1. Overview and Rationale for Project Carlos Toledo, PhD Chief, HIV Prevention Branch Centers for Disease Control and Prevention (CDC)-South Africa

2. 2 Background Continued need to expand prevention interventions Oral PrEP –Results from iPrex announced CDC Interim Guidance for MSM in the US Southern Africa Physician’s Society guidelines in development –FemPrEP, Partners PrEP, TDF-2, VOICE –CDC-Thailand IDU Study Vaginal Microbicides –Results from CAPRISA –VOICE –FACTS Considerations for eventual implementation and use in South Africa

3. 3 Implementation and Use WHO/UNAIDS meeting on TFV Gel in June 2011 identified activities focusing on implementation and use Midterm global TFV gel coverage goal for implementation post approval Service delivery options (level of provision, public/private mix, type of service) Operations research plan Establish and maintain pharmacovigilance program Plan and launch demonstration projects Implementation research Policy meeting held in Johannesburg for PrEP

4. 4 Current Project Purpose –To identify potential appropriate service delivery models for oral PrEP and vaginal microbicides in South Africa –To develop standards for assessing implementation readiness and aptitude in service delivery sites –To assist South African government as decisions are made regarding implementation of these interventions Outcome –Tool for assessing site/provider readiness to provide these interventions, based on South African context

5. 5 Why this project? Planning is key for successful implementation of public health interventions to ensure efficient, safe, high quality services once new approaches are validated Need to ensure that service delivery scenarios are given ample consideration Tailored to account for the South African epidemic, economy, workforce, health regulations, and the existing health system Project represents only a minor portion of a larger effort to evaluate and plan for the potential rollout of these prevention Activities must be aligned with South African government priorities

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7. 7 CDC Pre-PrEP Planning Activities Developed Working Group –Multiple Branches across CDC Developed planning –Logic model –Task-specific subgroups and timelines External discussions (small meetings) –Guidelines development –Funding reimbursement –Ethics –Network models –Evaluation framework –Discordant couples and pregnancy Outreach and community preparedness Begin development of toolkits Plan for implementation pilots Begin implementation research

8. 8 Unknowns Mixed results in clinical studies of oral PrEP and vaginal microbicides have raised new questions about the timing and potential of rollout for these interventions Policy & programmatic implications (who, how much, when, how?)

9. 9 Meeting Objectives Introduce the project Introduce the proposed methodology for the development of the tool Identify the optimal profile for sites for piloting the tool Define the basic health systems requirements for delivery of oral PrEP and vaginal microbicides Discuss the proposed format of the tool Discuss how the tool should be implemented

10. 10 Agenda Update on research and policy developments Overview of lessons learned from previous biomedical HIV prevention interventions Overview of key considerations for potential rollout Development of a Site Readiness Assessment Tool Facilitated discussion on Tool development and implementation strategy

11. 11 Questions