Dapivirine Ring: Using a Common Agenda to Plan for Introduction

IPM, the dapivirine ring’s developer and regulatory sponsor, is managing the regulatory process and regularly provides updates on the status of filings.

IPM, Microbicide Trials Network (MTN), AVAC and others have made clinical trial findings and plans for upcoming studies widely available on their websites to support regulatory decision making.

Next Steps

• Prepare submission to regulatory processes at FDA and WHO
• Prepare submission to national regulatory processes in target countries for market authorization
• Ensure regulatory opinion and status are well known by key stakeholders at the global and national levels

Resources

• IPM Dapivirine Ring Product Page
• Ring Backgrounder
• OPTIONS Dapivirine Ring Market Authorization 101

The availability of adequate policy and clinical guidance plays a major role in determining the timing of product introduction in countries.

Aligning the planning process for demonstration projects with the development of WHO guidance will be critical to ensure early implementation experiences can further inform WHO guidance.

Next Steps

• Support WHO review and guideline development, including provision of information needed before and after initial guidance
• Support national policymakers to adapt WHO guidelines to local context

Resources

• WHO Guidelines on Oral PrEP
• Oral PrEP Introduction Framework: Develop policies and guidelines

Advocates, including previous trial participants who support the ring’s potential introduction, can be powerful voices to keep attention on the ring and move media, donors and implementers. IPM has a global advocacy program, AVAC has several programs to support advocates, including an Advocacy Fellows Program, and community based organizations (CBOs) in some countries are advocating for introduction of the ring.

However, this work lacks a funding stream to develop and implement a comprehensive advocacy effort for the ring.

Next Steps

• Coordinate interested donors to galvanize advocacy efforts for the ring
• Outline a clear advocacy strategy to amplify voices calling for ring introduction within key countries
• Support coordination and alignment of key messages and engage supporters at both country and global level

IPM and others are designing introduction initiatives for the ring, building on lessons learned from the oral PrEP introduction process:

• Ensuring initiatives address highest priority questions raised by key national and global stakeholders, especially policymakers
• Ensuring initiatives are at sufficient scale to demonstrate meaningful findings
• Ensuring initiatives are directly linked to national plans for ring introduction and do not operate as “stand alone” projects
• Exploring links to sexual health services and HIV self-testing

Next Steps

• Identify project leads and develop introduction initiative plans (e.g., locations, design, outcomes) and share for input, ideas and coordination
• Analyze and prioritize questions from national stakeholders to ensure that initiatives align to support country adoption; gather questions and input from additional countries

Resources

• OPTIONS Private and Public Introduction Stakeholder Consultations
• Learning from Oral PrEP Experience
• Oral PrEP demonstration studies
• The Landscape for End User Research: Mapping and findings
• Dapivirine Ring End-User Assessment and Recommendations for Ring Introduction to Healthcare Workers presented in Rwanda at ICASA 2019

Current donors for the ring include: USAID in partnership with PEPFAR, DFID, Ministry of Foreign Affairs of the Netherlands, Danish Ministry of Foreign Affairs, Irish Aid, Flanders Department of Foreign Affairs, Bill & Melinda Gates Foundation (BMGF) and the German Federal Ministry of Education and Research (BMBF) through the KfW Development Bank. IPM also receives in-kind support from Johnson & Johnson Global Public Health.

Funding has not yet been secured for implementation research for ring introduction initiatives.

Next Steps

• Continue donor coordination and build momentum to secure funding for implementation research studies
• Engage and collaborate with advocates to drive political and financial support for the ring in early adopter countries

A wide array of end user market research is currently underway for consumers and providers. The research, some of which has been completed already, includes human centered design and end user segmentation.

Next Steps

• Summarize existing end-user research findings related to the ring and relevant oral PrEP research into digestible compendium
• Widely disseminate market research on the ring to increase transparency and accessibility and minimize duplication

Resources

• Dapivirine Ring Social Behavioral Literature Review and Bibliography (OPTIONS, 2017) — a summary of social and behavioral factors influencing dapivirine ring use
• The Dapivirine Ring Design Guide: Human-centered Design Research to Increase Uptake and Use (USAID, 2017) — design concepts and tools to increase the adoption and sustained use of the DPV ring
• Acceptability Studies
• Vaginal ring acceptability and related preferences among women in low- and middle-income countries: A systematic review and narrative synthesis (OPTIONS, Nov 2019) – This systematic review provides an overview of women’s experience with and opinions for a wide variety of vaginal rings used to address various sexual health needs.

Informed by market research, IPM is leading the development of a demand creation strategy that can be adapted for use at country and population levels to encourage product uptake and use.

Next Steps

• Translate existing dapivirine ring market research and oral PrEP best practices into comprehensive demand generation strategies

Resources

• PrEP Communications Accelerator

IPM/J&J have contracted Imperial Logistics to conduct a 7-country supply chain analysis.

OPTIONS is developing an analysis of the potential to make the ring available via private sector healthcare channels (focus on South Africa, Kenya and Zimbabwe).

Next Steps

• Identify country-level partners based on supply chain analysis
• Plan supply chain needs for implementation studies, if different from long-term supply chain planning

Resources

• Greater Than the Sum of its Parts: Blended finance roadmap for global health (USAID, 2019)
• Assessment of Opportunities to Deliver Oral PrEP for Women Through Private Sector Health Care (OPTIONS, 2017): Summary of Key Findings, Kenya Research Findings, South Africa Research Findings and Zimbabwe Research Findings

IPM is leading the development of initial provider training materials based on insights from provider research in seven countries involved in ring trials.

Next Steps

• Collect training curricula and materials for oral PrEP; review and share assessment about what needs to be adapted for the ring
• Develop provider training materials; share with implementers of implementation research studies and with national policymakers to prepare for broader introduction

Resources

Oral PrEP training materials as well as surveys of provider knowledge, attitudes and practices are useful guides to development of ring training materials.

• Knowledge, Attitudes and Practices (KAPB) Literature Review and Analysis
• KAP Literature and Survey Analysis
• KAP Literature Review and Current Studies
• OPTIONS General KAP Quantitative Survey Template
• Health Care Workers’ Knowledge, Attitudes and Practices Related to Oral PrEP Provision to Adolescent Girls and Young Women in Zimbabwe (Poster)
• Understanding Service Providers’ Knowledge of Oral PrEP and Attitudes Toward Provision to Populations at Substantial HIV Risk in South Africa (Poster)