"I Feel Like I Don't Even Have HIV Anymore"-Facilitators, Barriers, and Experience regarding Use of Long-Acting Injectable Antiretroviral Therapy Among Persons with HIV in North Carolina.

As access to long-acting injectable antiretroviral therapy (LAI ART) expands, understanding patient perceptions and experiences around LAI should inform equitable scale-up and effective implementation strategies. This study used qualitative research design relying on semi-structured interviews conducted among persons with HIV (PWH) who were either virally suppressed on oral treatment (n = 11) or had received at least one dose of injectables (n = 7). Approximately half of participants identified as male (10/18) and most identified as African American (17/18). Among participants on oral ART, many described the prospect of injectable treatment as likely convenient and discreet, relieving the stress of remembering to take daily pill. Nearly all had heard of LAI ART prior to the interview, often from television or internet commercials. Most were excited about less frequent dosing, though expressed concern about the logistics involved in coming to clinic every two months. Many expressed uncertainties regarding the relative effectiveness of LAI ART compared with oral therapy and were wary of potential pain related to injections. In contrast, all persons on LAI ART described injection-site soreness as manageable. In addition to acknowledging the convenience of every-two-month injections, some persons receiving LAI ART expressed relief by lifting the emotional stress of taking a daily-pill that reminded them of their HIV positive status. Emerging clinical trial data supports the individual and public health benefits of LAI ART, regardless of prior viral-suppression; our work adds to a growing body of literature demonstrating the potential psychological benefits associated with this novel treatment modality for PWH regardless of recent viral-suppression.

Quantifying the Time to Administer Outpatient Parenteral Antimicrobial Therapy: A Missed Opportunity to Compensate for the Value of Infectious Diseases.

Outpatient parenteral antimicrobial therapy (OPAT) relies on substantial uncompensated provider time. In this study of a large academic OPAT program, the median amount of unbilled OPAT management time was 27 minutes per week, per OPAT course. These data should inform benchmarks in pursuing novel payment approaches for OPAT.

Heart transplantation and human immunodeficiency virus-navigating drug-drug interactions: a case report.

BACKGROUND: Antiretroviral therapy (ART) has led to a decline in human immunodeficiency virus (HIV)-related mortality, but comorbidities, including organ dysfunction, are increasingly the focus of care. Heart transplant (HT) is a very effective therapeutic strategy for end-stage heart failure (HF); however, clinicians may be hesitant due to concerns of complex drug-drug interactions (DDIs) between ART and HT immunosuppressive regimens and the potential impact of ART on long-term HT outcomes. In this report, we describe long-term (76-month) follow-up of a patient with HIV-positive status who underwent orthotopic HT with special emphasis on complex drug interactions. CASE PRESENTATION: A 58-year-old man with HIV-1 developed ischemic cardiomyopathy, progressed to end-stage HF and underwent orthotopic HT. To avoid DDIs with planned immunosuppressive therapies, the ART regimen was modified to consist of lamivudine, tenofovir disoproxil fumarate, rilpivirine, and raltegravir. Following HT, the patient's immunosuppression consisted of tacrolimus and mycophenolate mofetil. He has had normal cardiac function and no opportunistic infections and was subsequently switched to tenofovir alafenamide, emtricitabine, and bictegravir in combination for convenience. Serial HIV-1 RNA blood levels were constantly below the limit of quantification, and his CD4 count remained above 200 cells/mm3 (30-35%). Several DDIs were identified and addressed; however, his long-term post-HT complications included one episode of asymptomatic acute cellular rejection, adenocarcinoma of the prostate, basal cell carcinoma, cardiac allograft vasculopathy, and peripheral neuropathy. CONCLUSION: The clinical outcome of this case supports the conclusion of previously published reports, summarized here within, demonstrating that HIV-1 positive status should not preclude HT in carefully selected individuals. Both addressing potential DDIs prior to HT and long-term monitoring for routine post-transplant complications and secondary and incidental malignancies are imperative.

Feasibility, Acceptability and Appropriateness of MedViewer: A Novel Hair-Based Antiretroviral Real-Time Clinical Monitoring Tool Providing Adherence Feedback to Patients and Their Providers.

Antiretroviral therapy (ART) adherence is key to achieving viral load suppression and ending the HIV epidemic but monitoring and supporting adherence using current interventions is challenging. We assessed the feasibility, acceptability and appropriateness of MedViewer (MV), a novel intervention that provides real-time adherence feedback for patients and providers using infra-red matrix-assisted laser desorption electrospray ionization (IR-MALDESI) for mass spectrometry imaging of daily ART concentrations in patients' hair. We used mixed methods to feasibility test MV at a busy Infectious Diseases (ID) clinic, enrolling 16 providers and 36 patients. Providers underwent standardized training; patients and providers watched an 8-min informational video about MV. We collected patient and provider data at baseline and within 24 h of clinic visits and, with patients, approximately 1 month after clinic visits. MedViewer was feasible, liked by patients and providers, and perceived to help facilitate adherence conversations and motivate patients to improve adherence. Trial Registration: NCT04232540.

Evaluation of the efficacy and mechanisms of a novel intervention for chronic pain tailored to people with HIV: The STOMP protocol.

BACKGROUND: Behavioral interventions for chronic pain among people with HIV (PWH) are understudied, with great potential to improve pain and function. Chronic pain is an important comorbidity that affects between 30% and 85% of PWH and is associated with greater odds of functional impairment, increased emergency room utilization, suboptimal retention in HIV care, and failure to achieve virologic suppression. However, to date, there are few effective and scalable interventions for chronic pain in PWH. OBJECTIVE: This manuscript outlines the protocol for a randomized control trial of a novel theory-based pain self-management intervention, "Skills TO Manage Pain" (STOMP), developed for and tailored to PWH versus enhanced usual care controls. STOMP is a 12-week intervention developed from prior work on pain self-management in PWH and rigorous intervention mapping. The STOMP intervention has three major components: group sessions, one-on-one pain self-management sessions, and peer leaders. METHODS: STOMP is a 2-arm randomized trial conducted with PWH with chronic pain. The trial compares STOMP, a theory-based intervention tailored to improving chronic pain in PWH, with a comparison group receiving enhanced usual care effectiveness on pain and HIV proximal outcome measures. The proposed sample size is 280 PWH recruited from two high-volume Center for AIDS Research Network of Integrated Clinical Systems clinical sites. RESULTS: Study procedures are ongoing, and results will be recorded in future manuscripts. CONCLUSION: The study will generate evidence on the effectiveness of STOMP with the potential to dramatically change chronic pain treatment for PWH. TRIAL REGISTRATION: clinicialtrials.gov, Clinical Trials Registration # NCT03692611https://clinicaltrials.gov/ct2/show/NCT03692611?term=STOMP&cond=Hiv&draw=2&rank=1.

Alpha-Gal Syndrome in the Infectious Diseases Clinic: A Series of 5 Cases in Central North Carolina.

Background: Alpha-gal syndrome (AGS) is a recently described allergy to galactose-α-1,3-galactose, an oligosaccharide present in mammalian meat. AGS can present with angioedema, urticaria, and anaphylaxis arising 3-6 hours after ingestion, although symptoms such as gastrointestinal distress, fatigue, and arthralgias are also reported. Because AGS appears to be associated with tick bites, patients may present to infectious diseases (ID) clinics for evaluation. Methods: We documented a series of 5 patients referred to the University of North Carolina ID Clinic between 2020 and 2022 for various tick-borne infections that were found to have symptoms and laboratory testing consistent with AGS. Patients were subsequently referred to the Allergy and Immunology Clinic. Results: Patients were referred to the ID Clinic for persistent symptoms following positive tick-borne disease testing or presumed tick-borne infection. All patients had an elevated alpha-gal immunoglobulin E and clinical presentation consistent with AGS. Common symptoms included episodic gastrointestinal distress (eg, cramping, nausea, diarrhea), fatigue, arthralgias, and subjective cognitive impairment, but a notable absence of severe anaphylaxis. Four patients were seen by at least 1 nonallergy specialist prior to referral to ID. Patients reported substantial improvement in their symptoms following dietary restriction. Conclusions: ID physicians should be aware of AGS as a cause of persistent, nonspecific symptoms following a tick exposure or tick-borne illness. Further research is needed to determine the prevalence of alpha-gal sensitization and AGS following tick-borne bites.

Overdiagnosis of urinary tract infections by nursing home clinicians versus a clinical guideline.

PURPOSE: To inform overprescribing and antibiotic stewardship in nursing homes (NHs), we examined the concordance between clinicians' (NH primary care providers and registered nurses) diagnosis of suspected UTI with a clinical guideline treated as the gold standard, and whether clinician characteristics were associated with diagnostic classification. METHODS: We conducted a cross-sectional web-based survey of a U.S. national convenience sample of NH clinicians. The survey included a discrete choice experiment with 19 randomly selected clinical scenarios of NH residents with possible UTIs. For each scenario, participants were asked if they thought a UTI was likely. Responses were compared to the guideline to determine the sensitivity and specificity of clinician judgment and performance indicators. Multivariable logistic mixed effects regression analysis of demographic, work, personality, and UTI knowledge/attitudes characteristics was conducted. RESULTS: One thousand seven hundred forty-eight NH clinicians responded to 33,212 discrete choice scenarios; 867 (50%) were NH primary care providers and 881 (50%) were NH registered nurses, 39% were male, and the mean age was 45 years. Participants were uncertain about diagnosis in 30% of scenarios. Correct classification occurred for 66% of all scenarios (providers: 70%; nurses: 62%). Respondent judgment had a sensitivity of 78% (providers: 81%; nurses: 74%) and specificity of 54% (providers: 59%; nurses: 49%) compared to the clinical guideline. Adjusting for covariates in multivariable models, being a nurse and having higher closemindedness were associated higher odds of false positive UTI (odds ratio [OR] 1.61, p < 0.001; and OR 1.09, p = 0.039, respectively), although higher UTI knowledge and conscientiousness were associated with lower odds of false positive UTI ratings (OR 0.80, p < 0.001; OR 0.90, p = 0.005, respectively). CONCLUSIONS: Clinicians tend to over-diagnose urinary tract infections, necessitating systems-based interventions to augment clinical decision-making. Clinician type, UTI knowledge, and personality traits may also influence behavior and deserve further study.

Errors in Diagnostic Test Use and Interpretation Contribute to the High Number of Lyme Disease Referrals in a Low-Incidence State.

Lyme disease accounted for more than two-thirds (56 of 81, 69.1%) of all tick-borne disease referrals to a large, academic infectious diseases clinic in a low-incidence state. Deviations from diagnostic testing guidelines and errors in test interpretation were common (23 of 35, 65.7%), suggesting that frontline providers need additional clinical support.

Nursing Home Clinicians' Decision to Prescribe Antibiotics for a Suspected Urinary Tract Infection: Findings From a Discrete Choice Experiment.

OBJECTIVE: To determine which nursing home (NH) resident characteristics were most important to clinicians' decision to prescribe antibiotics for a suspected urinary tract infection (UTI), including both evidence-based and non-evidence-based characteristics. DESIGN: Web-based discrete choice experiment with 19 clinical scenarios. For each scenario, clinicians were asked whether they would prescribe an antibiotic for a suspected UTI. SETTING: Online survey. PARTICIPANTS: Convenience sample of 876 NH physicians and advanced practice providers who practiced primary care for NH residents in the United States. METHODS: Each scenario varied information about 10 resident characteristics regarding urinalysis results, resident temperature, lower urinary tract symptoms, physical examination, antibiotic request, mental status, UTI risk, functional status, goals of care, and resident type. We derived importance scores for the characteristics and odds ratios (ORs) for specific information related to each characteristic from a multinomial logistic regression. RESULTS: Approximately half of the participants were male (56%) with a mean age of 49 years. Resident characteristics differed in their importance (ie, part-worth utility) when deciding whether to prescribe for a suspected UTI: urinalysis results (32%), body temperature (17%), lower urinary tract symptoms (17%), physical examination (15%), antibiotic request (7%), mental status (4%), UTI risk (4%), functional status (3%), goals of care (2%), and resident type (1%). Information about "positive leukocyte esterase, positive nitrates" was associated with highest odds of prescribing [OR 19.6, 95% confidence interval (CI) 16.9, 22.7], followed by "positive leukocyte esterase, negative nitrates" (OR 6.7, 95% CI 5.8, 7.6), and "painful or difficult urination" (OR 4.8, 95% CI 4.2, 5.5). CONCLUSIONS AND IMPLICATIONS: Although guidelines focus on lower urinary tract symptoms, body temperature, and physical examination for diagnosing a UTI requiring antibiotics, these characteristics were considered less important than urinalysis results, which have inconsistent clinical utility in NH residents. Point-of-care clinical decision support offers an evidence-based prescribing process.

Using Real-Time Adherence Feedback to Enhance Communication About Adherence to Antiretroviral Therapy: Patient and Clinician Perspectives.

New technologies for real-time adherence monitoring hold the potential to enhance antiretroviral therapy adherence interventions by providing objective information about daily medication-taking behavior. To realize this potential, we need to understand how to integrate real-time adherence feedback into existing best practices to promote antiretroviral therapy adherence at the point of care. Using in-depth interviews with 30 HIV-infected patients and 29 HIV care clinicians, our primary aims were to understand patients' and clinicians' perceptions of anticipated benefits and preferred uses of objective feedback to enhance conversations about adherence and to identify concerns about the impact of objective monitoring on patient-clinician relationships and communication. Both patients and clinicians suggested that identifying patterns of nonadherence with real-time feedback could (a) facilitate collaborative adherence problem-solving, (b) motivate patient adherence, and (c) reinforce the importance of optimal adherence. Some clinicians worried that delivery of real-time feedback could imply mistrust of patient-reported adherence and suggested careful framing of monitoring results. A few patients and clinicians were concerned that negative reactions to monitoring could discourage retention in care and reduce adherence motivation. These results indicate the potential of real-time feedback to enhance existing evidence-based adherence interventions targeting the key adherence precursors of adherence information, motivation, and behavioral skills. Guidance for the delivery of real-time adherence feedback should focus on both optimizing adherence and mitigating negative perceptions of adherence monitoring.

Hospitalization Rates and Outcomes Among Persons Living With Human Immunodeficiency Virus in the Southeastern United States, 1996-2016.

BACKGROUND: Antiretroviral therapy (ART) advances, aging, and comorbidities impact hospitalizations in human immunodeficiency virus (HIV)-positive populations. We examined temporal trends and patient characteristics associated with hospitalization rates and outcomes. METHODS: Among patients in the University of North Carolina Center for AIDS Research HIV Clinical Cohort receiving care during 1996-2016, we estimated annual hospitalization rates, time to inpatient mortality or live discharge, and 30-day readmission risk using bivariable Poisson, Fine-Gray, and log-binomial regression models. RESULTS: The 4323 included patients (29% women, 60% African American) contributed 30 007 person-years. Overall, the hospitalization rate per 100 person-years was 34.3 (95% confidence interval [CI], 32.4-36.4) with a mean annual change of -3% (95% CI, -4% to -2%). Patients who were black (vs white), older, had HIV RNA >400 copies/mL, or had CD4 count <200 cells/µL had higher hospitalization rates (all P < .05). Thirty-day readmission risk was 18.9% (95% CI, 17.7%-20.2%), stable over time (P > .05 for both 2010-2016 and 2003-2009 vs 1996-2002), and higher among black patients, those with detectable HIV RNA, and those with lower CD4 cell counts (all P < .05). Higher inpatient mortality was associated with older age and lower CD4 cell count (both P < .05). CONCLUSIONS: Hospitalization rates decreased from 1996 to 2016, but high readmissions persisted. Older patients, those of minority race/ethnicity, and those with uncontrolled HIV experienced higher rates and worse hospitalization outcomes. These findings underscore the importance of early ART and care engagement, particularly at hospital discharge.

Syphilis-Associated Acute Renal Failure and Hepatitis in the Setting of Human Immunodeficiency Virus Coinfection.

Two individuals with human immunodeficiency virus presented in acute renal failure with nephrotic range proteinuria and were diagnosed with secondary syphilis. One of them also had elevated transaminases. Kidney biopsies revealed membranous nephropathy, a rare complication of secondary syphilis, in both cases. Normal hepatic and renal function were restored after treatment with penicillin.

Why Everyone (Almost) with HIV Needs to Be on Treatment: A Review of the Critical Data.

Since 2014, a consensus of landmark studies has justified starting antiretroviral therapy (ART) regardless of CD4 count. The evidence for immediate and universal ART is strong, clearly showing individual and population-level benefits, and is supported by all major guidelines groups. Altogether, improvements in ART and recognition of its clinical and epidemiologic benefits justify near-universal ART, preferably as soon after the diagnosis of human immunodeficiency virus (HIV) as possible. Case-based discussions provide a framework to explore the evidence behind the current recommendation for ART for all HIV-positive persons and specific scenarios are discussed in which ART initiation may be delayed.

Effectiveness of integrase strand transfer inhibitors among treatment-experienced patients in a clinical setting.

OBJECTIVE: Characterize virologic and immunologic outcomes of INSTI-based antiretroviral therapy (ART) in experienced patients with and without virologic failure. DESIGN: Prospective clinical cohort. METHODS: ART-experienced, INSTI-naive participants in the University of North Carolina Center for AIDS Research HIV Clinical Cohort (UCHCC) initiating an INSTI-containing regimen 2007-2016 were followed from INSTI initiation (baseline) to the earliest of: outcome of interest, loss to follow-up (LTFU, 1 year without clinical visit), or death. Outcomes of interest were virologic failure (first of two consecutive viral loads at least 200 copies/ml more than 2 weeks apart, or one viral load ≥200 before LTFU) and immune recovery (first CD4 ≥500 cells/µl). Patients with baseline viral load at least 50 copies/ml were given 24 weeks before meeting virologic failure criteria. Kaplan-Meier curves and Cox proportional hazards models compared INSTI regimens and patient characteristics. RESULTS: Of 773 patients, 32% were women, 59% African-American, and 42% had a viral load at least 50 copies/ml at INSTI initiation. After 2 years, 5% of patients with baseline viral load less than 50 copies/ml experienced virologic failure, compared with 35% of patients with baseline viral load at least 50 copies/ml (P < 0.01). Among patients with baseline viral load less than 50 copies/ml, dolutegravir/NRTIs was associated with longer time to virologic failure [adjusted hazard ratio (aHR) 0.11, 95% confidence interval (CI) 0.01-0.80], whereas among patients with baseline viral load at least 50 copies/ml, raltegravir/NRTIs was associated with longer time to virologic failure (aHR 0.35, 95% CI 0.18-0.68), both compared with elvitegravir/NRTIs. After 5 years suppressed, irrespective of baseline viral load, 61% of patients experienced immune recovery. CONCLUSION: In this cohort, INSTI-containing regimens led to low virologic failure rates in patients switching ART while suppressed. Viremic patients initiating INSTIs were at high risk of virologic failure during follow-up.

Patient and clinician perspectives on optimizing graphical displays of longitudinal medication adherence data.

OBJECTIVE: New pharmacological measures assessing medication adherence, including longitudinal drug levels in hair, are emerging. Little is known, however, about how best to present results from such measures to patients and clinicians in comprehensive, easy-to-understand, acceptable formats. We, therefore, developed three graphical display prototypes of hypothetical daily drug concentrations measured in hair, and assessed their acceptability among participants. METHODS: We interviewed 30 HIV-positive patients and 29 clinicians to examine perceived acceptability for each graphical display prototype. RESULTS: Patients and clinicians generally found the prototypes acceptable for facilitating understanding of patient adherence; however, areas for optimization were identified. For patients with lower health literacy, prototypes did not provide sufficient understanding of the link between medication-taking and drug concentrations in hair. These patients also preferred pictographs over bar or line graphs. Clinicians largely preferred daily drug concentration data in bar graphs with information included about the measure's accuracy. Participants questioned the utility of showing drug concentrations above a therapeutic range, though they found color-coding results acceptable. CONCLUSIONS: Assessing prototype versions of graphical displays of hypothetical longitudinal adherence data indicated ways to optimize their acceptability. PRACTICE IMPLICATIONS: Acceptable prototype-tested graphical displays of longitudinal patient-specific drug concentrations may enhance adherence monitoring in clinical settings.

Underutilization of HIV Testing Among Men with Incarceration Histories.

Annual HIV testing is recommended for individuals at high risk of infection, specifically incarcerated populations. Incarcerated men carry a higher lifetime risk of acquiring HIV than the general population, yet little is known about their HIV testing behaviors. We collected Audio Computer Assisted Self Interview data for 819 men entering a state prison in North Carolina. We assessed correlates of previous HIV testing, including stigmatizing attitudes and beliefs, and explored two outcomes: (1) ever HIV tested before current incarceration, and (2) recency of last HIV test. Eighty percent had been HIV tested before; of those, 36% reported testing within the last year. Being African American, having education beyond high school, prior incarceration, and higher HIV knowledge increased odds of ever having tested. Results of this study highlight the need to expand HIV testing and education specific to incarcerated populations. Additionally, efforts should be made to monitor and encourage repeat screening.

Postpartum HIV care continuum outcomes in the southeastern USA.

OBJECTIVE: The aim of this study was to evaluate postpartum HIV care outcomes. DESIGN: A prospective clinical cohort of women with HIV and a live birth at the University of North Carolina, 1996-2014. METHODS: We estimated two stages of the HIV care continuum in the first 24 months postpartum: care retention (at least two visits per year, ≥90 days apart) and viral suppression (HIV RNA < 400 copies/ml). Multivariable models were fit using logistic regression. RESULTS: Among 1416 women, 141 experienced a live birth at a median age of 28 years, with 74% virally suppressed at delivery. Among all women, 48% were retained in care and 25% maintained viral suppression for the first 24 months postpartum. Among women with available HIV RNA measures, 42% were suppressed at 24 months. HIV care retention estimates were stable across calendar years, but viral suppression rates at 24 months postpartum, among women with available HIV RNA measures, increased from 33 to 67% from 1996-2001 to 2009-2014 (P = 0.04). Being at least 30 years old was positively, and receiving less than 12 weeks of antenatal antiretroviral therapy was negatively, associated with HIV care retention at 24 months postpartum [adjusted odds ratio (AOR): 2.41, 95% confidence interval (95% CI): 1.09-5.29 and AOR: 0.27, 95% CI: 0.08-0.86]. Older maternal age and viral suppression at delivery were both positively associated with virologic suppression at 24 months postpartum (AOR: 2.52, CI: 1.02-6.22, and AOR: 6.42 CI: 1.29-31.97, respectively). CONCLUSION: HIV care continuum outcomes decrease substantially postpartum, with younger women and those with less antenatal HIV care less likely to successfully remain engaged in HIV care following childbirth.

"Inside These Fences Is Our Own Little World": Prison-Based HIV Testing and HIV-Related Stigma Among Incarcerated Men and Women.

Correctional facilities offer opportunities to provide comprehensive HIV services including education, testing, treatment, and coordination of post- release care. However, these services may be undermined by unaddressed HIV stigma. As part of a prison-based HIV testing study, we interviewed 76 incarcerated men and women from the North Carolina State prison system. The sample was 72% men, median age 31.5 years (range: 19 to 60). Thematic analysis revealed high levels of HIV-related fear and stigma, homophobia, incomplete HIV transmission knowledge, beliefs that HIV is highly contagious within prisons ("HIV miasma"), and the View of HIV testing as protective. Interviewees described social distancing behaviors and coping mechanisms they perceived to be protective, including knowing their HIV status and avoiding contact with others and shared objects. Interviewees endorsed universal testing, public HIV status disclosure, and segregation of HIV-positive inmates. Intensified education and counseling efforts are needed to ameliorate entrenched HIV-transmission fears and stigmatizing beliefs.