Current U.S. guidelines lack sensitivity for identifying young black men who have sex with men who need HIV pre-exposure prophylaxis (PrEP), researchers report.

"Half of the individuals who became HIV-positive over the course of the study did not qualify for PrEP by CDC guidelines,” Dr. Moira McNulty from the University of Chicago reported. “It is concerning because the guidelines for PrEP qualification may not be identifying many people most vulnerable to HIV acquisition.”

PrEP is one of the most promising prevention options we have to stop the spread of HIV, and yet it has been challenging to get it to the right people,” she said. “This mismatch needs to be addressed.”

Dr. McNulty’s team used data from uConnect, a longitudinal study of black men who have sex with men (YBMSM) ages 16 to 29 in Chicago, to evaluate the ability of existing guidelines to identify individuals at risk for HIV seroconversion and to determine PrEP awareness and use between 2013 and 2016. The findings were published online in AIDS.

Among 300 individuals who were HIV-negative at baseline, only about half (49%) met criteria for PrEP use according to CDC guidelines, 72% according to the HIV Incidence Risk Index for MSM (HIRI-MSM) screening tool, and 86% according to Gilead's TRUVADA for PrEP package insert.

The accuracy for identifying YBMSM who seroconverted during the 2-year follow-up ranged from 51% for the CDC guidelines to 54% for a HIRI-MSM score of 10 or higher to 57% for the Gilead guidelines. 

PrEP awareness increased from 32% in 2013 to 64% in 2015, but 36% of participants remained unaware of PrEP during this period. Factors associated with HIV seroconversion included being unemployed versus employed full-time, having no health insurance, having an anorectal STI test performed in the past two years, use of “poppers,” and having any partners who were 10 or more years older.

“We need to make sure that the guidelines are clear and reflective of who needs PrEP, and encourage uptake of PrEP for the most vulnerable populations,” Dr. McNulty said. “This will go a long way to improving PrEP implementation and ultimately decreasing HIV transmission.”

“It is important that each physician knows the local epidemiology and also limitations of the PrEP eligibility guidelines,” she said. “That way you can have an open, informed conversation with each patient about the risks and benefits of PrEP to help them make the best decision possible.”

Dr. Latesha Elopre from University of Alabama at Birmingham reported, "Seeing that among HIV seroconverters only 52% would have met PrEP eligibility using the CDC guidelines was concerning.

The CDC guidelines do have a caveat to know the incidence rates among certain risk groups in your area when considering referral for PrEP. However, with lack of this knowledge, fewer men at high-risk for HIV would likely be referred.”

“This mirrors what we found with risk-based HIV testing,” she said. “Stigma can unintentionally be perpetuated in an already highly stigmatized group with purely ‘risk-based’ referral, and missed opportunities may subsequently occur. Universal HIV testing programs allayed some of this stigma, and the same messaging could be adopted for this HIV prevention tool.”