A portable droplet microfluidic device for cortisol measurements using a competitive heterogeneous assay.

Point-of-care monitoring of chemical biomarkers in real-time holds great potential in rapid disease diagnostics and precision medicine. However, monitoring is still rare in practice, as the measurement of biomarkers often requires time consuming and labour intensive assay procedures such as enzyme linked immunosorbent assay (ELISA), which pose a challenge to an autonomous point-of-care device. This paper describes a prototype device capable of performing ELISA autonomously and repeatedly in a high frequency using droplet microfluidics. Driven by a specially designed peristaltic pump, the device can collect liquid samples from a reservoir, produce trains of droplets, complete magnetic bead based ELISA protocols and provide readouts with colourimetric measurement. Here, cortisol was chosen as a target analyte as its concentration in the human body varies on a circadian rhythm which may be perturbed by disease. The prototype device draws in and analyses 350 nL of the sample containing free bioactive cortisol every 10 seconds, with a sample-to-signal time of 10 minutes, and measures favourably in the analytical range of 3.175-100 ng ml-1, with reliably lower variability compared with the well plate based assay. As most ELISA type assays share similar procedures, we envisage that this approach could form a platform technology for measurement or even continuous monitoring of biomarkers in biological fluids at the point-of-care.

Alcohol policies, firearm policies, and suicide in the United States: a lagged cross-sectional study.

BACKGROUND: Alcohol and firearms are commonly involved in suicide in the United States. State alcohol and firearm policies may impact alcohol and firearm related suicide, yet little is known about these relationships. This study examines relationships between state alcohol and firearm policies and suicides involving alcohol, guns, or both, and explores interactive policy associations. METHODS: Alcohol policies were assessed with the Alcohol Policy Scale. Firearm policies were assessed using the Gun Law Scorecard from Giffords Law Center. Suicide data from the National Violent Death Reporting System in 2015 covered 22 states. State- and individual-level GEE Poisson and logistic regression models assessed relationships between policies and firearm- and/or alcohol-involved suicides with a 1-year lag. RESULTS: In 2015, there were 8996 suicide deaths with blood alcohol concentration test results in the 22 included states. Of those deaths, alcohol and/or firearms were involved in 5749 or 63.9%. Higher alcohol and gun law scores were associated with reduced incidence rates and odds of suicides involving either alcohol or firearms (adjusted incidence rate ratios [IRR] 0.72 (95% CI 0.63, 0.83) for alcohol policies, 0.86 (95% CI 0.82, 0.90) for firearm policies). Relationships were similar for suicides involving both alcohol and firearms, and there was an interactive effect, such that states with restrictive policies for both had the lowest rates of suicides involving alcohol or guns. CONCLUSIONS: More restrictive alcohol and firearm policies are associated with lower rates and odds of suicides involving alcohol or firearms, and alcohol and firearms, and may be a promising means by which to reduce suicide.

A Droplet Microfluidic-Based Sensor for Simultaneous in Situ Monitoring of Nitrate and Nitrite in Natural Waters.

Microfluidic-based chemical sensors take laboratory analytical protocols and miniaturize them into field-deployable systems for in situ monitoring of water chemistry. Here, we present a prototype nitrate/nitrite sensor based on droplet microfluidics that in contrast to standard (continuous phase) microfluidic sensors, treats water samples as discrete droplets contained within a flow of oil. The new sensor device can quantify the concentrations of nitrate and nitrite within each droplet and provides high measurement frequency and low fluid consumption. Reagent consumption is at a rate of 2.8 mL/day when measuring every ten seconds, orders of magnitude more efficient than those of the current state-of-the-art sensors. The sensor's capabilities were demonstrated during a three-week deployment in a tidal river. The accurate and high frequency data (6% error relative to spot samples, measuring at 0.1 Hz) elucidated the influence of tidal variation, rain events, diurnal effects, and anthropogenic input on concentrations at the deployment site. This droplet microfluidic-based sensor is suitable for a wide range of applications such as monitoring of rivers, lakes, coastal waters, and industrial effluents.

Subclinical tuberculosis among adults with HIV: clinical features and outcomes in a South African cohort.

BACKGROUND: Subclinical tuberculosis is an asymptomatic disease phase with important relevance to persons living with HIV. We describe the prevalence, clinical characteristics, and risk of mortality for HIV-infected adults with subclinical tuberculosis. METHODS: Untreated adults with HIV presenting for outpatient care in Durban, South Africa were screened for tuberculosis-related symptoms and had sputum tested by acid-fast bacilli smear and tuberculosis culture. Active tuberculosis and subclinical tuberculosis were defined as having any tuberculosis symptom or no tuberculosis symptoms with culture-positive sputum. We evaluated the association between tuberculosis disease category and 12-month survival using Cox regression, adjusting for age, sex, and CD4 count. RESULTS: Among 654 participants, 96 were diagnosed with active tuberculosis disease and 28 with subclinical disease. The median CD4 count was 68 (interquartile range 39-161) cells/mm3 in patients with active tuberculosis, 136 (72-312) cells/mm3 in patients with subclinical disease, and 249 (125-394) cells/mm3 in those without tuberculosis disease (P < 0.001). The proportion of smear positive cases did not differ significantly between the subclinical (29%) and active tuberculosis groups (14%, P 0.08). Risk of mortality was not increased in individuals with subclinical tuberculosis relative to no tuberculosis (adjusted hazard ratio 0.84, 95% confidence interval 0.26-2.73). CONCLUSIONS: Nearly one-quarter of tuberculosis cases among HIV-infected adults were subclinical, which was characterized by an intermediate degree of immunosuppression. Although there was no significant difference in survival, anti-tuberculous treatment of subclinical cases was common. TRIAL REGISTRATION: Prospectively registered on ClinicalTrials.gov , NCT01188941 (August 26, 2010).

Use of an android phone application for automated text messages in international settings: A case study in an HIV clinical trial in St. Petersburg, Russia.

BACKGROUND/AIMS: Reproducible outcomes in clinical trials depend on adherence to study protocol. Short message service (also known as text message) reminders have been shown to improve clinical trial adherence in the United States and elsewhere. However, due to systematic differences in mobile data plans, languages, and technology, these systems are not easily translated to international settings. METHODS: To gauge technical capabilities for international projects, we developed SMSMessenger, an automated Android application that uses a US server to send medication reminders to participants in a clinical trial in St. Petersburg, Russia (Zinc for HIV disease among alcohol users-a randomized controlled trial in the Russia Alcohol Research Collaboration on HIV/AIDS cohort). The application is downloaded once onto an Android study phone. When it is time for the text message reminders to be sent, study personnel access the application on a local phone, which in turn accesses the existing clinical trial database hosted on a US web server. The application retrieves a list of participants with the following information: phone number, whether a message should be received at that time, and the appropriate text of the message. The application is capable of storing multiple outgoing messages. With a few clicks, text messages are sent to study participants who can reply directly to the message. Study staff can check the local phone for incoming messages. The SMSMessenger application uses an existing clinical trial database and is able to receive real-time updates. All communications between the application and server are encrypted, and phone numbers are stored in a secure database behind a firewall. No sensitive data are stored on the phone, as outgoing messages are sent through the application and not by messaging features on the phone itself. Messages are sent simultaneously to study participants, which reduces the burden on local study staff. Costs and setup are minimal. The only local requirements are an Android phone and data plan. CONCLUSION: The SMSMessenger technology could be modified to be applied anywhere in the world, in any language, script, or alphabet, and for many different purposes. The novel application of this existing low-cost technology can improve the usefulness of text messaging in advancing the goals of international clinical trials.

HIV Stigma and Unhealthy Alcohol Use Among People Living with HIV in Russia.

Unhealthy alcohol use, highly prevalent in the Russian Federation (Russia), is associated with HIV risk behaviors among people living with HIV (PLWH). HIV stigma contributes to the HIV risk environment in Russia. To examine HIV stigma among Russian PLWH and to explore its association with unhealthy alcohol use, we conducted a longitudinal analysis of 700 PLWH in St. Petersburg, Russia. We assessed the association between alcohol dependence and HIV stigma measured at baseline and 12 months follow-up. Participants with alcohol dependence (n = 446) reported significantly higher HIV stigma scores over time than those without dependence (n = 254) (adjusted mean difference 0.60, 95% CI 0.03-1.17; p = 0.04). In secondary analyses, we examined recent risky alcohol use and did not detect an association with HIV stigma. Alcohol dependence is associated with high HIV stigma among Russian PLWH but the nature of the association is conjectural. HIV prevention efforts in Russia that address alcohol use disorders hold potential to mitigate HIV-related stigma and its possible adverse effects among PLWH.

Pain and Risk Behaviors Among HIV-Infected Persons in St. Petersburg, Russia.

We analyzed baseline data from an observational cohort of HIV-infected ART-naïve patients in St. Petersburg, Russia to explore whether pain was associated with HIV risk behaviors. The primary outcomes were (1) unprotected vaginal or anal sex in the past 90 days and (2) sharing of needles or equipment in the past month. Secondary outcomes included: use of alcohol prior to sex, current injection drug use, number of unprotected sex and sharing episodes, and days injected in the past month. The main independent variable was any past week pain. Multivariable regression models were fit for outcomes. After adjustment, the association with unprotected sex was of borderline significance (AOR = 2.06; 95 % CI 0.98-4.36, p = 0.058); there was no significant association between any past week pain and sharing of needles/equipment (AOR = 1.52; 95 % CI 0.65-3.59, p = 0.33). Participants with pain had higher odds of reporting alcohol use prior to sex (AOR = 2.42; 95 % CI 1.10-5.28, p = 0.03).

Alcohol Involvement in Homicide Victimization in the United States.

BACKGROUND: Although the association between alcohol and homicide is well documented, there has been no recent study of alcohol involvement in homicide victimization in U.S. states. The objective of this article was to determine the prevalence of alcohol involvement in homicide victimization and to identify socio demographic and other factors associated with alcohol involvement in homicide victimization. METHODS: Data from homicide victims with a reported blood alcohol content (BAC) level were analyzed from 17 states from 2010 to 2012 using the National Violent Death Reporting System. Logistic regression was used to investigate factors associated with the odds of homicide victims having a BAC ≥ 0.08%. RESULTS: Among all homicide victims, 39.9% had a positive BAC including 13.7% with a BAC between 0.01% and 0.79% and 26.2% of victims with a BAC ≥ 0.08%. Males were twice as likely as females to have a BAC ≥ 0.08% (29.1% vs. 15.2%; p < 0.001). Characteristics that were independent predictors of homicide victims having a BAC ≥ 0.08 included male sex, American Indian/Alaska Native race, Hispanic ethnicity, history of intimate partner violence, and nonfirearm homicides. CONCLUSIONS: Alcohol is present in a substantial proportion of homicide victims in the United States, with substantial variation by state, demographic, and circumstantial characteristics. Future studies should explore the relationships between state-level alcohol policies and alcohol involvement among perpetrators and victims of homicide.

Rapid urine lipoarabinomannan assay as a clinic-based screening test for active tuberculosis at HIV diagnosis.

BACKGROUND: World Health Organization (WHO) recommends tuberculosis (TB) screening at HIV diagnosis. We evaluated the inclusion of rapid urine lipoarabinomannan (LAM) testing in TB screening algorithms. METHODS: We enrolled ART-naïve adults who screened HIV-infected in KwaZulu-Natal, assessed TB-related symptoms (cough, fever, night sweats, weight loss), and obtained sputum specimens for mycobacterial culture. Trained nurses performed clinic-based urine LAM testing using a rapid assay. We used diagnostic accuracy, negative predictive value (NPV), and negative likelihood ratio, stratified by CD4 count, to evaluate screening for culture-positive TB. RESULTS: Among 675 HIV-infected adults with median CD4 of 213/mm3 (interquartile range 85-360/mm3), 123 (18%) had culture-confirmed pulmonary TB. The WHO-recommended algorithm of any TB-related symptom had a sensitivity of 77% [95% confidence interval (CI) 69-84%] and NPV of 89% (95% CI 84-92%) for identifying active pulmonary TB. Including the LAM assay improved sensitivity (83%; 95% CI 75-89%) and NPV (91%; 95% CI 86-94%), while decreasing the negative likelihood ratio (0.45 versus 0.57). Among participants with CD4 < 100/mm3, including urine LAM testing improved the negative predictive value of symptom based screening from 83% to 87%. All screening algorithms with urine LAM performed better among participants with CD4 < 100/mm3, compared to those with CD4 ≥ 100/mm3. CONCLUSION: Clinic-based urine LAM screening increased the sensitivity of symptom-based screening by 6% among ART-naïve HIV-infected adults in a TB-endemic setting, thereby providing marginal benefit.

Social support and mental health among adults prior to HIV counseling and testing in Durban, South Africa.

Poor social support and mental health may be important modifiable risk factors for HIV acquisition, but they have not been evaluated prior to HIV testing in South Africa. We sought to describe self-perceived mental health and social support and to characterize their independent correlates among adults who presented for voluntary HIV testing in Durban. We conducted a large cross-sectional study of adults (≥18 years of age) who presented for HIV counseling and testing between August 2010 and January 2013 in Durban, South Africa. We enrolled adults presenting for HIV testing and used the Medical Outcomes Study's Social Support Scale (0 [poor] to 100 [excellent]) and the Mental Health Inventory (MHI-3) to assess social support and mental health. We conducted independent univariate and multivariable linear regression models to determine the correlates of lower self-reported Social Support Index and lower self-reported MCH scores. Among 4874 adults surveyed prior to HIV testing, 1887 (39%) tested HIV-positive. HIV-infected participants reported less social support (mean score 66 ± 22) and worse mental health (mean score 66 ± 16), compared to HIV-negative participants (74 ± 21; 70 ± 18; p < 0.0001). In a multivariable analysis, significant correlates of less social support included presenting for HIV testing at an urban hospital, not having been tested previously, not working outside the home, and being HIV-infected. In a separate multivariable analysis, significant correlates of poor mental health were similar, but also included HIV testing at an urban hospital and being in an intimate relationship less than six months. In this study, HIV-infected adults reported poorer social support and worse mental health than HIV-negative individuals. These findings suggest that interventions to improve poor social support and mental health should be focused on adults who do not work outside the home and those with no previous HIV testing.

Homelessness during pregnancy: a unique, time-dependent risk factor of birth outcomes.

Evaluate homelessness during pregnancy as a unique, time-dependent risk factor for adverse birth outcomes. 9,995 mothers of children <48 months old surveyed at emergency departments and primary care clinics in five US cities. Mothers were classified as either homeless during pregnancy with the index child, homeless only after the index child's birth, or consistently housed. Outcomes included birth weight as a continuous variable, as well as categorical outcomes of low birth weight (LBW; <2,500 g) and preterm delivery (<37 weeks). Multiple logistic regression and adjusted linear regression analyses were performed, comparing prenatal and postnatal homelessness with the referent group of consistently housed mothers, controlling for maternal demographic characteristics, smoking, and child age at interview. Prenatal homelessness was associated with higher adjusted odds of LBW (AOR 1.43, 95 % CI 1.14, 1.80, p < 0.01) and preterm delivery (AOR 1.24, 95 % CI 0.98, 1.56, p = 0.08), and a 53 g lower adjusted mean birth weight (p = 0.08). Postnatal homelessness was not associated with these outcomes. Prenatal homelessness is an independent risk factor for LBW, rather than merely a marker of adverse maternal and social characteristics associated with homelessness. Targeted interventions to provide housing and health care to homeless women during pregnancy may result in improved birth outcomes.

Depressive symptoms and antiretroviral therapy (ART) initiation among HIV-infected Russian drinkers.

The impact of depressive symptoms on ART initiation among Russian HIV-infected heavy drinkers enrolled in a secondary HIV prevention trial (HERMITAGE) was examined. We assessed 133 participants eligible for ART initiation (i.e., CD4 count <350 cells/µl) who were not on ART at baseline. Depressive symptom severity and ART use were measured at baseline, 6- and 12-months. Association between depressive symptoms and subsequent ART initiation was evaluated using GEE logistic regression adjusting for gender, past ART use, injection drug use and heavy drinking. Depressive symptom severity was not significantly associated with lower odds of initiating ART. Cognitive depression symptoms were not statistically significant (global p = 0.05); however, those with the highest level of severity had an AOR of 0.25 (95 % CI 0.09-0.71) for delayed ART initiation. Although the effect of depression severity was not significant, findings suggest a potential role of cognitive depression symptoms in decisions to initiate ART in this population.

Associations of sex trafficking history with recent sexual risk among HIV-infected FSWs in India.

History of forced or coerced sex work entry and/or sex work entry prior to age 18 (i.e., sex trafficking) relate to early HIV risk; whether such risk persists is unclear. The current study assessed associations of reported sex trafficking histories and recent sexual risk among adult HIV-infected female sex workers (FSWs; n = 211) in Mumbai, India. Approximately one-half reported entering sex work prior to age 18 (50.2 %) or being forced or coerced into sex work (41.7 %). Past 90-day unprotected transactional sex was more prevalent among FSWs entering as minors than those entering as adults (AOR 2.06); in contrast, being forced or coerced into sex work related to reduction in such risk for HIV transmission (AOR 0.45). Histories of each form of sex trafficking may relate differently to later HIV risk. Intervention with HIV-infected FSWs entering sex work as minors should be prioritized based on potential elevated risk of HIV transmission.

Risk factors for recent nonfatal overdose among HIV-infected Russians who inject drugs.

Overdoses and HIV infection are common among Russians who inject drugs, yet risk factors have not been studied. We analyzed baseline data of 294 participants with 30-day injection drug use from an HIV secondary prevention trial for persons reporting "heavy" alcohol use (National Institute on Alcohol Abuse and Alcoholism [NIAAA] risky drinking definition) and risky sex in the past 6 months. The outcome was any self-reported overdose in the previous 3 months. We examined demographic, HIV-related, criminal justice, mental health, substance use, and injection risk factors. Participants' characteristics included median age 29 years, 117/294 (40%) female, and median CD4 cell count 345/µl. Over three quarters 223/294 (76%) reported a history of overdose and 47/294 (16%) reported overdose in the past 3 months. Past month injection frequency (adjusted odds ratio [AOR] 4.77, 95% confidence interval [CI]: 1.63-14.0 highest vs. lowest quartile; AOR 3.58, 95% CI: 1.20-10.69 second highest vs. lowest quartile) and anti-retroviral therapy (ART) at time of interview (AOR 3.96 95% CI: 1.33-11.83) were associated with 3-month overdose. Nonfatal overdose among HIV-infected Russians who inject drugs is common. Risk factors include injection frequency and anti-retroviral therapy (ART), which warrant further study. Overdose prevention efforts are needed among HIV-infected Russians who inject drugs.

Diagnostic accuracy of a point-of-care urine test for tuberculosis screening among newly-diagnosed HIV-infected adults: a prospective, clinic-based study.

BACKGROUND: A rapid diagnostic test for active tuberculosis (TB) at the clinical point-of-care could expedite case detection and accelerate TB treatment initiation. We assessed the diagnostic accuracy of a rapid urine lipoarabinomannan (LAM) test for TB screening among HIV-infected adults in a TB-endemic setting. METHODS: We prospectively enrolled newly-diagnosed HIV-infected adults (≥18 years) at 4 outpatient clinics in Durban from Oct 2011-May 2012, excluding those on TB therapy. A physician evaluated all participants and offered CD4 cell count testing. Trained study nurses collected a sputum sample for acid-fast bacilli smear microscopy (AFB) and mycobacterial culture, and performed urine LAM testing using Determine™ TB LAM in the clinic. The presence of a band regardless of intensity on the urine LAM test was considered positive. We defined as the gold standard for active pulmonary TB a positive sputum culture for Mycobacterium tuberculosis. Diagnostic accuracy of urine LAM was assessed, alone and in combination with smear microscopy, and stratified by CD4 cell count. RESULTS: Among 342 newly-diagnosed HIV-infected participants, 190 (56%) were male, mean age was 35.6 years, and median CD4 was 182/mm3. Sixty participants had culture-positive pulmonary TB, resulting in an estimated prevalence of 17.5% (95% CI 13.7-22.0%). Forty-five (13.2%) participants were urine LAM positive. Mean time from urine specimen collection to LAM test result was 40 minutes (95% CI 34-46 minutes). Urine LAM test sensitivity was 28.3% (95% CI 17.5-41.4) overall, and 37.5% (95% CI 21.1-56.3) for those with CD4 count <100/mm3, while specificity was 90.1% (95% CI 86.0-93.3) overall, and 86.9% (95% CI 75.8-94.2) for those with CD4 < 100/mm3. When combined with sputum AFB (either test positive), sensitivity increased to 38.3% (95% CI 26.0-51.8), but specificity decreased to 85.8% (95% CI 81.1-89.7). CONCLUSIONS: In this prospective, clinic-based study with trained nurses, a rapid urine LAM test had low sensitivity for TB screening among newly-diagnosed HIV-infected adults, but improved sensitivity when combined with sputum smear microscopy.

Prevalence and correlates of non-disclosure of HIV serostatus to sex partners among HIV-infected female sex workers and HIV-infected male clients of female sex workers in India.

This study examines non-disclosure of HIV serostatus to sex partners among HIV-infected adults involved with transactional sex in Mumbai, India. Surveys were conducted with HIV-infected female sex workers (n = 211) and infected male clients (n = 205) regarding HIV knowledge, awareness of sex partners' HIV serostatus, alcohol use, transactional sex involvement post-HIV diagnosis and non-disclosure of HIV serostatus. Gender-stratified multiple logistic regression models were used for analysis. Non-disclosure of one's serostatus to all sex partners was reported by almost three-fifths of females and two-fifths of males. Predictors of non-disclosure included lack of correct knowledge about HIV and no knowledge of sex partners' HIV serostatus. Among females, recent alcohol consumption also predicted non-disclosure. Among males, 10 + paid sexual partners in the year following HIV diagnosis predicted non-disclosure. Secondary HIV prevention efforts in India require greater focus on HIV disclosure communication and integrated alcohol and sexual risk reduction.

Associations between partner violence perpetration and history of STI among HIV-infected substance using men in Russia.

Studies document a significant association between victimization from intimate partner violence (IPV) and sexually transmitted infections (STIs) and HIV among substance using women in Russia and elsewhere, but no study has examined IPV perpetration and STI among Russian men or HIV-infected men in Eastern Europe. This study was designed to assess the association between lifetime history of IPV perpetration and STI (lifetime and current) among substance using HIV-infected men in Russia. Cross-sectional analyses were conducted with baseline data from 415 male participants enrolled in a randomized HIV intervention clinical trial [the HERMITAGE Study]. Participants were HIV-infected men reporting recent heavy alcohol use and unprotected sex in St. Petersburg, Russia. Baseline surveys assessed demographics, IPV perpetration, risk behaviors, and STI history. Current STI was assessed via blood testing for syphilis and urine testing for gonorrhea, Chlamydia and Trichomonas. Multiple logistic regression analyses were used to assess the association between history of IPV with lifetime and current STI. Participants were aged 20-57 years. Almost half of participants (46%) reported a history of IPV perpetration; 81% reported past 30-day binge alcohol use, and 43% reported past 30-day injection drug use. Past and current STI was 41% and 12%, respectively. Men reporting a history of IPV perpetration had significantly higher odds of reporting ever having an STI (AOR=1.6, 95% CI=1.1, 2.4) but lower odds of testing positive for a current STI (AOR=0.50, 95% CI=0.26, 0.96). These findings demonstrate that a history of male IPV perpetration is common in HIV-infected Russian men and associated with a history of STI. Programmatic work toward IPV prevention is needed in Russia and may be beneficial in mitigating STIs, but more research is needed to understand how and why the association between IPV and STI changes over time in this population.

A randomized trial to optimize HIV/TB care in South Africa: design of the Sizanani trial.

BACKGROUND: Despite increases in HIV testing, only a fraction of people newly diagnosed with HIV infection enter the care system and initiate antiretroviral therapy (ART) in South Africa. We report on the design and initial enrollment of a randomized trial of a health system navigator intervention to improve linkage to HIV care and TB treatment completion in Durban, South Africa. METHODS/DESIGN: We employed a multi-site randomized controlled trial design. Patients at 4 outpatient sites were enrolled prior to HIV testing. For all HIV-infected participants, routine TB screening with sputum for mycobacterial smear and culture were collected. HIV-infected participants were randomized to receive the health system navigator intervention or usual care. Participants in the navigator arm underwent a baseline interview using a strengths-based case management approach to assist in identifying barriers to entering care and devising solutions to best cope with perceived barriers. Over 4 months, participants in the navigator arm received scheduled phone and text messages. The primary outcome of the study is linkage and retention in care, assessed 9 months after enrollment. For ART-eligible participants without TB, the primary outcome is 3 months on ART as documented in the medical record; participants co-infected with TB are also eligible to meet the primary outcome of completion of 6 months of TB treatment, as documented by the TB clinic. Secondary outcomes include mortality, receipt of CD4 count and TB test results, and repeat CD4 counts for those not ART-eligible at baseline. We hypothesize that a health system navigator can help identify and positively affect modifiable patient factors, including self-efficacy and social support, that in turn can improve linkage to and retention in HIV and TB care. DISCUSSION: We are currently evaluating the clinical impact of a novel health system navigator intervention to promote entry to and retention in HIV and TB care for people newly diagnosed with HIV. The details of this study protocol will inform clinicians, investigators, and policy makers of strategies to best support HIV-infected patients in resource-limited settings. TRIAL REGISTRATION: Clinicaltrials.gov. unique identifier: NCT01188941.

Brugia pahangi: immunization with early L3 ES alters parasite migration, and reduces microfilaremia and lymphatic lesion formation in gerbils (Meriones unguiculatus).

Previous studies have shown that intradermally (ID) injected Brugia pahangi L3 s migrate through various tissues and into the lymphatics of gerbils in a distinct pattern. Excretory/secretory products (ES) produced at the time of invasion of B. pahangi are likely to be important in this early migration phase of the parasite life cycle in their rodent host. Hence, early L3 ES was collected from 24h in vitro cultures of B. pahangi L3 larvae and used in immunization experiments to investigate the effect of immunity to early L3 ES on worm migration, survival and development of B. pahangi. Immunization of gerbils with ES in RIBI adjuvant produced antibodies to numerous ES proteins eliciting a strong humoral response to ES and indirect fluorescent antibody (IFA) assay using anti-ES serum recognized the ES proteins on the surface of B. pahangi L3 larvae. Following ES immunization, gerbils were challenged either ID or intraperitoneally (IP) with 100 L3 s of B. pahangi and euthanized at 3 or 106 days post inoculation (DPI). Immunization with early ES slowed the migration of ID inoculated L3 at 3 DPI and significantly altered the locations of adult worms at 106 DPI. Immunization did not induce protection in any treatment group. However, immunized animals had significantly fewer microfilariae per female worm suggesting the antigens in ES are important in microfilariae development or survival in the host. The number of lymphatic granulomas was also significantly reduced in ES immunized animals. It is important to note that microfilariae serve as a nidus in these granulomas. Our results shows immunization with early Brugia malayi L3 ES alters the worm migration, affects circulating microfilarial numbers and reduces lymphatic granulomas associated with B. pahangi infection in gerbils.

Association Between Material Hardship in Families With Young Children and Federal Relief Program Participation by Race and Ethnicity and Maternal Nativity.

Importance: Even brief periods of hardship during early childhood may have lifelong consequences. Prior cross-sectional research limited to respondents with English proficiency and internet access during the COVID-19 crisis documented families with young children that struggled to afford basic needs like food and rent. Few studies have examined experiences of families with young children by race and ethnicity and maternal nativity. Objective: To examine the association of COVID-19 relief programs with the mitigation of household food insecurity among families with young children, as well as being behind on rent and disparities in program receipt. Design, Setting, and Participants: This cohort study used data from the ongoing repeat cross-sectional Children's HealthWatch study comprising families surveyed at baseline (January 1, 2018, to March 20, 2020) and during the COVID-19 crisis (September 1, 2020, to June 30, 2021). Baseline questionnaires were administered face to face to caregivers of children aged 48 months or younger in English or Spanish in emergency departments or primary care clinics in 5 US cities. The follow-up questionnaires were administered via telephone. Exposures: Supplemental Nutrition Assistance Program (SNAP) participation or receipt of at least 1 Economic Impact Payment (EIP; ie, stimulus check) during the COVID-19 crisis. Main Outcomes and Measures: The primary outcomes were household food insecurity (assessed via the US Household Food Security Survey Module: Six-Item Short Form) and being behind on rent. Logistic and binomial regression models were used to calculate adjusted odds ratios (aORs) and unadjusted and adjusted prevalence ratios (PRs). Results: Of 1396 caregiver-child dyads (20.3% response rate), race and ethnicity data were available for 1357 caregivers: 514 (37.9%) were Black, non-Latino; 558 (41.1%) were Latino; 230 (16.9%) were White, non-Latino; and 55 (4.1%) were of other non-Latino race or ethnicity. Among 1390 responses with nonmissing data, 417 children (30.0%) had an immigrant mother, and among 1388 responses, 1238 (33.5%) were publicly insured. During the crisis, 467 of 1395 respondents (33.5%) reported household food insecurity, and 567 of 1391 respondents (40.8%) reported being behind on rent. Families with immigrant mothers had lower odds of EIP and SNAP participation than families with US-born mothers (eg, aOR, 0.07 [95% CI, 0.05-0.12] for both EIP and SNAP vs neither), despite being more likely to report household food insecurity (adjusted PR [aPR], 1.48 [95% CI, 1.28-1.71]) and being behind on rent (aPR, 1.14 [95% CI, 1.00-1.30]). Families with Black (unadjusted PR [uPR], 1.40 [95% CI, 1.08-1.82]) or Latino (uPR, 1.54 [95% CI, 1.19-1.98]) caregivers or caregivers of other race and ethnicity (uPR, 1.67 [1.12-2.49]) were also more likely than families with White, non-Latino caregivers to experience household food insecurity or being behind on rent (families with Black caregivers: uPR, 2.02 [95% CI, 1.58-2.58]; families with Latino caregivers: 1.68 [95% CI, 1.30-2.16]; families with caregivers of other race or ethnicity: uPR, 1.94 [95% CI, 1.34-2.80]). Adjustment for covariates and differential participation in relief programs did not entirely account for these disparities. Conclusions and Relevance: The results of this cohort study suggest that the COVID-19 crisis exacerbated preexisting inequities in food insecurity and difficulty paying rent according to race and ethnicity and maternal nativity and that equity-focused policy changes are needed to ensure that all children and their families in the US can afford basic needs for optimal health.