Is TDF/FTC registered for prevention or treatment in your country?
Registration is the process by which a drug or other health commodity is approved for importation, marketing and use in a given country. Here is the current list of countries where the drug is registered for treatment. For a map of the current regulatory status of TDF/FTC for PrEP, click here.
If Truvada is registered and used for treatment, does it need separate regulatory consideration for use as PrEP?
Not necessarily. There is already a precedent of using ARVs for prevention in newborns to reduce the risk of HIV acquisition. These ARVs are used in HIV-negative infants without having an indication on their labels that they can be used as preventive agents. There is also regulatory precedent from the US Food and Drug Administration and the WHO, both recognizing Truvada as a choice for preventing HIV in adults at risk of HIV. The bottom line for advocates is there isn’t one clear regulatory pathway to PrEP access using TDF/FTC in countries where the drug is already registered. You can use advocacy to shape the outcomes.
If TDF/FTC isn’t registered, then daily oral PrEP can’t be introduced outside of a clinical research setting.
Gilead, the manufacturer of brand name TDF/FTC (Truvada), must submit the regulatory dossier for in country registration. A country can also request that this dossier be submitted. Advocates can apply pressure to both Gilead and the national drug authority to advance registration.
You don’t have to wait for TDF/FTC to be registered to begin to work towards PrEP access.
Are there any demonstration projects of daily oral PrEP or clinical trials of long-acting injectables happening in your country?
Great news! Demonstration projects and PrEP research are an excellent way to gather information that can help shape future roll out. It’s key to start planning, while demonstration projects are ongoing, for the policy and practical framework for broader introduction. This includes asking questions like the one below.
There may not be any PrEP demo projects in your country at present—but there could be. Here are some avenues to explore:
The PEPFAR DREAMS initiative, operating in 10 countries, is providing resources for high impact prevention in adolescent girls and young women. PrEP is an option for DREAMS programs. You can lobby PEPFAR to include your group in development and monitoring of DREAMS and to build PrEP into its plans.
Existing biomedical prevention research partners. Click here for a global map. These projects have community liaison officers that can be points of entry.
Are there any national documents such as guidance, position statements, national strategic policies in place addressing PrEP?
There are a range of documents that can and have been developed to frame PrEP use in different settings. Advocates can choose to focus on development of one or more of these documents as a key step and/or for implementation of existing tools.
Visit Access Basics for a description of a few different types of documents and samples from different countries — such as:
National Strategic Plans
National PrEP-specific Guidelines/Policies
What can advocates do to influence national policy and guidance?
Guidelines can spark change or sit on a shelf. To a large degree, it’s up to you. Each of the documents described above serves a slightly different function, and reaches a different audience. But all can and have been used to catalyze demand.
Some key considerations for advocates include:
Lobbying for the guidelines to be broad. PrEP is recommended for anyone who is at risk of HIV. A guideline that focuses on a specific population risks stigmatizing that group and putting the strategy out of reach of others who need or want it.
Helping to establish a pathway to guidelines in countries that say they are not ready. There’s a lot to consider in terms of where and how to make PrEP available so that people who want and need it can take it effectively. Some countries may feel more information is needed before crafting national guidelines. Advocates can guide the development of this process by asking: What additional information is needed? Who needs to be involved? What resources are needed? – And acting on the answers.
The New Vision reports that the Ugandan government is rolling out oral PrEP to public health facilities across the country. PrEP will be first available at seven public health facilities, to be rolled out across the country when resources allow.
In a piece for TheBody.com, journalist and activist Jennifer Johnson Avril writes about community involvement (or lack thereof) in recent PrEP trials as well as the opportunities afforded by (and at times, limitations) of the Good Participatory Practice (GPP) Guidelines for stakeholder engagement in research.
The Namibia Ministry of Health and Social Services 2016 National Guidelines has expanded the provision of PrEP to individuals at extensive risk of HIV acquisition, as per WHO prevention guidelines released in 2015.