WHO Guidelines Exclude HIV Self-Testing in Lenacapavir Recommendations

At the International AIDS Society (IAS) 2025 conference held in Kigali, Rwanda, significant discussions emerged surrounding the role of HIV self-testing amidst new guidelines for lenacapavir, a long-acting injectable drug for HIV pre-exposure prophylaxis (PrEP). Despite strong advocacy for self-testing from experts, the World Health Organization (WHO) declared it was not included in the forthcoming guidelines due to insufficient evidence supporting its efficacy in this context.

Cheryl Johnson, M.A., Ph.D., a technical officer at WHO, emphasized the importance of self-testing as a means to enhance engagement in HIV prevention. "Self-testing can help us preserve the hard-won gains across the treatment and prevention components of our programs," Johnson stated. However, Michelle Rodolph, M.S., M.P.H., another technical officer at WHO, clarified that while self-testing is valuable, it will not be recommended for lenacapavir injections, primarily due to a lack of conclusive evidence.

Rodolph articulated, "There wasn't enough evidence to come up with a recommendation on HIV self-testing for long-acting injectable practice," during the session. She did, however, highlight the potential for self-testing to increase flexibility in program implementation, stating, "HIV self-testing may be an important implementation consideration in some contexts, which should enable greater program flexibility and increase testing frequency."

The IAS 2025 conference showcased various topics, including the impact of funding cuts on HIV prevention efforts, a reference to reductions in funding from the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR). In the fiscal year concluding in September 2025, PEPFAR funding is expected to be $5.5 billion, primarily allocated to HIV prevention and treatment programs in sub-Saharan Africa.

Johnson reported that 23 African countries distributed 6.3 million HIV self-testing kits, notably in eastern and southern Africa, where uptake is highest among men aged 35 to 49 years—an age group with a significant number of undiagnosed HIV cases. Moreover, she indicated a decline in self-test kit prices, which have dropped from $5-$40 to $1-$3 in low- and middle-income countries.

Brooke Nichols, M.Sc., Ph.D., an associate professor at Boston University School of Public Health, presented research findings indicating that HIV self-testing yielded 0.6 to 6 additional HIV-positive diagnoses per 100 tests distributed across several African nations. However, only Kenya demonstrated a significant increase in antiretroviral initiations as a result of these tests.

Johnson advocated for the incorporation of self-testing into routine health services, stating, "We’re seeing across Africa some new work showing this [HIV self-testing] can be quite cost-effective and could be a really good opportunity when we don’t have the same capacity in health facilities that we’ve had before."

The WHO's mixed messages regarding self-testing reflect a broader dialogue about the need for more robust evidence to support new testing methodologies in HIV prevention. As the global community continues to grapple with HIV/AIDS, the implications of these discussions are critical for future funding strategies and health interventions aimed at combating the epidemic effectively.

In conclusion, while HIV self-testing remains a promising avenue for increasing testing rates and enhancing program flexibility, the lack of formal WHO recommendations for its use in conjunction with lenacapavir highlights a crucial gap in evidence that must be addressed. As research continues, stakeholders are encouraged to consider the potential of self-testing alongside traditional testing methods to bolster HIV prevention efforts globally.