Male circumcision, microbicides and other tools set to change HIV prevention landscape

In a new report released this week, fifty top AIDS experts warn that a range of promising new HIV prevention approaches are nearing completion of clinical trials, but the world is unprepared to ensure widespread access for those in need.

In addition, while some of these prevention approaches could potentially be proven effective within the next one to five years -- such as male circumcision and microbicides -- an array of practical and ethical challenges threaten to slow, or derail, critical research, including the need for many thousands of additional trial participants.

The report, New Approaches to HIV Prevention: Accelerating Research and Ensuring Future Access, was released at the XVI International AIDS Conference in Toronto by the Global HIV Prevention Working Group. The Working Group includes leading public health experts, clinicians, researchers, and people affected by HIV/AIDS, and is co-convened by the Henry J. Kaiser Family Foundation and the Bill & Melinda Gates Foundation.

"Very soon, we could have new, highly effective ways to prevent many of the four million new HIV infections that occur each year," said Helene Gayle, MD, MPH, co-chair of the Working Group, president and CEO of CARE USA, and co- chair of the International AIDS Conference. "But these tools will have little impact in the real world unless we take immediate steps to complete current trials, mount new ones, and reach people most in need."

The report surveys the state of research on six promising new HIV prevention approaches:

• Male circumcision
• Cervical barriers such as diaphragms
• Daily administration of antiretroviral drugs currently used for HIV treatment
• Suppression of herpes, which increases HIV risk up to three times
• Topical microbicides
• HIV vaccines

Preparing for Access

As HIV prevention research moves forward, the Working Group report warns that the world is falling far behind in preparing to ensure access to all those in need.

"The development of effective new HIV prevention approaches could help millions avoid crippling illness and death," said David Serwadda, MBChB, MPH, director, Institute of Public Health at Makerere University in Kampala, Uganda, and co-chair of the Working Group. "But unless we prepare now to make new, lifesaving tools accessible in developing countries, this scientific triumph will turn into a moral failure."

The report makes three major recommendations to prepare now for immediate roll-out of new HIV prevention approaches that are proven effective in clinical trials:

• Resources: Major new donor funding will be needed to help developing countries introduce and deliver new prevention tools that prove effective in trials -- for example, to purchase new prevention tools, train health care providers, conduct public education campaigns, and monitor effectiveness. Donors should commit to providing these resources without taking funding away from current AIDS programs.
• Provider training: New HIV prevention approaches -- such as male circumcision -- must be safely and properly implemented by trained health providers, yet many developing countries suffer acute shortages of qualified health personnel. International agencies should develop formal public health guidance, and develop health care provider training programs.
• Preventing increased risk behavior: It is essential that the introduction of new prevention approaches does not lead people to become complacent about HIV risk behavior, which could actually lead to an increase in HIV infections. Because no new HIV prevention method is likely to be 100 percent effective, public health officials should develop education campaigns that emphasize the importance of using new prevention approaches in combination with existing prevention strategies -- such as behavior change, condoms, HIV testing, and treatment for other sexually transmitted diseases.

"New prevention tools hold real promise, especially when combined with prevention programs and services that address underlying cultural and societal issues, and that give people the knowledge and hope to protect themselves," said Drew Altman, PhD, president and CEO of the Kaiser Family Foundation, and co-convener of the Working Group.

Accelerating HIV Prevention Research

The report also finds that HIV prevention research faces significant financial, logistical, and ethical obstacles that, if not quickly addressed, could delay the completion of critical clinical trials.

"Trials of potential microbicides and other new HIV prevention approaches are hugely complex undertakings," said Gita Ramjee, PhD, director, HIV Prevention Research Unit, Medical Research Council of South Africa. "We face challenges on a number of fronts -- the world's ability to conduct these trials is reaching maximum capacity, and current clinical trial ethical guidelines were not written with today's HIV prevention research in mind."

The Working Group makes three key recommendations to avoid bottlenecks in conducting trials of promising new HIV prevention approaches:

• Trials capacity: Capacity to conduct prevention trials in developing countries is severely limited -- including an inadequate number of participants, well-equipped study sites, and trained staff. The HIV prevention efficacy trials underway involve approximately 80,000 study participants, and many thousands more will be needed for future trials.
• The Working Group recommends that relevant agencies work together to inventory existing capacity, identify specific needs and sites for scale-up, and prioritize prevention approaches for testing.
• Ethical issues: Existing ethical guidelines for medical research do not sufficiently address key issues that have emerged in HIV prevention clinical trials. For example, there is no formal consensus on which existing prevention services should be provided to all trial participants, or on how to facilitate HIV treatment access for participants who become HIV-infected. The Working Group recommends that UNAIDS and the World Health Organization convene a broadly inclusive panel of experts to develop updated guidance on these and other ethical issues facing HIV prevention research.
• Community engagement: Inadequate communication between researchers and local stakeholders has slowed, and even stopped, some critical prevention studies. To help ensure productive relationships with local communities, the Working Group recommends that trial investigators and sponsors involve members of the community in key aspects of the research process from the outset, including development of trial protocols and ongoing trial oversight.

For more information about the Global HIV Prevention Working Group and past reports, visit www.gatesfoundation.org or www.kff.org.