Pre-Exposure Prophylaxis in the Urgent Care Setting: A Systematic Review

Pre-Exposure Prophylaxis in the Urgent Care Setting: A Systematic Review

The Journal for Nurse Practitioners 15 (2019) 595e599 Contents lists available at ScienceDirect The Journal for Nurse Practitioners journal homepage...

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The Journal for Nurse Practitioners 15 (2019) 595e599

Contents lists available at ScienceDirect

The Journal for Nurse Practitioners journal homepage: www.npjournal.org

Original Research

Pre-Exposure Prophylaxis in the Urgent Care Setting: A Systematic Review Jack J. Mayeux, MSN, FNP-C, Yeow Chye Ng, PhD, FNP-BC a b s t r a c t Keywords: HIV pre-exposure prophylaxis PrEP systematic review urgent care

Pre-exposure prophylaxis (PrEP) was approved in 2012 as the biomedical preventative treatment for HIV. Articles published between January 2012 and December 2018 were reviewed using PRISMA guidelines for research involving PrEP services offered within urgent care and emergency department settings. Of 2,044 articles reviewed, 9 were found to pertain to the urgent care and emergency department settings. Both departments have extended business hours compared with primary care clinics. This study emphasizes the current practice gap in HIV prevention. Nurse practitioners practicing in urgent care and emergency department settings should embrace the challenge and begin offering PrEP services. © 2019 Elsevier Inc. All rights reserved.

An estimated 1.1 million people in the United States are infected with HIV, and approximately 15% of those infected are unaware of their current status.1 With the approval of pre-exposure prophylaxis (PrEP) for the prevention of HIV infection in 2012, there is now a more viable option in the fight against HIV transmission.2 With approximately 37,000 additional HIV infections each year, PrEP increases the possibility of reducing this number with continued use.1 Unfortunately, the number of annual HIV diagnoses has remained stable from 2013 to 2017 despite PrEP approval.3 This plateau in HIV rates could be due to provider and/or patient barriers to PrEP use, limiting individuals at high risk throughout the world to have the opportunity to decrease their chance of contracting this infection.4 Currently, PrEP within the United States consists of a once-daily oral antiretroviral medication containing tenofovir (TDF) and emtricitabine (FTC).5 PrEP can reduce the risk of contracting HIV from sex by more than 90% and from injection drug use by more than 70%.5 This medication is intended for those who engage in high-risk behaviors, consisting of multiple sexual partners, injection drug use, or relationships with an HIV-infected person.6 Currently, the initiation and use of PrEP is limited to evaluation by a medical provider and laboratory screenings.6 Laboratory screening for PrEP initiation consists of a negative HIV test, with fourthgeneration testing as confirmation.6 Although rapid HIV testing can be completed, those relying on oral fluid are not currently recommended or acceptable when initiating PrEP.6 Additional required testing includes assessment of renal function, pregnancy status, and screening for sexually transmitted infections (STI).6 Although laboratory screening is essential to PrEP initiation,

https://doi.org/10.1016/j.nurpra.2019.06.001 1555-4155/© 2019 Elsevier Inc. All rights reserved.

assessment for clinical signs and symptoms of acute HIV infection should also be conducted on examination. Many individuals may seek treatment from a primary care provider or specialist for much of their medical care, including the initiation of PrEP, but there is an ever-growing trend of patients seeking medical care at urgent care centers. At present, there are approximately 7,400 urgent care centers in the United States.7 They have seen a 2.5-fold increase in service utilization, totaling nearly 160 million patients per year.7-9 The increase in patient use of urgent care services may be due to several reasons, including the multitude of services provided in this setting. In addition, there has been a reported rise in requests for STI screenings.9 Because of this increased usage, extended hours of operation, and often having the ability to provide onsite laboratory testing, urgent care centers are primed to improve access and usage of PrEP across the United States.8 Currently, PrEP is primarily being used within the community health unit or HIV specialty care settings, with some use within primary care and emergency department (ED) settings.10 Although PrEP use has been increasing with more than 79,000 individuals being initiated on PrEP between 2012 and December 2015,10 this represents only a small fraction of those who could benefit from PrEP. At this time, there are approximately 1.1 million individuals at substantial risk for HIV infection, with the highest rate of HIV being attributed to male-to-male sexual contact.3,11 The community and HIV specialty care clinics have surged to the forefront as leaders of initiation and continuation of PrEP, but the availability of these clinics to cover the needs for PrEP within the United States is limited.10,12

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Numerous studies have been performed on PrEP use, implementation, adherence, and the effects on all body systems.13,14 Additionally, there have been reviews of literature on the effectiveness and safety of PrEP.15 However, to date, there has not been a systematic review of the literature involving the initiation of PrEP within the urgent care setting and the associated research gaps. Thus, a systematic review of the current literature was performed to assess the current state of evidence. Methods The Preferred Reporting Items for Systemic Reviews and Meta-Analysis (PRISMA) Statement was used as a guideline for conducting and reporting this systemic review.16 The PRSIMA statement consists of a checklist and flow diagram for reporting systematic reviews and meta-analysis. This guide is used to help ensure evidence from these reviews contains key information that is reported accurately and completely. Additionally, the flow diagram, included as part of the PRISMA review, allows the reader a quick visual reference of the review conducted. Eligibility Criteria The titles and abstracts of all studies retrieved in the literature search performed were reviewed for inclusion. The period for studies considered for inclusion began with January 2012 through December 31, 2018. This period was selected because PrEP was not approved for patients within the United States until 2012.2 Studies were included for analysis if they were found to include PrEP use for the prevention of HIV within the urgent care setting. Those studies without mention of PrEP within the urgent care context or for HIV prevention were eliminated. Also, following the PRISMA statement, studies were removed for duplication if they had already been included from a previous search term and/or electronic database. Because of the limited literature and research conducted on PrEP within the urgent care setting, additional studies dealing with PrEP use within the ED setting were also reviewed for inclusion. Information Sources and Search Strategy Electronic databases, including CINHAL, Scopus, Embase, and PubMed, were thoroughly searched. The databases were searched in this order for studies published between January 2012 through December 31, 2018, for those allowing specific date exclusion. Those electronic databases not allowing for search exclusion to the day or month were searched for studies published between January 2012 through 2018 with the last search being performed on January 9, 2019. The following search terms were used within each database search and timeframe: “pre-exposure prophylaxis,” “preexposure prophylaxis,” “PrEP,” “pre-exposure prophylaxis urgent care,” “preexposure prophylaxis urgent care,” and “PrEP urgent care.” Numerous results were returned with the previously stated search terms, except for “preexposure prophylaxis” and “preexposure prophylaxis urgent care” returning few or no results. Studies researching PrEP within the ED were also identified while reviewing the urgent care search results. An additional search string consisting of “pre-exposure prophylaxis” AND “emergency department” and limited to full text was also used to return articles dealing with PrEP in the ED setting. Results The literature search initially revealed 22,032 possible relevant articles for inclusion.

After excluding the articles pertaining to PrEP but not to HIV, and with the exclusion of duplicate articles, 2,044 titles and abstracts were screened for eligibility. Of these, 1,982 articles were excluded because they were not specific to the urgent care or ED setting. In total, 9 studies were included in our systematic review (Figure 1). Of the included articles, one specifically dealt with PrEP in the urgent care, 7 with PrEP in the ED setting, and 1 article studied PrEP in both the urgent care and ED settings (Table 1). Of the selected articles, 1 speaks to PrEP use, billing implications, and general information on methods of initiation within the urgent care setting.8 This article begins by providing background information related to PrEP use by speaking of the current laboratory requirements for initiation. Although urgent care services and use have increased over the past 4 years, this article shows a lack of PrEP utilization within the urgent care setting throughout the United States. The article discusses lessons learned from the implementation of PrEP in the urgent care setting by an experienced practitioner. One lesson includes establishing a relationship with local primary care and specialty providers to provide continued care and follow-up needed to continue safe PrEP use. Additional lessons include supporting patients and commending them for being responsible, counseling on screening patients who requested additional STI screenings, and learning to compassionately deny those patients who are not appropriate candidates for PrEP. Although this article discusses many aspects of offering and implementing PrEP services within the urgent care, it strongly stresses that urgent care should not replace primary care or specialty services for long-term patient management. This article provides brief insight into the notion and ability of PrEP initiation and continuation within the urgent care setting. Although it does not include any research into successful methods for implementation, it does provide expert experience for PrEP use to guide the urgent care provider successfully. Limitations of this article are the lack of original research and the use of expert opinion. The second article for inclusion is a 2-stage qualitative study of men who have sex with men (MSM) and men who engage in streetbased sex work in the United States.17 Underhill et al17 attempted to understand experiences in men’s health care and their access to STI and HIV testing within the context of PrEP implementation. The sample size of Stage 1 consisted of 38 participants divided into focus groups (n ¼ 16 MSM street-based sex workers and n ¼ 22 MSM not focused on street-based sex work). Stage two consisted of 56 participants placed into semistructured interview groups (n ¼ 31 MSM sex workers and n ¼ 25 MSM not engaged in sex work). Stage 1 was conducted from February to June 2012, and Stage 2 from April 2013 to April 2014. All participants completed written questionnaires, and focus group sessions were audio-recorded and transcribed in addition to being double-coded. The overall results of this study revealed that many participants reported frequent and recent HIV testing, HIV testing at least annually, infrequent STI testing, and infrequent offering of prevention services like PrEP. Additionally, although participants sought care from various venues (ED, primary care, public health clinics, and urgent care facilities), none were offered PrEP. Reasons for lack of PrEP information being offered can only be speculated, but Underhill et al17 concluded that the lack of comfort and knowledge among providers as reasons for not offering PrEP services. Another finding of this study was the lack of PrEP uptake by participants who were offered services due to cost. A lack of insurance coverage and cost of medication proved to be a significant barrier to PrEP use for individuals at high risk. Although the main aspects of the research methodology for this study were sound, there were 2 limitations. The first is that due to this study employing an anonymous interview procedure, the number of individuals who enrolled versus participated in both stages is not known. Subsequently, there is no

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Figure 1. Preferred Reporting Items for Systemic Reviews and Meta-Analysis (PRISMA) flow diagram. ED ¼ emergency department; PEP ¼ postexposure prophylaxis; UC ¼ urgent care.

With limited literature and research conducted on PrEP within the urgent care setting, studies dealing with PrEP use within the ED were also reviewed for inclusion. Similarities were found with both settings that would allow PrEP research conducted in the emergency care setting to translate to the urgent care setting. Urgent care clinics were created by emergency medicine physicians as the need arose to provide immediate care found in the ED setting without the high acuity or price tag.18

et al19 found that only 13.3% of participants reported any knowledge of PrEP, and 40% indicated they were unlikely to use PrEP in the future. These results should be interpreted with caution because this study was conducted just after initial approval of PrEP in 2012, and many advertising campaigns have since been completed to increase patient awareness. A second study, conducted by Moore et al,20 attempted to study if confidentiality could be a concern and cause for a lack of PrEP use in the adolescent and young adult population. A common theme throughout this study was that those individuals who worried about parental knowledge of PrEP initiation and use were less willing to initiate this prevention method. Another finding of this study demonstrated a need for increased education and guidance from the standpoint of the ED provider. Both studies show a lack of patient knowledge and willingness to use PrEP and the need for provider education and patient engagement in HIV prevention methods.

ED Patient Views and Attitudes Toward PrEP

ED Provider Aspects on PrEP Use

Issues surrounding the use of PrEP within the ED setting can often be broken down by either patient or provider barriers to initiation. Two studies sought to understand patient knowledge and attitudes toward PrEP within the ED setting.19,20 Calderon

Although patient education and involvement is a critical step in providing PrEP and reducing the spread of HIV, the same education and engagement should be given to the medical provider. Six of the 8 studies identified for inclusion dealt with the provider aspect of

assessment of the dropout rate for this study. The second limitation is that due to the method of recruitment, the reflected sample is more likely to be low-income or disabled, nongay identified, and white. Because of the lack of a diverse sample size, generalizability of the findings is reduced. Emergency Department Use of PrEP

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Table 1 Study Characteristics Citation

Sample Size/Characteristics

Design

Calderon et al, 2012

n ¼ 474 (ED patients identified as high risk and MSM)

Moore et al, 2018 Ng et al, 2018

n ¼ 156 (ED adolescent and young adults; male and female participants) None

Okoye et al, 2017

n ¼ 504 (patients who visited health care facility)

Ridgway et al, 2018

n ¼ 180 (ED patients)

Stanley et al, 2017

None

Tortelli et al, 2017

n ¼ 88 (ED physicians)

Underhill et al, 2014

n ¼ 94 (male sex workers and other MSM)

Wood et al, 2018

n ¼ 735 (medical providers consisting of physicians, nurse practitioners, and physician assistants)

Survey: Cross-sectional with convenience sampling of ED patients in New York City. Focused on evaluation PrEP knowledge and attitudes of patients. Survey: Cross-sectional with convenience sampling of ED patients between 18 and 25 years. Assessed factors associated with willingness to use PrEP. Clinician opinion and evidence paper on initiating PrEP in the urgent care setting. Retrospective: analyzed the South Carolina HIV/AIDS database for individuals diagnosed with HIV infection and identified those individuals who sought care from a health care facility before HIV diagnosis. Assessed missed opportunities to initiate PrEP. Predictive analysis: Study developed an electronic medical record (EMR) risk score to alert patients at high risk for HIV. Clinician opinion and evidence paper discussing the importance of initiating antiretrovirals as PrEP and postexposure prophylaxis (PEP) to prevent HIV. Survey: Online convenience sampling of ED physicians at Washington University in St. Louis. Purpose of the study was to assess comfort, concerns, and knowledge of PrEP. Qualitative: Two-stage consisting of focus groups and semi-structured interviews. Focused on accessing to health care for STI testing and related health care needs. Survey: Online convenience sampling of Washington State providers to assess knowledge, practices, and barriers to PrEP prescribing.

ED ¼ emergency department; MSM ¼ men who have sex with men; PrEP ¼ pre-exposure prophylaxis.

PrEP use within the ED setting.17,21-25 Multiple studies found that although most providers were aware of PrEP, only 23.9%24 were knowledgeable of current guidelines and referral information.25 Often, because of the lack of knowledge and misconceptions associated with antiretroviral therapy, there was a significant lack of PrEP use by the ED practitioner. One study found that only 54% of ED providers in Washington State knew of PrEP, with many feeling uncomfortable discussing this topic with patients.25 Additionally, due to a lack of ED provider knowledge and comfort, individuals at the highest risk (MSM and intravenous drug use) for HIV infection were not offered PrEP, resulting in missed opportunities to counsel and initiate this method of prevention.17,21 Often, the ED offers little assistance or information regarding HIV prevention services.22 As a result of these missed opportunities, of approximately 504 new individuals who were infected with HIV from January 2013 to September 2016, 84% had ED visits before HIV diagnosis.21 Overall, just as with urgent care settings, the ED setting is associated with a lack of knowledge, failure to provide that knowledge to patients, and a lack of recognition for patients who can benefit from PrEP counsel and use. Discussion The findings of this literature review and subsequent evaluation of the selected articles present the notion of a lack of PrEP use and knowledge within the urgent care and ED settings. Underhill et al’s17 findings show that even for those individuals falling into high-risk categories of MSM and sex-based work, there is a lack of use and initiation of PrEP. The overall appraisal of this review was limited by the lack of material within the context of the urgent care setting. However, it does provide evidence of the large gap in research pertaining to PrEP and the urgent care setting specifically. There are currently thousands of articles researching various topics dealing with PrEP initiation, continuation, and effect; these are conducted from a primary care or specialty clinic viewpoint. Within the ED setting, which is similar to an urgent care setting, research shows a lack of PrEP use, knowledge, and willingness to initiate.21,24,25 With regard to the primary care and specialty settings, research has also shown a lack of provider knowledge of current guidelines and comfort with patient counseling.26,27

The lack of willingness to initiate PrEP in the urgent care and ED settings has been shown to be limited by multiple factors, including laboratory and follow-up requirements.28 Due to the multiple initial and follow-up laboratory requirements needed to manage PrEP, many providers are reluctant to consider providing this medication.6,28 The lack of knowledge and comfort with laboratory requirements can be lessened with the development of a PrEP guideline to support the busy clinician. Additionally, the need to schedule and maintain follow-up appointments may also deter many providers in these acute and episodic settings. Patients initiated on PrEP require 1 month follow-up, and those maintained require follow-up every 3 months.6 Many providers within these settings, and the settings themselves, are either not equipped or comfortable with follow-up visits. PrEP resources, education, and partnerships with local health providers will be needed to give urgent care and ED providers the capability to initiate or continue PrEP comfortably. Future Research The use of PrEP within the urgent and emergent care setting is in need of further research to determine the outcomes of use, best methods of initiation, and procedures to increase the utilization of this preventative method. One area of needed research is that of provider barriers to initiation or continuation within the urgent care setting. Studies have shown a lack of PrEP utilization in conjunction with a lack of provider knowledge, comfort, and resources.26,28 Identification of specific barriers to provider initiation of PrEP as part of patient care is needed to understand the lack of use. Whether the barrier is a lack of knowledge, lack of feasibility, or understanding of need, the reasons for the lack of PrEP use must be determined if there is to be any improvement of use in the future. A second area of need is the development of a PrEP implementation method specific to the urgent care and ED settings. Although there are current guidelines for the initiation of PrEP by the Centers for Disease Control and Prevention, these are specific to the primary care and specialty areas.2 Due to the uniqueness of the urgent care and ED settings, these guidelines need to be adapted to suit the fast-paced flow, nature, and mentality of the urgent care setting. The urgent care provider often uses clinical references and

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tools that provide concise information in a quick and easy to understand format. With the development of specific PrEP guidelines for the urgent care and ED, the harried provider can reference information needed to initiate or continue PrEP quickly and with confidence. Furthermore, with tailored PrEP guidelines, providers will have a resource not only for initiation but also continuation of PrEP. Those patients who are unable to follow up with their primary care or specialty provider will have another resource to continue their medication without lapse, and the urgent care or ED provider will have a resource to help with guidance. Ultimately, with urgent care specific guidelines, expansion and increased use of PrEP and reduced HIV spread can become a reality. Limitations In compiling this review, the authors made every attempt to locate and include relevant literature; however, inadvertent exclusions are always a possibility. This review did exclude systematic reviews on the topic and opinion pieces to limit reporting of duplicate studies and subjective data. Additionally, any review of literature is limited to the quality and accuracy of the studies being included for evaluation. Some studies did use patient interviewing and expert opinion. Although these are evaluable sources of research, the inclusion of high-quality, randomized studies would have been ideal. Conclusion The findings of this literature review support the need for research related to PrEP specific to the urgent care setting. Although many areas dealing with PrEP have been thoroughly reviewed and researched, its use in the urgent care and ED settings is a vital area lacking research-based evidence. With the increased number and use of urgent care services around the country, the distinct possibility exists to expand PrEP utilization and reduce the spread of HIV. Support for PrEP use within the urgent care and ED settings can be enhanced by increasing patient awareness, assisting providers in feeling comfortable administering PrEP and the use of research-based information.7,8 Although the ultimate goal will be to refer a patient initiated or continued on PrEP to a primary care or specialty provider for follow-up, the urgent care and ED settings have the potential to provide a significant and vital role in the prevention of HIV. References 1. Centers for Disease Control and Prevention. HIV/AIDS. 2017. https://www.cdc. gov/hiv/basics/statistics.html. Accessed February 12, 2019. 2. Centers for Disease Control and Prevention. Pre-exposure prophylaxis (PrEP) for HIV prevention. 2014. https://www.cdc.gov/hiv/pdf/PrEP_fact_sheet_final. pdf. Accessed March 9, 2019. 3. Centers for Disease Control and Prevention. Estimated HIV incidence and prevalence in the United States, 2010e2016. HIV Surveillance Supplemental Report. 2019;24(1). http://www.cdc.gov/hiv/library/reports/hiv-surveillance. html. Published February 2019. Accessed April 22, 2019. 4. Ryan B. As, PrEP turns five, the HIV prevention pill is a major success. POZ. 2017. https://www.poz.com/article/prep-turns-five-hiv-prevention-pillmajor-success. Accessed November 14, 2018. 5. US Department of Health and Human Services. Pre-exposure prophylaxis. 2017. https://www.hiv.gov/hiv-basics/hiv-prevention/using-hiv-medicationto-reduce- risk/pre-exposure-prophylaxis. Accessed April 12, 2019. 6. Centers for Disease Control and Prevention. Preexposure prophylaxis for the prevention of HIV infection in the United Statesd2017 update: a clinical practice guideline. 2017. https://www.cdc.gov/hiv/pdf/risk/prep/cdc-hiv-prepguidelines-2017.pdf. Accessed February 12, 2019.

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Jack J. Mayeux, MSN, FNP-C, is a nurse practitioner at Coastal Urgent Care in Gonzales, LA. He can be reached at [email protected]. Yeow Chye Ng, PhD, FNP-BC, is an assistant professor at the University of Alabama in Huntsville, College of Nursing, Huntsville Alabama. He can be reached at [email protected]. In compliance with national ethical guidelines, the authors report no relationships with business or industry that would pose a conflict of interest.