Overview and Rationale for Project

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

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. 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. 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. 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

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. 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. 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. 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. Questions