Abstract
Objective:
To study the infection-related needs of patients with substance use disorders initiating care at a low-barrier-to-access program (LBAP) by describing the proportion with human immunodeficiency virus (HIV), hepatitis B and C virus (HBV, HCV), syphilis, gonorrhea, and chlamydia and determining rates of treatment and/or linkage to care.
Methods:
We reviewed the records of patients who completed an intake visit at an LBAP in Boston, MA during the first 9 months after implementation of a standardized intake laboratory panel (1/1/2017-9/30/2017).
Results:
Among 393 patients initiating care, 84.7% (n=333) completed at least one screening test. Baseline rates of HIV (9/393, 2.3%), current or past HCV (151/393, 38.4%), and chronic HBV (2/393, 0.5%) were high. Sixty-one new, active infections were identified through screening, including 1 HIV, 3 syphilis, 4 gonorrhea, 3 chlamydia, 1 chronic and 1 acute HBV, and 48 cases of viremic HCV. Many patients were non-immune to HBV (102/270, 37.8%) and HAV (112/255, 43.9%). Among new diagnoses, treatment was documented in 88% of bacterial infections and linkage occurred in 0/1 HIV, 2/2 HBV (100.0%), and 16 /48 HCV (33.3%) cases.
Conclusions:
Patients initiating SUD care at an LBAP have substantial, unmet infection-related needs. Results justify the inclusion of comprehensive infection prevention, screening, and linkage-to-treatment protocols in LBAPs.
Keywords: Substance use disorders (SUD), injection drug use (IDU), low-barrier-to-access programs (LBAP), human immunodeficiency virus (HIV), sexually transmitted infection (STI), screening
INTRODUCTION
Low barrier to access programs (LBAPs) rapidly link patients with substance use disorders (SUD) to addiction treatment. Born of the opioid crisis, these programs offer harm reduction services, rapid access to medications for opioid use disorder (MOUD), a flexible and patient-centered program design, and availability in nontraditional settings.1,2,3,4,5. LBAP also serve as a bridge to longitudinal care by reducing wait times for treatment and offering access and stabilization to patients who struggle in traditional outpatient settings.6 Evaluations of LBAPs have demonstrated good treatment outcomes, including improved retention in care.7,8 Due to the urgency of unmet MOUD treatment needs, existing LBAPs have prioritized medication initiation. However, LBAPs also represent a promising opportunity to address transmittable infectious complications of SUD.
People with active SUD, many of whom are people who inject drugs (PWID), are at high risk for sexually transmitted and blood-borne infections.9,10,11 Nearly 80% of PWID report receptive needle sharing and/or condom-less sex in the past year, and transactional sex is prevalent.12,13,14 Although the proportion of new human immunodeficiency virus (HIV) cases attributed to injection drug use (IDU) has declined since the height of the HIV epidemic, 10% of new cases remain IDU-related and the opioid crisis – now driven by illicitly manufactured fentanyl that requires frequent injection events – has contributed to a surge in new HIV infections among PWID in many communities. Indeed, recent HIV outbreaks have been linked to IDU in Indiana , West Virginia, Massachusetts, Florida, and Washington State. 15,16,17,18,19,20,21,22,23 The high prevalence of hepatitis C (HCV) in many regions of the country has also been attributed to IDU, and PWID have been impacted by recent outbreaks of hepatitis B (HBV) and hepatitis A (HAV), the latter a result of high rates of homelessness and communal living.24,25,26 However, despite the outsized burden of transmittable infections borne by people with SUD and pilot data demonstrating the successful integration of HCV treatment into opioid treatment programs (OTPs), 27 infection screening and treatment services are often siloed from SUD treatment. Integration and co-location of SUD and infection-related services has the potential to address the syndemics of opioid use disorder, injection drug use, and sexually-transmitted and blood-borne infections.28,29
In order to inform infection screening and linkage-to-care algorithms in the new and evolving LBAP care setting, this study sought to determine a) the prevalence of transmittable bacterial and viral infections among patients with SUD presenting for an initial LBAP visit and b) the proportion of these infections successfully treated or linked to care. Furthermore, we describe an innovative care setting and a method for carrying out comprehensive infection screening at intake among patients with SUD at exceptionally high risk. To our knowledge, this is the first evaluation of the utility of integrating infection services in the LBAP setting.
METHODS
Overview
A retrospective, cross-sectional chart review was performed of all patients who completed a new intake at an LBAP in Boston, MA between January 1, 2017 and September 30, 2017. An intake was defined as new if the patient had never been seen in the clinic before or if they had been out of care for more than four weeks, per clinic policy. Individuals <18 years of age and those not completing a full intake (e.g. patients presenting for medical clearance for inpatient medically-managed withdrawal only) were excluded. Patients who attended an intake appointment but did not complete one or more screening lab tests were included in the description of the overall sample but were censored for analyses related to lab tests that they did not complete. Patients with multiple intakes were linked by a unique study ID number and data from their first intake visit only were included in analyses. Data were abstracted by electronic medical record review performed by two of the study authors. Random records were reviewed for reliability and all positive screening test results were confirmed by the first two authors.
Site
The study site was Faster Paths, an LBAP at Boston Medical Center (BMC) in Boston, MA that opened in 2016 with funding from the Massachusetts Department of Public Health Bureau of Substance Addiction Services. Faster Paths is a multidisciplinary, outpatient bridge clinic that offers rapid access to MOUD (i.e. buprenorphine and naltrexone) as well as medications for alcohol use disorder and tobacco use disorder and is open to any patient with a history of substance use. In addition to medication, patients are offered overdose prevention services and linkage to community resources including methadone programs, inpatient medically-managed withdrawal, residential recovery programs, primary care, behavioral health, and referral for housing, insurance, and employment assistance. Faster Paths seeks to engage patients at high risk for opioid overdose (e.g. patients immediately post-overdose, -incarceration release, or -inpatient hospitalization). During the 2016-2017 academic year, the majority of patients were publicly insured (68.8%).30 The clinic accepts walk-ins and referrals from the Emergency Department, the inpatient Addiction Consult Service, primary care providers, methadone maintenance programs, residential addiction treatment programs, and recovery programs. It is located in close proximity to the Emergency Department, a phlebotomy station, and an outpatient pharmacy. During the study period, clinician and nurse services were supported by the above grant; laboratory testing and prescriptions were billed to patient insurance.
Workflow
New patients typically meet with a licensed drug and alcohol counselor and a nurse case manager to complete a substance use history and an intake laboratory panel (Table 1). During the study period, screening for gonorrhea and chlamydia was available on urine samples only. Screening for infections is offered to all patients, who may opt out of any test without any impact on their addiction or other harm reduction care. Patients next meet with an addiction medicine prescriber (physician or nurse practitioner) for a comprehensive addiction assessment, physical examination, and review of laboratory results. Patients initiate MOUD during this visit if indicated. The majority of buprenorphine inductions are done as home inductions, but office inductions are done when indicated. When expedited MOUD access is needed, the nurse intake may be deferred, and the prescriber typically takes responsibility for lab orders.
Table 1:
Standardized Laboratory Panel
| Blood Tests | Urine Tests |
| Comprehensive metabolic panel | Human chorionic gonadotropin level |
| Hepatitis A virus (HAV) IgG antibody | Urine chlamydia and gonorrhea |
| Hepatitis B virus (HBV) surface antigen, surface antibody, and core antibody | Urine expanded opioid panel4 |
| Hepatitis C virus (HCV) antibody with reflex to PCR1 viral load and genotype | Urine toxicology screen |
| HIV 4th generation antigen/antibody | |
| Syphilis RPR1 with reflex to TPPA2 |
PCR: polymerase chain reaction
Rapid plasma reagin
Treponema pallidum particle agglutination
Detects codeine, morphine, hydrocodone, hydromorphone, oxycodone, oxymorphone, methadone, and fentanyl (Quest diagnostics)
Patients are followed in Faster Paths for several weeks to months until they are stable for transition to a traditional office-based addiction treatment setting or it is determined that they would benefit from a higher level of care (e.g. methadone treatment program, residential treatment). Treatment of diagnosed STIs occurs during the intake clinician visit when results are available or is coordinated after the visit. Linkage to care for newly diagnosed viral infection occurs via utilization of clinic staff and public health navigators to facilitate outpatient appointments.
Data Abstraction and Analysis
Data were collected and cleaned in Microsoft Excel (Microsoft Office Professional Suite, version 15.31, 2017). Demographics, clinical characteristics, laboratory results, and follow-up visit data were abstracted from the electronic medical record. Intake labs were defined as those occurring within one month of intake visit. Housing insecurity was defined as current residence on the street, in a shelter, or temporarily with family or friends.31 Overdose history was determined by chart review of intake assessments and notes. Linkage to care was defined as attendance of a referral appointment for treatment of the newly identified infection.
Descriptive statistics were used to characterize the study population. Differences between groups completing and not completing full screening were assessed with χ2 tests for categorical variables and t tests for continuous variables.
This study was determined to be exempt by the Boston University Institutional Review Board (IRB).
RESULTS
Patient Characteristics
A total of 393 unique patients completed 410 new intake visits during the study period. The majority completed the typical intake protocol with an RN intake visit followed by an MD intake visit (n=285/393, 72.5%), while 20.6% (n=81/393) had an MD intake only and 6.9% (n=27/393) completed RN intake and did not return to see a prescriber.
Patients had a median age of 38 years (range 20-69) and were majority male (n=279/393, 70.9%), white (n=251/393, 63.8%), and housing insecure (n=222/393, 56.4%) (Table 2). They sought care from across Massachusetts, with 106 different zip codes represented. Most commonly, referrals were from the Emergency Department (n=107/393, 27.2%) and word-of-mouth (n=75/393, 19.1%).
Table 2:
Patient Demographics and Characteristics
| Patient Characteristic (N=393) | N (%) |
|---|---|
| Gender (self-report) | |
| Male | 279 (71) |
| Female | 114 (29) |
| Race and Ethnicity | |
| Non-Hispanic White | 238 (60) |
| Non-Hispanic Black | 67 (17) |
| Non-Hispanic Other | 26 (7) |
| Hispanic | 62 (1) |
| Current Housing | |
| Friends/Family | 105 (27) |
| Shelter | 95 (24) |
| Other | 63 (16) |
| Rents Property | 52 (13) |
| Owns Property | 25 (6) |
| Street | 21 (5) |
| Unknown | 32 (8) |
| Past 30-Day Substance Use 2 | |
| Heroin, Illicit Fentanyl | 363 (93) |
| Cocaine, Crack | 320 (81) |
| Alcohol | 229 (58) |
| Benzodiazepine | 187 (47) |
| Gabapentin | 183 (46) |
| Opioid Pills | 147 (37) |
| Amphetamine | 58 (15) |
| Opioid Overdose Experience | |
| Prior Overdose (lifetime) | 203 (52) |
| Has Naloxone kit at time of intake | 174 (44) |
| Treatment Experience | |
| Previous MOUD3 | 346 (88) |
| Methadone | 118 (30) |
| Buprenorphine | 183 (46) |
| Naltrexone | 39 (10) |
| Not specified | 6 (1) |
| Educational Level | |
| ≤ Junior High School | 41 (10) |
| High School | 205 (52) |
| Some College | 4 (1) |
| ≥ College | 75 (20) |
“Other” housing included temporary arrangements with acquaintances, in vacant buildings, and residential treatment facilities, among others
Self-reported substance use
Medication for opioid use disorder
Infection Screening Completion
Overall, 37.9% of the sample (149/393) were completely screened for HIV, HBV, HCV, syphilis, gonorrhea, chlamydia, and HAV immunity and 84.7% (333/393) completed at least one screening test. Among patients completing at least one screening test, the mean number of tests completed was 5.7 out of a possible 7 (range 1-7, median 6). Among all patients completing intake, the mean number of tests completed was 4.9 (range: 0-7, median 6). The most commonly missed screening tests were gonorrhea/chlamydia and HAV antibody.
Patients seen by the RN as part of intake were significantly more likely than those seen by an MD only to have completed the full lab intake panel (44.2% vs. 13.6%, p <0.001). Patients who were completely screened were also slightly younger (mean age 37.7 vs 42.0 years, p < 0.05). No significant differences in sex (p=0.91), race (p=0.53), ethnicity (p=0.48), or reported injection drug use (p=0.92) were seen between those completely versus incompletely screened.
Infection History and Screening Results
Participants reported high rates of known, baseline infection including HIV (9/393, 2.3%), HCV (151/393, 38.4%), and HBV (2/393, 0.5%). Intake screening identified 61 new, active infections, including 1 HIV (1/393, 0.3%), 1 chronic and 1 acute HBV (2/393, 0.7%), 48 cases of active, viremic HCV (48/393, 12.2%), 3 syphilis (3/393, 0.8%), 4 gonorrhea (4/393, 1.0%), and 3 chlamydia (3/393, 0.8%) across 55 unique patients. Screening also identified important gaps in vaccination coverage. One third of patients screened (104/270, 38.5%) were non-immune to HBV and almost one half (112/255, 43.9%) were non-immune to HAV.
Substance Use
Two-thirds of patients endorsed current or past injection drug use (258/393, 65.6%) and over half (203/393, 51.6%) had experienced opioid overdose. Patients reported high rates of polysubstance use (Table 2), which were supported by intake urine drug screen results, over one-third of which were positive for more than one substance (143/393, 36.3%). Nearly half of intake urine drug screens were positive for buprenorphine (175/393, 44.5%), which may have represented prescribed and/or non-prescribed use. High rates of positivity for fentanyl (131/393, 33.3%), benzodiazepines (109/393, 27.7%), opiates (106/393, 26.9%), and cocaine (104/393, 26.4%) were also observed.
HIV
A total of 76.1% (299/393) were screened for HIV at intake (Figure 1). Screening identified one new HIV infection (1/299, 0.3%) and one patient with known infection (1/299, 0.3%) who was inadvertently tested. Of the 94/393 patients not screened for HIV at intake, 8 had known HIV infection, 28 had documentation of a negative HIV Ag/Ab within 12 months, and 58 had no testing in the past year on file. The patient with the new diagnosis of HIV (as well as syphilis) was lost to follow-up and could not be contacted after extensive outreach by clinic staff and the Department of Public Health.
Figure 1: HIV Screening at a Low-Barrier Substance Use Disorder Medication Clinic.
* Patient was inadvertently screened
Hepatitis C
Of the 393 intakes, 76.3% (n=300) were screened for HCV, over half of whom had a reactive HCV Ab (168/300). Sixty one percent of patients with a positive antibody had a prior positive on file or documentation about their diagnosis (102/168), while 39.2% (66/168) did not have a record of prior infection. Overall, 43.0% (129/300) of patients screened had detectable HCV RNA levels, indicating current HCV infection. One third (16/48) of newly diagnosed patients were successfully linked to care, which was defined as attendance of a referral appointment.
Among the 93 patients not screened for HCV, 53% (49/93) had a known history of HCV confirmed by laboratory review or history. The majority of these patients’ last HCV RNA level on file were detectable (35/49). Forty-four of the 93 patients not screened had no known history of HCV. Seventeen had negative testing within the past year, while 27 had no testing in the past year on file (Figure 2).
Figure 2: HCV Screening at a Low-Barrier Substance Use Disorder Medication Clinic.
*known HCV via lab review or patient-reported history
+ Last RNA on file
Overall, 55.2% (217/393) of the sample were HCV Ab positive by laboratory testing or self-report and 41.7% (164/393) had evidence of active infection (i.e. viremia).
Hepatitis B
Sixty-nine percent of patients (270/393) had complete hepatitis B serologies done at intake. A positive surface antigen was identified in 3 patients (3/270), including 1 patient with known chronic HBV and 2 patients without a history of HBV infection. Follow-up testing confirmed one new acute and one new chronic HBV case. Both newly diagnosed patients were successfully linked to care.
Approximately forty percent of those screened (112/270) were immune from vaccination, 16% (43/270) were immune from prior infection, 4% (10/270) had an isolated core antibody, and 38% (102/270) were non-immune (Figure 3).
Figure 3: HBV Screening at a Low-Barrier Substance Use Disorder Medication Clinic.
HBsAb = hepatitis B surface antibody. HBsAg = surface antigen. HBcAb= core antibody
*Immune from vaccination = HBcAb negative, anti-HBs positive, HBsAg negative. +Immune from prior infection = HBcAb positive, anti-HBs positive, HBsAg negative. ^Non-immune: HBcAb negative, anti-HBs negative, HBsAg negative.
Hepatitis A
A total of 255/393 patients (64.8%) were screened for HAV immunity. Over forty percent (112/255, 43.9%) were non-immune.
Bacterial Sexually Transmitted Infections
Among the 286/393 (72.8%) patients screened for syphilis, five had a reactive RPR. Follow-up testing determined that three of these cases were latent syphilis of unknown duration requiring treatment (3/286, 1.1%) and two were false positives. Among the 251/393 (63.9%) patients screened for gonorrhea and chlamydia, four cases of gonorrhea (4/251, 1.6%) and three cases of chlamydia (3/251, 1.2%) were identified. Two of three latent syphilis infections (66.6%) and all seven gonorrhea and chlamydia infections were appropriately treated with guideline-recommended antibiotics.
DISCUSSION
LBAPs are a new and innovative care model that was developed in response to the urgent need to improve MOUD access for patients who are not successfully reached by traditional outpatient settings. LBAPs offer an exciting opportunity to expand access to prevention, screening, and treatment for transmittable infections for people with SUD; however, screening and treatment protocols have yet to be optimized. Consistent with prior work in high-risk populations in other settings, our study found high rates of known and previously undiagnosed HIV, HCV, HBV, and bacterial STI’s.32,33 However, to our knowledge, this is the first description of a standardized infection screening protocol within an LBAP, and we believe that the results support the integration of comprehensive infection screening across LBAP settings.
Study results also confirmed the necessity of infection treatment services and linkage-to-care algorithms within LBAPs. In our cohort, linkage rates for patients with new diagnoses of HCV were low but consistent with prior trials, likely reflecting the complex, multi-level barriers people with unstable SUD face in transitioning to office-based care settings.34,35 Low linkage rates suggest opportunities to develop and test more intensive referral strategies, such as individualized patient navigation. These gaps also suggest an opportunity to improve HCV treatment access by offering treatment within LBAPs. Newer HCV treatment regimens allow shorter treatment durations (e.g. 8 weeks) for treatment-naïve patients without cirrhosis and may make HCV treatment delivery more feasible in the LBAP setting. This delivery model has been proven to be successful in similar low-barrier settings.36,37
The high prevalence of bacterial STI’s in the study sample supports the expansion of gonorrhea and chlamydia testing to include screening at sites-of-contact (e.g. oropharyngeal, rectal, vaginal), as studies have previously demonstrated high rates of asymptomatic, extra-genital infection in patients at high risk, including men who have sex with men and women seeking care at STI clinics.38,39 Screening for trichomonas should also be considered, as Centers for Disease Control and Prevention (CDC) guidelines advise this testing in patients with illicit drug use, multiple sexual partners, or transactional sex.40 Although bacterial STIs have lower mortality rates than the blood-borne viral infections, LBAP and other low-barrier settings represent a key intervention point in order to avoid the significant morbidity and potential long-term sequelae of untreated bacterial infections. Likewise, LBAP offer an opportunity to continually re-test patients at high risk for reinfection.
LBAPs also represent an ideal setting to deploy prevention services including HIV post-exposure prophylaxis (PEP) and pre-exposure prophylaxis (PrEP), two interventions that are not consistently reaching PWID in spite of CDC recommendations and current HIV outbreaks in this population.41 Although this study did not capture the history elements required to determine PEP and PrEP eligibility (e.g. last receptive syringe exchange, last condom-less sex with a partner at substantial HIV risk) nor rates of PEP and PrEP prescribing, the high rates of self-reported IDU and observed bacterial STIs in this cohort suggest that many patients would benefit from biomedical HIV prevention. For patients with ongoing, high-risk exposures, the “PEP-to-PrEP” approach may be the safest and most efficient way to prevent HIV, and it has been well received by both patients and providers in our LBAP.42
Moreover, the high rates of HAV and HBV non-immunity suggest important opportunities for vaccination, particularly given the current outbreaks in PWID.43,44 Although vaccination was not available in our LBAP during the study period, based upon these data, we now offer both HAV and HBV immunization.
This study has several limitations. First, our data represent the experience of a single LBAP within a medical center that provides significant infrastructure to support patients with SUD. The study site is also located in an urban setting with a high density of external addiction resources and within a state that provides comprehensive Medicaid coverage for MOUD, laboratory testing, and antibiotic and antiviral therapy. These issues may limit generalizability to other settings, including suburban and rural settings and regions with more limited state Medicaid coverage of addiction and infection services. Second, rates of completed screening for infectious and immunity markers of interest ranged from just 65% (HAV immunity) to 77% (HCV infection) despite implementation of a universal, opt-out screening protocol. Although the reason for non-screening was not documented systematically, chart review suggests that downstream factors, such as long waits for phlebotomy or patient refusal of phlebotomy were more frequent contributors than deviations from protocols. Likewise, patients who did not undergo RN intake were less likely to be screened, suggesting an opportunity for clinician education and systems interventions to ensure all patients are screened in a comprehensive manner.
Steps taken based on the results of this study include provider education, improvements in electronic medical record laboratory order sets, and access to swabs to screen for gonorrhea and chlamydia at sites of contact. However, results highlight that an opt-out protocol is an impactful but perhaps insufficient intervention to achieve the goal of universal testing and that some patients may benefit from additional outreach and navigation.
Finally, as a retrospective chart review reliant on some patient-reported data, the data may be subject to under-reporting due to stigma or privacy concerns. Nonetheless, we find the rates of self-reported risk behaviors in this cohort compelling.
CONCLUSIONS
Patients establishing SUD care at an LBAP have substantial and unmet infection-related needs. Although the primary aim of LBAPs is, and should remain, rapid MOUD access, results justify the inclusion of comprehensive infection screening, prevention, and linkage to treatment services in the LBAP setting. Future work should evaluate more intensive HIV prevention services and linkage-to-care navigation in this setting.
ACKNOWLEDGEMENTS
The authors thank Kathleen Masters for help with data collection and Mary Tomanovich for proof-reading and formatting.
Sources of Support: This work was supported by a grant from the Massachusetts Department of Public Health Bureau of Substance Addiction Services to develop Opioid Urgent Care Centers [RFR #163274] and the National Institute of Drug Abuse [K23DA044085 to S.A.A].
Footnotes
Conflicts of interest: None
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