Overview and Rationale
for Project
Carlos Toledo, PhD
Chief, HIV Prevention Branch
Centers for Disease Control and Prevention (CDC)-South Africa
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
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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
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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
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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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CDC Pre-PrEP Planning Activities
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Developed Working Group
– Multiple Branches across CDC
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Developed planning
– Logic model
– Task-specific subgroups and timelines
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External discussions (small meetings)
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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
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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?)
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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
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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
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• Questions
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