Given its potential to advance health equity and speed progress toward universal health coverage, self-testing could transform health care. Self-testing options offer individuals and communities easy, fast, and confidential pathways to diagnosis and care for a growing number of diseases; for example, HIV, hepatitis C, COVID-19, and most recently, syphilis.
The emergence of more accessible and affordable self-tests, coupled with the growing self-care movement, provides greater opportunities for people to direct their own disease screening and make decisions based on their results safely, effectively, confidentially, and conveniently.
PATH has championed the generation of evidence, development of products, and delivery of services to increase access to self-testing in low- and middle-income countries. COVID-19 self-tests—uniquely introduced for a novel virus during a deadly, global pandemic—offer insights into self-testing's untapped potential.
Self-testing for COVID-19
As COVID-19 spread around the world, public health officials needed to identify infections early, isolate cases of active infection, and provide effective case management. This would require expanded access to high-quality, affordable diagnostics.
While reverse transcription polymerase chain reaction remains the gold standard method for COVID-19 diagnosis, we urgently needed faster and more accessible tests. Antigen-detecting rapid diagnostic tests—which enable individuals to self-test at home—filled that gap. These tests are easy-to-use, inexpensive, provide quick results, and require few human and material resources, making them important tools for reaching underserved populations, particularly in low- and middle-income countries with limited access to testing and treatment.
Integrating self-tests into public health programs rather than simply making them available as a consumer product can further amplify their appropriate use and impact. For example, self-testing not only identifies positive cases, but can also ensure linkages to necessary follow-up and treatment and enhance contact tracing, ultimately reducing the burden on individuals and the health care system. Where widely available, COVID-19 self-testing has done all that while simultaneously reducing health care workers' potential exposure to infection.
Unfortunately, many countries lack access to affordable COVID-19 self-tests. In Vietnam and India, PATH has supported the use of COVID-19 self-testing as part of routine screening in health facilities, at home, and work.
To generate additional evidence to inform COVID-19 self-testing policies and practices, PATH, through the Unitaid / Population Services International (PSI) Self-Testing Africa (STAR) project, is implementing studies in Brazil, India, and Uganda. We have also developed a COVID-19 Diagnostics Self-Test Dashboard to support product selection and procurement decisions by country governments and health system managers. The interactive dashboard notes the global availability of COVID-19 self-tests and includes information on regulatory body approval and performance against World Health Organization (WHO) standards.
Early adopters: HIV self-testing
The quick success of COVID-19 self-testing was made possible in part by years of public health learning and experience related to self-testing for HIV. In 2016, WHO released its first-ever HIV self-testing (HIVST) guidelines, recommending this method as “a safe, accurate and effective way to reach people who may not test otherwise, including people from key populations, men and young people.”
A breakthrough at the time, HIVST allowed individuals to collect their own oral or blood specimens, perform an HIV test, and interpret the results conveniently and confidentially. Access to HIVST remains especially important where stigma or physical distance to a facility places diagnostic services out of reach for many.
PATH’s HIVST implementation experience in Vietnam contributed to the evidence base for the current WHO HIVST guidelines. Through the USAID Healthy Markets project, we partnered with the Vietnam Ministry of Health to introduce and scale up access to HIVST kits. As part of this work, PATH and the University of the Witwatersrand in South Africa—through a collaboration with the Bill & Melinda Gates Foundation—generated test kit performance data to move HIVST kits through the WHO prequalification process. WHO approved the kits, and they are now on the market.
An early advocate of self-testing, PATH’s work then informed the next generation of HIVST kits, helping the global community understand how to make self-testing acceptable, accessible, and useable for diverse populations. Using a human-centered design approach to understand user needs, goals, behaviors, attitudes, and limitations, PATH developed a target product profile and user personas that informed the product development process to ensure that HIVST was appropriately designed for the people who need it.
In India, Indonesia, Kenya, Uganda, and Vietnam, PATH has increased access to HIVST through pharmacies and e-commerce platforms, with options for at-home delivery and pick up at community clinics. In the Democratic Republic of the Congo (DRC), we used HIVST to promote task-shifting, leveraging community pharmacists and lay providers to provide HIV testing services at community pharmacies and through integrated household testing campaigns for HIV and TB.
PATH has also leveraged social media and customized partner testing and notification services for a variety of contexts and population groups. The most dramatic result? In five months in the DRC, the number of people knowing their HIV status and linked to treatment increased five-fold. In Ukraine, PATH collaborated with community-based organizations and partners of people living with HIV in prisons or detention settings to offer HIVST as part of partner notification counseling. HIVST not only increased new HIV diagnoses but also resulted in new enrollments in pre-exposure prophylaxis (PrEP) and other HIV prevention services.
Advancing self-testing since 2014 through partnership and innovation: From R&D to scale
Building on what we know
Building upon these foundational efforts, PATH is expanding our work in self-testing to include screening for hepatitis C, diabetes, cervical cancer, and sexually transmitted infections:
- Hepatitis C transmission largely happens through sharing needles and syringes and condomless sex. This means that those at higher risk of HIV may also be at increased risk of hepatitis C. In Vietnam, PATH is partnering with Unitaid, PSI, and community groups to integrate hepatitis C self-testing into already-robust HIVST service delivery platforms.
- To help people living with diabetes, PATH and partners are using human-centered design to bundle diabetes medicines and products, including self-test kits for checking glucose levels, which can help patients prevent and monitor for complications that can lead to early death.
- To increase access to cervical cancer screening, PATH collaborated with private-sector partners to develop a low-cost cervical cancer self-sampling kit. Women can use the kit to collect their own vaginal samples, without a pelvic exam, a strategy that is transforming screening programs in low- and middle-income countries.
- Similarly, in Vietnam, PATH supports local clinics to develop systems and training tools to enable men who have sex with men and transgender people to collect their own genitourinary samples for gonorrhea, and chlamydia testing as part of a new Tele-PrEP service.
Getting closer to universal health coverage
PATH’s work is rooted in the belief that all people should have equitable access to people-centered care, during times of calm and during times of uncertainty. Before COVID-19, self-testing was already a central approach to advancing access to health care because it can improve equity and facilitate integrated service delivery.
Over the next five to ten years, making a wider range of self-testing products available where there are needed is a key approach to progressing toward equitable primary health care and universal health coverage.
