Overview and Rationale
for Project
Carlos Toledo, PhD
Chief, HIV Prevention Branch
Centers for Disease Control and Prevention (CDC)-South Africa
• 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
• Considerations for eventual implementation and use in
South Africa
Implementation and Use
• WHO/UNAIDS meeting on TFV Gel in June 2011
identified activities focusing on implementation and
• 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
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
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
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
Network models
Evaluation framework
Discordant couples and pregnancy
Outreach and community preparedness
Begin development of toolkits
Plan for implementation pilots
Begin implementation research
• 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?)
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
• Discuss the proposed format of the tool
• Discuss how the tool should be implemented
• Update on research and policy developments
• Overview of lessons learned from previous
biomedical HIV prevention interventions
• Overview of key considerations for potential
• Development of a Site Readiness
Assessment Tool
• Facilitated discussion on Tool development
and implementation strategy
• Questions

CDC South Africa