Community Voices: Forging the Path Forward for HIV Self-Testing and Personalized Viral Load Monitoring - Workshop Executive Summary

On November 1-2, 2023, the NIH Office of AIDS Research (OAR) hosted a workshop on HIV self-testing and personalized viral load monitoring. The meeting agenda was developed in consultation with HIV community partners to ensure priority topics to the community were woven into the discussions. The workshop provided a unique forum to discuss cutting-edge HIV diagnostic technologies and understand the U.S. Food and Drug Administration (FDA) perspectives on the regulatory guidance involved in the process of making these products available to end users.

Bill G. Kapogiannis, M.D., Acting Director of the NIH Office of AIDS Research, opened the workshop by recognizing the unequal impact of HIV on various communities—including men who have sex with men, gender-diverse people, and Black and Hispanic people—and the need for a nuanced public health message to reach each of these communities. Affordable and accessible HIV testing and viral load monitoring are critical tools to prevent HIV transmission and empower people living with HIV to take charge of their own health care. According to the Centers for Disease Control and Prevention (CDC), one in seven Americans with HIV does not know their status, and 80 percent of new HIV infections are transmitted by people who are not aware they have HIV and are not receiving care. These challenges and health inequities present obstacles to fulfilling the U.S. government's call for prompt action to meet goals to end the HIV epidemic by 2030.

Access to free or affordable HIV testing and viral load monitoring is crucial for sustaining the successful Undetectable = Untransmittable (U=U) campaign.¹ Recent guidance from the World Health Organization (WHO), informed by NIH-supported research, such as the HPTN 052 clinical trial, confirmed that undetectable viral load (e.g., the amount of HIV in a person’s blood), means zero risk of sexual transmission, and viral load of 200-1,000 copies per milliliter of blood poses almost zero or negligible risk of transmission.²

Workshop participants emphasized the value of self-administered HIV viral load testing to enhance quality of life for people with HIV and stressed the need to educate those with HIV, as well as health care providers, about the value and impact of rapid viral load results. Given the diversity of needs in the HIV community, researchers should consider the need for multiple testing modalities to fill the current HIV testing gap. For example, individuals undergoing analytic treatment interruption (ATI) to participate in HIV clinical trials are a group that would benefit greatly from viral load self-testing technologies.

Panelists also noted that, while much was learned from the NIH Rapid Acceleration of Diagnostics (RADx) initiative launched to speed innovation in technologies for COVID-19 testing, HIV testing presents unique technological, regulatory, and social acceptability challenges. Despite these factors, there are substantial lessons learned from COVID-19 testing that could contribute to the development of new HIV testing tools.

To bridge current challenges and gaps in access to HIV diagnostics and viral load testing in the United States, community leaders at the workshop agreed on the following needs:

• Clarification, in practical terms, about different levels of "Undetectable" HIV viral load with regard to newer, more sensitive diagnostic technologies;
• Incorporation of a geopolitical perspective on policies governing HIV self-testing and viral load monitoring;
• Consideration of ways to address social determinants of health and improve access to prevention and care; and
• Sustainable funding models for technology development, regulatory approval, and implementation.

Importantly, the workshop discussed the market need in the United States for new technologies for rapid self-testing and point-of-care testing after HIV exposure events. Such tools will be helpful to determine eligibility for pre-exposure prophylaxis (PrEP) initiation, and treatment monitoring if HIV acquisition has occurred. Of great interest are technologies that are now successfully used in other countries that allow the identification of very early HIV infection, such as fourth-generation tests that can detect HIV p24 antigen. Early detection soon after HIV exposure has been shown to enable improved health outcomes by allowing early initiation of antiretroviral therapy, as well as limit onward transmission. Technologies currently under development, such as user-friendly, smartphone-based devices for HIV self-testing and viral load monitoring, could allow people to determine their HIV status in the privacy of their homes, as well as enable people with HIV to monitor their viral loads over time. These tools are likely to improve adherence and engagement in HIV prevention and care.

The workshop also included a discussion about FDA regulatory requirements, emphasizing the stringent risk-benefit analysis and the high-risk category classification currently applied to HIV self-testing devices. In comparison, it was noted that non-regulatory bodies, such as the Global Fund Expert Review Panel on Diagnostics (ERPD) and WHO, have more expeditious review processes that have accelerated the approval of HIV self-testing kits outside of the United States. The community panel agreed about the need to streamline FDA regulatory pathways for HIV testing in response to community needs and the goal of ending the HIV epidemic in the United States. The panel stressed some take-home messages from the regulatory perspective:

• The urgent need for HIV tests to be implemented in a manner that facilitates early diagnosis and effective linkage to care;
• The need for HIV test manufacturers to include comprehensive product information in submissions for expedited FDA approval; and
• The significant public health benefits of aligning the FDA regulatory review process with the needs of the HIV community.

Closing this successful two-day workshop, Mr. Harold Phillips, M.R.P., Director of the White House Office of National AIDS Policy, thanked the participating federal, community, and global health partners for sharing their valuable insights during the discussions. He stressed the timeliness of the workshop, as the HIV community is ready to observe the 35^th World AIDS Day while committing to improving health outcomes for people impacted by HIV by expanding access to at home and point-of-care HIV self-testing and viral load monitoring.

¹About – Prevention Access Campaign

²https://iris.who.int/bitstream/handle/10665/360860/9789240055179-eng.pdf?sequence=1