Background: HPTN 073 evaluated initiation, acceptability, safety, and feasibility of pre-exposure prophylaxis (PrEP) for Black men who have sex with men (BMSM) a group disproportionately impacted by the US epidemic.
Methods: A total of 226 HIV-uninfected BMSM in three US cities were enrolled between 8/2013 and 9/2014 and offered once daily oral FTC/TDF combined with a Client Centered Care Coordination counseling (C4) intervention. This analysis examined clinical reasons for study exclusion and pre-existing conditions among those enrolled, in order to inform programs designed to increase PrEP use among BMSM.
Results: A total of 118 BMSM (27.1% ≤ 25 years of age) were excluded from enrollment. Of those, 39.8% were excluded due to medical reasons, including 21.2% with abnormal liver or kidney function, 8.5% with other abnormal lab results, and 8.5% with other serious and active mental or medical illnesses. Those enrolled were younger (40.3% < 25 vs. 27.1%, p< 0.02) and more likely to have annual household incomes >$20,000 (50.9% vs. 36.5%, p=0.005) than those not enrolled. Among those enrolled (N=226), only 19.0% presented without pre-existing conditions. Nearly two-thirds (65.5%) had at least one clinically significant comorbidity at enrollment (Table 1). Psychiatric (29.6%), cardiovascular (15.0%), endocrine (4.9%), pulmonary (13.7%), neurologic (11.9%) and hepatic (5.8%) conditions were common. Nearly one-third (31%) had comorbidities in least two or more organ systems.

Table 1: Signficant Pre-Existing Conditions among BMSM in a US PrEP study
[Table 1: Signficant Pre-Existing Conditions among BMSM in a US PrEP study]

Conclusions: Among BMSM presenting for enrollment in this PrEP study, clinically meaningful health co-morbidities were highly prevalent. These conditions not only excluded a significant number of BMSM from study participation but also were widespread among those who enrolled. This is important given that these are relatively young men, many of whom lack insurance and are economically disadvantaged. These findings highlight the urgent need to better address the myriad health needs of BMSM to optimize HIV prevention.

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