Global Interest in Microbicides
In 2010, UNAIDS estimated that 34 million people were infected with HIV worldwide. In sub-Saharan Africa, almost 60 percent of infected individuals are women. Despite their great risk, many women find it difficult to protect themselves from HIV infection through negotiating delay of sexual debut, partner reduction, and condom use. Therefore, a need exists for HIV prevention methods that women can use without their partner’s participation. As an Agency committed to international development and a key partner in the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR), USAID supports the development of microbicides (products that can be applied vaginally to prevent sexual transmission of HIV) as one of several methods to address this urgent and yet unmet need for protecting women in developing countries against HIV/AIDS.
Leadership in Microbicide Research and Development
For more than a decade, USAID has been a global leader in microbicide research and development. Since 2000, USAID has collaborated with the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration to develop and implement the U.S. Government Strategic Plan for Microbicides. Guided by this plan, USAID is committed to supporting the development of safe, effective, acceptable, and affordable microbicide products that are suitable for use in developing-country public sector programs.
USAID’s staff members have expertise in reproductive health, virology, product development, clinical trial design, social science research, pharmaceutical regulatory affairs, ethics, community involvement, gender issues, and international development. This enables USAID to provide technical leadership and strategic advice in collaboration with its implementing partners and other relevant stakeholders in order to achieve the objectives set by PEPFAR and the President’s Global Health Initiative.
Health research based on the best innovative science is integral to the ability of USAID to achieve its development objectives worldwide. USAID has had a critical role in the technical leadership and strategic direction of microbicide research and development (R&D) to meet developing country needs.
Scientific Breakthrough: CAPRISA 004
The Center for the AIDS Program of Research in South Africa (CAPRISA) 004 trial was recently completed in Durban, South Africa. Results from the trial provided the first-ever proof of a concept that a vaginal microbicide could safely and effectively reduce the risk of heterosexual transmission of HIV from men to vulnerable women.
The use of 1% tenofovir gel by 889 women at high risk of HIV infection proved the method to be 39 percent effective in reducing a woman’s risk of becoming HIV infected.
Once these results are confirmed in further studies, this microbicide could be a unique HIV prevention tool for women who are not able to negotiate HIV prevention methods. USAID will continue to work with PEPFAR, multilateral agencies, and partner countries to ensure that the full impact of this advance can be offered to vulnerable women and girls worldwide, especially in low-resource settings.
USAID funded 90 percent of the $18 million budget for this trial, which was conducted by CAPRISA with assistance from two USAID-funded implementing partners, FHI and CONRAD.
Additional Resources about CAPRISA 004
- Read Administrator Shah’s Statement on the results of CAPRISA 004.
- Background [PDF, 99KB]
- FAQs [PDF, 202KB]
- Fact sheets
- Study of Microbicide Gel Shows Reduced Risk of HIV & Herpes Infections in Women - 07/20/10
A Global Health Priority: Confirming 1% Tenofovir Gel
On November 29, 2010, USAID Administrator, Rajiv Shah convened a high-level discussion on HIV Prevention at the Microbicide Stakeholders Meeting.
The meeting brought together key stakeholders in the microbicide field to discuss the next steps in bringing 1% tenofovir gel to realization.
Proposal for a Shared Vision and Strategic Plan for Microbicide Introduction: [PDF, 180KB] At the conclusion of the meeting, and as a part of USAID’s continuing leadership in the microbicide field and unique role as a development agency, the Administrator identified the development of this Proposal for a Shared Vision and Strategic Plan for Microbicide Introduction as a high priority. The Administrator emphasized USAID’s commitment to move aggressively in pursuing these objectives.
Materials from the November 2010 Meeting
- Full Agenda [PDF, 144KB].
- Final Report [PDF, 267KB]
Executive Summary [PDF, 208KB]
Presentations from the November 2010 Meeting
From Research to Implementation: Insights from Accelerating Access to Life-Saving Pneumococcal Vaccines[PDF, 2 MB]
Presented by Orin S. Levine Executive Director, International Vaccine Access Center Associate Professor, International Health Johns Hopkins Bloomberg School of Public Health.
Safety and Effectiveness of 1% Tenofovir gel: Results of the CAPRISA 004 Trial [PDF, 2.6MB]
Presented by Salim S. Abdool Karim, MBChB, PhD
Programme Effectiveness [PDF, 537KB]
Presented by Glenda Gray, University of Witwatersrand.
Estimating Impact and Cost Effectiveness of Microbicides [PDF, 267KB]
Presented by Lori Heise, London School of Hygiene and Tropical Medicine.
State of the Microbicide Field [PDF, 2.4MB]
Presented by Catherine Hankins MD MSc FRCPC, Chief Scientific Adviser to UNAIDS, Office of the Deputy Executive Director.
- From Research to Implementation: Insights from Accelerating Access to Life-Saving Pneumococcal Vaccines[PDF, 2 MB]
USAID at the Forefront of Innovation to Prevent HIV
Over the past year, new technologies have been proven including a microbicide gel that could help prevent HIV transmission in women. On November 29, 2010, USAID Administrator Raj Shah convened a high-level meeting of global health professionals, experts, and policy makers at USAID headquarters to work on the aggressive roll out microbicide treatments to those most in need. Watch the video.
Current Activities: USAID Advancing Microbicide Research
In 2009, USAID’s financial support for microbicide research and development grew to $45 million, representing a dramatic increase from an initial $12 million in 2001 and bringing the total amount of funding since the program’s inception to more than $200 million.
USAID is committed to providing new HIV prevention options to vulnerable women and girls across the world, particularly those in low-resource settings. The Agency believes confirming tenofovir gel’s effectiveness is a fundamental and essential step in that direction.
USAID and the Bill & Melinda Gates Foundation are supporting the Government of South Africa in a confirmatory trial of 1% tenofovir gel. This confirmatory trial called FACTS 001 (Follow-on African Consortium for Tenofovir Studies) will be conducted by a newly-created South African-initiated and led consortium established to develop and conduct follow-on research on whether tenofovir gel can protect women against HIV infection as well as infection with herpes.
When microbicides are approved by appropriate national regulations for use in developing countries, the Agency will be ready with its experience in introductory studies, distribution, logistics management, service delivery, provider training, and social marketing to introduce the products and support their use in the fight against HIV/AIDS.
Given the success and landmark findings from the CAPRISA 004 trial, USAID believes this is an exciting partnership between our governments and reflects the larger cooperation between USG and South Africa on addressing the AIDS epidemic. This partnership is also a prime example of successful country ownership and South Africa’s prioritization of donor supported activities within the context of their own goals and aspirations for global health.
Partners for Success
USAID collaborates with partners, including the CDC, World Health Organization, the CONRAD Program, Family Health International, the Global Campaign for Microbicides, the International Partnership for Microbicides, PATH, and the Population Council.
Last updated: August 05, 2014