Pushing For A Plan! Research On AIDS Drugs As HIV Prevention Is Just The Start Of The Challenge to Expand Prevention Options

By Pat Nixon

CHAMP and partners call on NIH, CDC, Gates & USAID to move research forward and link forces to address the prevention justice issues of funding and access.

HIV prevention justice activists and advocates, recognizing the desperate need for effective biomedical interventions as part of the toolkit to prevent HIV, met in July to unite efforts to explore issues around pre-exposure prophylaxis (PrEP). This strategy, in which HIV-negative individuals would take anti-retroviral drugs to possibly reduce the risk of HIV infection, is widely considered the best near-term hope given the stern scientific challenges that the vaccine and microbicide fields face.

By mid-2009, more people will be enrolling in PrEP clinical trials than in all HIV vaccine and microbicide efficacy trials combined. Already around the world (including in the United States), thousands of HIV-negative people are enrolled in PrEP trials, recruited from diverse populations including women, gay men and other men who have sex with men, injecting drug users, and serodiscordant heterosexual couples (in which one person is positive and the other isn’t).

Results from efficacy trials may be available in the next 18 months. HIV prevention research advocates are insisting that we need a plan NOW to ensure access to PrEP for all it could help (if proven effective). We are demanding that planners address the need for new prevention options to overcome racial, social and economic health care disparities instead of replicating them.

In response to this challenge, the Prevention Research Advocacy Working Group (PRAWG) of the Community HIV/AIDS Mobilization Project (CHAMP) formed a PrEP Committee in July 2008, co-sponsored by Project Inform and the AIDS Vaccine Advocacy Coalition (AVAC). The PrEP Committee, which has already grown to over 50 researchers and community advocates, identifies questions that must be answered, fosters discussions in and beyond our communities about the opportunities and challenges of this potentially successful intervention, and prepares for advocacy efforts to ensure access to PrEP if proven effective.

In September, the PrEP Committee contacted PrEP research sponsors, which include the National Institutes of Allergies and Infectious Diseases (NIAID), the Centers for Disease Control and Prevention (CDC), the Gates Foundation and the United States Agency for International Development (USAID). In addition to commending the sponsors for their support and investment in PrEP trials, the committee also calls on them to provide resources and strategic planning to ensure concrete outcomes and further study into a PrEP research agenda.

Given the potential of PrEP, the committee urged the sponsors to:

• Ensure that appropriate resources are invested in PrEP trials so that definitive answers regarding efficacy in diverse populations can be obtained as rapidly and reliably as possible;
• Ensure priority questions are addressed in PrEP research without placing undue burden on clinical trials;
• Ensure that resources are allocated to collect longer-term safety data and conduct careful studies of the behavioral impacts of PrEP should efficacy be shown;
• Move rapidly to begin the next generation of PrEP trials;
• Plan now for PrEP trial outcomes; and
• Be responsive to community stakeholders.

The committee is deepening its efforts through wide inclusion and engagement of people from all communities carrying the burden of the epidemic. The group is producing a Call to Action that poses questions and recommendations to all who have a stake in expanding HIV prevention options.

We invite people to join the PrEP committee of CHAMP's Prevention Research Advocacy Working Group (PRAWG). To join the committee, contact Josh Thomas at josh [at] champnetwork [dot] org or 401-427-2302 x 30.