Dapivirine Ring: Using a Common Agenda to Plan for Introduction

Purpose of the Common Agenda

The Common Agenda serves as a shared guide for stakeholders working on a wide array of activities required for the introduction of the monthly dapivirine vaginal ring. It will serve as a framework for keeping stakeholders informed and engaged in a coordinated, efficient and transparent planning process for introduction and scale-up. The Common Agenda will also help to streamline and accelerate collective efforts.

The OPTIONS Consortium developed this common agenda in collaboration with the International Partnership for Microbicides (IPM). With the Common Agenda, OPTIONS, IPM and USAID/PEPFAR seek to engage and support coordination between partners at the global and national levels in the planning and introduction process for the dapivirine ring.

Ring Introduction Process: Where we are today

graphic showing stages of development and introduction for the dapivirine ring

As of December 2019, the ring is under review by the European Medicines Agency.

Common Agenda for Ring Introduction

graphic detailing common agenda components — available in text form below

Common Agenda Details

1. Regulatory Approval

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

2. Clinical & Policy Guidelines

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

3. Advocacy for the Ring

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
4. Introduction Initiatives

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

5. Donor Support

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
6. Market Research

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

7. Demand Creation

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

8. Supply Chain

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

9. Provider Engagement and Training

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.

If you would like to contribute to Common Agenda planning, reach out to us.