Financing and sustainability: How much, how long, and who? Mitchell Warren UNAIDS Consultation:

1. National and International Policies Financing and sustainability: How much, how long, and who? Mitchell Warren UNAIDS Consultation: Creating Effective Partnerships for HIV Prevention Trials 20-21 June 2005

2. How much will it cost? • Lots and lots and lots • But how much will it cost not to do it? • It’s not the money (only)

3. Treatment in trials • Trial participants who become infected with HIV during a trial should receive care, including provision of ARVs, when they need them, and on an ongoing basis.

4. Who pays? • Trial volunteers make an enormous personal investment by participating in PREP research. • Researchers, in turn, must make investments in the future of these communities. • But that does not mean sponsors, manufacturers or research institutions should bear the full burden of lifetime HIV treatment for trial volunteers.

5. Who pays? • National governments need to take responsibility, with the help of aid organizations. • In research settings where host governments now provide no ARV care, phased-in responsibility for AIDS treatment of trial volunteers should be negotiated in advance.

6. So what? • Leaving Communities Better Off • T-T-T • The Correlates of Readiness • Vaccines as part of a comprehensive response

7. Leaving Communities Better Off • Success in HIV prevention trials to leaving communities better off is not just a matter of money. • Fundamentally, it’s a matter of attitude. • Instead of doing research on communities, scientists need to do research with communities. Instead of narrowly focusing on trial outcomes only, scientists need to care about the overall health of individuals and their communities.

8. The Correlates of Readiness • For over a decade, the AIDS vaccine field has been stymied by the lack of immunological correlates of protection that could be used to measure vaccine efficacy and provide an early indication of whether a particular candidate protected against HIV infection or HIV disease. • The field now faces a similar challenge in the arena of readiness for small, intermediate and large scale trials. Here, too, the absence of quantifiable measures makes it difficult to evaluate progress, setbacks and areas that require urgent attention.

9. The Correlates of Readiness • By setting priorities and goals for readiness and sharing them with other research, prevention and treatment efforts, the AIDS vaccine field can help formulate a readiness agenda that distinguishes between cross-cutting and field-specific items and can begin to build the necessary capacity as part of a comprehensive response to the epidemic. • This is the only way to ensure that the race to readiness does not become a scramble, and that we are neither duplicating efforts nor losing sight of specific priorities.

10. Policymakers, Press, Donors, Researchers, International NGOs Global Policy & Advocacy NGOs, CBOs, Policymakers, Women’s Groups, Health Professionals, Religious & Local Leaders National/Regional Outreach Trial Recruitment VCT, Potential Volunteers, Volunteer influencers Potential HIV+ at screening; potential access to ARVs Volunteers, Trial Staff, Ethics Committees, Regulatory Authorities Trial Conduct Potential sero-conversion during trial; potential future access to ARVs Eventual access to and use of a safe, efficacious, affordable vaccine

11. Trial Participant Participant’s family and close friends Global community: International NGOs, partnering vaccine trial sponsors, WHO/UNAIDS, other international organizations, international foundations/ donors/ funders… Surrounding community: CBOs, religious institutions, traditional healers, schools/ universities, vaccine trial site staff, CABs… Larger community: NGOs, local policymakers, local media, medical professionals… National community: National NGOs, parliamentarians, Ministries of Health, national media, regulatory bodies, ethical review committees…