a b s t r a c t

Objective: The objective of this study is to describe an Emergency Department (ED)-based, HIV prevention and navigation program and the individuals linked to an in-house clinic for HIV Pre-exposure prophylaxis (PrEP) in the first eleven months of program implementation.

Methods: This is a retrospective, observational study of an ED-based HIV prevention and navigation program be-

tween January 1, 2019, and November 30, 2019. A status neutral navigation program is housed in the ED with 2-3 navigators staffing approximately 80 h per week. Navigators provide HIV screening with Point-of-care testing, sexual health education and counseling, including PEP and PrEP information, and HIV risk assessments. They also make follow-up appointments, appointment reminder calls, and offer to accompany individuals to an in- house HIV clinic for clients who either test positive in the ED for HIV, are known to be living with HIV but are out-of-care, are HIV negative but require post-exposure prophylaxis and/or meet criteria for and are inter- ested in starting PrEP. Clients are approached if they request HIV or other sexually transmitted infection testing, present to the ED with genitourinary complaints, or are referred to the program by ED medical providers. Funding for the program is from a New York City Department of Health (NYCDOH) service grant. Data were man- ually abstracted from program records and from a NYCDOH database. The primary study outcomes are how many clients accepted clinic referral for PrEP, attended their appointments, and received a prescription for PrEP. Results: In the time-period reviewed, complete demographic data and CDC risk factors for HIV were available for 1174 patients. Our program provided appointments for 22 patients who met CDC criteria for PrEP and expressed interest in initiating PrEP. Thirteen patients who attended their scheduled appointment had same day appoint- ments at the on-site clinic, and 11 (85%) were prescribed PrEP. From 1024 paper records with complete data, 914 clients reported that they do not consider themselves at risk for HIV infection.

Conclusions: Most clients that were both eligible and interested in PrEP were prescribed PrEP if given a same day follow-up appointment. Of the clients engaged in this navigation program, almost 80% did not perceive that they were at-risk for HIV infection.

(C) 2022

1. Introduction

In the US in 2018, 1.2 million people are reported to live with human immunodeficiency virus , with an annual incidence of 36,400 new HIV infections [1]. Although the incidence rate has decreased signifi- cantly since its peak in the mid-1980s, new HIV infections continue to af- fect disproportionately Black/African Americans, Hispanics/Latinos, men who have sex with men (MSM) and women of color [1]. HIV prevention remains a priority with pre-exposure prophylaxis (PrEP) as an important biomedical strategy in key populations at risk for HIV infection [2].

* Corresponding author.

E-mail address: [email protected] (J. Mahal).

Emergency Departments (EDs) have historically engaged in the HIV care continuum through screening, testing and the administra- tion of post-exposure prophylaxis (PEP) [3]. Missing from emer- gency medicine practice is access to PrEP from the ED. For those with newly diagnosed HIV infections, many will have visited the ED prior to being diagnosed. In one study based in New York City, over 60% of patients who tested newly positive for HIV had visited the ED at least once within three years prior to their diagnosis [4]. These visits are missed opportunities to engage patients in HIV pre- vention. Daily PrEP, tenofovir disoproxil fumarate/emtricitabine (ap- proved for adults in 2012) or tenofovir alafenamide/emtricitabine (approved in 2019) has been reported to prevent up to 92% of new HIV-1 infections, yet PrEP has not been incorporated into practice patterns in most EDs [5] [6] [7] [8] [9] [10] [11].

https://doi.org/10.1016/j.ajem.2022.01.038

0735-6757/(C) 2022

The objective of this study is to describe an ED-based, HIV preven- tion and navigation program and the clients linked to an in-house clinic for HIV pre-exposure prophylaxis (PrEP) from January to November 2019. The primary study outcomes are the number of clients that ac- cepted clinic referral for PrEP, attended their appointments, and re- ceived a prescription for PrEP. Factors that put the clients at risk to acquire HIV and client self-perceived risk to acquire HIV are also re- ported.

1. Methods
   1. Study design

This was a retrospective, cohort study of clients seen by status neu- tral navigators in the Jacobi Medical Center (JMC) Adult ED between January 1, 2019 and November 30, 2019. The purpose of the review was to determine how many clients were linked to outpatient clinical care for PrEP and if the patients were prescribed and then filled a PrEP prescription. This study was approved by the Internal Review Board (IRB) at JMC and the Albert Einstein College of Medicine.

• 1. Setting

Jacobi Medical Center, located in the Bronx, NY, is one of eleven New York City municipal hospitals and has an annual ED volume of approxi- mately 70,000 and with a payor mix that includes 57% Medicaid pa- tients in fiscal year 2020.

The status neutral navigation program is housed in the ED, with 2-3

navigators staffing 80 h a week during the study period. The goal of the navigation program is to provide status neutral HIV services to unin- sured patients. This includes screening with point-of-care testing when individuals or providers request, providing sexual health educa- tion and counseling, including PEP and PrEP information and condom distribution. Navigators coordinate with the in-house HIV clinic ap- pointment desk to provide follow-up appointments, make appointment reminder calls, and offer to accompany individuals to appointments for those who: test positive in the ED for HIV, are known to be living with HIV but are out-of-care, are HIV negative but require post-exposure prophylaxis (PEP) and/or are interested in starting PrEP. Funding for the prevention and navigation program is from a New York City Department of Health (NYCDOH) service grant. Navigators receive training, including but not limited to: HIV, PrEP, PEP, and motivational interviewing via the NYCDOH training programs.

• 1. Navigator workflow

The navigators identify clients using two electronic ED lists: 1) a white board of all ED patients that includes the patient’s chief com- plaint, and 2) a list of patients that agree to HIV testing in triage. The white board allows the navigator to identify individuals that are seeking care in the ED for sexually transmitted infection checks, dysuria, vagi- nal/urethral discharge, occupational and non-occupational bodily fluid exposure, intercourse without condoms or PrEP. Medical providers are educated about the navigator program and can request the navigator to see their patient.

The navigator process for a PrEP visit includes completion of NYCDOH forms that collect demographic information and document a baseline medical and risk assessment, PrEP/PEP history, HIV testing, and sexually transmitted infection screening. If the patient is HIV nega- tive based on point-of-care or plasma testing and has behaviors that put them at risk to acquire HIV based on CDC criteria [12], navigators discuss client eligibility for PrEP and offer an appointment to the in-house clinic to further discuss PrEP with a medical doctor. If the patient is interested in starting PrEP, an appointment is made at the clinic to speak to a phy- sician. During the time of this study, the clinic employed 6 full-time phy- sicians and 4 Infectious Disease Fellows.

Navigators arrange same day appointments if the patient is in the ED on a weekday and during clinic hours, 9 am-5 pm. Otherwise, navigators make a follow-up appointment and provide an appointment reminder call within 48 h of the appointment date offering to meet and accom- pany the client to the in-house clinic. Records are kept if clients can- celled their appointment or do not show for their appointment. Efforts to contact and re-engage clients are made three times before the case is closed.

• 1. Data collection and statistical analysis

The study cohort consists of the client population seen by the status neutral navigators in the study period and those who were referred to the in-house clinic for PrEP. Data collected include demographic data, reasons for not being interested in PrEP, risk factors for PrEP, whether the patient attended the initial appointment made to see a physician about PrEP, if a PrEP prescription was given at the initial visit. CDC criteria for PrEP eligibility were used and include sexual partner living with HIV, contractual sex work, diagnosis of STI, history of injecting drugs, use of previously used injection equipment, and inconsistent use of condoms with partners of unknown HIV status [12].

Demographic data and criteria that put clients at risk for HIV acqui- sition was obtained via a retrospective review of the program data base kept by the NYCDOH for the study period. Reasons for not wanting PrEP were abstracted manually from program paper records. Only paper re- cords that had this information completed were included. Risk factors for the clients referred to clinic and whether a prescription was given were manually abstracted from the program paper records and an elec- tronic medical record review. Clients were not excluded based on their ability to speak English, ethnicity or gender.

The primary study outcomes are how many clients accepted clinic referral for PrEP, attended their appointments, and received a prescrip- tion for PrEP. Other outcomes reported include demographics, PrEP- eligibility in the 6 months prior to the ED visit and client reasons for not being interested in PrEP. Descriptive statistics including mean, stan- dard deviation, proportions and confidence intervals are reported for demographic information and primary outcomes was completed in Excel(R) 2019 (Microsoft(R), Redmond, Washington).

1. Results

Our navigation program reported 1174 clients to the NYCDOH for the study period. Baseline demographic data is in Table 1. Twenty-two PrEP-eligible and interested clients scheduled a follow-up appointment to discuss PrEP with a physician at an in-house clinic (Table 2). Of the 22 patients, 8 (36%) did not show up for their scheduled appointment; 7 of the 8 did not respond to calls to reschedule. One of the 8 decided there were other health priorities. Thirteen (59%, 95%CI: 38.5-80%) were seen on the same day as their ED visit and, of these, 11 (85%, 95%CI: 65-100%) received a prescription (Table 2).

A manual review of 1024 completed paper charts that recorded PrEP-eligibility criteria for the six months period prior to the navigator interview reported 951 (81%, 95%CI: 79%-83%) eligible patients. Sexual intercourse with 1 or more partners without condom use is the most common behavior reported by 934 clients (80%, 95%CI: 77-82%). (Table 3) Of these, 94 (10%) clients reported having more than 2 sexual partners with whom they had condomless intercourse; 21 (22%) had 3 or more, and 6 (6%) had 4 or more. Considering PrEP-eligibility criteria and only clients with 2 or more partners, 111 (9%, 95%CI: 8%-11%) of the 1174 clients were eligible for PrEP.

When asked about why a client is not interested in PrEP, 914 (90%, 95%CI: 87%-91%), did not consider themselves at sexual risk for HIV, 64 (6%, 95%CI: 5%-7%), were not interested in hearing about PrEP. Twenty patients (2%, 95%CI: 1.1%-3%) had concerns about taking the medicine citing side effects and concerns about taking a daily pill.

Table 1

Demographic information for clients referred to an in-house HIV clinic for PrEP.

Characteristic	All clients (n = 1174)					Eligible and interested in PrEP (n = 22)
	Mean	SD	N	%	95% CI (%)	Mean	SD	N	%	95% CI (%)
Age	35	11	1174		34.3-35.6	29	9.7	22		24.7-33.3
Gender identity
Male			484	41%	38-44			16	73%	54-91
Female			687	59%	56-61			6	27%	5-40
Transgender Female			3	0.3%
					0-1
Race/ethnicity
Black			473	40%	37-43			6	27%	9-46
White			123	11%	9-12			4	18%	2-34
Other/Unknown			578	49%	46-52			1	5%	-4 - 13
Hispanic			646	55%	52-58			11	50%	25-66
Non-Hispanic			526	45%	42-48			11	50%	34-75
Orientation
Heterosexual			1046	89%	87-91			13	59%	34-75
Homosexual			23	2%	1-3			6	27%	9-46
Bisexual			17	1%	1-2			3	14%	-1-28

Table 2

Risk Factors and Linkage Status of PrEP Clients (n = 22).

A potential explanation of low PrEP referrals despite an assessment of a higher number of eligible patients may be the gap between self-

perceived and actual risk. In our population, almost 90% of clients that

Risk factors	N	%	95% CI (%)
MSM	8	36%	14.7-57.3
Multiple partners	20	91%	78.3-100
Serodiscordant relationship	2	9%	0-21.7
History of STI	1	5%	0-14.7
Linkage status Follow-up visit scheduled in ER	22	100%
Attended follow-up visit	13	59%	38.5-80
PrEP prescription at initial follow-up visit	11	85%	65-100

were not interested in PrEP also did not consider themselves at sexual risk. While we did not correlate eligibility and self-perceived risk, Haukoos et al. report on this discordance with 38.7% of their PrEP- eligible population perceiving themselves at low risk and 29.4% as hav- ing zero risk for HIV [10].). Kulie et al. seconds this, finding that 20% of their total study population were PrEP-eligible and 79% of this popula- tion considered themselves at no/low risk for HIV [9].

Without validated criteria that can identify ED patients for PrEP, we used presentation for STI checks and genitourinary complaints as a proxy for eligibility. Ridgway and colleagues developed an EMR-based risk score using similar variables such as age, gender, and previous his-

tory of STI to identify patients who may benefit from PrEP in a large,

1. Discussion

An ED-based, patient navigation program enabled us to identify and attempt linkage for 22 clients to PrEP and HIV preventative care in the 11-month period reviewed. If eligible, interested and able to attend a clinic visit on the same day as their ED visit, we were able to navigate 13 (59%) patients to clinic and found that 11 (85%) clients received a PrEP prescription suggesting that same day access may be an important driver to linking patients to preventative care. The small population size limits our ability to assert significance.

When reviewing risk factors in the 6 months prior to interview, we

found a much larger population that met PrEP-eligibility criteria, 951 or 81% of the 1174 clients, indicating a potentially large, missed eligible population. We do not have the data to determine how many of the 840 clients with 1 partner and inconsistent condom use were with low-risk partners - known HIV status or non-Injection drug use. This data would contribute to understanding the reality of their risk for HIV and the true degree of a missed opportunity for engagement and linkage.

Table 3

Six-month risk factors (n = 1174).

In the past 6 months, Yes No

Were any of your partners a person living with HIV? 4 1025

urban ED setting. Of 51 patients identified by the risk score, 9 patients (17.6%) were linked to a follow-up visit and 4 of 51 (7.8%) were ulti- mately prescribed PrEP [6]. Zhao also reports using history of STI or cur- rent presentation for STI complaints. In their program, they describe a cascade of care that led to 10.3% of their patients attending a clinic ap- pointment and initiating PrEP [11]. Using STI checks and/or symptoms as a proxy for eligibility focuses only on inconsistent use of condom and potentially, on a STI diagnosis. HIV status of partners, use of injection drugs, and PEP usage are not actively used to identify clients. Leaving these factors out decrease the sensitivity of the criteria our navigators use and may explain low identification and thus, low recruitment numbers.

There are several limitations to this study. The navigator program covers around 80 h of clinical time, limiting the resource and its applica- tion to the entirety of ED patients. The data reported in this study reflects allowable services per the contractual terms of the funded pro- gram which contributes to a sample bias. Lastly and importantly for generalizability, this is a human resource heavy program that may not be replicable or easily sustainable in other EDs especially if same day referral to clinic is a driver to receiving a PrEP prescription. academic centers may be able to provide same day referrals depending on clinic availability and work flow and thus may not require the resource.

1. Conclusion

Have you been diagnosed with any of the following: syphilis, gonorrhea and/or chlamydia?

9 99

This preliminary analysis of our program describes a resource-heavy navigation program linking patients to PrEP from an ED at a large, urban

Have you had sex in exchange for drugs, money, food or shelter? 1 1039

Have you injected drugs that were not prescribed by a medical care provider?

2 1167

hospital over an 11-month period. This review is of our first year of op- erations and can add to the literature as a proof of concept. Our primary

Have you used injection equipment that others used before you? 1 1159

Have you had sex without using a condom? 934 82

finding that same day access to PrEP greatly increases the chance of receiving a prescription begs the question of why PrEP cannot be

prescribed from the ED as a bridge to continuing care in clinic. Basic lab tests, education and a referral to clinic in-line with ED-specific work flows are possible and would lower barriers to this important and underutilized biomedical option to prevent HIV.

Author contribution statement

JM conceived the study, supervised the extraction of patient data from the electronic medical record, managed the database, conducted the Qualitative and quantitative data analysis and revised initial manu- script. SD and RS analyzed initial data, conducted the literature search and drafted the initial manuscript. Gabriela Rodriguez and Audrey Sloma contributed to data collection for which their efforts are appreci- ated.

Meetings

Presented at the American College of Emergency Physicians Annual Research Forum, October 2020.

Presented at the New York City PlaySure Network, NYCDOH Pro- vider Meeting, November 2020.

Funding

This project was funded in part by the New York City Department of Health and Hygiene through a contract with Public Health Solutions. Its contents are solely the responsibility of the authors and do not necessar- ily represent the views of the funders.

Declaration of Competing Interest

Dr. Mahal is on the Board of Directors of FHI360.

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