Evaluation of an emergency department opt-out provider-driven HIV and syphilis screening and linkage-to-care program.

OBJECTIVE: While the effectiveness of emergency departments (ED) in screening for HIV and syphilis is understood, less is known about dual screening programs. We aim to evaluate the impact of an opt-out provider-initiated HIV and syphilis program on screening, diagnosis, and linkage to care outcomes. METHODS: We performed a retrospective review of patients screened pre (2014-2017) and post (2017-2021) program implementation. Primary outcomes include HIV and syphilis screening, incidence of positive tests, and proportion of patients linked to care. Secondary outcomes included pre-exposure prophylaxis (PrEP) referral and successful linkage rates for HIV-negative syphilis-positive patients. RESULTS: Pre-implementation, 882 HIV tests were performed, of which 22 (2.49%) were new cases and 18 (81.82%) were linked to care; 754 syphilis tests were performed, of which 33 (4.38%) were active infections and 30 (90.91%) were treated. No eligible patients received PrEP referral. Post-implementation, 12,999 HIV tests were performed, of which 73 (0.56%) were new cases and 55 (75.34%) were linked to care; 10,885 syphilis tests were performed, of which 216 (1.98%) were active infections and 188 (87.04%) were treated. 25 (9.09%) eligible patients were referred for PrEP, and four (16.0%) attended their appointment. CONCLUSIONS: Post-implementation, there was a 1373.81% and 1343.63% increase in screening, and a 231.82% and 554.55% increase in positive cases of HIV and syphilis, respectively. Dual screening programs can be successfully implemented within the existing ED framework to increase screening and early detection for HIV and syphilis.

Heroin Use Is Associated With Vascular Inflammation in Human Immunodeficiency Virus.

BACKGROUND: Heroin use may work synergistically with human immunodeficiency virus (HIV) infection to cause greater immune dysregulation than either factor alone. Unraveling how this affects end-organ disease is key as it may play a role in the excess mortality seen in people with HIV (PWH) who use heroin despite access to care and antiretroviral therapy. METHODS: This is a prospectively enrolled, cross-sectional study of adults with and without HIV who use and do not use heroin using (18)F-fluorodeoxyglucose (FDG) positron emission tomography/computed tomography (PET/CT) to compare tissue-specific inflammation including aortic (target-to-background ratio [TBR]), splenic, and bone marrow (standardized uptake value [SUV]). RESULTS: A total of 120 participants were enrolled. The unadjusted mean difference in aortic TBR was 0.43 between HIV-positive [HIV+] heroin+ and HIV+ heroin-negative [heroin-] (P = .02); however, among HIV-, aortic TBR was similar regardless of heroin-use status. Further, HIV-by-heroin-use status interaction was significant (P = .02), indicating that the relationship between heroin use and higher aortic TBR depended on HIV status. On the other hand, both HIV (1.54 vs 1.68; P = .04, unadjusted estimated means for HIV+ vs HIV-) and heroin use were associated with lower bone marrow SUV, although the effect of heroin depended on sex (heroin-use-by-sex interaction, P = .03). HIV-by-heroin-use interaction was not significant for splenic or bone marrow SUV. CONCLUSIONS: Aortic inflammation was greatest in PWH who use heroin, but paradoxically, bone marrow activity was the least in this group, suggesting complex and possibly divergent pathophysiology within these different end organs.

Excess cancer prevalence in men with HIV: A nationwide analysis of Medicaid data.

BACKGROUND: Cancer is one of the most common comorbidities in men living with HIV (MLWH). However, little is known about the MLWH subgroups with the highest cancer burden to which cancer prevention efforts should be targeted. Because Medicaid is the most important source of insurance for MLWH, we evaluated the excess cancer prevalence in MLWH on Medicaid relative to their non-HIV counterparts. METHODS: In this cross-sectional study using 2012 Medicaid Analytic eXtract data nationwide, we flagged the presence of HIV, 13 types of cancer, symptomatic HIV, and viral coinfections using codes from the International Classification of Diseases, Ninth Revision, Clinical Modification. The study population included individuals administratively noted to be of male sex (men), aged 18 to 64 years, with (n = 82,495) or without (n = 7,302,523) HIV. We developed log-binomial models with cancer as the outcome stratified by symptomatic status, age, and race/ethnicity. RESULTS: Cancer prevalence was higher in MLWH than in men without HIV (adjusted prevalence ratio [APR], 1.84; 95% confidence interval [CI], 1.78-1.90) and was higher among those with symptomatic HIV (APR, 2.74; 95% CI, 2.52-2.97) than among those with asymptomatic HIV (APR, 1.73; 95% CI, 1.67-1.79). The highest APRs were observed for anal cancer in younger men, both in the symptomatic and asymptomatic groups: APR, 312.97; 95% CI, 210.27-465.84, and APR, 482.26; 95% CI, 390.67-595.32, respectively. In race/ethnicity strata, the highest APRs were among Hispanic men for anal cancer (APR, 198.53; 95% CI, 144.54-272.68) and for lymphoma (APR, 9.10; 95% CI, 7.80-10.63). CONCLUSIONS: Given the Medicaid program's role in insuring MLWH, the current findings highlight the importance of the program's efforts to promote healthy behaviors and vaccination against human papillomavirus in all children and adolescents and to provide individualized cancer screening for MLWH.

Levels of Soluble CD14 and Tumor Necrosis Factor Receptors 1 and 2 May Be Predictive of Death in Severe Coronavirus Disease 2019.

People infected with severe acute respiratory syndrome coronavirus 2 display a wide range of illness, from asymptomatic infection to severe respiratory distress resulting in death. We measured serum biomarkers in uninfected individuals and in individuals with mild, moderate, or critical coronavirus disease 2019 (COVID-19) disease. Levels of monocyte activation (soluble CD14 and fatty acid-binding protein 4) and inflammation (tumor necrosis factor receptors 1 and 2 [TNFR1 and TNFR2]) were increased in COVID-19 individuals, regardless of disease severity. Among patients with critical disease, individuals who recovered from COVID-19 had lower levels of TNFR1 and TNFR2 at hospital admission compared to these levels in patients with critical disease who ultimately died.

An HIV Diagnostic Testing Algorithm Using the cobas HIV-1/HIV-2 Qualitative Assay for HIV Type Differentiation and Confirmation.

Human immunodeficiency virus types 1 and 2 (HIV-1 and HIV-2) diagnostic testing algorithms recommended by the Centers for Disease Control involve up to three tests and rely mostly on detection of viral antigen and host antibody responses. HIV-1 p24 antigen/HIV-1/HIV-2 antibody-reactive specimens are confirmed with an immunochromatographic HIV-1/HIV-2 antibody differentiation assay, and negative or indeterminate results from the differentiation assay are resolved by an HIV-1-specific nucleic acid amplification test (NAT). The performance of a proposed alternative algorithm using the cobas HIV-1/HIV-2 qualitative NAT as the differentiation assay was evaluated in subjects known to be infected with HIV-1 (n = 876) or HIV-2 (n = 139), at low (n = 6,017) or high (n = 1,020) risk of HIV-1 infection, or at high-risk for HIV-2 infection (n = 498) (study A). The performance of the cobas HIV-1/HIV-2 qualitative test was also evaluated by comparison to an HIV-1 or HIV-2 alternative NAT (study B). The HIV-1 and HIV-2 overall percent agreements (OPA) in study A ranged from 95% to 100% in all groups. The positive percent agreements (PPA) for HIV-1 and HIV-2 were 100% (876/876) and 99.4% (167/168), respectively, for known positive groups. The negative percent agreement in the HIV low-risk group was 100% for both HIV-1 and HIV-2. In study B, the HIV-1 and HIV-2 OPA ranged from 99% to 100% in all groups evaluated (n = 183 to 1,030), and the PPA for HIV-1 and HIV-2 were 100% and 99.5%, respectively, for known positive groups. The cobas HIV-1/HIV-2 qualitative assay can discriminate between HIV-1 and HIV-2 based on HIV RNA and can be included in an alternative diagnostic algorithm for HIV.

SARS-CoV-2 Infection among Serially Tested Emergency Medical Services Workers.

BACKGROUND: Emerging research has examined the prevalence of severe acute respiratory syndrome virus 2 (SARS-CoV-2) infections in numerous settings, but a critical gap in knowledge is an understanding of the rate of infection among first responders. METHODS: We conducted a prospective serial serologic survey by recruiting public first responders from Cleveland area emergency medical services agencies and fire departments. Volunteers submitted a nasopharyngeal swab for SARS-CoV-2 PCR testing and serum samples to detect the presence of antibodies to SARS-CoV-2 on two visits scheduled approximately 3 weeks apart. RESULTS: 296 respondents completed a first visit and 260 completed the second. While 71% of respondents reported exposure to SARS-CoV-2, only 5.4% (95% CI 3.1-8.6) had positive serologic testing. No subjects had a positive PCR. On the first visit, eight (50%) of the test-positive subjects had no symptoms and only one (6.2%) sought healthcare or missed school or work. None of the subjects that tested negative on the first visit were positive on their second. CONCLUSIONS: While our results show a relatively low rate of test positivity for SARS-CoV-2 amongst first responders, most were either asymptomatic or mildly symptomatic. The potential risk of asymptomatic transmission both between first responders and from first responders to vulnerable patients requires more study.

Doubling Hepatitis C Virus Screening in Primary Care Using Advanced Electronic Health Record Tools-A Non-Randomized Controlled Trial.

BACKGROUND: Hepatitis C virus (HCV) infection is a major public health burden, affecting over 4 million people. The Centers for Disease Control and Prevention and the US Preventive Services Task Force guidelines recommend screening everyone born between 1945 and 1965, but screening rates remain low. OBJECTIVE: To determine whether bulk ordering and electronic messaging to patients improves guideline-based HCV screening rates. DESIGN: A non-randomized controlled trial of 1024 adults from November 2016 to March 2017. PARTICIPANTS: Patients due for HCV screening with at least one primary care office visit in one of three primary care clinics and enrolled in the healthcare system's tethered personal health record (tPHR). INTERVENTIONS: Control patients received normal care for HCV screening, consisting of passive HCV reminders to providers during face-to-face visits and passive HCV screening notification through the patient's tPHR. Intervention patients received normal care and also had HCV antibody tests ordered for them and customized messages sent through their tPHR inviting them to go directly to the lab for HCV screening over a 12-week period. MAIN MEASURES: Percentage/number of patients receiving HCV antibody tests during the intervention period. Percentage/number of intervention group patients receiving HCV screening with other blood work. KEY RESULTS: In the intervention group, 33% (168 of 514) completed HCV testing, compared with 19% (97 of 510) of controls (OR 1.7, 95% CI 1.2-2.1). Bulk lab ordering appeared to have a large impact while bulk messaging appeared to have a less significant role. CONCLUSIONS: Leveraging population analytics and bulk ordering in an electronic health record with bulk messaging to a tPHR directly engages patients in blood screening tests and can significantly improve completion. This methodology has a broad range of applications including many recommended screening or disease-specific testing. This bulk ordering and direct-to-patient messaging approach improves patient screening while decreasing provider/staff work. TRIAL REGISTRATION: MetroHealth IRB16-00776 (ClinicalTrials.gov).

Low Awareness of and Access to Pre-exposure Prophylaxis But High Interest Among Heterosexual Women in Cleveland, Ohio.

Women received <5% of all US pre-exposure prophylaxis (PrEP) prescriptions in 2016. Among 351 heterosexual women surveyed in Cleveland, Ohio, 14.5% were aware of PrEP, 20.5% knew where to access PrEP, 75.9% were willing to try PrEP, and 50.9% expressed interest in more information.

Depressive Symptom Trajectories Among People Living with HIV in a Collaborative Care Program.

Depressive symptoms may differ in severity and change over time in people living with HIV (PLWH). Describing depression trajectories and associated clinical characteristics of PLWH in an interventional study may help in developing a more personalized medicine approach. Using latent class growth analysis four, 15-month self-reported depression trajectories were identified in 416 PLWH participating in a collaborative care program. The four subgroups were characterized by improving (58.4% [of participants]), worsening (9.4%), highly responsive (19.5%) and persistently severe (12.7%) depressive symptoms. A high proportion of individuals were in trajectories marked by improvement. Further, the highly responsive group had on average, over 50% reduction of self-reported depressive symptoms. Self-reported trauma, posttraumatic stress disorder, lower neighborhood-level education and fewer HIV and psychiatry clinic visits were associated with worsening or persistently severe depressive symptom trajectories. Members of the persistently severe group were less likely to be virally suppressed after 12-months. Identifying subgroups of PLWH based on changes in self-reported depressive symptoms may further inform intervention approaches that can advance care.

Positive Peers Mobile Application Reduces Stigma Perception Among Young People Living With HIV.

Background. The burden of HIV-related stigma is associated with disparities in linkage to HIV care and viral suppression. The Positive Peers smartphone application aims to provide young people living with HIV with a supportive virtual community to counteract perceived stigma and better manage their illness. Method. A mixed-methods study that included a prospective survey and in-depth interviewing was conducted with young adults living with HIV, aged 13 to 34 years (n = 128). As part of a larger study, participants used the Positive Peers mobile application and reported demographic data, perceived stigma, and other psychosocial variables at enrollment, 6 months, and 12 months (n = 128). Select participants (n = 15) described their experiences in audio-recorded qualitative interviews. Verbatim transcripts were analyzed for potential themes and patterns. Results. A longitudinal multivariate model was developed to assess changes in stigma over the study period, overall, and with respect to participant characteristics. Baseline and 6-month stigma scores were higher for White and Other ethnicity persons relative to Black participants. At the 12-month time point, no statistical differences in stigma scores based on ethnicity were apparent. Interviews revealed Positive Peers as a nondiscriminatory community that offered a sense of belonging that appeared to have a restorative effect on negative self-image. Conclusions. Positive Peers provides a protected virtual space where young people living with HIV can converge in the common desire to support similar others. Mobile health applications that offer peer interaction may provide a persistent sense of belonging that neutralizes internalized stigmas in addition to benefits derived from application activity.

Jail-Based Case Management Improves Retention in HIV Care 12 Months Post Release.

Continuous and coordinated HIV care is essential for persons living with HIV to benefit from the advances in medical treatment of the disease. Approximately one in seven individuals living with HIV pass through correctional facilities annually. While sentenced individuals may receive discharge planning services, detainees in local jails usually do not. The multisite evaluation of the EnhanceLink initiative demonstrated that jail based services including discharge planning were associated with high rates of linkage to community HIV care upon release. Follow up for the multisite evaluation was limited to 6 months. This paper extends follow up to 12 months at one site and demonstrates that clients who were linked by the jail based case manager to a Ryan White community based case manager were more than nine times more likely to be retained in care at 12 month post release. (OR 9.39, CI 1.11-79.12).

Randomized clinical trial of a community navigation intervention to improve well-being in persons living with HIV and other co-morbidities.

Long-term survival of people living with HIV (PLWH) is associated with the development of co-morbid conditions and need for symptom management and other efforts to enhance quality of life. We conducted a longitudinal, randomized trial over 36 months to evaluate the effect of a community-based navigator intervention to provide early palliative care to 179 PLWH and other chronic conditions. Outcomes included quality of life, symptom management, coping ability, social support, self-management, and completion of advance directives. Data were analyzed using SAS mixed effects model repeat measurement. Our navigator program showed variable improvement over time of three outcome variables, self-blame, symptom distress, and HIV self-management. However, the program did not improve overall quality of life, social support, or completion of advance directives.

Gepotidacin for the Treatment of Uncomplicated Urogenital Gonorrhea: A Phase 2, Randomized, Dose-Ranging, Single-Oral Dose Evaluation.

Background: In this phase 2 study, we evaluated the efficacy and safety of oral gepotidacin, a novel triazaacenaphthylene bacterial type II topoisomerase inhibitor, for the treatment of uncomplicated urogenital gonorrhea. Methods: Adult participants with suspected urogenital gonorrhea were enrolled and completed baseline (day 1) and test-of-cure (days 4-8) visits. Pretreatment and posttreatment urogenital swabs were collected for Neisseria gonorrhoeae (NG) culture and susceptibility testing. Pharyngeal and rectal swab specimens were collected if there were known exposures. Participants were stratified by gender and randomized 1:1 to receive a 1500-mg or 3000-mg single oral dose of gepotidacin. Results: The microbiologically evaluable population consisted of 69 participants, with NG isolated from 69 (100%) urogenital, 2 (3%) pharyngeal, and 3 (4%) rectal specimens. Microbiological eradication of NG was achieved by 97%, 95%, and 96% of participants (lower 1-sided exact 95% confidence interval bound, 85.1%, 84.7%, and 89.1%, respectively) for the 1500-mg, 3000-mg, and combined dose groups, respectively. Microbiological cure was achieved in 66/69 (96%) urogenital infections. All 3 failures were NG isolates that demonstrated the highest observed gepotidacin minimum inhibitory concentration of 1 µg/mL and a common gene mutation. At the pharyngeal and rectal sites, 1/2 and 3/3 NG isolates, respectively, demonstrated microbiological cure. There were no treatment-limiting adverse events for either dose. Conclusions: This study demonstrated that single, oral doses of gepotidacin were ≥95% effective for bacterial eradication of NG in adult participants with uncomplicated urogenital gonorrhea. Clinical Trials Registration: NCT02294682.

Impact of Pharmacy Proximity and Delivery Services on HIV Viral Suppression Among Low Income Urban Patients.

Adherence to antiretrovirals is essential to achieve viral suppression in HIV patients. Unfortunately, numerous barriers to adherence and subsequent viral suppression still exist. This study examines the association between pharmacy location and viral suppression for low income HIV patients. We evaluated whether home delivery services or closer proximity to in-store pharmacies was associated with viral suppression. Patients utilizing delivery pharmacy had increased likelihood of sustained viral suppression compared to in-store pharmacy patients (aOR = 3.430). For patients traveling to pharmacies, there were no differences in proximity for suppressed and non-suppressed patients. Home delivery may aid adherence and improve viral suppression.

Case Series of People With HIV on the Long-Acting Combination of Lenacapavir and Cabotegravir: Call for a Trial.

Background: Injectable cabotegravir (CAB)/rilpivirine (RPV) is the only combination long-acting (LA) antiretroviral regimen approved for HIV. RPV may not be effective among individuals with non-nucleoside reverse transcriptase inhibitor (NNRTI) resistance, which has >10% prevalence in many countries. Lenacapavir (LEN) is an LA capsid inhibitor given every 6 months, but has not been studied in combination with other LA agents. Methods: We assembled a case series from 4 US academic medical centers where patients with adherence challenges were prescribed LEN subcutaneously every 26 weeks/CAB (+/- RPV) intramuscularly every 4 or 8 weeks. Descriptive statistics, including viral load (VL) outcomes, were summarized. Results: All patients (n = 34: 76% male; 24% cis/trans female; 41% Black; 38% Latino/a; median age [range], 47 [28-75] years; 29% and 71% on CAB every 4 or 8 weeks) reported challenges adhering to oral ART. The reasons for using LEN/CAB with or without RPV were documented or suspected NNRTI mutations (n = 21, 59%), integrase mutations (n = 5, 15%), high VL (n = 6, 18%), or continued viremia on CAB/RPV alone (n = 4, 12%). Injection site reactions on LA LEN were reported in 44% (32% grade I, 12% grade 2). All patients but 2 (32/34; 94%) were suppressed (VL <75 copies/mL) after starting LEN at a median (range) of 8 (4-16) weeks, with 16/34 (47%) suppressed at baseline. Conclusions: In this case series of 34 patients on LEN/CAB, high rates of virologic suppression (94%) were observed. Reasons for using LEN/CAB included adherence challenges and underlying resistance, mostly to NNRTIs. These data support a clinical trial of LEN/CAB among persons with NNRTI resistance.

Jails as an opportunity to increase engagement in HIV care: findings from an observational cross-sectional study.

Linkage, engagement, retention and adherence to care are necessary steps along the HIV care continuum. Progression through these steps is essential for control of the disease and interruption of transmission. Identifying and re-engaging previously diagnosed but out-of-care patients is a priority to achieve the goals of the National HIV/AIDS strategy. Participants in the EnhanceLink cohort who were previously diagnosed HIV+ (n = 1,203) were classified as not-linked to of care and non-adherent to medication prior to incarceration by self report. Results based on multivariate models indicate that recent homelessness as well as high degrees of substance abuse correlated with those classified as not-linked to care and non-adherent to medications while having insurance was associated with being linked to care and adherent to care. The majority of detainees reported being linked to care but not currently adherent to care confirming that jails are an important site for re-engaging HIV+ individuals.

Adherence to HIV treatment and care among previously homeless jail detainees.

HIV-infected persons entering the criminal justice system (CJS) often experience suboptimal healthcare system engagement and social instability, including homelessness. We evaluated surveys from a multisite study of 743 HIV-infected jail detainees prescribed or eligible for antiretroviral therapy (ART) to understand correlates of healthcare engagement prior to incarceration, focusing on differences by housing status. Dependent variables of healthcare engagement were: (1) having an HIV provider, (2) taking ART, and (3) being adherent (≥95% of prescribed doses) to ART during the week before incarceration. Homeless subjects, compared to their housed counterparts, were significantly less likely to be engaged in healthcare using any measure. Despite Ryan White funding availability, insurance coverage remains insufficient among those entering jails, and having health insurance was the most significant factor correlated with having an HIV provider and taking ART. Individuals interfacing with the CJS, especially those unstably housed, need innovative interventions to facilitate healthcare access and retention.

Correlates of retention in HIV care after release from jail: results from a multi-site study.

Retention in care is key to effective HIV treatment, but half of PLWHA in the US are continuously engaged in care. Incarcerated individuals are an especially challenging population to retain, and empiric data specific to jail detainees is lacking. We prospectively evaluated correlates of retention in care for 867 HIV-infected jail detainees enrolled in a 10-site demonstration project. Sustained retention in care was defined as having a clinic visit during each quarter in the 6 month post-release period. The following were independently associated with retention: being male (AOR = 2.10, p ≤ 0.01), heroin use (AOR 1.49, p = 0.04), having an HIV provider (AOR 1.67, p = 0.02), and receipt of services: discharge planning (AOR 1.50, p = 0.02) and disease management session (AOR 2.25, p ≤ 0.01) during incarceration; needs assessment (AOR 1.59, p = 0.02), HIV education (AOR 2.03, p ≤ 0.01), and transportation assistance (AOR 1.54, p = 0.02) after release. Provision of education and case management services improve retention in HIV care after release from jail.

Gender differences in baseline health, needs at release, and predictors of care engagement among HIV-positive clients leaving jail.

Women represent a significant and growing segment of jail detainees and persons living with HIV. This paper examines gender differences in health status, care and social service needs, and care engagement among jail releasees with HIV. Data are from 1,270 participants in the HRSA-funded Enhancing Linkages to HIV Primary Care and Social Services multisite demonstration project (EnhanceLink). Compared to men, more women reported homelessness, reduced adherence to prescribed ART, worse health, more severe substance use disorders, and more chronic health conditions. Men and women generally reported different needs post-release. As the number of expressed needs increased, women were more likely to drop out of care. Our findings suggest that effective and gender-specific strategies are required to identify needs, link services between jails and communities, and sustain retention of women with HIV in programs after release from criminal justice settings.

Understanding the revolving door: individual and structural-level predictors of recidivism among individuals with HIV leaving jail.

Incarceration, particularly when recurrent, can significantly compromise the health of individuals living with HIV. Despite this, the occurrence of recidivism among individuals with HIV has been little examined, particularly among those leaving jail, who may be at especially high risk for return to the criminal justice system. We evaluated individual- and structural-level predictors of recidivism and time to re-incarceration in a cohort of 798 individuals with HIV leaving jail. Nearly a third of the sample experienced at least one re-incarceration event in the 6 months following jail release. Having ever been diagnosed with a major psychiatric disorder, prior homelessness, having longer lifetime incarceration history, having been charged with a violent offense for the index incarceration and not having health insurance in the 30 days following jail release were predictive of recidivism and associated with shorter time to re-incarceration. Health interventions for individuals with HIV who are involved in the criminal justice system should also target recidivism as a predisposing factor for poor health outcomes. The factors found to be associated with recidivism in this study may be potential targets for intervention and need to be further explored. Reducing criminal justice involvement should be a key component of efforts to promote more sustainable improvements in health and well-being among individuals living with HIV.