New Approaches Promote Shared Responsibility for Women and Men to Prevent HIV and Unplanned Pregnancy

SEATTLE -- The Bill & Melinda Gates Foundation today announced a series of grants that will combine innovative uses of existing tools with research and development of technologies that could offer important new approaches to HIV prevention and contraception. 

The grants parallel recommendations issued in the Global HIV Prevention Working Group's July 2002 report, entitled Global Mobilization for HIV Prevention:  A Blueprint for action. The report, released at the International AIDS Conference in Barcelona this summer, provides a comprehensive plan of action to prevent 29 million HIV infections between now and 2010 through new technologies and by scaling up existing prevention tools and strategies.

"Approaches like those announced today that combine innovative uses of existing tools, the development of new technologies, and behavioral changes that promote shared responsibilities could provide new opportunity and capacity to substantially decrease the number of new HIV infections," said Dr. Helene Gayle, former Director of the foundation's HIV/AIDS & TB Program and co-chair of the Global HIV Prevention Working Group. "These grants advance the strategy of combination prevention, attacking risk factors and risk behaviors in multiple, reinforcing ways. They also could provide greater options for women's protection against HIV and other STDs."

The foundation's new grants demonstrate the important link between contraception and disease prevention. For example, the grants include testing novel applications for existing tools and procedures, such as the diaphragm and adult male circumcision, and developing new products, such as a vaginal microbicidal gel and a contraceptive injection for men. The diaphragm and circumcision approaches build on research that shows the cervix and foreskin are "hot spots" in terms of susceptibility to HIV infection and other sexually transmitted diseases (STDs).

While condoms have been shown to greatly reduce HIV transmission, there is a strong need for a product women can control themselves. Women now account for half of all new HIV infections. Among people in their late teens and early 20s, females account for nearly two-thirds of new cases. Women are physiologically more vulnerable to HIV transmission, and often lack the power to negotiate condom use with their partners.

"It is critical that we also pursue new male-controlled methods of contraception that will allow men to share the responsibility for family size," said Gordon Perkin, M.D., Director of Reproductive and Child Health, Bill & Melinda Gates Foundation. "The grants announced today represent an important step forward, but more resources are needed from every sector to continue to fund the research and development of potential tools and technologies that are affordable, effective, and accessible to people worldwide."

Women's Global Health Imperative, University of California, San Francisco, $28 million
The University of California, San Francisco's (UCSF) Women's Global Health Imperative (WGHI)—a joint program of UCSF's AIDS Research Institute and the department of obstetrics, gynecology and reproductive sciences—today announced a $28 million grant from the foundation to continue testing the diaphragm as a potential prevention method for HIV and sexually transmitted diseases. The study will be conducted among 4500 women in Southern Africa. Dr. Nancy Padian, director of UCSF's WGHI, initially conducted a study of diaphragm acceptability among women who were unable to convince their male partners to use condoms. The study was conducted in Zimbabwe, where close to a third of the population is infected with HIV. Although participants were aware that the effectiveness of the diaphragm was unproven, the study showed that Zimbabwean women were eager to use a product they could control. 

"In countries like Zimbabwe, we have a moral imperative not only to search for new products, but also to consider new uses for existing ones," said Dr. Nancy Padian, PhD, director of UCSF's Women's Global Health Imperative. "Diaphragms are safe products, readily available in most countries. A positive outcome from this study could rapidly put an urgently needed female-controlled HIV prevention technology into the hands of women throughout the world who are at risk for HIV."

The WGHI is a global research program based at UCSF's AIDS Research Institute (ARI) and UCSF's department of obstetrics, gynecology and reproductive sciences.  Scientists at WGHI conduct research and training related to HIV/AIDS, gender and reproductive health. This research is used to design and rapidly implement practical and effective prevention and treatment strategies for women at risk for or living with HIV. The WGHI is directed by Nancy Padian, PhD, UCSF professor of obstetrics, gynecology, and reproductive sciences and director of international programs at UCSF's ARI. ARI houses hundreds of scientists and dozens of programs throughout UCSF and affiliated labs and institutions, making ARI one of the largest AIDS research entities in the world.

Contraceptive Research and Development Program, Eastern Virginia Medical School, $11.9 million
Also announced today, the CONRAD (Contraceptive Research and Development) Program at Eastern Virginia Medical School will use an $11.9 million grant from the foundation to research microbicides that are effective both as contraceptives and in preventing the spread of HIV and other sexually transmitted infections. The grant will also support contraceptive clinical trials of microbicides developed through the Global Microbicide Project (GMP).  Several promising microbicidal agents, formulated as gels and designed for vaginal use, are being tested for safety and efficacy in preventing sexually-transmitted diseases and HIV in women.  Another approach to contraception currently under study by CONRAD's CICCR (Consortium for Industrial Collaboration in Contraceptive Research) uses a combination of hormonal steroids, an androgen and a progestin, to be given by injection to men every two months. This combination will decrease the production of sperm, while maintaining the testosterone levels that ensure normal male sexual function. 

"This grant will enable CONRAD's CICCR project to accelerate research, development and clinical testing of innovative new technologies. Microbicidal gels hold the promise of both disease prevention and contraception, each a vital need in developing countries." said Michael J.K. Harper, Ph.D., Sc.D., director of CICCR and the Global Microbicide Project (GMP).
In 2000, CONRAD established the Global Microbicide Project (GMP) to help develop new microbicidal agents that specifically address the needs and perspectives of women. The main objective of this project is to develop vaginal methods that would protect women against sexually transmitted infections, including HIV.

The CONRAD Program is dedicated to developing better, safer and more acceptable methods of contraception that are especially suitable for use in developing countries and to improving reproductive health. The goals of the group's research are to expand the contraceptive choices of women and men and to help prevent the transmission of HIV and other sexually transmitted infections.

The CONRAD program, which was established in 1986 with funding from USAID (United States Agency for International Development), is a program of the Eastern Virginia Medical School. Core support comes from the USAID, with additional support from the William and Flora Hewlett Foundation, the Andrew W. Mellon Foundation, the David and Lucile Packard Foundation, the Rockefeller Foundation and a foundation that wishes to remain anonymous.

Rakai Project, Mailman School of Public Health at Columbia University, $5.8 million
A third announcement made today was a $5.8 million grant to the Mailman School of Public Health at Columbia University, in support of an adult male circumcision trial being conducted by the Rakai Project, Uganda. Scientists have observed that HIV infection may be less common in populations where men are circumcised.  Because the foreskin contains more HIV receptor cells and is vulnerable to trauma during intercourse, circumcision could play a role in decreasing HIV risk. The grant will expand the scope of the Rakai Project research to determine whether male circumcision also reduces other sexually transmitted infections in both men and women, whether rates of HIV infection decrease in women whose partners are circumcised, and whether the spread of HIV infection and other STDs declines within the population as a whole if a substantial proportion of men are circumcised.

"The grant will enable us to look at the broad public health effects of male circumcision. If the potential beneficial effects of male circumcision on men and women's health are proven, the procedure has the potential to gain widespread acceptance and have a lasting effect on the health of entire populations," said Dr. Maria Wawer, Professor of Clinical Public Health at Columbia and co-principal investigator on the study.

The Rakai Project is a research collaboration project between the Mailman School of Public Health at Columbia University in New York, the Uganda Virus Research Institute in Entebbe, and the Johns Hopkins Bloomberg School of Public Health in Baltimore.

Since 1988, the Rakai Project has conducted population-based HIV prevention and reproductive health research and service provision in over 50 unserviced rural villages in Rakai District in southwestern Uganda. The Project, which currently has a full time staff of over 250 Ugandan researchers, medical and support personnel, also provides training to expand the research and public health capability of Ugandan scientists and public health personnel. The Rakai Project has previously received a grant from the Bill & Melinda Gates Foundation. Support for the Rakai Project also comes from the US National Institutes of Health, the Henry M. Jackson Foundation, the Pediatric AIDS Foundation, the Fogarty International Foundation, and the Bill and Melinda Gates Institute for Population and Reproductive Health at Johns Hopkins.