidate, which is based on HIV subtype C. The candidate uses a delivery system or vector, derived from the Venezuelan Equine Encephalitis virus that was developed by the US-based company AlphaVax. Volunteers cannot become infected with HIV from this vaccine candidate.
Botswana has one of the most serious HIV epidemics in the world with an adult prevalence estimated at 37% in 2003. The country has a nationally-sponsored treatment program for HIV-infected individuals but the uptake has been slow and the US Centers for Disease Control and Prevention estimates that only a fraction of people in need receive treatment.
The annual World AIDS Vaccine Day took place on May 18th, eight years after US President Bill Clinton delivered an historic speech calling for new commitment worldwide toward the development of an AIDS vaccine. Clinton said, "Only a truly effective, preventive HIV vaccine can limit and eventually eliminate the threat of AIDS."
This year was commemorated by several international community events where people gathered to show their support for AIDS vaccine research. Many AIDS organizations also used the day to emphasize the urgent need for an effective vaccine. A statement issued by the International AIDS Vaccine Initiative (IAVI) details some of the challenges and promises of vaccine research. The AIDS Vaccine Advocacy Coalition (AVAC) also released their updated handbook on AIDS vaccines on the eve of World AIDS Vaccine Day.
All articles written by Kristen Jill Kresge
What role do Community Advisory Boards have in vaccine trials?
An important part of preparing for clinical trials of preventive AIDS vaccine candidates is engaging policymakers, government leaders, non-governmental organizations (NGOs), and members of the community where the trial is taking place. Each of these groups has a role in ensuring that trials are run ethically and that the entire community benefits from having access to information about AIDS vaccines and other prevention strategies.
The involvement of members of the local community is vital to a successful trial because they are the people who will be volunteering. Community Advisory Boards (CABs) are one way for members of the community to be closely involved in the process of planning and running vaccine trials.
CABs became part of the clinical trials process in the US and Europe in the early 1980s when AIDS activists urged researchers and regulatory groups, including the US Food and Drug Administration (FDA), to quickly find and approve treatments for HIV infection. Many community activists educated themselves about HIV and demanded that they be involved in the design of treatment trials. The community activists were successful in changing the drug approval process in the US so that essential drugs could be approved faster. Activists were also part of CABs that met with pharmaceutical companies and the FDA to review how trials were being run. The CAB members then shared this information with others, making them the liaison between the researchers and the community.
CABs were also part of the first AIDS vaccine trials that took place in the US and Europe and are now an important part of trials that are run throughout developing countries. Uganda formed one of the first CABs in Africa in the late 1990s, a year before the first AIDS vaccine trial began on the continent. The goal of CABs is to build a strong relationship between the researchers running vaccine trials and the local community where the vaccine candidates are being tested to ensure that the community has input into the process.
Who attends CAB meetings?
Participation in CABs is voluntary but in some communities members are asked to remain committed to the group for a set amount of time. The CABs for vaccine trials usually include community leaders like nurses, teachers, members of the media, or NGO staff. Many may also involve local religious leaders. CABS try to be as diverse as the local populations they represent so that all members of the community can benefit. The members of a CAB will have different educational backgrounds and concerns. Some members may understand medical or scientific issues while others may just be interested in HIV prevention. The early CABs in the US included mostly people who were HIV infected because the trials were testing HIV treatments. For vaccine trials, CABs may include people who are current or past volunteers in a trial and want to help improve the process in the future.
There are typically around 20 members in each CAB who meet regularly to discuss the trial process. A researcher or investigator from the trial site will often attend the meetings to provide updates on trials that are in progress or to explain those that are starting soon.
What does the CAB discuss?
CAB members are often asked to provide comments on the way trials are designed, including how volunteers are recruited for the trial. Members of the CAB can help recruiters by giving them culturally-specific advice on how to reach local populations that are important to include as trial volunteers. This may include where the best locations are to recruit volunteers or how the trial staff can use gender-specific approaches to encourage women to enroll in vaccine trials. The CAB also encourages other members of the community to volunteer by giving them information about the trial. For example, CAB members can explain that you cannot become infected with HIV from the vaccine candidate, which may ease some of the worries people have about participating in a trial.
CABS are also asked to share their questions and concerns about the informed consent process that all volunteers must participate in before joining a trial. This process includes a description of the trial, details of what participation in the trial entails, and explains the possible side effects of the vaccine candidate. Informed consent is one area where CABs can have a direct influence on trial protocols. CABs can advise the trial coordinators about what information to include in the process to ensure that volunteers understand the aim of the trial. They can also help researchers understand how to explain the process of informed consent to volunteers in a way that is culturally acceptable. Other issues a CAB may address include the compensation for volunteers in vaccine trials, the community's fears about participating in research, the stigma involved with HIV research, and understanding the results of vaccine trials.
The CAB meeting is a place where the members can ask questions and comment on any part of the trial process and where there is an exchange of information between the community and the research staff. This creates a supportive environment for vaccine trials because CAB members can be certain that researchers are considering the perspective of the participants.