What does “access” mean in the context of PrEP—or any other new prevention tool?
The answer depends on where you live—and you can visit the PrEPWatch Access Roadmap to find out more about what’s happening in your country and/or community.
But in many locations, access has some of the components described below:
Planning and Leadership from WHO, UNAIDS
The World Health Organization (WHO) has the authority and mandate to set norms and issue guidance on new health interventions including vaccines and medications. It reviews and weighs the evidence and then issues guidance on the implications of new research findings. It also develops technical documents that help country-level decision-making. Countries look to WHO for guidance and it is rare for developing countries, even those with relatively good capacity to conduct independent review, to implement policies, health innovations or new drugs without guidance, from WHO. Donors also look to WHO.
UNAIDS is the joint venture of all UN agencies working on HIV/AIDS (WHO being one of its members). With its global scope, UNAIDS can collect civil society and developing country input on emerging issues. Both WHO and UNAIDS have proven roles in preparing for implementation of new strategies. In order not to lose time once a new finding is released, some of this work needs to take place while trials are still being conducted.
Community Input and Engagement
A new prevention strategy can only work if people understand what it is, have access to it and use it. Conversations and planning consultations with members of communities that will be impacted by a new strategy are the only way to build trust, understanding and acceptance. Experience has shown that communities need to be brought into conversations about potential new prevention strategies before there are data from any trials. These conversations need to be honest. Raising expectations about strategies that might not work and/or might not be available for years can be counterproductive and confusing in the long-term. In best-case scenarios, these conversations can help generate ideas about how to talk about and introduce the new strategies.
Licensing and Regulatory Approval
"Licensing" refers to the steps that a country takes to legally allow a vaccine, medication or other health product to be marketed or distributed within its borders. A product is licensed on the basis of the information provided by the developers, including data from preclinical and clinical trials and ensuring the quality of the manufacturing process.
Product licensing also considers what the product label will say about what the product does or does not do, any warnings about side effects, use in pregnant women, etc. The licensure process is completed by regulatory agencies. The US Food and Drug Administration and the European Medicines Agency are two such bodies. Many developing countries also have regulatory agencies that consider product information and may also look to guidance from WHO in making their decisions.
Incorporation into National Guidance, Strategies and Implementation Plans
There are a range of documents that can be developed to as part of preparing for and implementing access in different settings. Here’s a description of a few different types of documents.
- Prescriber Guidelines: This type of document explains to health providers what’s known about daily oral PrEP and how to deliver it safely. Because TDF/FTC is already licensed and is available in many countries, people may seek it out even before there is a national policy or program. Prescriber guidance ensures that these people get accurate information to use PrEP safely and effectively. The South African HIV Clinicians Society has issued these guidelines, even though no national policy exists. The situation is similar in Britain. In the US, prescriber guidelines preceded national public health documents addressing PrEP for HIV prevention. Advocates can approach HIV clinicians societies, medical associations and other professional bodies to ask them to consider PrEP-related guidance. This may be an achievable first step as other policies are developed.
- Inclusion in National Strategic Plans: Most countries have long-term (e.g., five-year) strategies for the domestic AIDS response as well as annual plans that relate to these long-term roadmaps. These plans tend to be broad and over-arching, and also to be used as reference points by donors and implementers seeking to align programs with national priorities. Seeking to have PrEP mentioned as a prevention tool in the national strategic plan is a key step to putting it “on the radar.” In most cases, this inclusion won’t lead to introduction by itself—but it is a point of leverage for future work.
- National PrEP-specific Guidelines/Policy: This type of document is issued by the government and may include some or all of the following: description of who PrEP is meant for; targets for PrEP coverage; components of the minimum package of services to be associated with PrEP introduction. Once PrEP is mentioned in the National Strategic Plan or comparable document, a process should be triggered for developing these guidelines/policies.
Operations research refers to a range of studies that look at how to introduce and deliver a new strategy; how to add it to existing prevention or other health programs; logistics questions; what kinds of providers and information are best; and how to sustain and improve on these programs as access to the new intervention expands during the rollout (program implementation) process.
Operations research can be designed to address a wide range of questions and can be done over the course of many years. This research is one way that programs can become more effective and efficient at making health innovations available to people in different settings or population groups.
Some of the specific types of research can include:
- Pilot and or/Demonstration Projects or Pre-introductory Studies: Pilot, demonstration and pre-introductory projects can be designed to learn more about an intervention in real-world settings versus in the context of a clinical trial. These projects can happen while the regulatory approval process is underway, and before it is completed. They can address both infrastructure needs to deliver the intervention and individual and community responses to, perceptions of and questions regarding a new strategy. These projects are usually relatively small (i.e., providing a new strategy to a defined community, not an entire country). They may look at different strategies for delivering or communicating about the intervention and other issues.
- Phase IV Studies: Phase IV studies take place after a strategy has been approved or licensed. These studies generally focus on tracking large numbers of people as they use the strategy to see if there are any issues that were not found in earlier clinical trials, like rare events, long-term safety issues or effects on a particular population of users. These studies help to learn more about how a strategy works in the "real world" outside of the clinical trials setting. These studies may happen over a longer period of time and enroll a larger volunteer population than do Phase III studies. They can help identify rare side effects or drug interactions.
Process of ramping up access to new options for all who need them. Scale-up requires mobilization of sufficient resources for procurement, distribution, delivery, worker training and other costs associated with rollout; quick identification and resolution of potential bottlenecks; and engagement with many stakeholders including individuals and organizations who are in need of and voicing demand for new strategies to ensure service delivery is efficient, effective and accepted.