Abstract
To the Editor:
As of 2022, an estimated 1.2 million persons in the United States could benefit from human immunodeficiency virus (HIV) pre-exposure prophylaxis (PrEP), yet only 36% had been prescribed PrEP. 1 In the same year, Hispanic/Latine persons comprised 18% of the United States population but disproportionately accounted for 33% of new HIV infections. 1 Together, Hispanic/Latine and Black/African American persons represented approximately 70% of the estimated new HIV infections while comprising only 33% of the population. 1 These disparities underscore the need for targeted PrEP implementation strategies to optimize uptake among populations most affected by HIV.
National initiatives aim to reduce new HIV infections by 90% by 2030, prioritizing 57 high-incidence jurisdictions; however, additional strategies are needed outside these areas. 2 Pharmacist-managed PrEP programs represent one approach, particularly within federally qualified health centers (FQHCs). 2 Although pharmacist-managed PrEP services have demonstrated effectiveness in non-FQHC settings, data within FQHCs remains limited.3,4 Existing FQHC literature suggests provider interest in expanding PrEP services but identifies challenges including patient retention and provider comfort with prescribing/monitoring PrEP.5–7 OneWorld Community Health Centers (OneWorld), a FQHC in Omaha, Nebraska, serves a predominantly Hispanic/Latine population and offers PrEP through a pharmacist referral and collaborative practice agreement model. We evaluated OneWorld’s pharmacist-managed PrEP utilization to identify potential missed opportunities for PrEP referrals among patients at risk for HIV acquisition.
We conducted a retrospective evaluation of patients at risk for HIV acquisition between 1 January 2024 and 30 June 2024. The at-risk cohort included patients who met at least one of the following criteria during the study period: receipt of oral PrEP or non-occupational post-exposure prophylaxis; documented history of a sexually transmitted infection (STI; specifically, chlamydia, gonorrhea, and syphilis); request for STI screening; or new HIV diagnosis. Pregnant patients were excluded since they are excluded from the current pharmacist managed PrEP referral/collaborative practice agreement at OneWorld.
The primary outcome was the proportion of at-risk patients receiving oral PrEP. Secondary outcomes included the proportion of patients referred for pharmacist-management (PharmD-managed cohort), adherence to guideline-directed laboratory screenings at initiation (HIV and STI screenings, hepatitis serologies, and serum creatinine/liver function tests), 8 appropriate guideline-directed medication quantities prescribed (i.e., ≤90-day supply), and PrEP continuation, defined as a follow-up PrEP visit within 6 months after the study period. We performed descriptive statistics for cohort characteristics and primary and secondary outcomes. All analyses were completed using SPSS, Version 29.0 (IBM Corp., Armonk, NY). The project was deemed exempt by the UNMC institutional review board.
A total of 6898 patients met at-risk criteria for HIV acquisition (at-risk cohort), and only 72 (1%) were prescribed oral PrEP during our study period (Table 1). The at-risk cohort was predominantly female (66%), Hispanic/Latine (69%), and primarily Spanish-speaking (54%). Five new HIV diagnoses occurred within the at-risk cohort during the study period. In contrast, the PrEP cohort was predominantly male (94%), not Hispanic (51%), and primarily English-speaking (78%). Additional demographics are presented in Table 1. Of the 72 patients prescribed oral PrEP, only 11 (15%) were referred for pharmacist-management (Table 2). Patients in the PharmD-managed cohort were mainly male (82%) and White (82%), similar to those managed by a primary care provider (PCP) (Table 2). A higher proportion in the PharmD-managed cohort were uninsured/self-pay (45%). PharmD-managed cohort demonstrated high adherence to guideline-directed care. All had appropriate medication quantities prescribed and guideline-directed PrEP screening at initiation, except hepatitis serologies (82%) (Table 2). In comparison, among the PCP cohort, HIV testing, STI screenings, and hepatitis serologies were obtained in 87%, 89%, and 52% of patients, respectively (Table 2). Only 35 (49%) patients continued PrEP after the study period. Continuation was observed in 25% of the PharmD-managed cohort versus and 53% of the PCP-managed cohort.
Cohort Characteristics
Hispanic, also including those who self-reported as Mexican, Chicano, Cuban, Puerto Rican, and Other Hispanic.
Other languages in the at risk cohort include: Arabic (n = 5), Burmese (n = 3), Chin (n = 1), Chuukese (n = 1), Dari (n = 11), Kiche (n = 10), Kanjobal (n = 21), Karen (n = 34), Karenni (n = 25), Mandarin (n = 2), Nepali (n = 18), Nuer (n = 1), Pashto (n = 8), Portuguese (n = 4), Russian (n = 16), Shiluk (n = 3), Somali (n = 3), Swahili (n = 3), Tajik (n = 1), and not reported (n = 5).
Total number of STI screenings obtained in each cohort during the study time period.
HIV, human immunodeficiency virus; IQR, interquartile range; SDI, social deprivation index; STI, sexually transmitted infection.
Primary Care Provider vs Clinical Pharmacist Managed PrEP
Hispanic, also including those who self-reported as Mexican, Chicano, Cuban, Puerto Rican, and Other Hispanic.
No more than 90-day supply prescribed at a time.
Per the Center for Disease Control and Prevention 2021 Pre-exposure Prophylaxis for the Prevention of HIV Infection Clinical Practice Guideline.
F, emtricitabine; IV, intravenous; PrEP, pre-exposure prophylaxis; SD, standard deviation; TAF, tenofovir alafenamide; TDF, tenofovir disoproxil fumarate.
Despite the availability of PharmD-managed services, PrEP uptake among at-risk patients at OneWorld remained low. Only 1% of at-risk individuals were prescribed oral PrEP. In our cohort, Hispanic/Latine and female patients represented a majority of the at-risk population (69% and 66%, respectively) but less than half of PrEP recipients (46% and 7%, respectively).
Utilization of PharmD-managed PrEP was also limited, with only 15% of patients prescribed PrEP managed by clinical pharmacists. This represents an opportunity for expansion, particularly given prior evidence demonstrating the feasibility and effectiveness of pharmacist-led PrEP.3,4,9 In our PharmD-managed cohort, there were high rates of guideline-concordant laboratory monitoring. The only instance in which pharmacists did not obtain guideline-directed labs in 100% of patients was hepatitis serologies. However, since clinical pharmacists must have patients establish with a PCP prior to their initial PharmD-managed PrEP visit, these missed labs may reflect gaps in care transitions and can be viewed as a reminder to all providers to confirm that guideline-recommended labs have been completed prior to initiating or continuing treatment. More broadly, this workflow requirement itself may introduce unnecessary complexity. Reconsidering the need for a PCP visit prior to PharmD-managed PrEP could streamline care, reduce opportunities for missed laboratory testing during transitions, and lower barriers to initiation, particularly as alternative models without mandatory PCP visits have been successful. 10
The underrepresentation of Hispanic/Latine and female patients among PrEP recipients in our cohort is particularly concerning given that OneWorld serves a predominantly Hispanic/Latine community and is intentionally structured to meet the needs of the population with bilingual staff, culturally responsive services, and Spanish-language materials. This disparity persists despite the disproportionate HIV burden in these communities. However, our lower PrEP uptake in these specific populations is consistent with previous literature demonstrating low uptake in racial/ethnic minority and female populations. 11 This gap has primarily been attributed to a lack of awareness of PrEP, stigma associated with PrEP, or both. 11
Alternative PrEP delivery models may help address these barriers. For example, long-acting injectable therapies (LAI) for PrEP have been shown to decrease the stigma associated with PrEP in these communities.11,12 Incorporating LAI PrEP at our FQHC could further expand PrEP services; however, in order to equitably implement an LAI PrEP program, additional logistic, staffing, and financial support would be necessary.
Retention in PrEP care was also suboptimal, with less than 50% of patients continuing therapy after the study period. Although consistent with prior literature, this highlights the need for improved patient education on the importance of ongoing PrEP use. 4 Retention in PrEP care is challenging because it relies on patients’ ongoing perception of their risk for HIV acquisition. Integrating PrEP into routine primary care may normalize its use as preventative care rather than episodic treatment. Higher retention in the PCP-cohort (53% vs. 25%) may reflect coordination with routine medical visits. Furthermore, 89% of STI screenings were completed within the clinic, instead of the urgent care, setting, indicating that patients are already engaged in routine care at OneWorld and represents opportunities for prevention-focused discussions.
Although expanding PrEP within primary care may increase provider workload amid existing PCP shortages, our findings highlight a scalable opportunity to leverage clinical pharmacists as key partners in HIV prevention. Many FQHCs already integrate clinical pharmacists, who can support guideline-concordant PrEP delivery and monitoring. Enhancing provider education on sexual health discussion and HIV prevention, coupled with the expansion of pharmacist-managed PrEP, are practical strategies to increase equitable PrEP access and utilization.
Authors’ Contributions
J.W., J.P.H., S.H.B., and S.W.S. contributed to conception and methodology of the project. J.W., M.C., and J.D. organized the database. J.H. and S.S. validated the data. J.P.H. and S.W.S. performed the formal analysis. J.W. and S.S. wrote the first draft of the article. S.H.B., A.D., and S.W.S. oversaw the project. All authors contributed to the reviewing and editing of the article and approved the submitted version.
Patient Consent Statement
Per the University of Nebraska Medical Center Institutional Review Board, this project does not include factors necessitating patient consent.
Data Availability Statement
The data underlying this article can be shared via a reasonable request to the corresponding author.
Footnotes
Author Disclosure Statement
J.H. receives research funding from Gilead Sciences paid to his institution and consulting fees from Merck and ViiV Healthcare. S.B. reports scientific advisory to Gilead Sciences and research grants paid to her institution form Gilead Sciences, ViiV healthcare, and Janssen. All are unrelated to this work. All other authors report no conflicts of interest relevant to this article.
Funding Information
No financial support was provided relevant to this article.