bluuebunny/crossref_metadata_2025 huggingface dataset:
98. COVID-19 Vaccine Breakthrough Hospitalizations and Deaths in the Veterans Health Administration
Authors: Oda Gina , Sharma Aditya , Lucero-Obusan Cynthia A , Schirmer Patricia , Holodniy Mark , Edson Connor W , Khaksar Ramin
Published: December 2021

Background

A COVID-19 vaccine breakthrough infection is defined as SARS-CoV-2 RNA or antigen detected ≥ 14 days after completion of a final vaccine dose. CDC’s May 25 MMWR report of 10,262 vaccine breakthrough infections in the U.S. is likely an underestimate. Herein, we report Veterans Health Administration (VHA) breakthrough cases, focusing on hospitalizations and deaths.

Methods

We extracted COVID-19 vaccine breakthrough infections tested between 1/19/2021 and 4/30/2021 from the VHA Corporate Data Warehouse (including screening tests). We reviewed medical records of cases who died and/or were hospitalized within 14 days of SARS-CoV-2 positive test for clinician documentation of conditions deemed high risk for COVID-19 and to confirm hospitalization or death was related to COVID-19. SARS-CoV-2 whole genome sequencing (Clear Labs platform) and antigen testing (Abbott BinaxNOW) from available patient samples were performed and Pangolin lineage determined.

Results

1,142 COVID-19 vaccine breakthrough infections were identified. 357/1,142 (31.3%) were hospitalized and/or died. 1,085 (95%) were male (Table 1), and median age was 72.5 years (74 years for hospitalized/deceased patients). COVID-19 infection contributed to hospitalization and/or death in 139 (38.9%) cases. The remaining 218 (61.1%) were hospitalized or died of causes apparently unrelated to COVID-19. Smoking and heart conditions were seen most frequently among hospitalized/deceased breakthrough cases (Table 2). Variant B.1.1.7 was predominant, present in 17/27 (63%) total samples sequenced, and 13/21 (61.9%) hospitalized/deceased. (Table 3). Of 21 sequenced hospitalized/deceased cases, SARS-CoV-2 antigen positivity was present in 11 (52.4%).

Conclusion

Compared to CDC reported breakthrough infections, VHA cases were more male, older, and hospitalized/died at higher frequency. Further study is needed to determine the contribution of specific underlying conditions, COVID-19 vaccine formulations and variants on hospitalization and death among COVID-19 vaccine breakthrough infections. Sequencing efforts for breakthrough cases should be intensified, particularly for those presenting with more severe infections.

Disclosures

All Authors: No reported disclosures
809. Evaluation of Antimicrobial Prophylaxis Prescribing in Post-operative Neurosurgical Procedures
Authors: Resso Clarice , Mott Kelsey , Reber Jasmine , Kheraj Malika N
Published: December 2021

Background

Due to lack of relevant clinical data or guidelines, duration of post-operative prophylactic antimicrobial therapy for neurosurgical procedures at the Kaiser Permanente Northern California (KPNC) hospitals has varied among patients and is largely based on the clinical judgment of surgeons. Non-standardized perioperative microbial prophylaxis practice has been associated with excessive antimicrobial therapy, increased risk of drug resistance, institutional cost, and adverse drug effects. This study aims to evaluate differences in prescribing practices of post-operative prophylactic antibiotics among neurosurgeons and to observe the incidence of surgical site infections and adverse drug events caused by antimicrobial prophylaxis that are associated with varying durations of post-procedure prophylaxis.

Methods

A retrospective, observational study of health plan members of KPNC who underwent neurosurgical procedures from 01/01/2011 to 12/31/2019. Prophylactic antimicrobial therapy and duration was identified from medication dispensing and administration records. The study analyzed rates of surgical site infection, post-surgical wound drainage, 60-day mortality, and adverse drug events within 60 days of surgery.

Results

The cohort consisted of 491 patients. 140 received antibiotics for >24 hours and 351 received antibiotics for ≤24 hours. The most common procedures analyzed in our patient population were VP shunt insertion (70.7%) and craniotomy subdural hematoma evacuation (17.9%). There were more surgical site infections in those who received antibiotics >24 hours (4.3% vs 1.4%, p value= 0.05). Univariate logistic regression model showed receiving antibiotics for ≤ 24 hours significantly decreased chance of composite drug event (odds ratio 0.345, 95% CI 0.172-0.691, p value= 0.003).

Conclusion

This study demonstrated that antimicrobial prophylaxis for neurosurgical procedures ≤24 hours decreases risk of adverse drug events. The study provides further evidence to support the development of a standardized protocol that recommends short duration of antibiotic prophylaxis for neurosurgical procedures at KPNC.

Poster

Disclosures

All Authors: No reported disclosures
811. Impact of the COVID-19 Pandemic on Surgical Volume and Surgical Site Infections (SSI) in a Large Network of Community Hospitals
Authors: Gettler Erin , Seidelman Jessica , Smith Becky A , Anderson Deverick J
Published: December 2021

Background

The COVID-19 pandemic significantly impacted hospitalizations and healthcare utilization. Diversion of infection prevention resources toward COVID-19 mitigation limited routine infection prevention activities such as rounding, observations, and education in all areas, including the peri-operative space. There were also changes in surgical care delivery. The impact of the COVID-19 pandemic on SSI rates has not been well described, especially in community hospitals.

Methods

We performed a retrospective cohort study analyzing prospectively collected data on SSIs from 45 community hospitals in the southeastern United States from 1/2018 to 12/2020. We included the 14 most commonly performed operative procedure categories, as defined by the National Healthcare Safety Network. Coronary bypass grafting was included a priori due to its clinical significance. Only facilities enrolled in the network for the full three-year period were included. We defined the pre-pandemic time period from 1/1/18 to 2/29/20 and the pandemic period from 3/1/20 to 12/31/20. We compared monthly and quarterly median procedure totals and SSI prevalence rates (PR) between the pre-pandemic and pandemic periods using Poisson regression.

Results

Pre-pandemic median monthly procedure volume was 384 (IQR 192-999) and the pre-pandemic SSI PR per 100 cases was 0.98 (IQR 0.90-1.04). There was a transient decline in surgical cases beginning in March 2020, reaching a nadir of 185 cases in April, followed by a return to pre-pandemic volume by June (figure 1). Overall and procedure-specific SSI PRs were not significantly different in the COVID-19 period relative to the pre-pandemic period (total PR per 100 cases 0.96 and 0.97, respectively, figure 2). However, when stratified by quarter and year, there was a trend toward increased SSI PR in the second quarter of 2020 with a PRR of 1.15 (95% CI 0.96-1.39, table 1).

Conclusion

The decline in surgical procedures early in the pandemic was short-lived in our community hospital network. Although there was no overall change in the SSI PR during the study period, there was a trend toward increased SSIs in the early phase of the pandemic (figure 3). This trend could be related to deferred elective cases or to a shift in infection prevention efforts to outbreak management.

Disclosures

All Authors: No reported disclosures
813. Implementing a Nurse-driven Nasal Decolonization Intervention to Prevent Surgical Site Infections within the Veterans Health Administration
Authors: Sherlock Stacey Hockett , Goedken Cassie , Balkenende Erin C , Dukes Kimberly , Perencevich Eli N , Reisinger Heather Schacht , Schweizer Marin L
Published: December 2021

Background

Staphylococcus aureus surgical site infection (SSI) is common and devastating clinically. Pre-operative decolonization is associated with reduced incidence, but has been variably adopted due to barriers implementing high-efficacy prevention bundles, including unintentional non-compliance applying intra-nasal mupirocin by patients at home. Three Veterans Affairs (VA) facilities attempted to implement an alternate evidence-based SSI prevention program that included intranasal povidone-iodine used in the pre-operative setting to reduce challenging patient-burden steps and to overcome other mupirocin barriers. Our objective was to identify strategies used for successful implementation of intranasal povidone-iodine.

Methods

We conducted pre- and post-implementation semi-structured interviews and site visits at three VA hospitals. Participants included surgery and clinic staff (e.g., nurses, physicians, care managers), infection control staff, and administrative leadership. Interviews were audio recorded and transcribed. Our interdisciplinary team performed a deductive and inductive consensus-based analysis.

Results

Implementation of this SSI prevention process was successful when nurse champions drove the implementation. Qualitative interviews indicate that nurses used a variety of strategies and messages variant on their audience. Nurse-driven facilitators included: key leadership buy-in and strategic decisions about timing and setting of implementation (i.e., start implementation in units with likely early adopters then when project is working well circle back to the early detractors). The primary implementation barrier identified was lack of a champion. One site stated that in the absence of a champion, a mandate or top-down approach may be needed for implementation at their facility.

Conclusion

Nurse champions facilitated successful SSI prevention process implementation. Nurses used strategies and approaches dependent on their knowledge and understanding of the stakeholders and setting to obtain buy-in. Future implementation of new clinical practices should consider utilizing nurse champions to promote uptake.

Disclosures

Marin L. Schweizer, PhD, 3M (Grant/Research Support)PDI (Grant/Research Support)
101. PCV13 Pediatric Vaccination Disparity and Impact Due to COVID-19 Pandemic in the US
Authors: Huang Liping , Nguyen Jennifer L , Perdrizet Johnna , Alfred Tamuno , Arguedas Adriano
Published: December 2021

Background

Existing disparities in vaccination rates across different social and demographic groups in the US may have been exacerbated during the Coronavirus Disease 2019 (COVID) pandemic, leaving some children at risk for vaccine-preventable diseases. This study examined sociodemographic and risk factors of PCV13 infant primary series vaccination completion, before and during COVID.

Methods

Retrospective data from the Optum’s de-identified Clinformatics Data Mart Database were used to create 3 cohorts: C1, Pre-COVID; C2, During COVID; C3, Cross-COVID (Figure 1). C1 and C3 (C1&3) were combined and compared with C2 for primary dosing completion before and during COVID according to infant/caregiver characteristics. Full completion (FC) was defined as receipt of 3 doses of PCV13 within 8 months of birth. Multivariable logistic regression was used to compare FC vs. partial completion or no vaccine. Descriptive analyses were used to compare FC before and during COVID within subgroups.

Figure 1: Study population and inclusion criteria

Results

A total of 132,183 and 16,522 infants with at least 8 months of follow up time were enrolled in C1&3 and C2, respectively. FC was significantly higher before COVID-19 (adjusted odds ratio = 1.12, 95% CI: 1.07-1.17). Adjusting for COVID, FC was significantly lower in infants who were Black, with co-morbidities or risk factors, living in households with >1 children or no children, household annual income < &99k, residing in a neighborhood with median education of high school or below, and whose primary caregiver was aged <25 years (Table 1). Comparing FC before and during COVID, the % decline relative to pre-COVID was > 2% among infants who were White, residing in the Mountain, New England or Pacific regions, in a household with 2 children, >&100k annual income, employer-based insurance or HMO, and median neighborhood education of bachelor degree plus (Table 2).

Table 1. Multivariable binomial logistic regression results for PCV13 full primary dosing completion vs. not full completion (partial or no vaccine), N=144,799*

Table 2. Primary dosing full completion rate pre-COVID vs. during COVID by social, demographic, and clinical risk factors

Conclusion

Health inequities in PCV13 primary series completion existed prior to COVID-19 and have remained during the pandemic. Our results, however, suggest that during the pandemic, groups traditionally considered to have better healthcare access (Whites, higher income, more education) had more impact on vaccine uptake. Further research is needed to confirm these trends as COVID mitigation measures subside.

Disclosures

Liping Huang, MD, MA, MS, Pfizer Inc (Employee) Jennifer L Nguyen, ScD, MPH, Pfizer Inc. (Employee) Johnna Perdrizet, MPH, Pfizer Inc (Employee) Tamuno Alfred, PhD, Pfizer Inc. (Employee) Adriano Arguedas, MD, Pfizer (Employee)
821. Changes in Cleaning Practices and Non-conventional Personal Protective Equipment Use due to SARS-CoV-2 and Association with Increases in Multi-drug Resistant Organism Cases
Authors: Witwer Medora L , Kline Susan E , Ferrieri Patricia , Saunders Samantha , Dobbins Ginette , Gand Kari , Galdys Alison
Published: December 2021

Background

During the pandemic of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), policy at a Minnesota hospital changed to state that environmental services would not clean rooms of patients with confirmed or suspected SARS-CoV-2 infections, requiring nursing staff to perform these duties. Investigation of a cluster of carbapenem-resistant Enterobacterales (CRE) in patients hospitalized in the same or adjoining rooms on the medical intensive care unit (MICU) raised concern over whether SARS-CoV-2 cleaning practices and non-conventional personal protective equipment (PPE) use led to transmission of multi-drug resistant organisms (MDROs).

Methods

Infection Prevention conducts passive surveillance for MDRO acquisition in inpatient units. Passive surveillance of SARS-CoV-2 was performed early in the pandemic. Active surveillance SARS-CoV-2 testing on admission was initiated in July 2020 and active surveillance testing for admitted patients every 7 days was initiated in December. Incident cases of vancomycin-resistant Enterococcus (VRE), extended-spectrum-β-lactamase-producing organisms (ESBL), methicillin-resistant S. aureus (MRSA), and CRE were determined for hospitalized patients between March 1, 2020 and February 28, 2021, excluding patients with infection on admission. Rates of hospitalized patients testing positive for SARS-CoV-2 per 100 patient days were compared to rates of patients testing positive for VRE, ESBL, MRSA, and CRE per 100 patient days respectively. The same rate comparisons were completed for the MICU. Using the F-Test Two-Sample to determine variance, the Two-Sample T-test assuming unequal variances was applied to each comparison.

Results

Correlation was significant between rates of SARS-CoV-2 and VRE (p< 0.005), ESBL (p< 0.005), MRSA (p< 0.005), and CRE (p< 0.005) (Table 1). MICU correlation was significant between rates of SARS-CoV-2 and VRE (p< 0.005), ESBL (p< 0.005), MRSA (p< 0.005), and CRE (p< 0.005) (Table 2).

Table 1: Two-sample T-test results assuming unequal variances: Hospital COVID rates per 100 patient days vs. rates of incident positive tests for VRE, ESBL, MRSA, and CRE per 100 patient days

Table 2: Two-sample T-test results assuming unequal variances: MICU COVID rates per 100 patient days vs. rates of incident positive tests for VRE, ESBL, MRSA, and CRE per 100 patient days

Conclusion

The relationships between the rates of SARS-CoV-2 and four MDROs were statistically significant. It can be inferred from this data that changes in hospital cleaning and non-conventional PPE use may have led to an increase in transmission of MDROs in this facility.

Disclosures

All Authors: No reported disclosures
830. Central Nervous System Involvement in Disseminated Mycobacterium avium Complex Infection in Patients with Newly Diagnosed HIV
Authors: Camiro Antonio , Llamas-López Andrea , Aranda-Audelo Mercedes , Martínez-Oliva David H , Sienra-Iracheta Estefania , Rodriguez-Zulueta Patricia
Published: December 2021

Background

Disseminated Mycobacterium avium complex (MAC) infection occurs in 20-40% of patients with < 50 CD4/mm3. Data describing central nervous MAC involvement (CNS-MAC) in disseminated infection is scarce.

Methods

We conducted a retrospective case series in the outpatient infectious diseases clinic in the hospital “Dr. Manuel Gea Gonzales” in Mexico City. We reviewed all records from October 2020 to May 2021 and identified all culture proven MAC infections.

Results

We found 7 cases of MAC, with disseminated infection (positive bone marrow cultures) with 3 out of those 7 meeting our definition for CNS-MAC (positive cerebrospinal fluid culture). All cases of CNS-MAC infection occurred in patients with < 50 CD4/mm3 and recent HIV diagnosis (1-4 months) that were referred to our institution with consumptive syndrome and fevers. All patients were receiving antiretroviral treatment (ART) with BIC/FTC/TAF and initiated ART in less than 1 month since HIV diagnosis. Opportunistic infections were ruled-out at the moment of CNS-MAC diagnosis (criptococcal meningitis, cytomegalovirus retinitis, tuberculosis and histoplasmosis). All patients exhibited non-specific neurologic symptoms at arrival (headache and bradipsiquia) mixed with more severe symptoms (one case of ataxia, one case of vertigo, one case of III nerve palsy). All patients were treated with Clarithromycin/Levofloxacin/Ethambutol. Two patients achieved symptom remission and 1 patient was lost to follow-up. Of important note, all CSF analysis and CNS imaging studies carried-out were normal. No MAC bacilli were identified with direct Ziel-Neelsen staining of CSF.

Conclusion

We found a high proportion of CNS-MAC in patients with disseminated MAC infection (42.8%) during the study period. All patients presented CNS symptoms and normal CSF characteristics. In our setting, patients with suspected disseminated MAC infection CD4 counts < 50 cells/mm3 might represent a specific population that could benefit from routine targeted diagnostic test at presentation in order to establish CNS involvement.

Disclosures

All Authors: No reported disclosures
832. Body Mass Index and Quality of Life in People Living With HIV
Authors: Ken-Opurum Jennifer , Prajapati Girish , Matos Joana E , Goswami Swarnali , Kumar Princy N
Published: December 2021

Background

Weight gain among people living with HIV (PLWH) on antiretroviral therapy (ART) may lead to obesity. This study evaluated association between body mass index (BMI) and health-related quality of life (HRQoL) from the patient’s perspective.

Methods

A cross-sectional study using self-reported data from the 2018 and 2019 US National Health and Wellness Survey (NHWS), a nationally representative online survey of ~75,000 adults was conducted. Respondents self-reporting a physician diagnosis of and prescription use for treatment of HIV were included. HRQoL was assessed using Short-Form 36-Item Health Survey Version 2 [Mental and Physical Component Summary scores (MCS and PCS)] and EQ-5D-5L [dimension responses: “no” vs “any problems”/“yes”); EQ-Visual Analogue Scale (VAS) score]. Bivariate analyses (chi-square tests for categorical and ANOVA for continuous variables) compared patient characteristics and HRQoL outcomes across BMI (kg/m2) categories: normal weight (NW; 18.5-< 25), overweight (OW; 25-< 30) and obese (OB; ≥30). Multivariable models analyzed each outcome as a function of BMI, controlling for age, sex, race, and Charlson Comorbidity Index (CCI; excluding HIV/AIDS).

Results

A total of 566 respondents were analyzed. Majority were aged ≥50 years (58%) and male (87%). The OB (vs NW) group had higher proportion of respondents who were female (22% vs 10%), Black (37% vs 24%), residing in the South (46% vs 33%), and higher mean CCI score (1.28 vs. 0.97) (Table 1). A higher proportion of OB (vs NW) respondents reported having pain/discomfort and problems with mobility and usual activities but not self-care. Anxiety/depression was reported less in OB vs NW groups (Table 1) However, self-reported use of prescription medications for anxiety (19% vs 20%) and depression (34% vs 25%) was similar in OB and NW groups. PCS and EQ-VAS scores were lower in OB vs OW and NW, but no difference in MCS score was observed (Table 1). Lower PCS and EQ-VAS scores were associated with higher BMI (both p=0.01) but not MCS (p=0.68) in multivariate models.

Conclusion

PLWH with higher BMI have poorer physical and general HRQoL. Impact of potential adverse weight gain and transition to higher BMI on humanistic and clinical outcomes should be considered when selecting ART regimens.

Table 1. Comorbidity Burden and Quality of Life in People Living with HIV by BMI Categories.

Disclosures

Jennifer Ken-Opurum, PhD, Kantar Health (Employee) Girish Prajapati, M.B.B.S., MPH , Merck & Co., Inc. (Employee, Shareholder) Joana E. Matos, PhD, Kantar Health (Employee) Princy N. Kumar, MD, AMGEN (Other Financial or Material Support, Honoraria)Eli Lilly (Grant/Research Support)Gilead (Grant/Research Support, Shareholder, Other Financial or Material Support, Honoraria)GSK (Grant/Research Support, Shareholder, Other Financial or Material Support, Honoraria)Merck & Co., Inc. (Grant/Research Support, Shareholder, Other Financial or Material Support, Honoraria)
838. A Multidisciplinary Approach to the Management of Renal Disease in Patients with HIV
Authors: Bennani Yussef , Perez Annalisa , Hasan Hira , Richey Lauren
Published: December 2021

Background

Chronic kidney disease (CKD) remains an important complication of HIV infection, with up to 30% of people with HIV (PWH) having abnormal renal function. Those with HIV and CKD are reported to have higher mortality than those with either alone. As survival of PWH continues to improve with antiretroviral therapy, additional risk factors for CKD become more prevalent with advancing age. Optimizing management of renal disease in this population to reduce mortality and progression to ESRD has become a more pressing need. Our study describes the implementation of a multidisciplinary HIV/nephrology clinic nested within a Ryan White HIV/AIDS Program-funded clinic on the progression of renal disease in PWH in New Orleans.

Methods

Clinic patients with HIV with at least CKD stage 3 (excluding those with end-stage renal disease) or significant proteinuria were eligible to be referred. Both an HIV primary care provider and a nephrologist evaluated patients at their initial visit, and the subspecialists jointly developed treatment plans. Patients included in the initial analysis were evaluated between January and May 2021. Baseline renal function and proteinuria were obtained, as well as additional studies as appropriate.

Results

A total of 1,968 patients were seen in the HIV clinic during the 18 months prior to the referral period. 305 (15.5%) had an ICD-10 diagnosis code for either CKD or proteinuria. During January – May 2021, 15 patients were referred and 13 evaluated in the multidisciplinary clinic, including 10 men and 3 women. Patients were seen an average of 1.3 times during this time. 8 patients were African-American, and 4 where white. Median age was 59. Median creatinine clearance at baseline was 45 mL/minute. Among those with proteinuria, median proteinuria was 891 mg/g. 8 patients had a diagnosis of hypertension, while 2 had diabetes mellitus. Initial data show a mean improvement in creatinine clearance of 4.2 mL/minute over a mean of 105 days of observation in those with repeat measurements.

Conclusion

There continues to be a high prevalence of CKD in PWH in the era of ART. Given the natural history of kidney disease, an improvement in creatinine clearance is promising. Aggressive co-management of HIV and CKD using a multidisciplinary model may limit progression of CKD and mortality.

Disclosures

Yussef Bennani, MD, MPH, Gilead Sciences (Scientific Research Study Investigator)ViiV Healthcare (Scientific Research Study Investigator)
840. Clinical Characteristics of Patients Living with HIV Hospitalized for COVID-19
Authors: Chaudhry Nimra , Cani Eris , Park Tae , Zeana Cosmina , Kelly Paul , Sun Haozhe
Published: December 2021

Background

Limited data exists regarding the impact of coronavirus disease 2019 (COVID-19) on people living with human immunodeficiency virus (PLWH). The purpose of the study was to compare the clinical outcomes of patients hospitalized with COVID-19 and HIV versus those without HIV.

Methods

This was a retrospective, cohort study of adult patients admitted with confirmed COVID-19 from March 1st to May 30th 2020 at an urban hospital in New York City. Data collected included demographics, past medical history, HIV status, baseline laboratory values, treatment and outcomes such as length of stay, mechanical ventilation, patient disposition at discharge, and in-hospital mortality. Fisher’s exact test was used to compare categorical values and a t-test was used to compare continuous values.

Results

Out of 983 patients, 6.9% were PLWH and 93.1% were HIV-negative. The average age in both groups was 61 vs. 62 years, respectively. There were more male patients in the PLWH than the non-HIV group (76.8% vs. 58.6%). Majority of PLWH were Black (49.3%). Forty-seven percent of PLWH were mechanically ventilated versus 33.3% of the non-HIV group. The most common comorbidity in both groups was hypertension (82.4% vs. 72.6%). When compared to HIV-negative patients, PLWH had a higher rate of kidney disease (72.1% vs. 53.6%, p=0.0086), chronic obstructive pulmonary disease (41.2% vs. 14.5%, p=0.0001), liver disease (45.6% vs. 11.5%, p=0.0001) and current smoking (14.3% vs. 5.8%, p=0.0103). In PLWH, 70.6% of patients were on an integrase-based regimen. Fifty-three percent of PLWH had a CD4 count of > 200 cells/mm3 and 35.3% had an undetectable viral load (< 20 copies/mL). Unadjusted hospital mortality was 51.4% in PLWH and 36.2% in the non-HIV cohort (p=0.0089). The average length of hospital stay was 9.1 days vs. 8.4 days in PLWH versus the non-HIV group (p=0.4493). More patients were discharged to a nursing home in the non-HIV group vs. PLWH (37.8% vs. 14.3%, p=0.0001).

Conclusion

Hospitalized patients with COVID-19 and HIV had a higher in-hospital mortality compared to those without HIV during the first COVID wave in New York City.

Disclosures

All Authors: No reported disclosures
841. Survey of Current HIV and HCV Policies and Practices in Prisons and Jails Serving High-Risk Geographic Hotspots
Authors: Min Sugi , Shin Jimin , Jacka Brendan , Bazerman Lauri , Nijhawan Ank E , Beckwith Curt
Published: December 2021

Background

The goal of the U.S. “Ending the HIV Epidemic” (EHE) initiative is to reduce new HIV infections by 90% within 10 years by focusing resources on high-risk geographic “hotspots.” (Figure 1). The criminal justice system bears a disproportionate burden of HIV, yet EHE lacks specific mention of correctional settings for intervention. We conducted a survey study of current HIV and HCV care practices in prisons and jails serving EHE hotspots.

Figure 1

Priority jurisdictions for the “Ending the HIV Epidemic” Initiative which include counties, rural states, and territories with the highest HIV burden, together accounting for more than 50 percent of new HIV diagnoses in recent years. Source: Division of HIV/AIDS Prevention, Centers for Diseases Control and Prevention, https://www.cdc.gov/endhiv/jurisdictions.html

Methods

An online survey on HIV/HCV testing, prevention, treatment, and surveillance was sent to Medical Directors or designees at 26 state prison systems and 37 county or city jails serving EHE hotspots in Spring 2021.

Results

Twenty-five responses were received (10/26 prisons, 15/37 jails) for an overall response rate of 40%. Routine HIV testing, defined as testing offered to all persons without known infection, was conducted in 76% of facilities (9/10 prisons, 10/15 jails), with policies of “opt-out” in 44% (5/10 prisons, 6/15 jails), “opt-in” in 20% (2/10 prisons, 3/15 jails), and “mandatory” in 12% of facilities (2/10 prisons, 1/15 jails). Most facilities (80%) provided HIV testing upon inmate request. For HIV prevention, education programs and/or treatment for opioid-use disorder was available in 76% of facilities, but PrEP and condoms were only available in 24% and 16%, respectively. All facilities reported providing antiretroviral therapy and 88% provided a short (3- to 30-day) supply upon discharge. Routine testing for HCV was conducted in 52% of facilities (7/10 prisons, 6/15 jails), with policies of “opt-out” in 36% (5/10 prisons, 4/15 jails), “opt-in” in 12% (1/10 prisons, 2/15 jails), and “mandatory” in one prison. Most facilities (80%) provided HCV testing upon inmate request. In 8/10 prisons and 6/15 jails, HCV treatment with direct-acting antivirals was continued if initiated prior to incarceration. Treatment for new diagnoses of HCV was less common (16-44%) and depended on expected length of incarceration.

Conclusion

In prisons and jails serving HIV “hotspot” regions, critical opportunities for improved HIV and HCV testing, treatment, prevention, and linkage-to-care services remain. Given these findings, we support the broader inclusion of the justice system as an integral component of the EHE initiative.

Disclosures

All Authors: No reported disclosures
847. A Qualitative Exploration of New and Existing HIV PrEP Modalities Among Men Who Have Sex with Men in Philadelphia
Authors: Tran Nguyen K , Martinez Omar , Goldstein Neal , Scheim Ayden , Welles Seth
Published: December 2021

Background

Daily oral pre-exposure prophylaxis (PrEP) is highly effective at preventing HIV when used as directed among men who have sex with men (MSM). However, challenges with uptake and adherence to daily oral PrEP have prompted the development of new modes of administration, including a long-acting, intramuscular injectable. We sought to explore the treatment characteristics that may influence the willingness and uptake of long-acting injectable PrEP as opposed to the daily pills among a racially diverse sample of MSM.

Methods

Between January and May 2021, we actively recruited 28 HIV-negative MSM (8 Black, 10 Latinx, 10 White) who lived in Philadelphia, PA during the past 12 months using social networking sites (e.g., Facebook and Instagram) and a community listserv. Qualitative data collection used a hybrid approach in which 4 focus groups and 10 semi-structured interviews were conducted virtually. Focus groups were kept racially and ethnically homogenous to identify differences in emerging themes related to PrEP willingness and preferences for specific prevention modalities.

Results

Participants discussed differing levels of interest and willingness to use long-acting injectable PrEP as opposed to the daily pills. The main perceived facilitator for injectable PrEP included convenience of use such as having fewer concerns with adhering to daily pills. Perceived barriers to injectable PrEP included (1) a dislike of needles as well as (2) concerns of potential side effects and (3) lower treatment efficacy (i.e., whether it will be as effective as the daily pills). While Black and Latinx MSM reported experiences of racism and discrimination within the healthcare system, they also reported greater willingness to consider intramuscular injectables if their healthcare providers would provide in-depth information about the risks and benefits of this new modality.

Conclusion

Our findings provide important guidance for the development and promotion of future strategies to enhance the uptake of long-acting injectable PrEP to address the HIV epidemic among MSM. Primary care providers should play a key role in ameliorating concerns related to hesitancy towards injectable PrEP, including emphasizing ease of dosing, effectiveness, and safety of long-acting PrEP to prevent infection.

Disclosures

All Authors: No reported disclosures
852. Bridging the Gap in PrEP Provider Training: An Implementation Science Study
Authors: Ramakrishnan Aditi , Sales Jessica , McCumber Micah , Psioda Matthew , Powell Leah , Sheth Anandi N
Published: December 2021

Background

Training healthcare providers in a variety of clinical settings to deliver pre-exposure prophylaxis (PrEP) is a key component of the Ending the HIV Epidemic (EHE) initiative. Self-efficacy, the individual’s belief in their ability to carry out the steps of PrEP delivery, is a core part of provider training and necessary for successful PrEP implementation. We characterized self-efficacy among providers from family planning (FP) clinics that do not provide PrEP to inform provider training strategies.

Methods

We surveyed providers (any clinical staff who could screen, counsel, or prescribe PrEP) from FP clinics in 18 Southern states (Feb-June 2018, N=325 respondents from 224 clinics not providing PrEP) using contraception- and PrEP-specific self-efficacy questions (overall and grouped into PrEP delivery steps: screening, initiation, and follow-up). We compared self-efficacy scores (5-point Likert scale) by prescriber status, between PrEP delivery steps, and used linear mixed models to analyze provider-, clinic-, and county-level covariates associated with overall PrEP self-efficacy.

Results

Among 325 FP providers, self-efficacy scores were lowest in the PrEP initiation step, higher in follow-up, and highest in screening (p < 0.0001, Table). Mean overall PrEP self-efficacy scores were significantly higher among prescribers compared to non-prescribers (p < 0.0001). However, providers reported lowest self-efficacy regarding insurance navigation for PrEP with no significant difference by prescriber status. The mixed model demonstrated overall PrEP self-efficacy was positively associated with favorable PrEP attitudes among non-prescribers, PrEP knowledge among prescribers, and contraception self-efficacy in both groups, but was not associated with availability of insurance navigation on-site or other covariates (Figure).

Provider Self-Efficacy along the PrEP Delivery Model stratified by prescriber status

Conclusion

FP providers reported low confidence in their ability to perform the steps that comprise PrEP initiation. Provider training focused on elements of PrEP initiation are critical to improve PrEP implementation and EHE initiatives. Alternatively, programs employing referral or telehealth models to support the PrEP initiation step can successfully bridge this gap.

Disclosures

All Authors: No reported disclosures
865. Social Media Secret Facebook Groups for HIV Pre-Exposure Prophylaxis Awareness among Female Sex Workers in Cameroon
Authors: Guillamet Laia Jimena Vazquez , Babey Mary Mah , Mercy Njah , Blake Hassanatu , Jasani Amy , Kyeng Rahel , Tih Pius , Khan Eveline Mboh , Dionne Jodie
Published: December 2021

Background

About 25% of Cameroonian female sex workers (FSW) lived with HIV in 2018. PrEP was introduced in Cameroon in 2019, with minimal uptake as of 2021. The goal of this pilot project was to evaluate the potential of a novel social media intervention to raise Pre-Exposure Prophylaxis (PrEP) awareness and complement HIV prevention strategies among FSW, a key risk population.

Methods

From October 2020 to April 2021, sixty adult HIV-negative FSW who owned a phone with internet access joined the study; 40 in the intervention arm and 20 in the control arm. The intervention had a Secret Facebook Group (SFG) platform for confidentiality. It included 12 videos on HIV prevention in the local dialect, released over 8 weeks. In-person surveys were administered before and after the intervention, and three months later. Likert scale was used to evaluate the main outcome: PrEP awareness. Data was analyzed using Stata IC/version 14.2.

Results

Demographic characteristics were similar between intervention and control groups for age (29 years, SD7.3), literacy (45% secondary school), parity (1.9, SD1.5), and years as sex worker (7.8, SD5.1). One FSW had heard about PrEP before the intervention. After a brief introduction, 39% (15/38) of FSW in the intervention group and 50% (10/20) in the control group strongly agreed to be interested in taking PrEP (p=0.2). Baseline PrEP knowledge was poor in the intervention group (15/40, 38%) and very poor in the control group (19/20,95%) (p=0.0001). In the second survey, the intervention and control groups’ PrEP knowledge improved (p=0.0001 and p=0.02, respectively). It was more significant in the intervention group, with all FSW reporting good level of knowledge (p=0.0001) (Figure 1). In addition, more FSW in the intervention group (67%,27/40) strongly agreed to be interested in taking PrEP (p=0.01), while numbers remained similar in the control group (55%, 11/20, p=0.8). Three months after the intervention, 31.5% (12/38) of participants reported excellent PrEP knowledge, a significant improvement since the second survey (p=0.02).

Figure 1. Self-reported Pre-Exposure Prophylaxis knowledge before and after intervention in the intervention and control groups.

Conclusion

The use of a social media HIV prevention tool tailored to FSW in Cameroon improved PrEP awareness with good retention of knowledge. Cross contamination between groups might have hindered the differential impact of the brief intervention.

Disclosures

All Authors: No reported disclosures
871. Sexual Health Service Experience and Preferences for Non-Traditional Service Delivery Among a Predominately Immigrant Latino MSM Population in Miami
Authors: Herbert Samantha , Klose Katie , Rivera Liz , Erazo Brahian , Leon Brian Baez , King Katherine , Batalien Blonsky , Olivier-Bros Max , Doblecki-Lewis Susanne
Published: December 2021

Background

Miami-Dade County (MDC) has the highest rate of new HIV diagnoses in the United States (US), with highest incidence among Black and Latino men who have sex with men (MSM). Immigrants may be especially vulnerable to HIV acquisition and may lack or avoid accessible sexual health services. The University of Miami Mobile PrEP (MP) Clinic provides sexual health services including STI and HIV testing as well as PrEP initiation and follow-up in four highly impacted areas of MDC. The majority of MP clients are immigrant Latino MSM. We evaluated sexual healthcare access, preferences, and facilitators or barriers to receiving sexual health services through non-traditional platforms.

Methods

A brief survey was offered to clients at four MP locations from September 2020 to June 2021. Multiple-choice questions addressed healthcare access, usage, and experience as well as preferences for service receipt including home-based, mobile clinic, and telehealth options. Brief qualitative short answer responses were also elicited. Results were tabulated and presented descriptively.

Results

A total of 115 clients were surveyed. Mean age was 36; 82.6% identified as male. Most respondents were either White/Caucasian (56.5%) or Black/African-American (19.1%) and 78 (67.8%) identified as Hispanic/Latinx. Of the 66% that reported being born outside the US, 34.2% had immigrated in the past 5 years. Only 41.7% of respondents had a primary care provider. Before coming to the MP clinic, 27% had not been seen for sexual health services in over 2 years. Most clients indicated satisfaction with MP services. The most important characteristics for a care site identified included comfort with staff, location, and affordability. 43.5% preferred a clinic time outside of 9am-5pm. Only 13% of clients preferred home-based labs using a self-collection kit with a majority preference for in-person follow-up at the MP clinic.

Conclusion

Key populations at risk for HIV infection including immigrants and Black and Latino MSM may experience barriers to traditional clinic care. Clients expressed satisfaction with MP services, and a preference for clinic-collected rather than self-collected specimens. Further research to tailor service delivery to client preferences is needed.

Disclosures

All Authors: No reported disclosures
875. Indirect Treatment Comparison of 48-Week Efficacy and Safety of Cabotegravir + Rilpivirine Long-Acting Every 2 Months to Bictegravir/Emtricitabine/Tenofovir Alafenamide in Suppressed HIV-1 Infected Participants
Authors: Snedecor Sonya J , Schroeder Melanie , Van de Velde Nicolas
Published: December 2021

Background

Switching to cabotegravir long-acting + rilpivirine long-acting (CAB LA + RPV LA) administered every month (Q1M) has demonstrated non-inferiority in viral suppression versus a range of standard of care (SoC) antiretroviral regimens, including tenofovir alafenamide based regimens, in two pivotal phase 3 clinical trials (ATLAS [NCT02951052] and FLAIR [NCT02938520]). Furthermore, CAB LA + RPV LA every 2 months (Q2M) has demonstrated non-inferiority in maintaining viral suppression compared with CAB LA + RPV LA Q1M in a phase 3b study (ATLAS-2M [NCT03299049]). As bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) was not widely used at study initiation, the regimen was not present in the SoC arms of ATLAS and FLAIR. The objective was to compare efficacy and safety of CAB LA + RPV LA Q2M to BIC/FTC/TAF using indirect treatment comparison.

Methods

Two switch studies appropriate for facilitating indirect comparison to BIC/FTC/TAF were identified via systematic literature review (Molina et al. 2018 [NCT02603120] and Sax et al. 2020 [NCT03110380]). Indirect comparison using a generalisation of Bucher’s methodology to calculate relative risk, odds ratio, and risk differences in efficacy (Week 48 HIV RNA < 50 c/mL and ≥50 c/mL per FDA Snapshot approach and CD4+ cell change from baseline) and safety (discontinuation due to adverse events [AEs] and overall and serious AEs excluding injection site reactions [ISRs]) was conducted. Results for CAB LA + RPV LA Q2M in ATLAS-2M participants with prior integrase inhibitor (INI) exposure, but without prior CAB exposure, were indirectly compared to those with prior INI use in ATLAS and FLAIR via the common CAB LA + RPV LA Q1M comparator and were then indirectly compared to BIC/FTC/TAF via the INI comparator (Figure 1).

Results

No statistically significant differences in virologic failure, virologic suppression, CD4+ cell change, discontinuations due to AEs, and non-ISR serious/non-serious AEs were found between CAB LA + RPV LA Q2M and BIC/FTC/TAF (Table 1).

Conclusion

Indirect treatment comparison indicated efficacy and safety of CAB LA + RPV LA Q2M is not different from BIC/FTC/TAF. These regimens will be further compared in a randomized head-to-head non-inferiority trial (SOLAR, NCT04542070).

Disclosures

Sonya J. Snedecor, PhD, ViiV Healthcare (Other Financial or Material Support, Author’s employer, OPEN Health received funding to execute this study) Melanie Schroeder, MSc, ViiV Healthcare (Employee) Nicolas Van de Velde, PhD, ViiV Healthcare (Employee)
888. In Vitro Forgiveness of INSTI-Containing Regimens at Drug Concentrations Simulating Variable Adherence
Authors: Acosta Rima K , Mulato Andrew , D’Antoni Michelle L , Yant Stephen R , Cihlar Tomas , White Kirsten L
Published: December 2021

Background

The integrase strand transfer inhibitor (INSTI)-based regimens bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF), dolutegravir (DTG)+FTC/TAF, DTG/lamivudine (3TC), and DTG/rilpivirine (RPV) are all used for treatment of HIV-infected patients. Here, relative time to in vitro viral breakthrough (VB) and resistance barrier using simulated human drug exposures at either full or suboptimal treatment adherence to each regimen were compared.

Methods

Wild-type HIV-1 (IIIb)-infected MT-2 cells were exposed to the combinations of BIC+FTC+TAF, DTG+FTC+TAF, DTG+3TC, or DTG+RPV for up to 35 days or until VB. Fixed drug concentrations were the human plasma-free adjusted clinical trough concentrations (Cmin) or fixed at simulated Cmin after missing 1 to 4 consecutive doses (Cmin-1 to -4), with many replicates. Drug resistance was studied by next-generation sequencing at ≥2% frequency.

Results

At drug concentrations corresponding to full adherence and 1 missed dose (Cmin and Cmin-1), no VB occurred with any regimen (Table). At Cmin-2, only DTG+3TC had VB, with some emergent resistance to both drugs. At Cmin-3, all regimens had VB: by day 12, 100% of DTG+3TC wells had VB; for BIC+FTC+TAF, DTG+FTC+TAF, and DTG+RPV, < 15% of wells had VB which began after day 14. Emergent RT or IN resistance was seen for DTG+RPV and DTG+3TC but not for BIC+FTC+TAF or DTG+FTC+TAF. At Cmin-4, all DTG+3TC and DTG+FTC+TAF wells had VB by day 12, while DTG+RPV had 94% VB by day 25 and BIC+FTC+TAF had 50% VB by day 35. Emergent Cmin-4 drug resistance was seen for all regimens but at differing frequencies; DTG+RPV had the most wells with resistance. Cumulatively, emergent RT and/or IN resistance was found in 1.3% BIC+FTC+TAF, 2.5% DTG+FTC+TAF, 7.9% DTG+3TC, and 8.8% DTG+RPV cultures.

Summary of Forgiveness and Barrier to Resistance of INSTI-Containing Regimens

Conclusion

Regimen forgiveness and resistance barrier are important factors in long term treatment. These INSTI-based regimens had high in vitro forgiveness and resistance barriers with concentrations simulating high adherence. When multiple missed doses were simulated in vitro, BIC+FTC+TAF had the highest forgiveness and barrier to resistance. When compared to DTG+3TC and DTG+FTC+TAF, DTG+RPV had higher forgiveness but lower resistance barrier after several simulated missed doses.

Disclosures

Rima K. Acosta, BS, Gilead Sciences, Inc. (Employee, Shareholder) Andrew Mulato, BS, MBA, Gilead Sciences, Inc. (Employee, Shareholder) Michelle L. D’Antoni, PhD, Gilead Sciences (Employee, Shareholder)Gilead Sciences, Inc (Employee, Shareholder) Stephen R. Yant, PhD, Gilead Sciences, Inc. (Employee, Shareholder) Tomas Cihlar, PhD, Gilead Sciences, Inc. (Employee, Shareholder) Kirsten L. White, PhD, Gilead Sciences, Inc (Employee, Shareholder)