Email Updates

Search form

You are here

Online Engagement

Important implementation steps that can happen on an ongoing basis

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.

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.

Country-level Communications and Consultations

Trials being implemented in any country must be approved by appropriate in-country regulatory bodies and Institutional Review Boards before a trial begins. Additionally, especially with large trials, researchers will generally need to work closely with local governments and key stakeholders to successfully implement a trial. Researchers will be expected to give ongoing updates about the trial. These communications are important for the success of the trial.

Looking at the possibility of eventual implementation of an intervention (should it be safe and effective), country-level consultations with policy makers and program implementers are important even before trial results are released, especially in the countries where trials are going on. These discussions help decision makers prepare to respond to the data when they are announced. They can also help to collect and share information on estimated need and demand for new strategies.

Access Plans for Trial Participants and Communities

Every trial should have plans for providing participants and their communities with access to strategies that show benefit. This access often starts with trial participants and extends to eligible members of the surrounding community. The duration of trial-sponsored access may vary. For example, many ongoing PrEP trials have committed to providing six months or a year of the study drug, should the trial show benefit. Community consultations should help guide access plans, and they should be negotiated up front as part of the agreement for a community to host a trial.

Manufacturing Scale-up

The processes that are used to manufacture an experimental vaccine or microbicide in the small or moderate amounts needed for clinical trials may not be the same processes that would be used to produce thousands or millions of doses for widespread access. "Process development" for large-scale manufacturing ideally starts while the trial is being conducted and so should work on identifying or building manufacturing capacity, the factories and equipment needed to produce the product.