Antiretroviral therapy (ART) is recommended for all persons living with HIV (PLWH), regardless of CD4+ T-cell count, to reduce morbidity and mortality and to prevent HIV transmission (Cohen et al., 2016; Palella et al., 2016; Panel on Antiretroviral Guidelines for Adults and Adolescents, 2018). However, the timeline for the initiation of ART is influenced by the national guideline (Panel on Antiretroviral Guidelines for Adults and Adolescents, 2018). According to this guideline, at initial medical visits for a new HIV diagnosis, a complete medical history, physical examination, and laboratory evaluation should be completed, as well as counseling regarding the implications of HIV infection. Additional recommendations include a discussion of the benefits of ART from a health-related and an HIV transmission perspective. Psychosocial issues need to be addressed, along with an evaluation of the patient's readiness for ART, assessment of high-risk behaviors, substance abuse, social support, mental illness, comorbidities, economic factors (e.g., unstable housing), medical insurance status and adequacy of coverage, and other factors that are known to impair adherence to ART and increase the risk of HIV transmission.
Currently, baseline laboratory testing, including genotyping, is required before ART initiation (Panel on Antiretroviral Guidelines for Adults and Adolescents, 2018). In an effort to expedite receipt of these results, laboratory testing may be performed with recommended evaluations before the medical visit (Colasanti et al., 2018; Pilcher et al., 2017). In practice, the turnaround time for receipt of baseline genotype results typically introduces a delay of 3 to 4 weeks for an appointment with a prescribing provider and ART prescription.
Current World Health Organization (World Health Organization, 2017) recommendations for viral suppression (VS) include rapid initiation of ART (≤ 7 days) that can only be accomplished if patients are seen in a timely manner by a medical provider. However, despite these recommendations, the United States guidelines remain equivocal, noting that rapid ART initiation is resource intensive and may not be available in all settings (Panel on Antiretroviral Guidelines for Adults and Adolescents, 2018). The guidelines also state that the long-term clinical benefits of same-day ART initiation have yet to be proven and the approach remains investigational.
At the Peter Ho Memorial Clinic in Newark, New Jersey, the standard of care for entry into medical care was similar to other clinical sites in the United States until 2016 (Colasanti et al., 2018; Pilcher et al., 2017). Before 2016, newly diagnosed patients met with a designated linkage coordinator who ensured they met with a registered nurse for an intake visit. Baseline laboratory testing was completed, and a medical visit was scheduled at least 1 week later when results, including a baseline genotype, were available for review. Beginning in January 2016, patients with an HIV-positive antibody or presumptive positive test result were seen by a medical provider on the same day as receipt of these results. A presumptive HIV-positive test result was based on concordant results from a sequential, rapid test algorithm using two different rapid HIV tests (Centers for Disease Control and Prevention, 2014). It assumed that laboratory-based HIV confirmatory diagnostic testing would ensue. Most patients had two positive orthogonal rapid tests, as was the practice at New Jersey's community and outpatient clinical testing sites (Martin, Salaru, Paul, & Cadoff, 2011). A statewide network of 157 test sites were scattered throughout the state of New Jersey, at the time of our study, with a larger number of facilities located in Essex County, where the study clinic was located (E. Martin, personal oral communication, January 15, 2018).
We compared the proportion of newly diagnosed patients achieving VS before (2014–2015) and after (2016–2017) implementation of medical visits on the same day as an HIV diagnosis was established at the Peter Ho Memorial Clinic. In addition, we compared the median time to VS in both time periods.
A retrospective review of medical records from 2014 to 2017 was conducted at the Peter Ho Memorial Clinic, a large urban HIV clinic located in Northern New Jersey. The first Ryan White–funded clinic in the state, the Peter Ho Memorial Clinic, has provided medical care to PLWH for more than 30 years. At the time of the study, the clinic had a case load of approximately 1,200 patients. They were primarily Black (70%), male (60%), heterosexual (63%), older than 50 years (65%), lived at or below the federal poverty limit (65%), and had a history of cocaine or heroin use (40%). They were served by 2.6 full-time equivalent (FTE) medical providers (1.4 FTE nurse practitioners [NPs], 0.2 FTE infectious diseases fellows, 0.6 FTE infectious diseases physicians, 0.2 FTE psychiatric NPs, and 0.2 FTE pain management NPs).
Demographic data from the electronic medical record were downloaded, and the date and occurrence of the following were manually abstracted by the first author: date of diagnosis, date of the first medical visit, date of the first viral load, date of the second viral load, date of the first suppressed viral load, date of ART prescription, and status of the patient (moved, lost to care, or active). After quality checks, the data were deidentified before analysis.
Patients were referred for medical care from test sites located at Saint Michael's Medical Center, including the emergency department, onsite testing by designated staff, and inpatient hospital units. As part of the New Jersey statewide testing program, patients were referred from community-based test sites for a second rapid test and linkage to medical care. In addition, patients were referred for medical care after testing positive for HIV from surrounding primary care offices.
All patients newly diagnosed with HIV infection and at least 18 years of age, from 2014 to 2017, were eligible for inclusion in this study. Patients had to have received baseline laboratory testing, seen a medical provider, and been provided with an ART prescription for inclusion in the study. Excluded patients were those who had (a) moved before a medical provider visit and/or receipt of an ART prescription or (b) a transmission risk of injection drug use as they were too few to detect group differences.
The primary outcome was the proportion of patients who became virally suppressed in 2014–2015 and 2016–2017. Secondary outcomes included time to VS, defined as the time from diagnosis (based on either presumptive or laboratory-based testing) to an HIV viral load of less than 200 copies/mL, in 365 or fewer days; the median time in days was calculated as the difference between the diagnosis and first medical visit, receipt of ART prescription, and VS after diagnosis and receipt of ART.
Demographic variables included age as of December 31, 2017 (20–29, 30–39, 40–49, and ≥50 years), gender (male and female), and race/ethnicity (non-Hispanic Black, Hispanic, and other [non-Hispanic White, Asian, American Indian/Alaskan Native, Native Hawaiian, and multiple races]). Transmission risk factors included men who have sex with men (MSM) and heterosexuals. Other variables were AIDS at the time of diagnosis (yes/no), year of diagnosis (2014–2015 and 2016–2017), type of insurance (public [Medicare and Medicaid], private, and none [Ryan White, self-pay]), and income in U.S. dollars (≤$12,060 and >$12,060, based on the federal poverty level for 1 person in 2017; U.S. Department of Health and Human Services, 2017). Mental illness (yes/no) was a composite of patient self-report, routine psychiatric visits, and medications documented in the electronic medical record; history of substance use included cocaine and/or heroin (yes/no) because these were the most common illicit substances reported by patients or were present when urine drug screens were performed in this setting. ART included the use of integrase-based therapy (yes/no) and single-tablet regimens (yes/no).
Data collection was complete as of March 30, 2018. The Statistical Analysis System (SAS, version 9.3; SAS Institute, Cary, NC) was used for all analyses. Characteristics of newly diagnosed patients were compared by the years of diagnoses using Fisher exact tests with a p value set at <.05. Competing risk models for time to VS were evaluated using the Gray test for equality of cumulative incidence, with statistical significance set at p < .05. Patients with competing risks included patients who were lost to care or moved after an ART prescription was provided. Otherwise, data for patients who did not achieve VS were censored on March 31, 2018, the last date for the study. We used Cox proportional hazards ratio to evaluate factors influencing time to VS. Additional descriptive statistics using a Wilcoxon two-sample test evaluated median times after diagnosis to first medical visit, ART prescription, and VS after diagnosis and ART prescription. Our study was approved by the Saint Michael's Medical Center Institutional Review Board.
A total of 156 newly diagnosed patients were linked to the Peter Ho Memorial Clinic for medical care from 2014 to 2017. Thirteen patients were excluded from this analysis: Seven patients moved to another clinical site or were lost to care before receipt of ART, and six patients had a history of injection drug use. Ten patients were censored because they moved or were lost to care after receipt of an ART prescription or did not achieve VS by the administrative censoring date of March 31, 2018.
Demographic characteristics were similar for patients in the two time periods (Table 1). The use of integrase inhibitor therapy increased from 57% to 77%, 2014 to 2015 and 2016 to 2017, respectively (p = .0128). The use of a single-tablet regimen was the same in both time periods (81%). A total of 37 patients (25.9 %) included in the study had a medical visit on the same day as diagnosis from 2014 to 2017. When 2016–2017 was compared with 2014–2015, the proportion of patients seen on the same day as diagnosis almost doubled (24 [34%] vs. 13 [18%] patients, respectively). In 2016–2017, compared with 2014–2015, these patients were 18–29 years of age (54% from 30%), Black (63% from 34%), reported heterosexual contact (42% from 23%), and had public funding for medical care (42% from 31%).
A higher proportion of patients achieved VS in 2016–2017 compared with 2014–2015 (96% and 90%, respectively; p = .0292; Table 2). Insurance status and income levels were significant factors contributing to VS. A lower proportion of patients with public insurance (Medicaid or Medicare) compared with those with private insurance (87% vs. 100%, respectively; p = .0231) and with an income at or below the federal poverty limit for 2017 compared with those earning higher incomes (89% and 98%, respectively; p =.0031) became virally suppressed. VS rates did not differ statistically by other characteristics.
In an adjusted model, VS was more likely for those diagnosed in 2016–2017 compared with 2014–2015 (adjusted hazard ratio [aHR] 1.90; 95% confidence interval [CI]: 1.27–2.86). Those less likely to achieve VS included MSM compared with heterosexuals (aHR: 0.48; 95% CI: 0.29–80) and those with an income at or below the federal poverty limit for 2017 compared with those with a higher income (aHR: 0.56; 95% CI: 0.37–0.86). Decreases in the median time to the first medical visit from 12 to 5 days (p = .0045) were noted, 2014–2015 and 2016–2017, respectively (Table 3). In addition, decreases in median times to receipt of ART prescription (from 28 to 21 days; p = .0531) and VS after diagnosis (from 101 to 88 days; p = .0730) and after receipt of ART prescription (from 70 to 44 days; p = .0547) were noted.
We compared the difference in the median time between the first and second viral loads (55 days; interquartile range [IQR]: 35–93 days) and second viral load and VS (0 days; IQR: 0–60 days) in 2014–2015 and 2016–2017, in an attempt to account for a change in practice in ordering laboratory testing, but these were not statistically significant.
We observed barriers to same-day medical visits in our clinic (Table 4). Many presenting for HIV testing did not have the required documents to enroll in public insurance plans and/or medical care on the same day as their HIV diagnoses, and referrals from a primary care physician were needed for those with managed care plans (mostly Medicaid). In addition, for patients with managed care insurance, prior authorizations for prescribed medications delayed the timely start of ART. Other identified issues included the following: patients were tested positive late in the day, medical staff were unavailable, or appointment times were inconvenient.
VS rates improved at this clinic by 6% from 2014–2015 to 2016–2017. Younger individuals (i.e., ages 20–29 years) were 1.45 times more likely to achieve VS than those ages at least 50 years, which has not been supported by previous research. Of note, the CI crossed “1, indicating that VS was similar to that in other age groups. Population-based studies in New York and King's County, Washington, have reported that younger, newly diagnosed persons were less likely to be virally suppressed (Feller & Agins, 2017; Toren, Buskin, Dombrowski, Cassels, & Golden, 2016). Conversely, our results were similar to those of a recently published study from New Jersey, which found that VS was less likely in those younger than 55 years, from 2007 to 2015, but when stratified by year, by 2015, this disparity had been eliminated, with younger persons as likely to achieve VS as older persons (Mohammed et al., 2018).
A lower proportion of patients with public insurance (Medicaid and Medicare) compared with those with private insurance achieved VS (87% vs. 100%, respectively; p < .05). Higher proportions of patients with public insurance were Black (58%) or Hispanic (30%) compared with White (20%; p < .05), which was consistent with national data (Henry J. Kaiser Family Foundation, 2013). MSM were 52% less likely to become virally suppressed than heterosexuals. These MSM were more likely to be Black, have public insurance, have an income below the federal poverty level for 2017, and have HIV (not AIDS) at diagnosis. This was similar to findings suggesting that social determinants contributed to disparity in VS in Black MSM (Buchacz et al., 2018; Singh, Mitsch, & Wu, 2015).
The median time to the first medical visit decreased by 58% (Table 3). Patients were seen earlier for medical care, which may have provided an opportunity to develop patient–provider relationships that were important for engaging in care and VS (Dang, Westbrook, Njue & Giordano, 2017; Wood et al., 2018).
The median time to VS after diagnosis decreased by 12% after implementation of the same-day medical visit as HIV diagnosis by a medical provider. Before implementation, the median time to VS after diagnosis was 101 days at this clinic, which was shorter than that reported in San Francisco in the comparison group for same-day initiation of ART (170 days) and national reports of an average of 6.9 months (Hess & Hall, 2018; Pilcher et al., 2017). After implementation of the same-day medical visit as HIV diagnosis, the median time to VS (88 days) was comparable to the evaluation of San Francisco's “Getting to Zero SF” (median = 3 months; Scheer et al., 2018), as well as an observational study of rapid initiation of ART conducted between 2010 and 2014 (Hoenigl et al., 2016).
The median times to ART prescription and VS decreased but were not statistically significant. However, we believe that these data are clinically important and provide support for rapid initiation of ART in 7 days or less. Rapid initiation of ART at our clinic, in addition to our already-instituted same-day medical visits for patients newly diagnosed with HIV, has the potential to further reduce the time to VS to a median of 44 days (IQR: 30–77 days), similar to findings in other studies (Bacon et al., 2018; Blank et al., 2018).
A presumptive positive HIV test result from two sequential orthogonal rapid tests facilitates entry into medical care and allows patients to schedule medical visits; however, these results are not acceptable to access federally funded ART. The wait for confirmatory viral loads and HIV-positive test results typically leads to a 1-week delay before an application to the AIDS Drug Distribution Program can be completed (New Jersey Department of Health, 2018). Pending approval of this application delays receipt of ART by at least another 3 days. By implementing a statewide rapid HIV screening program, New Jersey achieved great strides in testing and timely entry into care from 2007 to 2015 (Mohammed et al., 2018). It now becomes necessary to reevaluate federal guidelines to ensure that patients will have timely access to medications (Public Health Service Act, 2015). At the time this law was initially written, testing technology used screening enzyme-linked immunoassay and Western Blot for confirmation (Centers for Disease Control And Prevention, 1987).
Limitations were noted in our study. The study was conducted in a single practice located in the Northeastern United States, limiting generalizability of the results. Because this was an observational study, it was not possible to control for other factors that may have contributed to achieving VS.
Rapid ART initiation in the future remains possible, although it may not be feasible in fewer than 7 days because of factors identified by our attempt to provide medical care on the same day as an HIV diagnosis at one clinical site. System-wide changes at the federal, state, and clinic levels will be necessary to make rapid initiation of ART for all patients a reality. A same-day medical visit as HIV diagnosis is a step toward improving access to medical care and ART to decrease transmission, morbidity, and mortality associated with the infection.
- Effective linkage to health care for persons living with HIV includes a medical visit with a provider and initiating ART, in addition to performing laboratory testing for CD4+ T-cell counts and viral load measurements.
- Receipt of federally funded ART requires confirmatory testing for HIV infection. Current requirements are based on laws that were relevant when different testing technologies were available. This will continue to be a barrier to early initiation of ART until changes are instituted at the federal level.
- National guidelines require baseline genotype testing before initiating ART, which leads to delays in ART prescription. A low incidence of transmitted drug resistance is associated with current first-line ART. Therefore, clinicians can initiate ART immediately instead of waiting for these results to be available.
Debbie Mohammed is a member of the speakers' bureaus for Gilead and Janssen. Eugene Martin has no real or perceived vested interests related to this article that could be construed as a conflict of interest. Russell Brewer is an advisor for ViiV Healthcare's Accelerate Initiative, Gilead Implementation Science Advisory Board, and the Louisiana Public Health Institute. Jihad Slim is a member of the speakers' bureaus for Gilead, AbbVie, and Merck.
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Keywords:© 2019 Association of Nurses in AIDS Care
HIV; rapid initiation of therapy; retrospective study; same-day medical appointment; viral suppression