Thematic Areas

Global Preparation for Pre-Exposure Prophylaxis to Prevent the Transmission of HIV

The Issue in Brief

The purpose of this project is to prepare for the global, regional and in-country delivery and implementation of the use of antiretroviral drugs as a pre-exposure prophylaxis (PrEP) in comprehensive HIV prevention programs should clinical trials demonstrate safety and efficacy.

This project is part of a larger global effort that includes the Institute for Global Health at Imperial College London, the London School of Hygiene and Tropical Medicine, WHO, UNAIDS, NIH, and AVAC. In part a follow-up to Planning for PrEP, this two-year project was developed by the O’Neill Institute and our project partners with support from the Bill & Melinda Gates Foundation (BMGF).

Selected Project Highlights

July 15, 2011: Stakeholder Meeting in Rome, Italy. Coordinated by the O’Neill Institute and immediately preceding the 2011 6th International AIDS Society Conference on HIV Pathogenesis, Treatment and Prevention, the meeting convened approximately 80 HIV prevention stakeholders - advocates, donors, health care providers, normative agency representatives, regulators, researchers, policymakers, and program implementers. The Stakeholder Meeting commenced with a keynote address by Ambassador Eric Goosby and was followed by discussions on the scientific data and results from the various PrEP clinical trials (CAPRISA 004, CDC 4323, FEM-PrEP, iPrEX, and Partners PrEP) and their impact on integrating oral and topical PrEP as part of comprehensive combination prevention. Additionally, the day concluded with panels comprised of in-country policymakers and international partners.

February 4-5, 2011: Southern Africa Regional Consultation in Johannesburg, South Africa. The consultation was the third in a series of regional consultations on PrEP. Coordinated by the O’Neill Institute and co-chaired by Dr. Brian Pazvakavambwa of WHO AFRO, Dr. Helen Rees of the University of the Witwatersrand, and Dr. Sheila Tlou of UNAIDS, the meeting convened approximately 70 Southern African advocates, health care providers, researchers, and policymakers to discuss the potential implications of PrEP in Southern Africa.

November 29, 2010: Global Regulatory Meeting 2 in the Republic of Singapore. The meeting was the second of two global regulatory meetings on PrEP. Coordinated by the O’Neill Institute and held during the 14th International Conference of Drug Regulatory Authorities, the meeting convened approximately 30 regulators from across the world to discuss ways forward in terms of regulatory pathways for PrEP should clinical trials demonstrate safety and efficacy.

July 16, 2010: Stakeholder Meeting in Vienna, Austria. The meeting was a follow-up to the Planning for PrEP meeting held in June 2009 in London, United Kingdom. Coordinated by the O’Neill Institute and held immediately preceding the 2010 International AIDS Conference, the meeting convened approximately 70 HIV prevention stakeholders, including advocates, donors, health care providers, normative agency representatives, regulators, researchers, and policymakers to discuss the evolving landscape of PrEP and next steps in light of the impending clinical trial results (e.g., CAPRISA and iPrEx). Reflective of the expanding global dialogue on PrEP, this meeting was nearly three times as large as the Planning for PrEP meeting, and included participants from across the world.

June 28-29, 2010: West Africa Regional Consultation in Dakar, Senegal. The consultation was the second in a series of regional consultations on PrEP. Coordinated by the O’Neill Institute and co-chaired by Dr. Meskerem Grunitzky-Bekele of UNAIDS and Dr. Papa Salif Sow of the University of Dakar, the meeting convened approximately 30 West African advocates, health care providers, researchers, and policymakers to discuss the potential implications of PrEP in West Africa.

May 25, 2010: Global Regulatory Meeting 1 in Pittsburgh, Pennsylvania. The meeting was the first of two global regulatory meeting on PrEP. Coordinated by the O’Neill Institute and held immediately following the 2010 International Microbicides Conference, the meeting convened regulators to discuss ways forward in terms of regulatory pathways for PrEP should clinical trials demonstrate safety and efficacy.

March 21-22, 2010: Delivery Working Group Meeting in Paris, France. Coordinated by the O’Neill Institute, the meeting convened approximately 30 HIV prevention experts to develop a “proof of deliverability” framework for PrEP. Proof of deliverability asks whether PrEP can be delivered (assuming proof of concept), examining four overarching components: (1) physical deliverability; (2) cost-effectiveness; (3) market acceptability; and (4) affordability and funding. At the meeting, the delivery working group strategized ways forward and developed four subgroups (product availability, modeling, service delivery, and policy and financing) which are tasked with looking at specific delivery and implementation issues in closer detail. The O’Neill Institute and BMGF are charged with coordinating and managing the various subgroups and their respective outputs.