Overview and Rationale for Project

Carlos Toledo, PhDChief, HIV Prevention Branch

Centers for Disease Control and Prevention (CDC)-South Africa

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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• 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

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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