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Standard-of-care HIV pre-exposure prophylaxis (PrEP) is highly efficacious, but uptake of and persistence on a daily oral pill is low in many settings. Evaluation of alternate PrEP products will require innovation to avoid the unpractically large sample sizes in noninferiority trials. We propose estimating HIV incidence in people not on PrEP as an external counterfactual to which on-PrEP incidence in trial subjects can be compared. HIV recent infection testing algorithms (RITAs), such as the limiting antigen avidity assay plus viral load used on specimens from untreated HIV positive people identified during screening, is one possible approach. Its feasibility is partly dependent on the sample size needed to ensure adequate power, which is impacted by RITA performance, the number of recent infections identified, the expected efficacy of the intervention, and other factors. Screening sample sizes to support detection of an 80% reduction in incidence for 3 key populations are more modest, and comparable to the number of participants in recent phase III PrEP trials. Sample sizes would be significantly larger in populations with lower incidence, where the false recency rate is higher or if PrEP efficacy is expected to be lower. Our proposed counterfactual approach appears to be feasible, offers high statistical power, and is nearly contemporaneous with the on-PrEP population. It will be important to monitor the performance of this approach during new product development for HIV prevention. If successful, it could be a model for preventive HIV vaccines and prevention of other infectious diseases.

Purpose Social determinants of health and racial inequalities impact healthcare access and subsequent coronavirus testing. Limited studies have described the impact of these inequities on rural minorities living in Appalachia. This study investigates factors affecting testing in rural communities. Methods PCR testing data were obtained for March through September 2020. Spatial regression analyses were fit at the census tract level. Model outcomes included testing and positivity rate. Covariates included rurality, percent Black population, food insecurity, and area deprivation index (a comprehensive indicator of socioeconomic status). Results Small clusters in coronavirus testing were detected sporadically, while test positivity clustered in mideastern and southwestern WV. In regression analyses, percent food insecurity (IRR = 3.69×109, [796, 1.92×1016]), rurality (IRR=1.28, [1.12, 1.48]), and percent population Black (IRR = 0.88, [0.84, 0.94]) had substantial effects on coronavirus testing. However, only percent food insecurity (IRR = 5.98 × 104, [3.59, 1.07×109]) and percent Black population (IRR = 0.94, [0.90, 0.97]) displayed substantial effects on the test positivity rate. Conclusions Findings highlight disparities in coronavirus testing among communities with rural minorities. Limited testing in these communities may misrepresent coronavirus incidence.

West Virginia prioritized SARS-CoV-2 vaccine delivery to nursing home facilities because of increased risk of severe illness in elderly populations. However, the persistence and protective role of antibody levels remain unclear.To examine the persistence of humoral immunity after COVID-19 vaccination and the association of SARS-CoV-2 antibody levels and subsequent infection among nursing home residents and staff.In this cross-sectional study, blood samples were procured between September 13 and November 30, 2021, from vaccinated residents and staff at participating nursing home facilities in the state of West Virginia for measurement of SARS-CoV-2 antibody (anti-receptor binding domain [RBD] IgG). SARS-CoV-2 infection and vaccination history were documented during specimen collection and through query of the state SARS-CoV-2 surveillance system through January 16, 2022.SARS-CoV-2 vaccination (with BNT162b2, messenger RNA-1273, or Ad26.COV2.S).Anti-RBD IgG levels were assessed using multivariate analysis to examine associations between time since vaccination or infection, age, sex, booster doses, and vaccine type. Antibody levels from participants who became infected after specimen collection were compared with those without infection to correlate antibody levels with subsequent infection.Among 2139 SARS-CoV-2 vaccinated residents and staff from participating West Virginia nursing facilities (median [range] age, 67 [18-103] years; 1660 [78%] female; 2045 [96%] White), anti-RBD IgG antibody levels decreased with time after vaccination or infection (mean [SE] estimated coefficient, -0.025 [0.0015]; P .001). Multivariate regression modeling of participants with (n = 608) and without (n = 1223) a known history of SARS-CoV-2 infection demonstrated significantly higher mean (SE) antibody indexes with a third (booster) vaccination (with infection: 11.250 [1.2260]; P .001; without infection: 8.056 [0.5333]; P .001). Antibody levels (calculated by dividing the sample signal by the mean calibrator signal) were significantly lower among participants who later experienced breakthrough infection during the Delta surge (median, 2.3; 95% CI, 1.8-2.9) compared with those without breakthrough infection (median, 5.8; 95% CI, 5.5-6.1) (P = .002); however, no difference in absorbance indexes was observed in participants with breakthrough infections occurring after specimen collection (median, 5.9; 95% CI, 3.7-11.1) compared with those without breakthrough infection during the Omicron surge (median, 5.8; 95% CI, 5.6-6.2) (P = .70).In this cross-sectional study, anti-RBD IgG levels decreased after vaccination or infection. Higher antibody responses were found in individuals who received a third (booster) vaccination. Although lower antibody levels were associated with breakthrough infection during the Delta surge, no significant association was found between antibody level and infection observed during the Omicron surge. The findings of this cross-sectional study suggest that among nursing home residents, COVID-19 vaccine boosters are important and updated vaccines effective against emerging SARS-CoV-2 variants are needed.

Given high relapse rates and the prevalence of overdose deaths, novel treatments for substance use disorder (SUD) are desperately needed for those who are treatment refractory. The objective of this study was to evaluate the safety of deep brain stimulation (DBS) for SUD and the effects of DBS on substance use, substance craving, emotional symptoms, and frontal/executive functions. DBS electrodes were implanted bilaterally within the Nucleus Accumbens/Ventral anterior internal capsule (NAc/VC) of a man in his early 30s with >10-year history of severe treatment refractory opioid and benzodiazepine use disorders. DBS of the NAc/VC was found to be safe with no serious adverse events noted and the participant remained abstinent and engaged in comprehensive treatment at the 12-week endpoint (and 12-month extended follow-up). Using a 0-100 visual analog scale, substance cravings decreased post-DBS implantation; most substantially in benzodiazepine craving following the final DBS titration (1.0 ± 2.2) compared to baseline (53.4 ± 29.5; p < .001). A trend toward improvement in frontal/executive function was observed on the balloon analog risk task performance following the final titration (217.7 ± 76.2) compared to baseline (131.3 ± 28.1, p = .066). FDG PET demonstrated an increase in glucose metabolism in the dorsolateral prefrontal and medial premotor cortices at the 12-week endpoint compared to post-surgery/pre-DBS titration. Heart Rate Variability (HRV) improved following the final titration (rMSSD = 56.0 ± 11.7) compared to baseline (19.2 ± 8.2; p < .001). In a participant with severe, treatment refractory opioid and benzodiazepine use disorder, DBS of the NAc/VC was safe, reduced substance use and craving, and improved frontal and executive functions. Confirmation of these findings with future studies is needed. (PsycInfo Database Record (c) 2021 APA, all rights reserved).

The opioid epidemic is one of the greatest public health problems that the USA faces. Opioid overdose death rates have increased steadily for more than a decade and doubled in 2013-17, as the highly potent synthetic opioid fentanyl entered the drug supply. Demographics of new HIV diagnoses among people who inject drugs are also changing, with more new HIV diagnoses occurring among White people, young people (aged 13-34 years), and people who reside outside large central metropolitan areas. Racial differences also exist in syringe sharing, which decreased among Black people and Hispanic people but remained unchanged among White people in 2005-15. Recent HIV outbreaks have occurred in rural areas of the USA, as well as among marginalised people in urban areas with robust HIV prevention and treatment services (eg, Seattle, WA). Multiple evidence-based interventions can effectively treat opioid use disorder and prevent HIV acquisition. However, considerable barriers exist precluding delivery of these solutions to many people who inject drugs. If the USA is serious about HIV prevention among this group, stigma must be eliminated, discriminatory policies must change, and comprehensive health care must be accessible to all. Finally, root causes of the opioid epidemic such as hopelessness need to be identified and addressed.

With more than 1·2 million people living with HIV in the USA, a complex epidemic across the large and diverse country, and a fragmented health-care system marked by widening health disparities, the US HIV epidemic requires sustained scientific and public health attention. The epidemic has been stubbornly persistent; high incidence densities have been sustained over decades and the epidemic is increasingly concentrated among racial, ethnic, and sexual and gender minority communities. This fact remains true despite extraordinary scientific advances in prevention, treatment, and care-advances that have been led, to a substantial degree, by US-supported science and researchers. In this watershed year of 2021 and in the face of the COVID-19 pandemic, it is clear that the USA will not meet the stated goals of the National HIV/AIDS Strategy, particularly those goals relating to reductions in new infections, decreases in morbidity, and reductions in HIV stigma. The six papers in the Lancet Series on HIV in the USA have each examined the underlying causes of these challenges and laid out paths forward for an invigorated, sustained, and more equitable response to the US HIV epidemic than has been seen to date. The sciences of HIV surveillance, prevention, treatment, and implementation all suggest that the visionary goals of the Ending the HIV Epidemic initiative in the USA might be achievable. However, fundamental barriers and challenges need to be addressed and the research effort sustained if we are to succeed.

Background Limited specialty care access is a major contributor to rural health disparities. Extensions for Community Healthcare Outcomes (ECHO) is an innovative training and education strategy to address the need for trained specialty care in rural areas, such as West Virginia (WV). This article describes the successful implementation of ECHO projects in diverse subject areas facilitated by unique partnerships between the WV Clinical and Translational Science Institute (WVCTSI) and its practice partners. WV Project ECHO aims to provide education and training in specialty areas through the use of technology and partnerships. Methods A case-based session coupled with a brief relevant didactic presentation is used to amplify rural provider specialty expertise through education of primary care physicians (PCPs) in specific clinical areas. Foundational partnerships and impact are described. Conclusions Key lessons learned include leveraging existing partnerships and implementing projects based on provider needs. A unique result of WV Project ECHO is WV Medicaid's decision to accept case presentations made during the Hepatitis C ECHO session as the specialty consultation requirement (e.g., hepatologist or infectious diseases) for Medicaid coverage of hepatitis C drugs, thus increasing the number of patients receiving Hepatitis C treatment. A multi-partnered community approach facilitated by the widespread use of a technology-based provider education platform has facilitated the availability of curative therapy for a potentially fatal disease.

Background Merely having the tools to end HIV is insufficient. Effectively ending the epidemic necessitates addressing barriers that impede engagement in biomedical and behavioral prevention and wide scale implementation and utilization of existing interventions. This qualitative study identifies suggestions for increasing access to, engagement in, and impact of HIV prevention among women living in cities in high HIV burden counties in the eastern US. Methods Data analyzed for the current study were collected via a qualitative sub-study within the HIV Prevention Trials Network Study 064 (HPTN 064), a multisite observational cohort study designed to estimate HIV incidence among women residing in communities with elevated HIV prevalence who also reported personal or partner characteristics associated with increased risk of HIV acquisition. Focus group and interview participants in the qualitative sub-study (N = 288) were from four cities in the eastern US. Results Thematic analyses revealed four themes describing women’s most frequently stated ideas for improving prevention efforts: 1) Promote Multilevel Empowerment, 2) Create Engaging Program Content, 3) Build “Market Demand”, and 4) Ensure Accessibility. We conducted additional analyses to identify contradictory patterns in the data, which revealed an additional three themes: 1) Address Structural Risk Factors, 2) Increase Engagement via Pleasure Promotion, 3) Expand Awareness of and Access to Prevention Resources. Conclusions Findings may be useful for enhancing women’s engagement in and uptake of behavioral and biomedical HIV prevention resources, improving policy, and addressing multilevel risk factors. Trial registration Clinicaltrials.gov: NCT00995176, prospectively registered.

IMPORTANCERural communities are among the most underserved and resource-scarce populations in the United States (US), yet there are limited data on COVID-19 mortality in rural America. Furthermore, rural data are rarely centralized, precluding comparability across urban and rural regions.OBJECTIVEThe purpose of this study is to assess hospitalization rates and all-cause inpatient mortality among persons with definitive COVID-19 diagnoses residing in rural and urban areas.DESIGN, SETTINGS, AND PARTICIPANTSThis retrospective cohort study from the National COVID Cohort Collaborative (N3C) examines a cohort of 573,018 patients from 27 US hospital systems presenting with SARS-CoV-2 infection between January 2020 and March 2021, of whom 117,897 were hospitalized. A sample of 450,725 hospitalized persons without COVID-19 diagnoses was identified for comparison.EXPOSURESZIP Codes provided by source hospital systems were classified by urban-rural gradient through a crosswalk to the US Department of Agriculture Rural-Urban Commuting Area Codes.MAIN OUTCOMES AND MEASURESPrimary outcomes were hospitalization and all-cause mortality among hospitalized patients. Kaplan-Meier analysis and mixed effects logistic regression were used to estimate 30-day survival in hospitalized patients and associations between rurality, hospitalization, and inpatient mortality while controlling for major risk factors.RESULTSRural patients were more likely to be older, white, have higher body mass index, and diagnosed with SARS-CoV-2 later in the pandemic compared with their urban counterparts. Rural compared with urban inhabitants had higher rates of hospitalization (23% vs. 19%) and all-cause mortality among hospitalized patients (16% vs. 11%). After adjustment for demographic and baseline differences, rural residents (both urban adjacent and non-adjacent) with COVID-19 were more likely to be hospitalized (Adjusted Odds Ratio (AOR) 1.41, 95% Confidence Interval (CI), 1.37-1.45 and AOR 1.42, CI 1.35-1.50) and to die or be transferred to hospice (AOR 1.62, CI 1.30-1.49 and 1.38, CI 1.30-1.49), respectively. Similar differences in mortality were noted for hospitalized patients without SARS-CoV-2 infection.CONCLUSIONSHospitalization and inpatient mortality are higher among rural compared with urban persons with COVID-19, even after adjusting for several factors, including age and comorbidities. Further research is needed to understand the factors that drive health disparities in rural populations.KEY POINTSQUESTIONDo mortality and hospitalization rates among rural SARS-CoV-2 infected patients in the United States differ from that of their urban counterparts?FINDINGSHospitalization and mortality rates were significantly greater among rural compared with urban patients, even after adjusting for rural-urban differences including age and comorbidities. Similarly, in persons without SARS-CoV-2 infection, mortality rates were also higher among rural patients.MEANINGThese findings demonstrate a pervasive rural-urban discrepancy in all-cause inpatient mortality among rural individuals in the U.S. infected with SARS-COV-2 as well as among those who were uninfected. Further research is needed to understand factors driving health disparities among rural populations.

The SARS-CoV-2 pandemic has affected all types of global communities. Differences in urban and rural environments have led to varying levels of transmission within these subsets of the population. To fully understand the prevalence and impact of SARS-CoV-2 it is critical to survey both types of community. This study establishes the prevalence of SARS-CoV-2 in a rural community: Montgomery, West Virginia. Approximately 10% of participants exhibited serological or PCR-based results indicating exposure to SARS-CoV-2 within 6 months of the sampling date. Quantitative analysis of IgG levels against SARS-CoV-2 receptor binding domain (RBD) was used to stratify individuals based on antibody response to SARS-CoV-2. A significant negative correlation between date of exposure and degree of anti-SARS-CoV-2 RBD IgG (R2 = 0.9006) was discovered in addition to a correlation between neutralizing anti-SARS-CoV-2 antibodies (R2 = 0.8880) and days post exposure. Participants were confirmed to have normal immunogenic profiles by determining serum reactivity B. pertussis antigens commonly used in standardized vaccines. No significant associations were determined between anti-SARS-CoV-2 RBD IgG and age or biological sex. Reporting of viral-like illness symptoms was similar in SARS-CoV-2 exposed participants greater than 30 years old (100% reporting symptoms 30-60 years old, 75% reporting symptoms >60 years old) in contrast to participants under 30 years old (25% reporting symptoms). Overall, this axnalysis of a rural population provides important information about the SARS-CoV-2 pandemic in small rural communities. The study also underscores the fact that prior infection with SARS-CoV-2 results in antibody responses that wane over time which highlights the need for vaccine mediated protection in the absence of lasting protection.

The blood–brain barrier (BBB) presents a significant challenge for treating brain disorders. The hippocampus is a key target for novel therapeutics, playing an important role in Alzheimer’s disease (AD), epilepsy, and depression. Preclinical studies have shown that magnetic resonance (MR)-guided low-intensity focused ultrasound (FUS) can reversibly open the BBB and facilitate delivery of targeted brain therapeutics. We report initial clinical trial results evaluating the safety, feasibility, and reversibility of BBB opening with FUS treatment of the hippocampus and entorhinal cortex (EC) in patients with early AD. Six subjects tolerated a total of 17 FUS treatments with no adverse events and neither cognitive nor neurological worsening. Post-FUS contrast MRI revealed immediate and sizable hippocampal parenchymal enhancement indicating BBB opening, followed by BBB closure within 24 h. The average opening was 95% of the targeted FUS volume, which corresponds to 29% of the overall hippocampus volume. We demonstrate that FUS can safely, noninvasively, transiently, reproducibly, and focally mediate BBB opening in the hippocampus/EC in humans. This provides a unique translational opportunity to investigate therapeutic delivery in AD and other conditions.

Summary Given the range of pre‐exposure prophylaxis (PrEP) products currently being tested to prevent HIV in women, a standardized Acceptability and Use of PrEP Products Among Women Tool may facilitate comparisons of product acceptability and use across different geographies, trials, and users. We conducted three rounds of cognitive interviewing over 2 months in 2016, with 28 South African women who had experience participating in a range of PrEP product trials. The final instrument contained 41 items, including five new items that improved construct validity and 22 items modified for clarity. Changes were made due to unclear wording, difficulty answering, participant embarrassment, low response variability, and administrative formatting. Cognitive interviewing provided a means to address issues that would have inhibited this tool's ability to accurately collect data otherwise. This rapid, low‐cost study provided valuable insight into participants' understanding of questions and demonstrated the utility of cognitive interviewing in international clinical trials.

During the COVID-19 pandemic, West Virginia developed an aggressive SARS-CoV-2 testing strategy which included utilizing pop-up mobile testing in locations anticipated to have near-term increases in SARS-CXoV-2 infections. In this study, we describe and compare two methods for predicting near-term SARS-CoV-2 incidence in West Virginia counties. The first method, Rt Only, is solely based on producing forecasts for each county using the daily instantaneous reproductive numbers, Rt. The second method, ML+ Rt, is a machine learning approach that uses a Long Short-Term Memory network to predict the near-term number of cases for each county using epidemiological statistics such as Rt, county population information, and time series trends including information on major holidays, as well as leveraging statewide COVID-19 trends across counties and county population size. Both approaches used daily county-level SARS-CoV-2 incidence data provided by the West Virginia Department Health and Human Resources beginning April 2020. The methods are compared on the accuracy of near-term SARS-CoV-2 increases predictions by county over 17 weeks from January 1, 2021-April 30, 2021. Both methods performed well (correlation between forecasted number of cases and the actual number of cases week over week is 0.872 for the ML+Rt method and 0.867 for the Rt Only method) but differ in performance at various time points. Over the 17-week assessment period, the ML+Rt method outperforms the Rt Only method in identifying larger spikes. We also find that both methods perform adequately in both rural and non-rural predictions. Finally, we provide a detailed discussion on practical issues regarding implementing forecasting models for public health action based on Rt, and the potential for further development of machine learning methods that are enhanced by Rt.

This editorial review covers current trends in the epidemiology of HIV among people who inject drugs (PWID) in the United States, including four recent HIV outbreaks. We discuss gaps in the prevention and treatment cascades for HIV and medications for opioid disorder and propose lessons learned to prevent future HIV outbreaks. Over the last decade, North America has been in the throes of a major opioid epidemic, due in part to over-prescribing of prescription opiates, followed by increasing availability of cheap heroin, synthetic opioids (e.g. fentanyl), and stimulants (e.g. methamphetamine). Historically, HIV infection among PWID in the US had predominantly affected communities who were older, urban and Black. More recently, the majority of these infections are among younger, rural or suburban and Caucasian PWID. All four HIV outbreaks were characterized by a high proportion of women who inject drugs and underlying socioeconomic drivers such as homelessness and poverty. We contend that the US response to the HIV epidemic among PWID has been fractured. A crucial lesson is that when evidence-based responses to HIV prevention are undermined or abandoned because of moral objections, untold humanitarian and financial costs on public health will ensue. Restructuring a path forward requires that evidence-based interventions be integrated and brought to scale while simultaneously addressing underlying structural drivers of HIV and related syndemics. Failing to do so will mean that HIV outbreaks among PWID and the communities they live in will continue to occur in a tragic and relentless cycle.

BACKGROUND: The integrase inhibitor regimen [elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (TDF)] demonstrated superior efficacy when compared with a protease inhibitor regimen [ritonavir-boosted atazanavir (ATV + RTV) and FTC/TDF] in 575 treatment-naive women at week 48. We investigated the efficacy, safety, and tolerability of switching to a TAF-based, single-tablet regimen containing elvitegravir, cobicistat, FTC, and tenofovir alafenamide (E/C/F/TAF) versus remaining on ATV + RTV plus FTC/TDF. METHODS: After completing the initial randomized, blinded phase, virologically suppressed (HIV-1 RNA

AIDS in America Ending AIDS as a public health threat in the United States is achievable, but it will not be a simple endeavor. The effort can be informed by the latest advances in science and public health and by earlier bipartisan initiatives to tackle HIV globally.

Background Women and those with non-B subtype HIV-1 are typically underrepresented in clinical trials. WAVES (GS-US-236-0128) was a double-blind phase 3b study among treatment-naïve HIV-1-infected women that demonstrated that elvitegravir/cobicistat/emtricitabine/tenofovir DF (EVG/COBI/FTC/TDF; N = 289) was superior to atazanavir + ritonavir + FTC/TDF (ATV + RTV + FTC/TDF; N = 286) for HIV-1 RNA 50 copies/mL by FDA snapshot analysis at week 48. Here, we describe resistance development through week 48 in women with virologic failure and determine the impact of pre-existing mutations and HIV-1 subtype on viral suppression. Methods Genotypic analyses (population and deep sequencing) and phenotypic analyses of HIV-1 protease, reverse transcriptase (RT), and integrase (IN) were performed. The resistance analysis population (participants with HIV-1 RNA ≥ 400 copies/mL at confirmed virologic failure, at discontinuation ≥ week 8, or at week 48) had genotypic and phenotypic analyses at failure and baseline. Results The proportion of women qualifying for resistance analyses was similar between treatment groups (6.2% EVG/COBI/FTC/TDF; 7.3% ATV + RTV + FTC/TDF). Emergent resistance was rare (0% EVG/COBI/FTC/TDF; 1% ATV + RTV + FTC/TDF - 3 with M184V/I in RT). Deep sequencing of HIV-1 did not detect additional resistance development. Pre-existing mutations did not lead to virologic failure; most with the polymorphic primary IN substitution T97A (92%), or with substitutions in RT (i.e. A62V, V90I, K103N, or E138A/G/K/Q; 68-82%) demonstrated virologic suppression at week 48, with no resistance development except for one patient with M184V and pre-existing K103N in the ATV + RTV + FTC/TDF group. Most participants (74%) had non-B HIV-1, and subtype did not affect outcome. Conclusions Emergent resistance to study drugs was rare in this study of women, with no resistance observed among EVG/COBI/FTC/TDF-treated participants, despite a high proportion of participants with natural or transmitted viral mutations and non-B HIV-1 subtypes.

West Virginia is a rural state with an aging population that may experience barriers to accessing nutritional and lifestyle counseling. This study examined feasibility of an online personalized nutrition tracking application, Good Measures (GM), with patients at seven health care clinics throughout the state. Fourteen healthcare providers and 64 patients 18 years or older with a Body Mass Index (BMI) greater than or equal to 30 and access to the Internet were recruited for this 12-week feasibility study. Patient participants logged meals and exercise into the GM application via smart phone, tablet, or computer and virtually engaged with a Registered Dietitian Nutritionist (RDN) in one-on-one sessions. The primary endpoint was to examine feasibility of the program by usage of the application and feedback questions regarding the benefits and challenges of the application. Participants were predominately white (92%) and female (76%). Minimal improvements in weight and systolic blood pressure were found. Participant attitude survey data declined from 4-weeks to 12-weeks of the intervention. Interestingly though, patients in a rural clinic had lesser declines in attitudes than peri-urban participants. Qualitative feedback data identified participants predominately had a positive overall feeling toward the approach. Participants expressed favorability of RDN access, the variety of foods, but did give suggestions for in-person meetings and more updating of the application. Implementing a technology approach to nutrition in rural areas of West Virginia using a mobile application with RDN access may be one strategy to address public health issues such as obesity.

OBJECTIVE: Funding to address the current opioid epidemic has focused on treatment of opioid use disorder (OUD); however, rates of other substance use disorders (SUDs) remain high and non-opioid related overdoses account for nearly 30% of overdoses. This study assesses the prevalence of co-occurring substance use in West Virginia (WV) to inform treatment strategies. The objective of this study was to assess the prevalence of, and demographic and clinical characteristics (including age, gender, hepatitis C virus (HCV) status) associated with, co-occurring substance use among patients with OUD in WV. METHODS: This retrospective study utilized the West Virginia Clinical and Translation Science Institute Integrated Data Repository, comprised of Electronic Medical Record (EMR) data from West Virginia University Medicine. Deidentified data were extracted from inpatient psychiatric admissions and emergency department (ED) healthcare encounters between 2009 and 2018. Eligible patients were those with OUD who had a positive urine toxicology screen for opioids at the time of their initial encounter with the healthcare system. Extracted data included results of comprehensive urine toxicology testing during the study timeframe. RESULTS: 3,127 patients met the inclusion criteria of whom 72.8% had co-occurring substance use. Of those who were positive for opioids and at least one additional substance, benzodiazepines were the most common co-occurring substances (57.4% of patients yielded a positive urine toxicology screen for both substances), followed by cannabis (53.1%), cocaine (24.5%) and amphetamine (21.6%). Individuals who used co-occurring substances were younger than those who were positive for opioids alone (P < 0.001). There was a higher prevalence of individuals who used co-occurring substances that were HCV positive in comparison to those who used opioids alone (P < 0.001). There were limited gender differences noted between individuals who used co-occurring substances and those who used opioids alone. Among ED admissions who were positive for opioids, 264 were diagnosed with substance toxicity/overdose, 78.4% of whom had co-occurring substance use (benzodiazepines: 65.2%; cannabis: 44.4%; cocaine: 28.5%; amphetamine: 15.5%). Across the 10-year timespan, the greatest increase for the entire sample was in the rate of co-occurring amphetamine and opioid use (from 12.6% in 2014 to 47.8% in 2018). CONCLUSIONS: These data demonstrate that the current substance use epidemic extends well beyond opioids, suggesting that comprehensive SUD prevention and treatment strategies are needed, especially for those substances which do not yet have any evidence-based and/or medication treatments available.

Women living in poverty suffer more post-traumatic stress disorder (PTSD) symptoms than do members of the general population; however we know little about factors associated with changes in their PTSD symptoms over time. Using data from HPTN 064, a cohort of women from low-income, high-HIV-prevalence communities across six eastern states (n=1,860), we assessed the prevalence of and changes in PTSD symptoms over 12 months and the effect of potential predictors on symptom acquisition and remission (via the Primary Care-PTSD symptoms scale). Forty-three percent screened positive for PTSD symptoms. Those reporting food insecurity, ongoing abuse, depressive symptoms, or binge drinking were more likely to acquire PTSD symptoms. Those with ongoing abuse or depressive symptoms were less likely to experience PTSD symptom remission. Findings suggest a need to integrate programs to reduce abuse, depression, and economic hardship with those that address sexual health risks among women living in low-income, high-HIV-prevalence neighborhoods.

Background: Single-tablet regimens are preferred prescription choices for HIV treatment, but there are limited outcomes data comparing single-tablet regimens to multiple-tablet regimens. Methods: We retrospectively assessed treatment-naïve patients at a single urban HIV clinic in the United States for viral load suppression at 6 and 12 months after initiating either single-tablet or multiple-tablet regimens. Multivariate regression was performed to obtain relative risks and adjust for potential confounders. Results: Of 218 patients, 47% were on single-tablet regimens and 53% on multiple-tablet regimens; 77% of single-tablet regimen patients had undetectable viral load at 6 months compared to 61% of multiple-tablet regimen patients (p = 0.012). At 12 months, 82% on single-tablet regimens and 66% on multiple-tablet regimens (p = 0.019) had undetectable viral load. Relative risk of any detectable viral load was 1.6 (95% confidence interval: 1.1–2.5) for patients on multiple-tablet regimens compared to single-tablet regimens at 6 months, and 2.2 (95% confidence interval: 1.2–4.0) at 12 months. Conclusion: Single-tablet regimens may provide better virologic control than multiple-tablet regimens in urban HIV-infected persons.

Using data from HIV Prevention Trials Network 064, a multisite, observational cohort study conducted to estimate HIV incidence rates among women living in areas of high poverty and HIV prevalence in the United States, we examined the use of HIV risk characteristics to predict emotional abuse, physical violence, and forced sex.Participants included 2099 women, 18-44 years of age, who reported unprotected vaginal or anal sex with a male partner and an additional personal or perceived male partner HIV risk characteristic in the past 6 months. Adjusting for time-varying covariates, generalized estimating equations were used to assess the ability of HIV risk characteristics to predict violence 6 months later.Reported analyses were limited to the 1980 study participants who reported having a male sex partner at that assessment. Exchanging sex, perceived partner concurrency, and perceived partner incarceration were significantly predictive of emotional abuse 6 months later (adjusted odds ratio [AOR]: 1.60; 1.59; 1.34, respectively). Prior sexually transmitted infection diagnosis, exchanging sex, and binge drinking were significantly predictive of physical violence 6 months later (AOR: 1.62; 1.71; 1.47, respectively). None of the variables measured was significantly predictive of forced sex.Strategies that address reducing violence against women should be studied further in the context of HIV prevention programs.

Identifying venues where women meet sexual partners, particular partners who increase women's risk of acquiring HIV, could inform prevention efforts. We categorized venues where women enrolled in HPTN 064 reported meeting their last three sex partners as: (1) Formal, (2) Public, (3) Private, and (4) Virtual spaces. We used multinomial logistic regression to assess the association between these venues and women's individual characteristics and reports of their partners' HIV risk characteristics. The 2099 women reported meeting 3991 partners, 51 % at Public, 30 % Private, 17 % Formal and 3 % at Virtual venues. Women meeting partners at Formal venues reported more education and condom use than women meeting partners at other venues. Fewer partners met through Formal venues had "high" risk characteristics for HIV than through other venues and hence may pose less risk of HIV transmission. HIV prevention interventions can help women choose partners with fewer risk characteristics across all venue types.

We describe the sexual behaviors of women at elevated risk of HIV acquisition who reside in areas of high HIV prevalence and poverty in the US. Participants in HPTN 064, a prospective HIV incidence study, provided information about participants’ sexual behaviors and male sexual partners in the past 6 months at baseline, 6- and 12-months. Independent predictors of consistent or increased temporal patterns for three high-risk sexual behaviors were assessed separately: exchange sex, unprotected anal intercourse [UAI] and concurrent partnerships. The baseline prevalence of each behavior was >30% among the 2,099 participants, 88% reported partner(s) with > one HIV risk characteristic and both individual and partner risk characteristics decreased over time. Less than high school education and food insecurity predicted consistent/increased engagement in exchange sex and UAI, and partner's concurrency predicted participant concurrency. Our results demonstrate how interpersonal and social factors may influence sustained high-risk behavior by individuals and suggest that further study of the economic issues related to HIV risk could inform future prevention interventions.

Background Maraviroc (MVC) is a candidate drug for HIV preexposure prophylaxis (PrEP). Objective To assess the safety and tolerability of MVC-containing PrEP over 48 weeks in U.S. women at risk for HIV infection. Design Phase 2 randomized, controlled, double-blinded study of 4 antiretroviral regimens used as PrEP. (ClinicalTrials.gov: NCT01505114). Setting 12 clinical research sites of the HIV Prevention Trials Network and AIDS Clinical Trials Group. Participants HIV-uninfected women reporting condomless vaginal or anal intercourse with at least 1 man with HIV infection or unknown serostatus within 90 days. Intervention MVC only, MVC-emtricitabine (FTC), MVC-tenofovir disoproxil fumarate (TDF), and TDF-FTC (control). Measurements At each visit, clinical and laboratory (including HIV) assessments were done. Primary outcomes were grade 3 and 4 adverse events and time to permanent discontinuation of the study regimen. All randomly assigned participants were analyzed according to their original assignment. Results Among 188 participants, 85% completed follow-up, 11% withdrew early, and 4% were lost to follow-up; 19% discontinued their regimen prematurely. The number discontinuing and the time to discontinuation did not differ among regimens. Grade 3 or 4 adverse events occurred in 5 (MVC), 13 (MVC-FTC), 9 (MVC-TDF), and 8 (TDF-FTC) participants; rates did not differ among regimens. One death (by suicide) occurred in the MVC-TDF group but was judged not to be related to study drugs. Of available plasma samples at week 48 (n = 126), 60% showed detectable drug concentrations. No new HIV infections occurred. Limitations Participants were not necessarily at high risk for HIV infection. The regimen comprised 3 pills taken daily. The study was not powered for efficacy. Conclusion Maraviroc-containing PrEP regimens were safe and well-tolerated compared with TDF-FTC in U.S. women. No new HIV infections occurred, although whether this was due to study drugs or low risk in the population is uncertain. Maraviroc-containing PrEP for women may warrant further study. Primary Funding Source National Institutes of Health.

Knowledge of sexual partners’ HIV infection can reduce risky sexual behaviors. Yet, there are no published studies to-date examining prevalence and characteristics associated with knowledge among African-American women living in high poverty communities disproportionately affected by HIV. Using the HIV Prevention Trial Network’s (HPTN) 064 Study data, multivariable logistic regression was used to examine individual, partner, and partnership-level determinants of women’s knowledge (n = 1,768 women). Results showed that women’s demographic characteristics alone did not account for the variation in serostatus awareness. Rather, lower knowledge of partner serostatus was associated with having two or more sex partners (OR = 0.49, 95 % CI 0.37–0.65), food insecurity (OR = 0.68, 95 % CI 0.49–0.94), partner age >35 years (OR = 0.68, 95 % CI 0.49–0.94), and partner concurrency (OR = 0.63, 95 % CI 0.49–0.83). Access to financial support (OR = 1.42, 95 % CI 1.05–1.92) and coresidence (OR = 1.43, 95 % CI 1.05–1.95) were associated with higher knowledge of partner serostatus. HIV prevention efforts addressing African-American women’s vulnerabilities should employ integrated behavioral, economic, and empowerment approaches.

Substance use is associated with HIV sexual risk behaviors, yet few studies have examined substance use patterns longitudinally. We evaluated the types and frequency of substances used over a six-month period among U.S. women at risk for HIV acquisition.Women reporting unprotected sex with a man in the previous six months and at least one other personal or partner HIV risk characteristic enrolled in a multisite cohort study and completed interviews about substance use at study visits. Prevalence and frequency of substance use at the baseline and six-month visits were compared and correlates of decreased substance use at the six-month visit were assessed.Of 2099 women enrolled, 1882 had substance use data at baseline and six-months. Of these, 76.1% reported using at least one drug or binge drinking in the previous six months; 37.5% were frequent and 38.6% non-frequent substance users. Binge drinking was most frequently reported (63.3%), followed by cocaine (25.0%) and opioids (16.5%). Fifty-five percent of opiate users and 30% of cocaine users reported daily/almost daily use. At the six-month visit, 40.5% reported a decrease in frequency of use. Adjusting for income and type of drug used, poly-substance users were less likely to decrease frequency of use compared to those who only used one substance.A substantial decrease in frequency of substance use over time was observed in this cohort. Poly-substance users were less likely to reduce frequency of use over time, suggesting that specific substance use interventions targeting these users are warranted.

Multiassay algorithms (MAAs) can be used to estimate cross-sectional HIV incidence. We previously identified a robust MAA that includes the BED capture enzyme immunoassay (BED-CEIA), the Bio-Rad Avidity assay, viral load, and CD4 cell count. In this report, we evaluated MAAs that include a high-resolution melting (HRM) diversity assay that does not require sequencing. HRM scores were determined for eight regions of the HIV genome (2 in gag , 1 in pol , and 5 in env ). The MAAs that were evaluated included the BED-CEIA, the Bio-Rad Avidity assay, viral load, and the HRM diversity assay, using HRM scores from different regions and a range of region-specific HRM diversity assay cutoffs. The performance characteristics based on the proportion of samples that were classified as MAA positive by duration of infection were determined for each MAA, including the mean window period. The cross-sectional incidence estimates obtained using optimized MAAs were compared to longitudinal incidence estimates for three cohorts in the United States. The performance of the HRM-based MAA was nearly identical to that of the MAA that included CD4 cell count. The HRM-based MAA had a mean window period of 154 days and provided cross-sectional incidence estimates that were similar to those based on cohort follow-up. HIV diversity is a useful biomarker for estimating HIV incidence. MAAs that include the HRM diversity assay can provide accurate HIV incidence estimates using stored blood plasma or serum samples without a requirement for CD4 cell count data.

Author(s): Amico, K Rivet; Ramirez, Catalina; Caplan, Margaret R; Montgomery, Brooke Ee; Stewart, Jennifer; Hodder, Sally; Swaminathan, Shobha; Wang, Jing; Darden-Tabb, Noshima Y; McCauley, Marybeth; Mayer, Kenneth H; Wilkin, Timothy; Landovitz, Raphael J; Gulick, Roy; Adimora, Adaora A; HPTN 069/A5305 Study Team and HPTN Women at Risk Committee | Abstract: IntroductionLimited data exist on acceptability of candidate pre-exposure prophylaxis (PrEP) regimens among US women. We evaluated PrEP experiences, attitudes and future use intentions among sexually active women who completed the US-based HIV Prevention Trials Network 069/AIDS Clinical Trials Group 5305 study.MethodsWomen participated in the study between March 2013 and November 2015. We analysed computer-assisted self-interview (CASI) surveys among 130 women and conducted in-depth interviews among a subset of 26 women from three sites. Interviews were conducted in mid/late-2015.ResultsMost women (57%) reported very good/excellent PrEP adherence on CASI, although 21% acknowledged over-reporting adherence at least some of the time. Commitment to preventing HIV infection, a sense of ownership of the study, and keeping pills stored in a visible location facilitated adherence. Adherence barriers included "simply forgetting" and being away from home. Most women interviewed did not intend to use PrEP in the future because of lack of perceived need due to their own (as opposed to their partners') low-risk behaviour and concerns about affordability - but not because of side effects or other characteristics of the regimens.DiscussionImproving HIV prevention options for US women will require access to affordable PrEP as well as expanding women's understanding of relationship- and community-level factors that increase their risk of acquiring HIV.

Week 96 efficacy and safety of the non-nucleoside reverse transcriptase inhibitor (NNRTI) rilpivirine (RPV) was compared to efavirenz (EFV) in subset of 1,096 subjects who received emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) in pooled data from 2 phase 3 studies.ECHO and THRIVE are double-blind, double-dummy, randomized, active-controlled, non-inferiority phase 3 studies of RPV versus EFV plus 2 NRTIs in antiretroviral-naïve adult subjects. The primary and secondary endpoints were the proportion of subjects with HIV-1 RNA50 copies/ mL using an intent-to-treat, time to loss of virologic response (ITT-TLOVR) analysis at weeks 48 and 96, respectively. Safety, tolerability, immunologic response, adherence level, and other measures were also evaluated.At week 48, noninferior efficacy of RPV+FTC/TDF over EFV+FTC/TDF was established, and at week 96 RPV+FTC/TDF remained noninferior (77% overall response rate in both groups). Through week 96, rates of virologic failure were higher in the RPV+FTC/ TDF group, with low and similar rates of virologic failure and resistance mutations occurring during the second year of follow-up. Treatment with RPV+FTC/TDF was associated with a lower rate of discontinuation due to adverse events and grade 2-4 adverse events including dizziness, abnormal dreams/nightmares, rash, and lipid abnormalities.The pooled ECHO and THRIVE studies demonstrated noninferiority of RPV+FTC/TDF in achieving virologic response with safety and tolerability advantages over EFV+FTC/TDF through 96 weeks. Higher rates of virologic failure in the RPV+FTC/TDF group were balanced with higher rates of discontinuations due to adverse events in the EFV+FTC/TDF group.

Background ODIN (once-daily darunavir in treatment-experienced patients) was a 48-week, phase III, randomized, open-label trial comparing once-daily (qd) darunavir/ritonavir (DRV/r) 800/100 mg with twice-daily (bid) DRV/r 600/100 mg, both with an optimized background regimen [OBR; at least two nucleoside reverse transcriptase inhibitors (NRTIs)], in treatment-experienced, HIV-1-infected adults with no DRV resistance-associated mutations (RAMs) at screening. Week 48 analyses of virological response by subgroups are reported. Methods A total of 590 patients were randomized to receive qd (n = 294) or bid (n = 296) DRV/r. Virological response (HIV-1 RNA 50 000 copies/mL. Response rates for the qd and bid treatment arms by baseline CD4 cell count were also similar (69.6 vs. 65.2% for

This chapter describes the study from which these data were taken. The study was designed to estimate HIV incidence among women living in neighborhoods characterized by high levels of poverty and high prevalence of HIV infection. Anticipating that the incidence might be high, we wished to contextualize our findings by describing the lives of these women living in poverty. The chapter gives some background information on poverty and HIV in women, and then describes the study design, eligibility criteria, procedures, and results.

We sought to understand the multilevel syndemic factors that are concurrently contributing to the HIV epidemic among women living in the USA. We specifically examined community, network, dyadic, and individual factors to explain HIV vulnerability within a socioecological framework. We analyzed data from four diverse locations: Atlanta, New York City (the Bronx), Raleigh/Durham, and Washington, D.C. The following themes were identified at four levels including (1) exosystem (community): poverty prevalence, discrimination, gender imbalances, community violence, and housing challenges; (2) mesosystem (network): organizational social support and sexual concurrency; (3) microsystem (dyadic): sex exchange, interpersonal social support, and intimate partner violence; and (4) individual: HIV/STI awareness, risk taking, and substance use. A strong theme emerged with over 80 % of responses linked to the fundamental role of financial insecurity underlying risk-taking behavioral pathways. Multilevel syndemic factors contribute to women’s vulnerability to HIV in the USA. Financial insecurity is a predominant theme, suggesting the need for tailored programming for women to reduce HIV risk.

This chapter discusses the methods used to collect and analyze data for the HIV Prevention Trials Network (HPTN) 064 Study. Four study sites (the Bronx, NY; Washington, D.C.; Raleigh/Durham, NC; and Atlanta/Decatur, GA) conducted semi-structured interviews (SSIs) and focus groups (FGs) between June 2009 and August 2010 designed to explore social, structural, and contextual factors related to HIV risk among participants. We conducted 120 SSIs (30 per site) and 32 FGs (6–12 per site). SSI participants were selected using sequential sampling and quota sampling was used to identify FG participants. All transcripts were structurally coded, a method that identified text associated with each question in the SSI/FG guide. A random sample of transcripts (36 [30 %] of SSIs, 16 [51 %] of FGs) was selected for advanced systematic coding and analysis. Saturation (i.e., no new codes emerged) was achieved once 90 % of the sample was coded. Twenty percent of the transcripts were double-coded and intercoder reliability (ICR) was assessed throughout coding. The final ICR was a combined average Kappa score of 0.92. Data were analyzed using NVivo (QSR International Zty Ltd. Version 9.0).

Background Persistent immune activation and inflammation in virologically suppressed human immunodeficiency virus (HIV) infection are linked to excess cardiovascular risk. Objective To evaluate atorvastatin as a strategy to reduce cardiovascular risk. Methods A5275 was a multicenter, prospective, randomized, double-blind, placebo-controlled, cross-over pilot study of atorvastatin (10 mg/day for 4 weeks then 20 mg/day for 16 weeks) with a planned enrollment of 97 HIV-infected participants ≥18 years old, receiving boosted protease inhibitor–based antiretroviral therapy for ≥6 months, with plasma HIV-1 RNAs below limits of quantification ≥180 days, and fasting low-density lipoprotein (LDL) cholesterol ≥70 and + /DR + ) and plasma levels of IL-6 and D-dimer. Arms were compared using the Wilcoxon rank-sum tests and also summarized changes pre-to-post atorvastatin treatment. Analyses were as-treated. Results Ninety-eight participants were enrolled at 31 U S sites and 73 completed study treatment. Atorvastatin treatment did not decrease T-lymphocyte or monocyte activation, circulating biomarker levels (interleukin-6, D-dimer, soluble CD14, soluble CD163, monocyte chemoattractant protein-1, interferon-gamma–induced protein-10, high-sensitivity C-reactive protein, CD40L, and P-selectin) or white blood cell Kruppel-like Factor 2/4 messenger RNA levels. Pre-to-post atorvastatin reductions in calculated LDL (−38%), oxidized-LDL (−33%), and lipoprotein-associated phospholipase A2 (−31%) were significant ( P Conclusion In virologically suppressed individuals with HIV infection, atorvastatin did not significantly decrease levels of soluble or cellular biomarkers of immune activation and inflammation but resulted in robust reductions in LDL cholesterol, oxLDL, and lipoprotein-associated phospholipase A 2 , biomarkers associated with cardiovascular risk.

Summary Background Women are under-represented in HIV antiretroviral therapy (ART) studies. Guidelines for selection of ART as initial therapy in patients with HIV-1 infection do not contain sex-specific treatment. We aimed to assess the safety and efficacy of the single tablet integrase inhibitor regimen containing elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate compared with a boosted protease inhibitor regimen of ritonavir-boosted atazanavir with emtricitabine and tenofovir disoproxil fumarate. Methods In this international, randomised, controlled, double-blind, phase 3 study (Women AntiretroViral Efficacy and Safety study [WAVES]), we recruited treatment-naive HIV-infected women with an estimated creatinine clearance of 70 mL/min or higher from 80 centres in 11 countries. Women were randomly assigned (1:1) to receive elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate (integrase inhibitor regimen) or ritonavir-boosted atazanavir with emtricitabine and tenofovir disoproxil fumarate (protease inhibitor based regimen); regimens were masked with matching placebos. Randomisation was done by a computer-generated allocation sequence (block size four) and was stratified by HIV-1 RNA viral load and race. Investigators, patients, study staff, and those assessing outcomes were masked to treatment group. All participants who received one dose of study drug were included in the primary efficacy and safety analyses. The main outcome was the proportion of patients with plasma HIV-1 RNA less than 50 copies per mL at week 48 as defined by US Food and Drug Administration snapshot algorithm (prespecified non-inferiority margin of 12%). This study is registered with ClinicalTrials.gov, number NCT01705574. Findings Between Nov 28, 2012, and March 12, 2014, 575 women were enrolled. 289 were randomly assigned to receive the integrase inhibitor regimen and 286 to receive the protease inhibitor based regimen. 252 (87%) women in the integrase inhibitor group had plasma HIV-1 RNA less than 50 copies per mL at week 48 compared with 231 (81%) women in the protease inhibitor group (adjusted difference 6·5%; 95% CI 0·4–12·6). No participant had virological failure with resistance in the integrase inhibitor group compared with three participants ([1%]; all Met184Val/Ile) in the protease inhibitor group. 19 women in the protease inhibitor group discontinued because of adverse events compared with five in the integrase inhibitor group. Interpretation WAVES shows that clinical trials of ART regimens in global and diverse populations of treatment-naive women are possible. The findings support guidelines recommending integrase inhibitor based regimens in first-line antiretroviral therapy. Funding Gilead Sciences.

Background It remains debated whether to include resting electrocardiogram (ECG) in the routine care of human immunodeficiency virus (HIV)–infected patients. Methods This analysis included 4518 HIV-infected patients (28% women and 29% blacks) from the Strategies for Management of Antiretroviral Therapy study, a clinical trial aimed to compare 2 HIV treatment strategies. ECG abnormalities were classified using the Minnesota Code. Cox proportional hazards analysis was used to examine the association between baseline ECG abnormalities and incident cardiovascular disease (CVD). Results More than half of the participants (n = 2325, or 51.5%) had either minor or major ECG abnormalities. Minor ECG abnormalities (48.6%) were more common than major ECG abnormalities (7.7%). During a median follow-up of 28.7 months, 155 participants (3.4%) developed incident CVD. After adjusting for the study-treatment arms, the presence of major, minor, and either minor or major ECG abnormalities was significantly predictive of incident CVD (hazard ratio [95% confidence interval]: 2.76 [1.74-4.39], P P = .006; 1.57 [1.14-2.18], P = .006, respectively). However, after adjusting for demographics, CVD risk factors, and HIV characteristics (full model), presence of major ECG abnormalities were still significantly predictive of CVD (1.83 [1.12-2.97], P = .015) but not minor or major abnormalities taken together (1.26 [0.89-1.79], P = .18; 1.25 [0.89-1.76], P = .20, respectively). Individual ECG abnormalities that significantly predicted CVD in the fully adjusted model included major isolated ST-T abnormalities, major prolongation of QT interval, minor isolated ST-T, and minor isolated Q-QS abnormalities. Conclusion Nearly 1 in 2 of the HIV-infected patients in our study had ECG abnormalities; 1 in 13 had major ECG abnormalities. Presence of ECG abnormalities, especially major ECG abnormalities, was independently predictive of incident CVD. These results suggest that the ECG could provide a convenient risk-screening tool in HIV-infected patients.

The objective of this study was to describe attitudes, opinions, and perceived health needs of HIV-infected women in the United States. In this cross-sectional study, women were invited to participate in the Women Living Positive survey, a structured interview instrument with 45 questions. Collected data were deidentified and the margin of error was calculated as four percentage points. Incoming toll-free phone interviews were conducted from December 21, 2006, through March 14, 2007 among subjects recruited from a U.S. national network of AIDS counseling centers. Seven hundred HIV-infected women (43% African American, 28.5% Hispanic, 28.5% Caucasian; median age, 42.5 years) receiving combination antiretroviral therapy for 3 years or more replied to recruitment flyers. Overall, 55% of survey participants had never discussed gender-specific HIV treatment issues with their HIV care providers. Of the 45% who did discuss these issues, almost all (96%) were satisfied. On average, one-third of the women had seen three or more providers since beginning HIV treatment; 43% indicated they had switched providers because of communication issues. Among women who had been or were pregnant at the time of the survey (n=159), more than half (57%) had not had pre-pregnancy discussions with their HIV provider about the most appropriate HIV regimens for women attempting to become pregnant. Significant communication gaps exist between HIV-infected women and their providers when discussing gender-specific treatment issues. These data highlight a need for U.S. health care providers to incorporate discussion of gender-specific issues, including preconception and reproductive counseling, into management strategies for HIV-infected women.

HIV/AIDS trends in the United States depict a concentrated epidemic with hot spots that vary by location, poverty, race/ethnicity, and transmission mode. HIV/AIDS is a leading cause of death among US women of color; two thirds of new infections among women occur in black women, despite the fact that black women account for just 14% of the US female population. The gravity of the HIV epidemic among US women is often not appreciated by those at risk as well as by the broader scientific community. We summarize the current epidemiology of HIV/AIDS among US women and discuss clinical, research, and public health intervention components that must be brought together in a cohesive plan to reduce new HIV infections in US women. Only by accelerating research and programmatic efforts will the hidden epidemic of HIV among US women emerge into the light and come under control.

Highly active antiretroviral therapy has substantially improved the outlook for persons with HIV, and the combination of clinical trial data and experience has provided guidance for the best use of highly active antiretroviral therapy to balance efficacy, safety, tolerability, and adherence. The nonnucleoside reverse transcriptase inhibitors (NNRTIs) and several of the boosted protease inhibitors (PIs, eg, lopinavir/ritonavir) have shown high levels of viral suppression and CD4 count increases as initial therapy. Preliminary evidence suggests that NNRTI regimens may be more forgiving of certain levels of nonadherence than PIs. The evidence also shows that not all agents or combinations of agents are appropriate for all HIV patients. Patient factors such as lipids and triglycerides, hyperglycemia/diabetes, renal function, weight, gender, probability of and desire for pregnancy, initial CD4 count, race, and mental health status will all need to be considered to select the best therapy for the individual.