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Persons living with human immunodeficiency virus (HIV) and others receiving antiretrovirals are at risk for medication errors during hospitalization and at transitions of care. These errors may result in adverse effects or viral resistance, limiting future treatment options. A range of interventions is described in the literature to decrease the occurrence or duration of medication errors, including review of electronic health records, clinical checklists at care transitions, and daily review of medication lists. To reduce the risk of medication-related errors, antiretroviral stewardship programs (ARVSPs) are needed to enhance patient safety. This call to action, endorsed by the Infectious Diseases Society of America, the HIV Medicine Association, and the American Academy of HIV Medicine, is modeled upon the success of antimicrobial stewardship programs now mandated by the Joint Commission. Herein, we propose definitions of ARVSPs, suggest resources for ARVSP leadership, and provide a summary of published, successful strategies for ARVSP that healthcare facilities may use to develop locally appropriate programs. [ABSTRACT FROM AUTHOR]

Background: An increasing number of HIV cure trials involve combining multiple potentially curative interventions. Until now, considerations for designing and implementing complex combination HIV cure trials have not been thoroughly considered. Methods: We used a purposive method to select key informants for our study. Informants included biomedical HIV cure researchers, regulators, policy makers, bioethicists, and community members. We used in-depth interviews to generate ethical and practical considerations to guide the design and implementation of combination HIV cure research. We analyzed the qualitative data using conventional content analysis focused on inductive reasoning. Results: We interviewed 11 biomedical researchers, 4 community members, 2 regulators, 1 policy researcher, and 1 bioethicist. Informants generated considerations for designing and implementing combination interventions towards an HIV cure, focused on ethical aspects, as well as considerations to guide trial design, benefit/risk determinations, regulatory requirements, prioritization and sequencing and timing of interventions, among others. Informants also provided considerations related to combining specific HIV cure research modalities, such as broadly neutralizing antibodies (bNAbs), cell and gene modification products, latency-reversing agents and immune-based interventions. Finally, informants provided suggestions to ensure meaningful therapeutic improvements over standard antiretroviral therapy, overcome challenges of designing combination approaches, and engage communities around combination HIV cure research. Conclusion: The increasing number of combination HIV cure trials brings with them a host of ethical and practical challenges. We hope our paper will inform meaningful stakeholder dialogue around the use of combinatorial HIV cure research approaches. To protect the public trust in HIV cure research, considerations should be periodically revisited and updated with key stakeholder input as the science continues to advance. [ABSTRACT FROM AUTHOR]

Engagement in HIV care and a high level of antiretroviral therapy (ART) adherence for people living with HIV is crucial to treatment success and can minimize the population burden of the disease. Despite this, there is a critical gap in HIV prevention science around the development of interventions for serodiscordant male couples. This paper reports on the results of a randomized controlled trial to assess the efficacy of Stronger Together, a dyadic counseling intervention aimed at increasing engagement in and optimizing HIV care among serodiscordant male couples in Atlanta, GA, Boston, MA, and Chicago, IL. Between 2014 and 2017, 159 male serodiscordant couples (total N = 318) in Atlanta, GA, Boston, MA, and Chicago, IL were enrolled and equally randomized to either the Stronger Together intervention arm (a three-session dyadic intervention involving HIV testing and adherence counseling) or a standard of care (SOC) control arm. Couples completed individual study assessments via an audio computer assisted self-interviewing (ACASI) system at baseline, 6, 12 and 18 months. Primary outcomes included being prescribed and currently taking ART, and fewer missed doses of ART in the past 30 days; because the trial was not powered to examine viral suppression, we examined this as an exploratory outcome. Longitudinal data analysis was by an intention-to-treat approach. Participants ages ranged from 18 to 69 (mean = 35.9), and are predominantly white (77.5%), and college educated (68.4% earned a college degree or higher). Participants randomized to the Stronger Together arm had a significantly greater odds of being prescribed and currently taking ART over time than those in the SOC arm (at 12 months OR 2.75, 95%CI 1.35–4.67, p-value 0.020, and at 18 months OR 2.91, 95%CI 1.61–4.88, p-value 0.013). Similarly, those in the Stronger Together arm had a significantly lower odds of missing a dose of ART in the past 30 days over time compared to those in the SOC arm (at 12 months OR 0.28, 95%CI 0.09–0.81, p-value 0.019, and at 18 months OR 0.25, 95%CI 0.07–0.82, p-value 0.023). Among male couples in serodiscordant relationships, the Stronger Together intervention resulted in significantly improved HIV treatment outcomes at both 12 and 18 months of follow-up. This trial is the first to date to demonstrate evidence of efficacy for a dyadic counseling intervention and has the potential to fill a critical gap in secondary HIV prevention interventions for serodiscordant male couples. [ABSTRACT FROM AUTHOR]

This paper describes sociodemographic, sexual risk behavior, and clinical care factors associated with sustained viral suppression (SVS) among heterosexual Black men with diagnosed HIV in the US. Sample was 968 men, 2015–2017 cycles of Medical Monitoring Project. We used prevalence ratios and a multivariable logistic regression model to identify independent predictors of SVS. About 9% of sexually active men had sex that carries a risk of HIV transmission. Nearly 2/3 lived at or below the poverty level, 13% were under or uninsured, 1/4 experienced food insecurity and 15% reported recent homelessness. About 26% were not engaged in HIV care, 8% not currently taking antiretroviral therapy (ART) and 59% had SVS. Among men taking ART, care engagement and adherence were the only significant independent predictors of SVS. Efforts to increase VS should focus on increasing ART use, care engagement, and ART adherence, and include strategies that address the social and structural factors that influence them. [ABSTRACT FROM AUTHOR]

leeman j., chang y.k., lee e.j., voils c.i., crandell j. & sandelowski m. (2010) Implementation of antiretroviral therapy adherence interventions: a realist synthesis of evidence. Journal of Advanced Nursing 66(9), 1915–1930. Aim. This paper is a report of a synthesis of evidence on implementation of interventions to improve adherence to antiretroviral therapy. Background. Evidence on efficacy must be supplemented with evidence on how interventions were implemented in practice and on how that implementation varied across populations and settings. Data sources. Sixty-one reports were reviewed of studies conducted in the United States of America in the period 2001 to December 2008. Fifty-two reports were included in the final analysis: 37 reporting the effects of interventions and 15 reporting intervention feasibility, acceptability, or fidelity. Review methods. An adaptation of Pawson’s realist synthesis method was used, whereby a provisional explanatory model and associated list of propositions are developed from an initial review of literature. This model is successively refined to the point at which it best explains empirical findings from the reports reviewed. Results. The final explanatory model suggests that individuals with HIV will be more likely to enrol in interventions that protect their confidentiality, to attend when scheduling is responsive to their needs, and both to attend and continue with an intervention when they develop a strong, one-to-one relationship with the intervener. Participants who have limited prior experience with antiretroviral therapy will be more likely to continue with an intervention than those who are more experienced. Dropout rates are likely to be higher when interventions are integrated into existing delivery systems than when offered as stand-alone interventions. Conclusion. The explanatory model developed in this study is intended to provide guidance to clinicians and researchers on the points in the implementation chain that require strengthening. [ABSTRACT FROM AUTHOR]

Introduction: An appropriate economic evaluation of post-exposure prophylaxis (PEP) should consider the effectiveness of different regimens prescribed for patients. Studies have not evaluated the comparative effectiveness of different PEP antiretrovirals (ARVs) based on their costs. Therefore, the aim of the present study was to determine the cost-effectiveness of ARVs regimens used for PEP in Nigerian tertiary hospitals. Material and methods: This cross-sectional study collated patients' demographic and clinical data from PEP databases of United States' President Emergency Plan for AIDS Relief - AIDS Prevention Initiative in Nigeria hospitals. Costs of ARVs were obtained from donors' price list. Effectiveness was measured as the percentage of human immunodeficiency virus (HIV)-negative patients one-month post-PEP. Average cost-effectiveness ratios (ACERs) were computed as the unit cost of the regimens/HIV infection averted (HIA). Probabilistic sensitivity analysis was conducted using 1,000 iterations using Monte-Carlo simulation. Results: Out of 575 patients identified, 198 (34.4%) had non-occupational exposure. Of the 14 regimens, tenofovir (TDF) + lamivudine (3TC) + ritonavir-boosted atazanavir (ATV/r) was prescribed for 230 (40.00%) patients. HIV-negative results were documented in 129 (22.4%) of the 185 patients with post-PEP test. Zidovudine (AZT) + 3TC + ATV-r was the most effective (95.5%, n = 63 of 66) regimen, while TDF + emtricitabine (FTC) + ritonavir-boosted lopinavir (LPV/r) was the most expensive ($23.66). With an ACER of $8.110/HIV infection prevented (95% CI: $8.052-$8.168), TDF + 3TC + efavirenz (EFV) was the most cost-effective regimen. Conclusions: AZT + 3TC + LPV/r was the most effective regimen, while TDF + FTC + ATV/r was the most expensive. However, TDF + 3TC + EFV combination was the most cost-effective regimen used in providing PEP service to HIV patients in Nigerian hospitals. [ABSTRACT FROM AUTHOR]

Purpose The purpose of this paper is to describe factors associated with incarceration as well as the association between recent incarceration and HIV-related sexual risk behaviors, access to insurance, healthcare utilization (emergency department (ED) and hospital use), antiretroviral therapy (ART) prescription, and viral suppression. Design/methodology/approach Using 2009-2010 data from a cross-sectional, nationally representative three-stage sample of HIV-infected adults receiving care in the USA, the authors assessed the demographic characteristics, healthcare utilization, and clinical outcomes of HIV-infected persons who had been recently incarcerated (detention for>24 hours in the past year) using bivariate analyses. The authors used multivariable logistic regression to examine associations of recent incarceration with insurance status as well as clinical and behavioral outcomes. Findings An estimated 22,949 (95 percent confidence interval (CI) 19,062-26,836) or 5.4 percent (CI: 4.7-6.1) of all HIV-infected persons receiving care were recently incarcerated. Factors associated with recent incarceration were age <50 years, being a smoker, having high school diploma or less, being homeless, income at or below the poverty guidelines, having a geometric mean of CD4 count <500 cells/ μL, and using drugs in the past 12 months. Results from multivariable modeling indicated that incarcerated persons were more likely to use ED services, and to have been hospitalized, and less likely to have achieved viral suppression. Originality/value Recent incarceration independently predicted worse health outcomes and greater use of emergency services among HIV-infected adults currently in HIV care. Options to improve the HIV continuum of care, including pre-enrollment for healthcare coverage and discharge planning, may lead to better health outcomes for HIV-infected inmates post-release. [ABSTRACT FROM AUTHOR]

This study aims to describe and understand the relationship between sociodemographic factors and PrEP awareness, and willingness to use a PrEP modality (oral or injectable).Despite the availability of effective prevention tools such as HIV preexposure prophylaxis (PrEP), African immigrants in the United States are disproportionately affected by HIV. Although PrEP can significantly reduce HIV infection in this population, research evidence on PrEP outcomes, such as awareness, knowledge, and willingness to use, is extremely limited. Between April and May 2022, 92 participants completed an online survey assessing their awareness, knowledge, and willingness to use oral or injectable PrEP. The association between sociodemographic characteristics and PrEP-related measures was examined using descriptive and Pearson's chi-squared or Fisher's exact tests. Participants (N = 92) were born between 1990 and 1999 (46.7%), female (70.76%) and highly educated (59.6%). About 52.2% were unaware of PrEP, and 65.6% were willing to use a PrEP modality. Findings indicate that individuals who reported being aware of PrEP demonstrated a high level of knowledge regarding the medication. Having a healthcare provider was associated with PrEP awareness and willingness to use, while educational status was associated with PrEP awareness. 51.1% of participants were willing to use an oral pill for prevention and 47.8% were willing to use injectable PrEP. Our findings highlight the need for PrEP-related research and interventions for African immigrants to increase awareness and provide options for HIV prevention, as African immigrants are currently not well-represented in PrEP delivery systems in the US. [ABSTRACT FROM AUTHOR]

The integration of original data from multiple antiretroviral (ARV) adherence studies offers a promising, but little used method to generate evidence to advance the field. This paper provides an overview of the design and implementation of MACH14, a collaborative, multi-site study in which a large data system has been created for integrated analyses by pooling original data from 16 longitudinal ARV adherence studies. Studies selected met specific criteria including similar research design and data domains such as adherence measured with medication event monitoring system, psychosocial factors related to adherence behavior, and virologic and clinical outcomes. The data system created contains individual data (collected between 1997 and 2009) from 2,860 HIV patients. Collaboration helped resolve the challenges inherent in pooling data across multiple studies, yet produced a data system with strong statistical power and potentially greater capacity to address key scientific questions than possible with single-sample studies or even meta-analytic designs. [ABSTRACT FROM AUTHOR]

Human immunodeficiency virus (HIV) infection is strongly associated with ischemic stroke in the young. Data obtained from the Nationwide Inpatient Sample in the United States show an increase in the number of stroke hospitalizations in the HIV-infected population despite an overall decrease in the number of stroke hospitalizations. Few data exist, however, that address the mechanism of HIV-associated stroke. Recent studies have demonstrated that HIV may infect the endothelium and alter cerebrovascular functions. Whether the proposed mechanism alters the stroke risk is undetermined. Epidemiological studies suggest that HIV-related stroke is associated with a risk factor profile that differs from the HIV-negative young stroke population in that HIV-associated strokes are less likely to have hypertension, diabetes, hyperlipidemia and smoking as risk factors. A large population-based study, moreover, suggests an association between antiretroviral therapy and increased cardio- and cerebrovascular risks. Specific antiretroviral agents such as protease inhibitors and non-nucleoside reverse transcriptase inhibitors have been implicated in the metabolic syndrome, accelerated atherosclerosis and an increased risk for ischemic stroke. In addition to discussing these developments, this paper also discusses the implications of recent data for stroke prevention in HIV-infected patients. Copyright © 2012 S. Karger AG, Basel [ABSTRACT FROM AUTHOR]

Despite the availability and proven efficacy of medical treatment, many individuals living with HIV in the United States today are not engaged in regular HIV medical care or receiving antiretroviral medications. This journal supplement highlights results of a national 5-year multisite Outreach Initiative, funded by the Health Resources and Services Administration (HRSA) in 2001 to “engage people in HIV care, turn sporadic users of care into regular users, and promote retention in care.” The introductory paper for the supplement provides background information on the characteristics of individuals who are not engaged in regular HIV care, the barriers they face, intervention options, and the public policy implications of this issue. Interventions to engage and retain underserved populations living with HIV in medical care are essential to ensure access to medical care and to reduce disparities in health outcomes. [ABSTRACT FROM AUTHOR]

In an effort to balance their budgets many states are considering reducing eligibility for Medicaid. Using variation in state policies, this paper models the effect of more stringent eligibility criteria for Medicaid on the insurance status and the use of antiretroviral therapy (HAART) for people living with HIV, a group heavily dependent on Medicaid. Using nationally representative data from the mid-1990's, we find that stricter eligibility thresholds for Medicaid raise uninsurance rates and reduce the use of antiretroviral therapy among HIV+ patients, especially for those who are disabled. These stricter eligibility thresholds in turn adversely affect the survival prospects of HIV+ patients by lowering the rate of HAART use. Our estimates suggest approximately 13,000 lives could have been saved if all states had adopted the eligibility thresholds of California. We do not find any evidence of a "crowding out" effect of public insurance on private coverage among these patients. [ABSTRACT FROM AUTHOR]

Although antiretrovirals can prolong life, medication adherence also poses a constant challenge for HIV-infected individuals because the success of antiretroviral regimens demands nearly perfect adherence to medications. This paper describes the psychiatric and social barriers to adherence in a convenience sample of HIV-positive clients in methadone treatment in the Bronx, New York. The study sample was part of a national study of HIV treatment adherence and health care utilization among triply diagnosed populations, the HIV/AIDS Treatment Adherence Health Outcomes and Cost Study. The triply diagnosed study sample is defined here as HIV-infected individuals who screened into the study with at least one psychiatric diagnosis in addition to opioid dependence on agonist therapy (methadone treatment) and at least one substance use diagnosis. Interviewers utilized modified versions of the Structured Clinical Interview for DSM-IV Disorders (SCID-I), the Structured Clinical Interview for DSM-IV Axis II Personality Disorders (SCID-II), and the Addiction Severity Index (ASI-Lite), among a battery of Cost Study instruments. Results showed that within this sample, borderline personality disorder was significantly associated with nonadherence to HIV medications. A related finding showed a significant relationship between serious social/family problems and nonadherence. These findings build on previous research on the impact of psychiatric illness on HIV medication adherence and suggest that psychiatric assessment and treatment options be linked to adherence interventions. [ABSTRACT FROM AUTHOR]

The response many gay men took to the HIV epidemic in the United States was largely informal, especially given distant state and federal governments. The condom code, a set of informal norms that encouraged the use of condoms, is one instance of this informal response, which was wholly uncoordinated. Yet, it is not clear why these informal norms emerged or why they have since eroded. This paper explores how gay men in particular generated expectations and normative beliefs regarding condom usage, which helped to establish the condom code as an informal norm. Furthermore, the erosion of the condom code is viewed as a result of changing expectations, which change as bio-medical means of HIV treatment and prevention develop and as online and digital communities facilitate serosorting, all of which provide alternatives to condoms as a means of prevention and their associated informal norms. Future HIV prevention campaigns should recognize the extent to which informal norms coordinate and encourage preventative behavior, as well as how beliefs and expectations alter the informal norms people adopt. [ABSTRACT FROM AUTHOR]

Improved life expectancy from advances in antiretroviral therapy (ART) has been followed by a rise in comorbidities and polypharmacy in this aging population. Historically, polypharmacy has been associated with suboptimal virologic outcomes in persons with HIV, although data in the current ART era and among historically marginalized populations in the United States are limited. We measured the prevalence of comorbidities and polypharmacy, evaluating their impact on virologic suppression. This retrospective IRB-approved cross-sectional study reviewed health records of adults with HIV on ART and receiving care (≥2 visits) in 2019 at a single center in a historically minoritized community. Virologic suppression (HIV RNA <200 copies/mL) based on polypharmacy (≥5 non-HIV medications) or multimorbidity (≥2 chronic conditions) was evaluated. Logistic regression analyses were performed to identify factors associated with virologic suppression, with age, race/ethnicity, and CD4 < 200 cells/mm3 as covariates. Of the 963 individuals that met the criteria, 67%, 47%, and 34% had ≥1 comorbidity, multimorbidity, and polypharmacy, respectively. The cohort demographics were: mean of 49 years (range, 18–81), 40% cisgender women, 46% Latinx individuals, 45% Black individuals, 8% White individuals. Virologic suppression rates were 95% among patients with polypharmacy compared with 86% in those with a lower pill burden (p = 0.0001). The odds of virologic success were higher for individuals with polypharmacy [adjusted odds ratio, aOR = 2.3 (95% confidence interval, CI: 1.2–4.4)] and Latinx identity [aOR = 2.4 (95% CI: 1.5–3.8)], but lower if a CD4 count <200 cells/mm3 [aOR = 0.07 (95% CI: 0.04–0.1)]. The comorbidity burden was higher than previously described, which are driving polypharmacy rates. In the current ART era, polypharmacy is not inherently associated with worse virologic outcomes. [ABSTRACT FROM AUTHOR]

The extended lifespan of people living with human immunodeficiency (HIV) and acquired immune deficiency syndrome (AIDS) (PLWHA) has increased the potential for ICU admissions unrelated to HIV infection. The objective of this review is to guide continued management of antiretroviral therapy (ART) recommended by the United States Department of Health and Human Services Antiretroviral Guidelines in critically ill adult PLWHA admitted to the intensive care unit (ICU). Pharmacists are uniquely positioned to mitigate these concerns, including whether to continue ART in the ICU, drug interactions with common ICU drugs, renal and hepatic dosing considerations, and alternative methods of administration. Despite these concerns, the original ART regimen should be continued or modified in conjunction with an HIV specialist. Discontinuation greater than 2 weeks should be avoided due to potential resistance and future HIV treatment failure. Use of ART in critically ill patients presents challenges that pharmacists are best equipped to address to prevent adverse events, administration errors, and treatment failure. [ABSTRACT FROM AUTHOR]

We examined associations between COVID-19 conspiracy beliefs and HIV status neutral care engagement among Black cisgender sexual minority men (BCSMM) and Black transgender women (BTW). Throughout April–July 2020, a total of 226 (222 in the current analysis: 196 BCSMM, 20 BTW, and 6 other) participants in Chicago's Neighborhoods and Networks (N2) cohort study completed virtual assessments. Participants reported their HIV status, changes in the frequency of PrEP/ART use, and COVID-19 conspiracy beliefs. Three-quarters of the sample believed at least one conspiracy theory that COVID-19 was either government-created or lab-created accidentally or purposefully. Believing one or more COVID-19 conspiracy theories was significantly associated with better PrEP or ART engagement (using PrEP more frequently or continuously using PrEP/Missing ART less or continuously using ART) (aPR = 0.75 [95% CI 0.56–0.99], p < 0.05). Believing COVID-19 came about naturally was strongly associated with worse PrEP engagement (i.e., use PrEP less or not on PrEP) or worse ART engagement (i.e., missed ART more or not on ART) (aPR = 1.56 [95% CI 1.23, 1.98], p < 0.001). Findings suggested substantial COVID-19 conspiracies among BCSMM and BTW, and this was associated with HIV care engagement. [ABSTRACT FROM AUTHOR]

There are an estimated 1.1 million individuals living with HIV/AIDS in the United States. In addition to the various medical comorbidities of HIV infection, depression is one of the most frequently co-occurring psychiatric conditions among HIV-infected individuals. Furthermore, depression has been found to be associated with nonadherence to antiretroviral therapy (ART), as well as HIV disease progression. Cognitive behavioral therapy (CBT) has repeatedly been found to effectively treat depression in adult populations, and CBT for adherence and depression (CBT-AD) is an effective treatment for improving depressive symptoms and medication adherence in the context of various chronic health conditions, including diabetes and HIV-infection. This paper provides a description of the CBT-AD approach to treat depression and ART adherence in HIV-infected adults, which we have developed and tested in our clinic, and for which detailed therapist and client guides exist. To augment the description of treatment, the present article provides video component demonstrations of several core modules that highlight important aspects of this treatment, including Life-Steps for medication adherence, orientation to CBT-AD and psychoeducation, and suggestions for adaptation of core CBT modules for HIV-infected adults. Discussion of video demonstrations highlights differences in patient presentations and course of treatment between HIV-infected adults receiving CBT-AD and HIV-uninfected adults receiving traditional CBT for depression. This description and the accompanying demonstrations are intended as a practical guide to assist therapists wishing to conduct such a treatment in the outpatient setting. [ABSTRACT FROM AUTHOR]

Improving adherence to antiretroviral therapy (ART) is essential for limiting HIV disease progression among young sexual minority men living with HIV. Daily diaries allow for a detailed examination of how fluctuations in psychosocial factors are associated with adherence over time. Across three cities in the United States, this study collected 60 days of quantitative data from 44 young men (between 16 and 24 years of age) living with HIV who have sex with men. Lagged transition models explored the associations of mood, stress, social support, substance use, and condomless intercourse with daily ART adherence. Baseline levels of illicit substance use and condomless intercourse, and a higher proportion of days with stress or marijuana use, were associated with lower ART adherence. Lapses in adherence predicted non-adherence the following day. Findings suggest prospective data collection may identify different predictors of adherence compared to retrospective recall. Lapse-management strategies are needed to improve adherence following a missed dose. [ABSTRACT FROM AUTHOR]

Long-acting injectable (LAI) modalities have been developed for ART and PrEP. Women face unique barriers to LAI use yet little research has examined women's perceptions of potential LAI HIV therapy candidates. We conducted 89 in-depth interviews at six Women's Interagency HIV Study (WIHS) sites with women living with HIV (n = 59) and HIV-negative women (n = 30) from 2017 to 2018. Interviews were recorded, transcribed, and analyzed using thematic content analysis. Participants identified specific sub-populations who could most benefit from LAI over daily pills: (1) young people; (2) women with childcare responsibilities; (3) people with adherence-related psychological distress; (4) individuals with multiple sex partners; and (5) people facing structural insecurities such as homelessness. Women are underserved by current HIV care options and their perspectives are imperative to ensure a successful scale-up of LAI PrEP and LAI ART that prioritizes equitable access and benefit for all individuals. [ABSTRACT FROM AUTHOR]

The U.S. Department of Health and Human Services Human Immunodeficiency Virus (HIV)/Acquired Immune Deficiency Syndrome (AIDS) treatment guidelines are modified several times per year to reflect the rapid evolution of the field (e.g., emergence of new antiretroviral drugs). As such, a treatment-decision support system that is capable of self-learning is highly desirable. Based on the fuzzy discrete event system (FDES) theory that we recently created, we have developed a self-learning HIV/AIDS regimen selection system for the initial round of combination antiretroviral therapy, one of the most complex therapies in medicine. The system consisted of a treatment objectives classifier, fuzzy finite state machine models for treatment regimens, and a genetic-algorithm-based optimizer. Supervised learning was achieved through automatically adjusting the parameters of the models by the optimizer. We focused on the four historically popular regimens with 32 associated treatment objectives involving the four most important clinical variables (potency, adherence, adverse effects, and future drug options). The learning targets for the objectives were produced by two expert AIDS physicians on the project, and their averaged overall agreement rate was 70.6%. The system's learning ability and new regimen suitability prediction capability were tested under various conditions of clinical importance. The prediction accuracy was found between 84.4% and 100%. Finally, we retrospectively evaluated the system using 23 patients treated by 11 experienced nonexpert faculty physicians and 12 patients treated by the two experts at our AIDS Clinical Center in 2001. The overall exact agreement between the 13 physicians' selections and the system's choices was 82.9% with the agreement for the two experts being both 100%. For the seven mismatched cases, the system actually chose more appropriate regimens in four cases and equivalent regimens in another two cases. It made a mistake in one case. These (preliminary) results show that 1) the System outperformed the nonexpert physicians and 2) it performed as well as the expert physicians did. This learning and prediction approach, as well as our original FDESs theory, is general purpose and can be applied to other medical or nonmedical problems. [ABSTRACT FROM AUTHOR]

The development of antiretroviral therapies (ARTs) has significantly lengthened the lifespan and changed the life course of most individuals infected with HIV and AIDS in the United States. Furthermore, ART use during pregnancy has significantly reduced the rate of mother-to-child (perinatal) HIV transmission. While perinatal infection rates among children in the United States have declined since the 1990s, ART regimens became standard treatment protocol, there remains a population of children entering adolescence who were born HIV-positive. This paper discusses: 1) the importance of diagnostic disclosure of HIV and AIDS status to infected children, 2) stigma and the disclosure process with children, and 3) the role of clinical social workers in facilitating the disclosure process. [ABSTRACT FROM AUTHOR]

Background: Drug resistance continues to be a major challenge in the treatment of HIV-1 infection. Virtually all currently available antiretroviral medications inhibit the viral reverse transcriptase or protease. Enfuvirtide is the first fusion inhibitor approved by the US Food and Drug Administration for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in treatment-experienced patients.Objective: This paper describes the pharmacologic properties and clinical usefulness of enfuvirtide.Methods: Relevant information was identified through searches of MEDLINE (1990 to October 2003), International Pharmaceutical Abstracts (1970 to October 2003), and meeting abstracts of major HIV/AIDS conferences (1996–2003) using the search terms enfuvirtide, pentafuside, T-20, DP-178, and fusion inhibitor.Results: In vitro, enfuvirtide exhibits activity against HIV-1 isolates that are resistant to all other classes of anti-retroviral medications. Enfuvirtide blocks the entry of HIV-1 into host cells by interfering with virus-cell fusion, making it unique among licensed antiretroviral medications. In human adults, enfuvirtide has a volume of distribution of 5.48 L, is highly bound to plasma protein (92%), has a plasma elimination half-life of 3.8 hours, and is catabolized by peptidases and proteinases in various tissues. Dose adjustment does not appear necessary on the basis of age, race, or body weight, but may be warranted in women weighing <50 kg. A literature review did not identify any data on the disposition of enfuvirtide in patients with hepatic or renal insufficiency. Clinical trials suggest that enfuvirtide reduces plasma HIV-1 RNA levels in highly treatment-experienced patients taking an optimized antiretroviral regimen. Pivotal trials indicated a mean change in HIV-1 RNA of −1.48 log10 copies/mL in the enfuvirtide arm at week 48, compared with −0.63 log10 copy/mL in the control arm (P < 0.001). The mean absolute increase on CD4 cell count was 46 cells/mm3 (91 cells/mm3) in the enfuvirtide arm vs 45 cells/mm3 in the control arm; P < 0.001). The most commonly reported (>15 cases per 100 patient-years of exposure) adverse events (AEs) in clinical trials included injection-site reactions, diarrhea, nausea, fatigue, insomnia, peripheral neuropathy, headache, vomiting, and fever. The most commonly reported (≥2%) laboratory abnormalities (grade III or IV) were eosinophilia, anemia, and increases in amylase, lipase, triglycerides, creatine phosphokinase, alanine aminotransferase, aspartate aminotransferase, and gamma-glutamyl transferase. In clinical trials, serious AEs leading to study discontinuation occurred in 12.9% (SHAPE="SOL" ALIGN="C" STYLE="S">114885) of patients in the enfuvirtide arm, compared with 10.7% (SHAPE="SOL" ALIGN="C" STYLE="S">12112) in the control arm (P = NS). The recommended dosag of enfuvirtide is 90 mg SC BID in adults and 2 mg/kg SC BID in children. Efficacy studies in children are ongoing.Conclusion: Although additional studies are needed, enfuvirtide appears to be a promising agent, in combination with other antiretroviral agents, for the treatment of HIV infection in treatment-experienced patients. [Copyright &y& Elsevier]

Optimal adherence to HIV antiretroviral therapy (ART) is challenging, and racial/ethnic disparities in adherence rates are substantial. The most common reason persons living with HIV (PLWH) give for missed ART doses is forgetting. We took a qualitative exploratory approach to describe, from the perspectives of African American/Black and Hispanic/Latino PLWH, what it means to forget to take ART and factors that influence forgetting. Participants (N = 18) were purposively sampled for maximum variability and engaged in semi-structured/in-depth interviews on HIV/ART management. The analysis took a directed content analysis approach. Participants were mostly male (56%) and African American/Black (79%), between 50 and 69 years old, and had lived with HIV for an average of 21 years. Findings were organised into six inter-related themes: (1) forgetting to take ART was a shorthand description of a complex phenomenon, but rarely a simple lapse of memory; (2) 'forgetting' was means of managing negative emotions associated with HIV; (3) life events triggered mental health distress/substance use which disrupted adherence; (4) historical traumatic events (including AZT monotherapy) and recent trauma/loss contributed to forgetting; (5) patient-provider interactions could support or impede adherence; and (6) intrinsic motivation was fundamental. Implications for HIV social service and health care settings are described. [ABSTRACT FROM AUTHOR]

Research suggests that language barriers in health care settings may adversely affect clinical outcomes and patient satisfaction. We describe the characteristics of adults with limited English proficiency (LEP) and diagnosed HIV in the United States. The Medical Monitoring Project is a complex sample survey of adults with diagnosed HIV in the United States that uses two-stage, probability-proportional-to-size sampling. We analyzed weighted interview and medical record data collected from June 2015–May 2018. The prevalence of LEP among adults with HIV was 10%. Higher percentages of adults with LEP, compared with adults with English proficiency (EP), were female, Hispanic/Latino, less educated and poor, only had Ryan White HIV/AIDS Program (RWHAP) health care coverage, attended RWHAP-funded facilities, were satisfied with their HIV medical care, were prescribed antiretroviral therapy (ART), were virally suppressed and received testing for sexually transmitted diseases. We found no statistical difference in ART adherence among adults with LEP and EP. Despite the association between LEP and the risk for health disparities, more persons with LEP were virally suppressed compared with persons with EP. One possible explanation is attendance at RWHAP-funded facilities by adults with LEP; however, future studies are needed to explore other possible explanations. [ABSTRACT FROM AUTHOR]

A large proportion of HIV infections among men who have sex with men occur within primary partnerships, however, there is a lack of research focused on serodiscordant male couples. We used baseline data collected as part of Project Stronger Together—a randomized controlled trial to improve treatment outcomes among 155 serodiscordant male couples. We described engagement in HIV care/prevention using the HIV treatment cascade and PrEP care continuum. Among partners living with HIV, 86.5% were linked to care, 77.4% retained in care, 81.3% prescribed ART, 60.7% adherent, and 67.7%virally suppressed. Among HIV-negative partners, 62.6% were willing to take PrEP, 48.4% had ever taken PrEP, and 26.5% were adherent to PrEP. Black partners living with HIV had lower odds of being virally suppressed compared to White partners. Our findings provide evidence to suggest designing programs to address the racial disparities in viral suppression, addressing barriers to HIV prevention/treatment, and improving PrEP education. [ABSTRACT FROM AUTHOR]

Background To evaluate the frequency and associated characteristics of chronic comorbid conditions and obstetrical complications among pregnant women with human immunodeficiency virus (HIV) and receiving antiretroviral therapy (ART) in comparison to those without HIV. Methods We compared 2 independent concurrent US pregnancy cohorts: (1) with HIV (International Maternal Pediatric Adolescent AIDS Clinical Trials Protocol P1025, 2002–2013) and (2) without HIV (Consortium for Safe Labor Study, 2002–2007). Outcomes were ≥2 chronic comorbid conditions and obstetrical complications. For women with HIV, we assessed whether late prenatal care (≥14 weeks), starting ART in an earlier era (2002–2008), and a detectable viral load at delivery (≥400 copies/mL) were associated with study outcomes. Results We assessed 2868 deliveries (n = 2574 women) with HIV and receiving ART and 211 910 deliveries (n = 193 170 women) without HIV. Women with HIV were more likely to have ≥2 chronic comorbid conditions versus those without HIV (10 vs 3%; adjusted OR [AOR]: 2.96; 95% CI: 2.58–3.41). Women with HIV were slightly less likely to have obstetrical complications versus those without HIV (both 17%; AOR:.84; 95% CI:.75–.94), but secondarily, higher odds of preterm birth <37 weeks. Late entry to prenatal care and starting ART in an earlier era were associated with a lower likelihood of ≥2 chronic comorbidities and obstetrical complications; detectable viral load at delivery was associated with a higher likelihood of obstetric complications. Conclusions Pregnant women with HIV receiving ART have more chronic comorbid conditions, but not necessarily obstetrical complications, than their peers without HIV. [ABSTRACT FROM AUTHOR]

Introduction: Although individual antiretroviral drugs have been shown to be associated with elevated cardiovascular disease (CVD) risk, data are limited on the role of antiretroviral drug combinations. Therefore, we sought to investigate CVD risk associated with antiretroviral drug combinations. Methods: Using an administrative health-plan dataset, risk of acute myocardial infarction (AMI) associated with current exposure to antiretroviral drug combinations was assessed among persons living with HIV receiving antiretroviral therapy (ART) across the U.S. from October 2009 through December 2014. To account for confounding-by-indication and for factors simultaneously acting as causal mediators and confounders, we applied inverse probability of treatment weighted marginal structural models to longitudinal data of patients. Results: Over 114,417 person-years (n = 73,071 persons) of ART exposure, 602 cases of AMI occurred at an event rate of 5.26 (95% CI: 4.86, 5.70)/1000 person-years. Of the 14 antiretroviral drug combinations studied, persons taking abacavir-lamivudine-darunavir had the highest incidence rate (IR: 11/1000; 95% CI: 7.4–16.0) of AMI. Risk (HR; 95% CI) of AMI was elevated for current exposure to abacavir-lamivudine-darunavir (1.91; 1.27–2.88), abacavir-lamivudine-atazanavir (1.58; 1.08–2.31), and tenofovir-emtricitabine-raltegravir (1.35; 1.07–1.71). Tenofovir-emtricitabine-efavirenz was associated with reduced risk (0.65; 0.54–0.78). Abacavir-lamivudine-darunavir was associated with increased risk of AMI beyond that expected of abacavir alone, likely attributable to darunavir co-administration. We did not find an elevated risk of AMI when abacavir-lamivudine was combined with efavirenz or raltegravir. Conclusion: The antiretroviral drug combinations abacavir-lamivudine-darunavir, abacavir-lamivudine-atazanavir and tenofovir-emtricitabine-raltegravir were found to be associated with elevated risk of AMI, while tenofovir-emtricitabine-efavirenz was associated with a lower risk. The AMI risk associated with abacavir-lamivudine-darunavir was greater than what was previously described for abacavir, which could suggest an added risk from darunavir. The results should be confirmed in additional studies. [ABSTRACT FROM AUTHOR]

Background: Despite remarkable achievements in antiretroviral therapy (ART), losses to follow-up (LTFU) might prevent the long-term success of HIV treatment and might delay the achievement of the 90-90-90 objectives. This scoping review is aimed at the description and analysis of the strategies used in high-income countries to reengage LTFU in HIV care, their implementation and impact.Methods: A scoping review was done following Arksey & O'Malley's methodological framework and recommendations from Joanna Briggs Institute. Peer reviewed articles were searched for in Pubmed, Scopus and Web of Science; and grey literature was searched for in Google and other sources of information. Documents were charted according to the information presented on LTFU, the reengagement procedures used in HIV units in high-income countries, published during the last 15 years. In addition, bibliographies of chosen articles were reviewed for additional articles.Results: Twenty-eight documents were finally included, over 80% of them published in the United States later than 2015. Database searches, phone calls and/or mail contacts were the most common strategies used to locate and track LTFU, while motivational interviews and strengths-based techniques were used most often during reengagement visits. Outcomes like tracing activities efficacy, rates of reengagement and viral load reduction were reported as outcome measures.Conclusions: This review shows a recent and growing trend in developing and implementing patient reengagement strategies in HIV care. However, most of these strategies have been implemented in the United States and little information is available for other high-income countries. The procedures used to trace and contact LTFU are similar across reviewed studies, but their impact and sustainability are widely different depending on the country studied. [ABSTRACT FROM AUTHOR]

Objectives: People living with HIV (PLWH) have increased risk of chronic disease and poor mental health. We aimed to explore HIV disease indicators, comorbidity, and risk behavior of recent antiretroviral therapy (ART) initiators to inform current needs of PLWH. Methods: Men who have sex with men (MSM) in the Multicenter AIDS Cohort Study (MACS) who initiated ART between 2010 and 2018 (recent initiators) were compared with age‐, race‐ and geographic location‐matched men who initiated ART during 2000–2009 (early initiators). Measures of HIV disease, behavior, comorbidity and mental health were collected prospectively every 6 months using standardized forms. Results: Recent initiators had higher current CD4 (median CD4 451 vs. 307 cells/μL, P < 0.0001) and nadir CD4 (451 vs. 300 cells/μL, P < 0.0001) than earlier initiators. The proportion achieving viral suppression within a year of starting ART was significantly higher in recent compared with earlier initiators (92% vs. 74%, P < 0.0001). Median [interquartile range (IQR)] time from HIV diagnosis to ART initiation was 5.4 (1.7–23.1) months in recent initiators. Comorbidity prevalence was high in recent initiators, including obesity (24%), hypertension (25%) and kidney disease (15%). Substance use continues to be common, including cigarette use (40%), daily alcohol use (88%) and marijuana use (46%). Conclusions: Improvements in getting individuals onto ART at an early stage have led to substantially higher CD4 cell counts at initiation. However, the high burden of comorbidity, substance use and poor mental health affecting MSM living with HIV in the US underscore ongoing challenges and our need to adapt and coordinate care. [ABSTRACT FROM AUTHOR]

Long-acting injectable antiretroviral therapy has been shown to be non-inferior to daily oral antiretroviral therapy in clinical trials and may soon become part of clinical care. While most trial participants to date have been men, approximately one quarter of ongoing Phase 3 trial participants are women offering an important opportunity to understand how long-acting antiretroviral therapy is perceived and experienced by women. We conducted in-depth interviews with 80 people living with HIV participating in Phase 2 and 3 clinical trials of long-acting antiretroviral therapy in the USA and Spain. Fifteen percent (12/80) of trial participants interviewed were women. Interviews were audio-recorded, transcribed and coded using content analysis, focused on gender-specific themes. Women shared many of the positive perceptions expressed by men but also had unique perspectives, including finding that long-acting antiretroviral therapy addressed the challenge of remembering pills amidst busy day-to-day realities including multiple roles and responsibilities, is less time consuming and creates less stress compared to oral antiretroviral therapy, and is emotionally freeing and empowering. The gendered nature of women's lives shaped why and how they were satisfied with long-acting antiretroviral therapy. Findings can inform interventions and support systems to facilitate uptake of and adherence to long-acting antiretroviral therapy in women. [ABSTRACT FROM AUTHOR]

HIV prevalence among transgender women of color (TWC) in the United States of America is high. We enrolled TWC living with HIV (N = 858) to evaluate 1nine HIV care interventions. We examined factors associated with four outcomes at enrollment: linkage to care, ever being on antiretroviral treatment, retention in care and viral suppression. The sample was 49% Hispanic/Latino, 42% Black; average age was 37 years; 77% were ever linked to care, 36% were ever on treatment, 22% were retained in care, and 36% were virally suppressed. Current hormone use was significantly associated with linkage, retention, and viral suppression (all aORs > 1.5), providing evidence for gender-affirming care as an important facilitator of engagement in HIV care. Greater health care empowerment was significantly associated with greater odds of all outcomes (aORs between 1.19 and 1.37). These findings identify potential intervention targets to improve the provision of care and treatment for TWC living with HIV. [ABSTRACT FROM AUTHOR]

Sexual and gender minority (SGM) adolescents assigned male at birth are at increased risk for HIV infection. Pre-exposure prophylaxis (PrEP) is a daily pill taken to prevent HIV, which the United States Food and Drug Administration approved for minors under age 18 years weighing at least 77.5 lb in 2018. A lack of awareness and knowledge of PrEP are barriers to uptake among adults and adolescents, but SGM adolescents' awareness and knowledge about PrEP remain underexplored and no studies have assessed SGM adolescents' informational needs. We collected data on 59 SGM adolescents' (ages 14-18 years) awareness, knowledge, and questions about PrEP in an online survey and six online focus groups. Although a majority of SGM adolescents (83.1%) were aware of PrEP before the study, many wanted more information about side effects and how to navigate potential barriers to PrEP initiation. Findings can inform public health efforts to promote PrEP knowledge and uptake among SGM adolescents. [ABSTRACT FROM AUTHOR]

We examined HIV viral load non-suppression (≥ 200 copies/mL) subsequent to person-periods (3–18 months) bookended by two self-reports of alcohol use on a standardized patient reported outcome assessment among adults in routine HIV care. We examined the relative risk (RR) of non-suppression associated with increases and decreases in alcohol use (relative to stable use), stratified by use at the start of the person-period. Increases in drinking from abstinence were associated with higher risk of viral non-suppression (low-risk without binge: RR 1.16, 95% CI 1.03, 1.32; low-risk with binge: RR 1.35, 95% CI 1.11, 1.63; high-risk: RR 1.89, 95% CI 1.16, 3.08). Decreases in drinking from high-risk drinking were weakly, and not statistically significantly associated with lower risk of viral non-suppression. Other changes in alcohol use were not associated with viral load non-suppression. Most changes in alcohol consumption among people using alcohol at baseline were not strongly associated with viral non-suppression. [ABSTRACT FROM AUTHOR]

Background: The suppression of viremia among persons with HIV (PWH) using antiretroviral therapy has been hypothesized to reduce HIV incidence at the population level. We investigated the impact of state level viral suppression among PWH in the United States on estimated HIV incidence between 2010 and 2015. Methods: Viral suppression data and HIV incidence estimates from the National HIV Surveillance System were available from 29 states and the District of Columbia. We assumed a one year delay for viral suppression to impact incidence. Poisson regression models were used to calculate the estimated annual percent change (EAPC) in incidence rate. We employed a multivariable mixed-effects Poisson regression model to assess the effects of state level race/ethnicity, socioeconomic status, percent men who have sex with men (MSM) and hepatitis C virus prevalence as a proxy for injection drug use on HIV incidence. Findings: Fitted HIV incidence for 30 jurisdictions declined from 11.5 in 2010 to 10.0 per 100,000 population by 2015 corresponding with an EAPC of -2.67 (95% confidence interval [95%CI] -2.95, -2.38). Southern states experienced the highest estimated incidence by far throughout this period but upon adjustment for viral suppression and demographics there was a 36% lower incidence rate than Northeast states (adjusted rate ratio [aRR] 0.64; 95%CI 0.42, 0.99). For every 10 percentage point (pp) increase in viral suppression there was an adjusted 4% decline in HIV incidence rate in the subsequent year (aRR 0.96; 95%CI 0.93, 0.99). While controlling for viral suppression, HIV incidence rate increased by 42% (aRR 1.42 95%CI 1.31, 1.54) for every 5 pp increase in percent Black race and by 27% (aRR 1.27 95%CI 1.10, 1.48) for every 1 pp increase in percent MSM in states. Interpretation: A decline in estimated HIV incidence from 2010 to 2015 was associated with increasing viral suppression in the United States. Race and sexual orientation were important HIV acquisition risk factors. [ABSTRACT FROM AUTHOR]

Background: Real-time, objective measures of adherence to antiretroviral therapy (ART) and pre-exposure prophylaxis (PrEP) are needed to better assess adherence levels and to expedite clinical response for those with suboptimal adherence. Point-of-care tenofovir (POC-TFV) testing has been proposed as a solution to facilitate real-time antiretroviral adherence monitoring, but little is known about how health care providers, people living with HIV (PLWH) receiving ART, and people receiving PrEP will perceive POC-TFV testing. Methods: We conducted an exploratory qualitative study to assess perspectives on the utility and interest in POC-TFV testing from potential end users. We conducted three focus group discussions (FGDs) among 17 PLWH receiving ART and four individuals receiving PrEP, as well as eight in-depth interviews (IDIs) with health care providers in the Seattle area and presented participants with a hypothetical urine-based POC-TFV test. FGDs and IDIs were audio recorded, transcribed, coded, and analyzed to describe emerging themes. Results: Overall, study participants demonstrated divergent opinions about the POC-TFV test. Among study participants, PLWH were most ambivalent about POC-TFV testing, first demonstrating reluctance to TFV-level monitoring and shifting positions during the FGDs. However, all PLWH participants were receptive to POC-TFV testing if requested by their provider. PrEP participants were generally supportive of POC-TFV testing for routine adherence monitoring and emphasized potential value in self-administered testing. Providers' perceptions were equally divided – half suggested POC-TFV testing would be valuable, particularly for people receiving PrEP, while half indicated the test would have little benefit for most individuals receiving ART or PrEP in the U.S. All providers agreed that POC-TFV test results could be beneficial for assessing discrepancies in viral load results and self-reported adherence among PLWH. The study also revealed that a low-cost, non-urine-based POC-TFV test with a long-term limit of detection would be preferred over the hypothetical urine-based test. Conclusions: Our findings indicate POC-TFV testing may be beneficial for routine, clinic-based adherence monitoring, particularly for individuals receiving PrEP or for PLWH with persistent viremia or following recent ART initiation. These findings should also be used to formulate a target product profile for a POC-TFV test and to guide further developments in tools for objective antiretroviral adherence monitoring. [ABSTRACT FROM AUTHOR]

Background: Long-acting (LA) injectable antiretroviral therapy (ART) has been found non-inferior to daily oral ART in Phase 3 trials. LA ART may address key barriers to oral ART adherence and be preferable to daily pills for some people living with HIV. To date, women have been less represented than men in LA ART research. Using longitudinal data from the Women's Interagency HIV Study (WIHS) cohort of women living with HIV in the United States, we examined barriers and facilitators of daily oral ART adherence that may be related to or addressed by LA ART.Methods: We conducted a secondary analysis of WIHS cohort data from 1998 to 2017 among participants seen for at least 4 visits since 1998 who reported using ART at least once (n = 2601). Two dichotomous outcomes, patient-reported daily oral ART adherence and viral suppression were fit using generalized linear models, examining the role of socio-demographic and structural factors.Results: At study enrollment, the median age was 40.5 years, 63% of participants were African American and 22% were Latina. The majority (82%) reported taking ART more than 75% of the time and 53% were virally suppressed. In multivariate analysis, several sub-groups of women had lower odds of reported adherence and viral suppression: 1) younger women (adherence aOR: 0.71; viral suppression aOR: 0.63); 2) women who inject drugs (adherence aOR: 0.38; viral suppression aOR: 0.50) and those with moderate (adherence aOR: 0.59; viral suppression aOR: 0.74) and heavy alcohol consumption (adherence aOR: 0.51; viral suppression aOR: 0.69); 3) those with depressive symptoms (adherence aOR: 0.61; viral suppression aOR: 0.76); and 4) those with a history of going on and off ART (adherence aOR: 0.62, viral suppression aOR: 0.38) or changing regimens (adherence aOR: 0.83, viral suppression aOR: 0.56).Conclusions: Current injectable contraceptive users (vs. non-users) had greater odds of oral ART adherence (aOR: 1.87) and viral suppression (aOR: 1.28). Findings identify profiles of women who may benefit from and be interested in LA ART. Further research is warranted focused on the uptake and utility of LA ART for such key subpopulations of women at high need for innovative approaches to achieve sustained viral suppression. [ABSTRACT FROM AUTHOR]

In the United States (U.S.), the HIV infection rate is disproportionately high among incarcerated individuals. HIV-infected individuals typically receive antiretroviral therapy (ART) to suppress HIV and reduce the threat of transmission. Although HIV-infected individuals are generally ART-adherent while incarcerated, the public health benefits experienced during incarceration are often lost as HIV-infected individuals struggle to maintain optimal adherence post-incarceration. While the importance of maintaining adherence in the post-incarceration period has been acknowledged, research on barriers to ART adherence during this period is limited. To better understand post-release barriers to ART adherence, we conducted in-depth interviews with 20 HIV-infected formerly incarcerated individuals in New York City; we also followed up with 18 (90%) participants after three months to explore whether their adherence challenges changed over time. Viral load testing results from their most recent physician visit were also recorded at each interview. Interviews were transcribed using transcription software and reviewed for accuracy by a researcher. Thematic coding based on discussion guide prompts were then used to identify commonly mentioned barriers to adherence. The results identified four overarching themes that affected study participants' efforts to adhere to their ART regimen: medication burden, forgetfulness, mental health and emotional difficulties, and perceived conflict between substance use and medication adherence. These barriers were the most commonly cited and largely persisted at three-month follow-up. The results suggest that interventions addressing these challenges are essential for promoting ART adherence among HIV-infected formerly incarcerated individuals. Effective interventions may include mobile-based text messaging reminders and those that facilitate patient-provider communication. Additionally, interventions or programs that integrate substance use and mental health treatment into HIV-related care, along with other types of behavioral health support, may also be beneficial for this population. Such interventions should be a routine part of discharge planning and support for incarcerated individuals returning to the community. [ABSTRACT FROM AUTHOR]

Homelessness is a substantial barrier to consistent, recommended HIV care, access and adherence to antiretroviral therapy (ART), and sustained viral suppression, thus increasing the risk for morbidity and transmission. We used data from the Medical Monitoring Project for June 1, 2015–May 31, 2017 to estimate the weighted prevalence of homelessness among persons with diagnosed HIV (PWH) (N = 7665) overall and by selected sociodemographic, behavioral, and clinical characteristics. Prevalence of homelessness was 8.5%. PWH experiencing homelessness were > 3 times as likely to have needed and not received shelter or housing services (32% vs. 10%), > 4 times as likely to inject drugs (9% vs. 2%), and > 7 times as likely to engage in exchange sex (10% vs. 1%), respectively, compared with PWH who did not experience homelessness. Homelessness was associated with lower HIV care retention, ART dose adherence, and sustained viral suppression. This analysis demonstrates substantial need for enhanced treatment, care, and service delivery for PWH experiencing homelessness. Research has demonstrated that housing assistance programs improve HIV-related outcomes and diminish HIV risk behaviors; therefore, housing assistance for PWH should be prioritized in public health policies and practice. [ABSTRACT FROM AUTHOR]

Background: Once-daily, single-tablet regimens (STRs) have been associated with improved patient outcomes compared to multi-tablet regimens (MTRs). This study evaluated real world adherence and persistence of HIV antiretroviral therapy (ART), comparing STRs and MTRs. Methods: Adult Medicaid beneficiaries (aged ≥ 18 years) initiating ART with ≥ 2 ART claims during the identification period (January 1, 2015–December 31, 2016) and continuous health plan enrollment for a 12-month baseline period were included. For STRs, the first ART claim date was defined as the index date; for MTRs, the prescription fill claim date for the last drug in the regimen was defined as the index date, and prescription fills were required to occur within a 5-day window. Adherence was assessed in 30-day intervals over a 6-month period, with adherence defined as having less than a 5-day gap between fills. Persistence was evaluated as median number of days on therapy and percent persistence at 12 months. Cox Proportional Hazard models were used to evaluate risk of discontinuation, controlling for baseline and clinical characteristics. Results: A total of 1,744 (STR = 1290; MTR = 454) and 2409 (STR = 1782; MTR = 627) patients newly prescribed ART had available data concerning adherence and persistence, respectively. Average age ranged 40–42 years. The patient population was predominantly male. Adherence assessments showed 22.7% of STR initiators were adherent to their index regimens over a 6-month period compared to 11.7% of MTR initiators. Unadjusted persistence analysis showed 36.3% of STR initiators discontinued first-line therapy compared to 48.8% for MTR initiators over the 2-year study period. Controlling for baseline demographic and clinical characteristics, MTR initiators had a higher risk of treatment discontinuation (hazard ratio [HR] = 1.6, p < 0.0001). Among STRs, compared to the referent elvitegravir(EVG)/cobicistat(COBI)/emtricitabine(FTC)/tenofovir alafenamide(TAF), risk of discontinuation was higher for efavirenz(EFV)/FTC/tenofovir disoproxil fumarate(TDF) (HR = 3.6, p < 0.0001), EVG/COBI/FTC/TDF (HR = 2.8, p < 0.0001), and abacavir (ABC)/lamivudine (3TC)/dolutegravir (DTG) (HR = 1.8, p = 0.004). Among backbones, FTC/TAF was associated with lower risk of discontinuation than FTC/TDF (HR = 4.4, p < 0.0001) and ABC/3TC (HR = 2.2, p < 0.0001). Conclusions: Among patients newly prescribed ART, STR initiators were significantly less likely to discontinue therapy and had greater adherence and persistence compared to MTR initiators. Regimens containing FTC/TAF as a backbone had higher persistence than those consisting of other backbones. [ABSTRACT FROM AUTHOR]

The purpose of this review was to understand research about treatment adherence among mothers in the US who are living with HIV. Treatment adherence included Antiretroviral Therapy and attending medical care appointments. A scoping review was conducted, and five peer-reviewed databases were searched with predetermined search terms for the period of 2006–2016. Thirty-five articles were identified for the review, including (n = 17) quantitative studies, (n = 6) qualitative studies, (n = 4) reviews and (n = 8) conceptual/theoretical articles. The most frequently identified theme among the articles was prevention of mother-to-child transmission of HIV. Authors disagreed about whether parenting children was a burden or a source of strength for the affected women. Implications identified for practice included a more longitudinal approach to care for mothers, rather than focusing narrowly on prevention of transmission to infants. [ABSTRACT FROM AUTHOR]

Re-engaging people living with HIV (PLWH) who are out of care (OOC) is of utmost importance to ending the HIV epidemic in the U.S. We used DC Department of Health (DCDOH) HIV surveillance data to determine whether re-engaging PLWH results in improved long-term clinical outcomes. PLWH identified as OOC for 6–12 months at both the clinic-level and using DCDOH data were targeted for re-engagement efforts through Recapture Blitz (RB). Uni- and bivariate analyses were conducted comparing engagement in care (EIC), CD4 counts, and viral suppression (VS) at 6, 12, and 18-months post-re-engagement between persons re-engaged through RB and those not re-engaged via RB. Of the 569 PLWH contacted; 57 were re-engaged through RB, 46 were not but may have reengaged on their own. Compared to those not re-engaged via RB, at 18-months of follow-up, more PLWH re-engaged through RB were EIC (71.9% vs. 56.5%) and VS (52.6% vs. 30.4%). Higher proportions of PLWH re-engaged through RB were virally suppressed at 6, 12, and 18-months (p = 0.0238, p = 0.0347, p = 0.0238, respectively). Combining surveillance and clinical data to identify persons OOC allowed for successful re-engagement and improved longer-term outcomes post-re-engagement, underscoring the importance of re-engagement efforts to improve rates of retention and viral suppression. [ABSTRACT FROM AUTHOR]

Introduction: Modern antiretroviral therapy (ART) has revolutionized HIV treatment. ART regimens are now highly efficacious, well-tolerated, safe, often with one multi-drug pill, once-daily regimens available. However, clinical challenges persist in managing ART in persons with HIV (PWH), such as drug–drug interactions, side effects, pregnancy, co-morbidities, and adherence. Areas Covered: In this review, we discuss the ongoing challenges of ART for adults in the United States. We review the difficulties of initiating ART and maintaining therapy throughout adulthood and discuss new agents and strategies under investigation to address these issues. A PubMed search was utilized to identify relevant publications and guidelines through July 2019. Expert Opinion: Challenges persist in initiation and maintenance of ART. An individual's coexisting medical, social and personal factors must be considered in selecting and continuing ART to ensure safety, tolerability, and efficacy throughout adulthood. Continued development of new therapeutics and novel approaches to ART, such as long acting drugs or dual therapy, are needed to respond to many of these challenges. In addition, future research must address therapeutic disparities for populations historically underrepresented in clinical trials, including women, people aging with HIV, and those with complex comorbidities. [ABSTRACT FROM AUTHOR]

Maraviroc (Pfizers UK-427857, Selzentry or Celsentri outside the USA) is the first agent in the new class of oral HIV-1 entry inhibitors to acquire approval by the US Food and Drug Administration and the European Medicine Agency. Considering the mechanism of action, it is expected that this drug will be effective only in a subpopulation of HIV-1-infected people, namely those harbouring the R5 virus. The favourable toxicity profile of the drug has been demonstrated in Phase III clinical trials in treatment-naive (MERIT) and treatment-experienced (MOTIVATE) patients. In the latter population, maraviroc showed a superior antiviral efficacy and immunological activity compared with optimized backbone therapy placebo. However, in MERIT, a prospective double-blind, randomized trial in treatment-naive patients, maraviroc zidovudine/lamivudine failed to prove non-inferiority to efavirenz zidovudine/lamivudine as standard of care regimen in the 48 week intention-to-treat analysis. Using an assay with higher sensitivity for minority CXCR4-using (X4) HIV variants (the enhanced Trofile™ assay—Monogram), non-inferiority was reached for the maraviroc- versus efavirenz-based combination. These data indicate the important impact of the sensitivity of tropism testing on treatment outcome of maraviroc-containing regimens. This paper discusses both the prospective and retrospective analyses of the MERIT data and highlights the impact of these results on daily practice in HIV care. [ABSTRACT FROM AUTHOR]

Black men who have sex with men (BMSM) have the highest HIV incidence rates among all men who have sex with men (MSM) and have been less likely than other MSM to be diagnosed, linked or retained in care for HIV. The Promoting Our Worth, Equality, and Resilience (POWER) study administered a behavioral health survey and HIV test to BMSM to estimate the HIV continuum of care among a community-derived sample. Of the N = 1,680 BMSM living with HIV, n = 956 (56.9%) were aware of their HIV-positive status. BMSM who had been previously diagnosed reported progression through the care continuum at greater than 80% for linkage to medical care (97.6%), retention in medical care (97.3%), prescription of antiretroviral therapy (93.6%) and viral suppression (86.4%). Results of this analysis reveal the urgent need to ensure BMSM are being screened and diagnosed. Additionally, community-driven samples are a promising method offering the opportunity to build on the resilience of BMSM progressing though the continuum as well as engage BMSM not yet in care. Lastly, such methods can assist in communicating with those lost to retention. [ABSTRACT FROM AUTHOR]

Importance: Effective prevention strategies for HIV infection are an important public health priority. Preexposure prophylaxis (PrEP) involves use of antiretroviral therapy (ART) daily or before and after sex to decrease risk of acquiring HIV infection.Objective: To synthesize the evidence on the benefits and harms of PrEP, instruments for predicting incident HIV infection, and PrEP adherence to inform the US Preventive Services Task Force.Data Sources: Ovid MEDLINE, the Cochrane Central Register of Controlled Trials, the Cochrane Database of Systematic Reviews, and EMBASE through June 2018, with surveillance through January 2019.Study Selection: English-language placebo-controlled randomized clinical trials of oral PrEP with tenofovir disoproxil fumarate/emtricitabine or tenofovir disoproxil fumarate monotherapy; studies on the diagnostic accuracy of instruments for predicting incident HIV infection; and studies on PrEP adherence.Data Extraction and Synthesis: Dual review of titles and abstracts, full-text articles, study quality, and data abstraction. Data were pooled using the Dersimonian and Laird random-effects model for effects of PrEP on HIV infection, mortality, and harms.Main Outcomes and Measures: HIV acquisition, mortality, and harms; adherence to PrEP; and diagnostic test accuracy and discrimination.Results: Fourteen RCTs (N = 18 837), 8 observational studies (N = 3884), and 7 studies of diagnostic accuracy (N = 32 279) were included. PrEP was associated with decreased risk of HIV infection vs placebo or no PrEP after 4 months to 4 years (11 trials; relative risk [RR], 0.46 [95% CI, 0.33-0.66]; I2 = 67%; absolute risk reduction [ARD], -2.0% [95% CI, -2.8% to -1.2%]). Greater adherence was associated with greater efficacy (RR with adherence ≥70%, 0.27 [95% CI, 0.19-0.39]; I2 = 0%) in 6 trials. PrEP was associated with an increased risk of renal adverse events (12 trials; RR, 1.43 [95% CI, 1.18-1.75]; I2 = 0%; ARD, 0.56% [95% CI, 0.09%-1.04%]) and gastrointestinal adverse events (12 trials; RR, 1.63 [95% CI, 1.26-2.11]; I2 = 43%; ARD, 1.95% [95% CI, 0.48%-3.43%]); most adverse events were mild and reversible. Instruments for predicting incident HIV infection had moderate discrimination (area under the receiver operating characteristic curve, 0.49-0.72) and require further validation. Adherence to PrEP in the United States in men who have sex with men varied widely (22%-90%).Conclusions and Relevance: In adults at increased risk of HIV infection, PrEP with oral tenofovir disoproxil fumarate monotherapy or tenofovir disoproxil fumarate/emtricitabine was associated with decreased risk of acquiring HIV infection compared with placebo or no PrEP, although effectiveness decreased with suboptimal adherence. [ABSTRACT FROM AUTHOR]

Objectives. To examine the effect of patient navigation models on changes in housing status and its subsequent effects on HIV outcomes for 700 people living with HIV (PLWH) who were unstably housed with co-occurring substance use and psychiatric disorders across 9 demonstration sites in the United States between the years of 2013 and 2017. Methods. Self-reported housing status was collected at baseline, and at 6 and 12 months during the intervention. HIV outcomes included linkage and retention in care, antiretroviral therapy prescription, and viral suppression collected via chart review. Results. In the 12 months after the intervention, 59.6% transitioned to more stable housing. Compared with those who became or remained unstably housed, participants with greater stability achieved significantly higher rates of retention (adjusted odds ratio [AOR] = 2.12; 95% confidence interval [CI] = 1.11, 4.05), were more likely to be prescribed antiretroviral therapy (AOR = 2.06; 95% CI = 1.62, 2.63), and had higher rates of viral suppression (AOR = 1.62; 95% CI = 1.03, 2.55). Conclusions. The use of patient navigators to create a network of services for PLWH who are unstably housed can improve housing stability and lead to improvements in HIV-related outcomes. [ABSTRACT FROM AUTHOR]

We evaluated national trends of in-hospital discharge rates, mortality outcomes, health care costs, length of stay in HIV patients with cognitive disorders. Neurological involvement in HIV is commonly associated with cognitive impairment termed as HIV-associated neurocognitive disorder (HAND) which includes a spectrum of neurocognitive dysfunction associated with HIV infection. Although severe and progressive neurocognitive impairment has become rare in HIV patients in the era of potent antiretroviral therapy, a majority of HIV patients have mild to moderate degree of neurocognitive impairment. Study population for this analysis was derived from the Nationwide Inpatient Sample from 2005 to 2014. Patients with ICD-9 code of HIV (042) with discharge diagnosis (Dx) listed top 1 through 5 were included in the analysis. Within this population, we identified patients with cognitive impairment using ICD-9 codes of 294 (persistent mental disorders; organic psychotic brain syndromes (chronic), 323.9 (encephalitis, myelitis, and encephalomyelitis), 331.83 (mild cognitive impairment) with Dx listed from 1 to 25. Patient variables obtained included: age, race, gender, length of stay, in-hospital mortality and insurance status. Hospital level variables included teaching status, location and region of country. SAS 9.4 software was used for data analysis. Comparisons of variables between hospitalized HIV patients with and without HAND showed significant increase in cost per hospital admissions, longer hospital stay and higher risk of mortality in patients with HAND. [ABSTRACT FROM AUTHOR]

Reports on the significant implications of the world trade negotiations for many scientists in the U.S. Accounts on the impediment to free trade; Increase of the supply of antiretrovirals and other medicines to poor countries; Schedule for the completion of the current round of trade negotiations.