An Evaluation of the Performance, Patient Acceptability and Feasibility of a Point-of-Care HIV-Syphilis Assay in an Urban Emergency Department.

BACKGROUND: Point-of-care (POC) tests for sexually transmitted infections (STIs) permit delivery of results during the patient's emergency department (ED) encounter. We evaluated performance, patient acceptability, and feasibility of a new duplex POC test, Chembio DPP® HIV-Syphilis Assay in an urban ED setting. METHODS: Convenience sampling approach prioritizing those considered at increased risk for an STI and/or with a history of HIV. For the performance evaluation, participants were tested for HIV/syphilis with the Chembio POC assay, and the reference laboratory tests; sensitivity and specificity were determined. For the patient acceptability evaluation, participants completed pre- and post-user surveys. For the feasibility evaluation, ED clinical technicians completed a survey evaluating their perceptions regarding feasibility of use of this POC test. RESULTS: 327 patients were consented and enrolled. The diagnostic sensitivity and specificity of the Chembio POC assay for HIV was 96.5% (95% CI: 90.1%, 99.3%) and 99.6% (95% CI: 97.7%, 100.0%), respectively, and for syphilis was 93.9% (95% CI: 85.0%, 98.3%) and 99.6% (95% CI: 97.9%, 100.0%), respectively. Regarding patient acceptability: 87% trusted the result; and 93% reported they were more likely to seek treatment if they received a positive STI test result in the ED rather than after the ED visit. Regarding feasibility: 90% of the technicians reported they would recommend using the test in EDs. CONCLUSIONS: The Chembio DPP® HIV-Syphilis POC assay had excellent performance characteristics when evaluated in an ED population, as well as high perceived acceptability from patients, and feasibility for ED use from clinical technicians. The test may have utility for HIV-syphilis screening among high-risk ED patients.

Human-centered design development of mHealth patient-to-peer referral tool in the emergency department.

Background: Given the steady increase of emergency department (ED) visits related to opioid overdoses, this study aims to determine the design and usability of an ED-centered mHealth patient-to-peer referral prototype tool that allows patients to refer peers to comprehensive HIV/HCV and opioid misuse prevention services. Methods: Two iterative focus group discussion (FDG) sessions and one use-case session were conducted. Eligible participants who were ≥18 years, had a history of injection drug use (IDU), and had utilized the ED in the past year were recruited through the distribution of flyers at the study institution, including the study ED. Human-centered design process was completed by using participant feedback on perceived utility, usability/accessibility, tool design, and clarity/readability to fine-tune prototype version and drive subsequent discussion sessions. Results: Sixteen consented individuals participated in at least one of the sessions. Feedback revealed that participants favored the inclusion of the webpage link on the referral card as means to bypass QR code if needed, more descriptions highlighting the exact services offered, and the fact that no personal information was required to complete the referral process. The prototype underwent several adjustments between user-centered FDG sessions, which ultimately ended in including features such as an online webpage with educational videos, SMS text-message communication system, and QR code usage into the final patient-to-peer referral tool prototype. Conclusion: The findings of this study suggest a human-centered designed patient-to-peer referral tool could be a feasible approach to linking community members at risk of IDU to HIV/HCV and opioid use-related preventive services from ED patients.

A pilot study of a mixed-method approach to design an ED-based peer mHealth referral tool for HIV/HCV and opioid overdose prevention services.

BACKGROUND: The intersecting epidemics of opioid misuse, injection drug use, and HIV/HCV have resulted in record overdose deaths and sustained high levels of HIV/HCV transmissions. Literature on social networks suggests opportunities to connect people who use drugs (PWUD) and their peers to HIV/HCV and opioid overdose prevention services. However, little evidence exists on how to design such peer referral interventions in emergency department (ED) settings. METHODS: A mixed-method study was conducted to assess the feasibility of an mHealth-facilitated 'patient to peer social network referral program' for PWUD. In-depth interviews (IDIs) and quantitative surveys were conducted with urban ED patients (n = 15), along with 3 focus group discussions (FGDs) (n = 19). RESULTS: Overall, 34 participants were enrolled (71 % males, 53 % Black). 13/15 IDI participants reported a history of opioid overdose; all had witnessed overdose events; all received HIV/HCV testing. From survey responses, most would invite their peers for HIV/HCV testing and naloxone training; and anticipated peers to accept referrals (HIV: 60 %, HCV: 73 %, naloxone: 93 %). Qualitative data showed PWUD shared health-related information with each other but preferred word of mouth rather than text messages. Participants used smartphones regularly and suggested using Internet advertising for prevention services. Participants expressed enthusiasm for ED-based peer mHealth referral platform to prevention services, as well as referring their peers to proposed services, with monetary incentives. CONCLUSION: ED-based peer referral intervention to HIV/HCV testing and naloxone training was viewed favorably by PWUD. Frequent smartphone use among PWUD suggests that the medium could be a promising mode for peer referral.

Characteristics of SARS-CoV-2 Seropositivity among Emergency Department Healthcare Workers at a Tertiary Care Center in Baltimore.

Early in the COVID-19 pandemic (March−July 2020 in Baltimore), emergency department (ED) healthcare workers (HCWs) were considered to be at greater risk of contracting SARS-CoV-2. Limited data existed, however, on the prevalence of SARS-CoV-2 infection and its impact in this workforce population. We enrolled 191 ED HCWs from a tertiary academic center, administered baseline and weekly surveys, and tested them twice (July and December 2020) for serum antibodies against SARS-CoV-2 spike protein. Approximately 6% (11 of 191, 5.8%) of ED HCWs had spike antibodies in July, a prevalence that doubled by December (21 of 174, 12.1%). A positive PCR test was self-reported by 15 of 21 (71%) seropositive and 6 of 153 (4%) seronegative HCWs (p < 0.001). Of the total 27 HCWs who had antibodies and/or were PCR positive, none required hospitalization, 18 (67%) had a self-perceived COVID-19 illness, and 12 of the 18 reported symptoms. The median number of missed workdays was 8.5 (ranging from 2 to 21). While most seropositive ED HCWs who reported symptoms took work absences, none required hospitalization, indicating that COVID-19's impact on staffing prior to vaccination was not as great as feared.

Impact of coinfection status and comorbidity on disease severity in adult emergency department patients with influenza B.

BACKGROUND: Influenza B accounts for approximately one fourth of the seasonal influenza burden. However, research on the importance of influenza B has received less attention compared to influenza A. We sought to describe the association of both coinfections and comorbidities with disease severity among adults presenting to emergency departments (ED) with influenza B. METHODS: Nasopharyngeal samples from patients found to be influenza B positive in four US and three Taiwanese ED over four consecutive influenza seasons (2014-2018) were tested for coinfections with the ePlex RP RUO panel. Multivariable logistic regressions were fitted to model adjusted odds ratios (aOR) for two severity outcomes separately: hospitalization and pneumonia diagnosis. Adjusting for demographic factors, underlying health conditions, and the National Early Warning Score (NEWS), we estimated the association of upper respiratory coinfections and comorbidity with disease severity (including hospitalization or pneumonia). RESULTS: Amongst all influenza B positive individuals (n = 446), presence of another upper respiratory pathogen was associated with an increased likelihood of hospitalization (aOR = 2.99 [95% confidence interval (95% CI): 1.14-7.85, p = 0.026]) and pneumonia (aOR = 2.27 [95% CI: 1.25-4.09, p = 0.007]). Chronic lung diseases (CLD) were the strongest predictor for hospitalization (aOR = 3.43 [95% CI: 2.98-3.95, p < 0.001]), but not for pneumonia (aOR = 1.73 [95% CI: 0.80-3.78, p = 0.166]). CONCLUSION: Amongst ED patients infected with influenza B, the presence of other upper respiratory pathogens was independently associated with both hospitalization and pneumonia; presence of CLD was also associated with hospitalization. These findings may be informative for ED clinician's in managing patients infected with influenza B.

Effect of Vitamin C, Thiamine, and Hydrocortisone on Ventilator- and Vasopressor-Free Days in Patients With Sepsis: The VICTAS Randomized Clinical Trial.

Importance: Sepsis is a common syndrome with substantial morbidity and mortality. A combination of vitamin C, thiamine, and corticosteroids has been proposed as a potential treatment for patients with sepsis. Objective: To determine whether a combination of vitamin C, thiamine, and hydrocortisone every 6 hours increases ventilator- and vasopressor-free days compared with placebo in patients with sepsis. Design, Setting, and Participants: Multicenter, randomized, double-blind, adaptive-sample-size, placebo-controlled trial conducted in adult patients with sepsis-induced respiratory and/or cardiovascular dysfunction. Participants were enrolled in the emergency departments or intensive care units at 43 hospitals in the United States between August 2018 and July 2019. After enrollment of 501 participants, funding was withheld, leading to an administrative termination of the trial. All study-related follow-up was completed by January 2020. Interventions: Participants were randomized to receive intravenous vitamin C (1.5 g), thiamine (100 mg), and hydrocortisone (50 mg) every 6 hours (n = 252) or matching placebo (n = 249) for 96 hours or until discharge from the intensive care unit or death. Participants could be treated with open-label corticosteroids by the clinical team, with study hydrocortisone or matching placebo withheld if the total daily dose was greater or equal to the equivalent of 200 mg of hydrocortisone. Main Outcomes and Measures: The primary outcome was the number of consecutive ventilator- and vasopressor-free days in the first 30 days following the day of randomization. The key secondary outcome was 30-day mortality. Results: Among 501 participants randomized (median age, 62 [interquartile range {IQR}, 50-70] years; 46% female; 30% Black; median Acute Physiology and Chronic Health Evaluation II score, 27 [IQR, 20.8-33.0]; median Sequential Organ Failure Assessment score, 9 [IQR, 7-12]), all completed the trial. Open-label corticosteroids were prescribed to 33% and 32% of the intervention and control groups, respectively. Ventilator- and vasopressor-free days were a median of 25 days (IQR, 0-29 days) in the intervention group and 26 days (IQR, 0-28 days) in the placebo group, with a median difference of -1 day (95% CI, -4 to 2 days; P = .85). Thirty-day mortality was 22% in the intervention group and 24% in the placebo group. Conclusions and Relevance: Among critically ill patients with sepsis, treatment with vitamin C, thiamine, and hydrocortisone, compared with placebo, did not significantly increase ventilator- and vasopressor-free days within 30 days. However, the trial was terminated early for administrative reasons and may have been underpowered to detect a clinically important difference. Trial Registration: ClinicalTrials.gov Identifier: NCT03509350.

Intravenous peramivir vs oral oseltamivir in high-risk emergency department patients with influenza: Results from a pilot randomized controlled study.

BACKGROUND: Peramivir offers a single-dose intravenous (IV) treatment option for influenza (vs 5-day oral dosing for oseltamivir). We sought to compare outcomes of emergency department (ED) patients at high risk for influenza complications treated with IV peramivir vs oral oseltamivir. METHODS: During the 2015-16 and 2016-17 influenza seasons, adult patients in two US EDs were randomized to either oral oseltamivir or IV peramivir treatment group. Eligibility included positive molecular influenza test; met CDC criteria for antiviral treatment; able to provide informed consent and agree to follow-up assessment. Outcomes were measured by clinical end-point indicators, including FLU-PRO Score, Ordinal Scale, Patient Global Impression on Severity Score, and Karnofsky Performance Scale for 14 days. Non-inferior t test was performed to assess comparative outcomes between the two groups. RESULTS: Five hundred and seventy-five (68%) of 847 influenza-positive patients were approached. Two hundred and eighty-four met enrollment criteria and 179 were enrolled; of these 95 (53%) were randomized to peramivir, and 84 to oseltamivir. Average FLU-PRO score at baseline was similar (peramivir: 2.67 vs oseltamivir: 2.52); the score decreased over time for both groups (day 5: peramivir: 1.71 vs oseltamivir: 1.62; day 10: peramivir: 1.48 vs oseltamivir: 1.37; day 14: peramivir: 1.40 vs oseltamivir: 1.33; all P < .05 for significantly non-inferior). Influenza-related complications were similar between two groups (All: peramivir: 31% vs oseltamivir: 21%, P > .05; pneumonia: peramivir: 11% vs oseltamivir: 14%, P > .05). CONCLUSIONS: Clinical outcomes of influenza-infected patients treated with single-dose IV peramivir were comparable to those treated with oral oseltamivir, suggesting potential utility of peramivir for influenza-infected patients in the ED.

Application of measurement error models to correct for systematic differences among readers and vendors in echocardiography measurements: the CARDIA study.

We illustrate the application of linear measurement error models to calibrate echocardiography measurements acquired 20 years apart in the CARDIA study. Of 4242 echocardiograms acquired at Year-5 (1990-1991), 36% were reread 20 years later. Left ventricular (LV) mass and 8 other measurements were assessed. A machine reproducibility study including 96 additional patients also compared Year-5 and Year-25 equipment. A linear measurement error model was developed to calibrate the original Year-5 measurements, incorporating the additional Year-5 reread and machine reproducibility study data, and adjusting for differences among readers and machines. Median (quartiles) of original Year-5 LV mass was 144.4 (117.6, 174.2) g before and 129.9 (103.8, 158.6) g, after calibration. The correlation between original and calibrated LV mass was 0.989 (95% confidence interval: 0.988, 0.990). The original and calibrated measurements had similar distributions. Additional comparisons of original and calibrated data supported the use of the model. We conclude that systematic differences among readers and machines have been accounted for, and that the calibrated Year-5 measurements can be used in future longitudinal comparisons. It is hoped that this paper will encourage the wider application of measurement error models.

Baseline assessment and comparison of arterial anatomy, hyperemic flow, and skeletal muscle perfusion in peripheral artery disease: The Cardiovascular Cell Therapy Research Network "Patients with Intermittent Claudication Injected with ALDH Bright Cells" (CCTRN PACE) study.

BACKGROUND: Peripheral artery disease (PAD) is important to public health as a major contributor to cardiovascular morbidity and mortality. Recent developments in magnetic resonance imaging (MRI) techniques permit improved assessment of PAD anatomy and physiology, and may serve as surrogate end points after proangiogenic therapies. METHODS: The PACE study is a randomized, double-blind, placebo-controlled clinical trial designed to assess the physiologic impact and potential clinical efficacy of autologous bone marrow-derived ALDHbr stem cells. The primary MRI end points of the study are as follows: (1) total collateral count, (2) calf muscle plasma volume (a measure of capillary perfusion) by dynamic contrast-enhanced MRI, and (3) peak hyperemic popliteal flow by phase-contrast MRI (PC-MRI). RESULTS: The interreader and intrareader and test-retest results demonstrated good-to-excellent reproducibility (interclass correlation coefficient range 0.61-0.98) for all magnetic resonance measures. The PAD participants (n=82) had lower capillary perfusion measured by calf muscle plasma volume (3.8% vs 5.6%) and peak hyperemic popliteal flow (4.1 vs 13.5mL/s) as compared with the healthy participants (n=16), with a significant level of collateralization. CONCLUSIONS: Reproducibility of the MRI primary end points in PACE was very good to excellent. The PAD participants exhibited decreased calf muscle capillary perfusion as well as arterial flow reserve when compared with healthy participants. The MRI tools used in PACE may advance PAD science by enabling accurate measurement of PAD microvascular anatomy and perfusion before and after stem cell or other PAD therapies.

Quality Control and Reproducibility in M-Mode, Two-Dimensional, and Speckle Tracking Echocardiography Acquisition and Analysis: The CARDIA Study, Year 25 Examination Experience.

INTRODUCTION: Few large studies describe quality control procedures and reproducibility findings in cardiovascular ultrasound, particularly in novel techniques such as speckle tracking echocardiography (STE). We evaluate the echocardiography assessment performance in the Coronary Artery Risk Development in Young Adults (CARDIA) study Year 25 (Y25) examination (2010-2011) and report findings from a quality control and reproducibility program conducted to assess Field Center image acquisition and reading center (RC) accuracy. METHODS: The CARDIA Y25 examination had 3475 echocardiograms performed in 4 US Field Centers and analyzed in a RC, assessing standard echocardiography (LA dimension, aortic root, LV mass, LV end-diastolic volume [LVEDV], ejection fraction [LVEF]), and STE (two- and four-chamber longitudinal, circumferential, and radial strains). Reproducibility was assessed using intraclass correlation coefficients (ICC), coefficients of variation (CV), and Bland-Altman plots. RESULTS: For standard echocardiography reproducibility, LV mass and LVEDV consistently had CV above 10% and aortic root below 6%. Intra-sonographer aortic root and LV mass had the most robust values of ICC in standard echocardiography. For STE, the number of properly tracking segments was above 80% in short-axis and four-chamber and 58% in two-chamber views. Longitudinal strain parameters were the most robust and radial strain showed the highest variation. Comparing Field Centers with echocardiography RC STE readings, mean differences ranged from 0.4% to 4.1% and ICC from 0.37 to 0.66, with robust results for longitudinal strains. CONCLUSION: Echocardiography image acquisition and reading processes in the CARDIA study were highly reproducible, including robust results for STE analysis. Consistent quality control may increase the reliability of echocardiography measurements in large cohort studies.

HIV and COPD: impact of risk behaviors and diseases on quality of life.

PURPOSE: Smoking worsens quality of life among HIV-infected individuals, but it remains unclear if this association is related simply to smoking or to chronic obstructive pulmonary disease (COPD), the end-organ disease caused by smoking. METHODS: Using cross-sectional data from the AIDS Linked to the Intravenous Experience study, we determined the independent effects of smoking, HIV and COPD assessed using the Medical Outcome Studies-HIV questionnaire. RESULTS: Of 973 participants, 287 (29.5%) were HIV infected and 151 (15.5%) had spirometry-defined obstruction. Eight hundred and thirty-four (85.7%) were current smokers with 23.3 mean pack-years history. HIV infection was independently associated with reduced physical and mental health. COPD was associated with a trend toward worse physical health (-1.48 units; 95%CI -3.33 to 0.38; p = 0.12) and was independently associated with worse mental health (-2.43 units; 95%CI -4.22 to -0.64; p < 0.01). After accounting for COPD and other covariates, smoking was not associated with changes in physical or mental health. CONCLUSIONS: The presence of COPD, rather than smoking, is associated with worse quality of life independent of HIV infection. Diagnosis and management of COPD in former or current smokers with or at risk for HIV may further improve quality of life.

Cross sectional analysis of respiratory symptoms in an injection drug user cohort: the impact of obstructive lung disease and HIV.

BACKGROUND: Injection drug use is associated with an increased risk of human immunodeficiency virus (HIV) infection and with obstructive lung diseases (OLD). Understanding how HIV and OLD may impact respiratory symptoms among injection drug users (IDUs) is important to adequately care for this high-risk population. We characterized the independent and joint effects of HIV and OLD on respiratory symptoms of a cohort of inner-city IDUs. METHODS: Demographics, risk behavior and spirometric measurements were collected from a cross-sectional analysis of the Acquired Immunodeficiency Syndrome Link to the IntraVenous Experience study, an observational cohort of IDUs followed in Baltimore, MD since 1988. Participants completed a modified American Thoracic Society respiratory questionnaire and the Medical Research Council (MRC) dyspnea score to assess respiratory symptoms of cough, phlegm, wheezing and dyspnea. RESULTS: Of 974 participants, 835 (86%) were current smokers and 288 (29.6%) were HIV-infected. The prevalence of OLD (FEV1/FVC < or = 0.70) was 15.5%, and did not differ by HIV status. OLD, but not HIV, was associated with increased frequency of reported respiratory symptoms. There was a combined effect of OLD and HIV on worsening of MRC scores. OLD and HIV were independently associated with an increased odds of reporting an MRC > or = 2 (OR 1.83 [95%CI 1.23-2.73] and 1.50 [95%CI 1.08-2.09], respectively). COPD, but not HIV, was independently associated with reporting an MRC >/= 3 (OR 2.25 [95%CI 1.43-3.54] and 1.29 [95%CI 0.87-1.91], respectively). CONCLUSIONS: While HIV does not worsen cough, phlegm or wheezing, HIV significantly increases moderate but not severe dyspnea in individuals of similar OLD status. Incorporating the MRC score into routine evaluation of IDUs at risk for OLD and HIV provides better assessment than cough, phlegm and wheezing alone.

Predictors of opiate agonist treatment retention among injection drug users referred from a needle exchange program.

AIMS: The aim of this study was to examine the effect of a case management intervention on retention in opiate agonist therapy among injection drug users (IDUs) referred from a needle exchange program (NEP). DESIGN, INTERVENTION, PARTICIPANTS, AND SETTING: A randomized trial of a strengths-based case management intervention versus passive referral (control) was conducted among NEP attendees requesting and receiving referrals to subsidized, publicly funded opiate agonist treatment programs in Baltimore, MD. MEASUREMENTS: Multivariable Cox regression models were used to identify predictors of treatment retention using an ecological model approach, taking into account factors at the individual, social, and environmental level. FINDINGS: Of 245 IDUs, 127 (51.8%) entered opiate agonist treatment, for whom median retention was 7.9 months. The intervention was not associated with longer retention (p = .91). Individual-level factors predictive of shorter retention included being employed and greater levels of psychiatric distress. Participants who had prior treatment experience and multiple treatment requests were retained significantly longer. Social factors adversely affecting treatment retention included unstable housing and buying drugs for others. Living further away from the treatment site was an environmental barrier that negatively affected treatment retention. CONCLUSIONS: Multilevel interventions that address individual, social, and environmental factors are necessary to improve substance abuse treatment retention and treatment outcomes among IDUs referred from NEP.

Relationship between lead exposure, cognitive function, and drug addiction: pilot study and research agenda.

Lead toxicity has been associated with behavioral handicaps, reading disability, antisocial and hyperactive behavior, juvenile delinquency, and impaired cognition. In addition, preclinical studies suggest an association with drug addiction; e.g., animals treated with lead either pre- or postnatally self-administer opiates at a much higher rate than untreated animals. Iron deficiency further increases the risk of lead toxicity through enhanced absorption of lead in the gastrointestinal tract. Female injection drug users have a high prevalence of iron deficiency, although the question remains as to whether this relationship is either a partial function of high lead exposure or heroin use. Specific aims were to preliminarily determine whether female injection heroin users have high tibial lead concentrations, a marker for cumulative lead exposure, compared with normal reference populations, and whether cognitive deficits potentiated the relationship between lead exposure and frequency of heroin use. Tibial lead concentrations were measured via 109 Cd-based K-shell X-ray fluorescence. In 26 female injection heroin users, mean (standard deviation (SD)) tibial lead concentration was 14.5 (6.8) microg/(g bone mineral), which was 1.8 times higher than the tibial lead concentration found among age-adjusted normal community-dwelling women. Interaction effects of tibial lead concentration and selected cognitive functions on frequency with which heroin was used were significant. Further research is warranted to determine whether a history of lead exposure is associated with increased proclivity to drug addiction.

The relationship between lifetime abuse and suicidal ideation in a sample of injection drug users.

This study examined the relationship between lifetime abuse and suicidal ideation in a sample of 245 injection drug users (IDUs) who attended the Baltimore Needle Exchange Program and received a referral for opiate agonist therapy. Data were obtained from baseline interviews and HIV antibody tests. The sample mean age was 42.2 (SD = 8.1 ); 77% were African American; 69% were male. Overall, 27% reported thoughts of suicide in the last six months, and lifetime emotional, physical and sexual abuse was reported by 17%, 12% and 10%, respectively. In bivariate analyses, recent suicidal ideation was associated with emotional (odds ratio [OR] = 3.2; p = 0.001), physical (OR = 2.5; p = 0.026), and sexual abuse (OR = 5.0; p < 0.001). In multiple logistic regression models controlling for HIV status and Center for Epidemiological Studies Depression (CES-D) score, individuals who experienced emotional abuse were more than twice as likely to report recent suicidal ideation (adjusted odds ratio [AOR] = 2.6; p = 0.011); those who experienced sexual abuse were four times more likely to report suicidal ideation (AOR = 4.0; p = 0.004). These findings suggest that emotional and sexual abuse might be risk factors for suicidality among IDUs and also might suggest that suicide prevention should be an integral part of drug treatment for treatment-seeking IDUs.

Hypothalamic-pituitary-gonadal function in men and women using heroin and cocaine, stratified by HIV status.

BACKGROUND: Most studies of hypothalamic-pituitary-gonadal (HPG) function in illicit drug users either focus on men or do not consider the impact of HIV. OBJECTIVE: This study investigated the relationships between cocaine and/or opiate use, HIV status, and HPG function in both men and women. METHODS: Men and women between 18 and 50 years of age were stratified by sex, drug use, and HIV status. Information on demographics, HIV disease and treatment, and illicit drug use patterns was collected. To determine potential effects on HPG function, free testosterone (free T), estradiol, and gonadotropin concentrations were measured. RESULTS: In a total of 197 men and women, free T concentrations were lower in men who used cocaine and/or opiates and in women infected with HIV Gonadotropin concentrations were elevated in seropositive men only. In women who received highly active antiretroviral therapy, HIV infection and illicit drug use had an additive or synergistic impact on free T concentrations. CONCLUSIONS: Our data reveal the importance of considering the independent effects of illicit drug use and HIV status for both men and women, so that risks may be identified and potential treatments designed for HPG dysfunction in these groups.

Effect of micronutrients and iron supplementation on hemoglobin, iron status, and plasma hepatitis C and HIV RNA levels in female injection drug users: a controlled clinical trial.

BACKGROUND: Iron deficiency is common among female injection drug users, but it is unclear whether iron supplementation can reduce anemia and improve iron status without increasing plasma hepatitis C virus (HCV) or HIV RNA levels. METHODS: We conducted a phase 3, double-blind, randomized, controlled clinical trial of daily micronutrients with 18 mg of iron (iron group) versus micronutrients without iron (control group) for 12 months among hepatitis C-positive female injection drug users in Baltimore, Maryland. The main outcome measures were hemoglobin, markers of iron status, plasma HCV RNA, plasma HIV RNA, and liver enzymes at 6 and 12 months of follow-up. RESULTS: Four hundred fifty-eight women (320 HIV-negative and 138 HIV-positive) enrolled in the trial. There were no significant differences in the proportion of women with anemia, ferritin<30 ng/mL, log10 plasma HCV RNA, or log10 plasma HIV RNA between treatment groups at enrollment. The proportion with anemia in the iron and control groups, respectively, was 20.7% versus 31.3% (P=0.026) at 6 months and 26.2% versus 30.4% (P=0.5) at 12 months; with ferritin<30 ng/mL, the proportion was 29.2% versus 55.5% (P<0.0001) at 6 months and 26.2% versus 46.9% (P=0.0018) at 12 months. In the iron and control groups, respectively, mean log10 plasma HCV RNA (IU/mL) was 5.2 versus 5.2 (P=0.86) at 6 months and 5.4 versus 5.3 (P=0.6) at 12 months. Among HIV-positive subjects, mean log10 plasma RNA (copies/mL) in the iron and placebo groups, respectively, was 3.8 versus 3.7 (P=0.75) at 6 months and 3.7 versus 4.1 (P=0.19) at 12 months. There were no significant differences in liver enzyme levels between the treatment groups at enrollment, 6 months, and 12 months. CONCLUSIONS: A daily micronutrient supplement with iron can reduce anemia and improve iron status in female injection drug users without increasing plasma HCV or HIV RNA levels or altering liver enzymes.

Adherence and retention of female injection drug users in a phase III clinical trial in inner city Baltimore.

Adherence and retention of female injection drug users (IDUs) in clinical trials are not well known and were evaluated among 458 female IDUs in a clinical trial in Baltimore. Of all, 62.9% were adherent to visits (attended > or = 80% of visits). Of women with > or = 1 visit after enrollment, 76% were adherent to treatment (took > or = 80% of pills); 27.7% were lost to follow-up (missed > or = 3 consecutive visits). Women nonadherent to visits were younger and less likely to be on methadone. Women lost to follow-up were younger, more often white, not on methadone, and injecting drugs daily. Fair-moderate adherence to visits and treatment occurs among female IDUs in a clinical trial.

The effect of a case management intervention on drug treatment entry among treatment-seeking injection drug users with and without comorbid antisocial personality disorder.

We examined the effect of a case management intervention on drug treatment entry among injection drug users (IDUs) with and without comorbid antisocial personality disorder (ASPD). Injection drug users attending the Baltimore Needle Exchange Program who sought and were granted referrals to opioid agonist treatment were randomized to receive a strengths-based case management intervention or passive referral. Of 162 IDUs, 22.8% met the DSM-IV criteria for ASPD. Compared to those without ASPD, IDUs with comorbid ASPD who spent 25 or more minutes with their case manager prior to their treatment entry date were 3.51 times more likely to enter treatment than those receiving less than 5 min, adjusting for intervention status, race, and treatment site (95% confidence interval 1.04-11.89). Providing case management services to IDUs with comorbid ASPD may facilitate treatment entry and reduce the negative consequences of drug abuse.