Planning and preparing for HIV, HCV and syphilis self-testing services

When considering HIVST, HCVST or SST introduction, developing a plan that will guide implementation, policy and regulatory development is important. When preparing implementation services, the following key steps are essential:

Conducting a situational analysis for HIVST, HCVST or SST is the necessary first step in planning self-testing services. This includes HIV, viral hepatitis and STIS epidemiological situation, health and community systems, and available resources, is the necessary first step in planning self-testing services for HIV, viral hepatitis and STIs that are adapted to the unique country context.

Integrating HIVST, HCVST or SST into national policy regulations: National health policies and regulations are essential to promote and support systematic implementation of good practices and evidence-based interventions. National guidelines are often a pre-requisite for the development of regulations, including the capacity to procure and import products.

Selection and registration of products is a critical step that ensures that a clear and transparent national registration pathway is established for HIVST, HCVST and SST. On the other hand, when selecting self-tests for procurement, it is important to establish if the selected products are already listed and registered by relevant national regulatory authorities. If no such products exist, or if listed products do not meet minimal standards, countries can select from those prequalified by WHO of from the Global Fund list. Selecting products from these sources will enable countries to forgo in-country performance evaluations because existing product assessments can be leveraged to fast-track national registration and product availability.

Identifying service delivery approaches and distribution models

• Consider where ST will be delivered, when, by who, and what services and support tools will be offered with self-testing;
• who are the intended users of self-tests (members of key populations or populations from specific age groups, social and/or sexual contacts);
• where and how will the kits be distributed (facilities, other fixed sites, communities, mobile outreach services); when and how are kits distributed (timing and frequency: ongoing, occasional, or event/campaign–based); and
• who distributes kits (in-person – providers, peers, clients; automated – vending machines; home delivery).

The planning process has to incorporate quality assurance systems and monitoring and evaluation.

Resources