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 dapivirine vaginal ring. It will keep stakeholders informed and engaged in a coordinated, efficient and transparent planning process for introduction and scale-up. The Common Agenda will also 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
Common Agenda for Ring Introduction
Common Agenda Details
IPM 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 EMA, FDA and WHO
- Prepare submission to national regulatory processes in target countries for implementation research (IRB) and market authorization
- Ensure regulatory opinion and status are well known by key stakeholders at the global and national levels
Resources
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
Advocates, including young women and previous trial participants, 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 some countries have CSOs advocating for the 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 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 implementation research studies for the ring, building on lessons learned from the oral PrEP process:
- Ensuring studies address highest priority questions raised by key national and global stakeholders, especially policymakers
- Ensuring studies are at sufficient scale to demonstrate meaningful findings
- Ensuring studies are directly linked to national plans for ring introduction and do not operate as “stand alone” projects
- Exploring links to contraception provision and HIV self-testing
Next Steps
- Identify project leads and develop implementation study plans (e.g., locations, protocols, outcomes) and share for input, ideas and coordination
- Analyze and prioritize questions from national stakeholders to ensure implementation studies align to support country adoption; gather questions and input from additional countries
Resources
Current donors for the ring include: USAID, DFID, Ministry of Foreign Affairs of the Netherlands, Danida, Irish Aid, Government of Flanders, Bill and Melinda Gates Foundation (BMGF) and the Germany Ministry of Research and Development (BMBF). IPM also receives in-kind support from Johnson & Johnson Global Public Health.
Funding has not yet been secured for implementation research for the ring.
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 includes human centered design and end user segmentation.
Next Steps
- Summarize existing end-user research findings and relevant oral PrEP research into digestible compendium
- Widely disseminate market research 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
Informed by market research, IPM is leading the development of a demand creation strategy that can be adapted for use at country and population level, which encourages continued use.
Next Steps
- Translate existing market research and oral PrEP best practices into comprehensive demand generation strategies
Resources
IPM/J&J have contracted Imperial Logistics to conduct a 7 country supply chain analysis. It is expected to be complete by June 2019.
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
- Based on Imperial analysis, identify partners to implement the supply chain
- 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 an initial provider training curriculum 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 and curricula; 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 curricula.
- 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)
If you would like to contribute to Common Agenda planning, reach out to us.