Development of benchmark datasets for text mining and sentiment analysis to accelerate regulatory literature review.

In the field of regulatory science, reviewing literature is an essential and important step, which most of the time is conducted by manually reading hundreds of articles. Although this process is highly time-consuming and labor-intensive, most output of this process is not well transformed into machine-readable format. The limited availability of data has largely constrained the artificial intelligence (AI) system development to facilitate this literature reviewing in the regulatory process. In the past decade, AI has revolutionized the area of text mining as many deep learning approaches have been developed to search, annotate, and classify relevant documents. After the great advancement of AI algorithms, a lack of high-quality data instead of the algorithms has recently become the bottleneck of AI system development. Herein, we constructed two large benchmark datasets, Chlorine Efficacy dataset (CHE) and Chlorine Safety dataset (CHS), under a regulatory scenario that sought to assess the antiseptic efficacy and toxicity of chlorine. For each dataset, ∼10,000 scientific articles were initially collected, manually reviewed, and their relevance to the review task were labeled. To ensure high data quality, each paper was labeled by a consensus among multiple experienced reviewers. The overall relevance rate was 27.21% (2,663 of 9,788) for CHE and 7.50% (761 of 10,153) for CHS, respectively. Furthermore, the relevant articles were categorized into five subgroups based on the focus of their content. Next, we developed an attention-based classification language model using these two datasets. The proposed classification model yielded 0.857 and 0.908 of Area Under the Curve (AUC) for CHE and CHS dataset, respectively. This performance was significantly better than permutation test (p < 10E-9), demonstrating that the labeling processes were valid. To conclude, our datasets can be used as benchmark to develop AI systems, which can further facilitate the literature review process in regulatory science.

Predictors of COVID-19 severity: A literature review.

The coronavirus disease 2019 (COVID-19) pandemic is a rapidly evolving global emergency that continues to strain healthcare systems. Emerging research describes a plethora of patient factors-including demographic, clinical, immunologic, hematological, biochemical, and radiographic findings-that may be of utility to clinicians to predict COVID-19 severity and mortality. We present a synthesis of the current literature pertaining to factors predictive of COVID-19 clinical course and outcomes. Findings associated with increased disease severity and/or mortality include age > 55 years, multiple pre-existing comorbidities, hypoxia, specific computed tomography findings indicative of extensive lung involvement, diverse laboratory test abnormalities, and biomarkers of end-organ dysfunction. Hypothesis-driven research is critical to identify the key evidence-based prognostic factors that will inform the design of intervention studies to improve the outcomes of patients with COVID-19 and to appropriately allocate scarce resources.

Violence, HIV Risks, and Polysubstance Use Among HIV-Positive People Who Inject Drugs in Ukraine.

Violence experience has been consistently associated with HIV risks and substance use behaviors. Although many studies have focused on intimate partner violence (IPV), the role of violence at a structural level (i.e., police abuse) remains relevant for people who inject drugs. This study evaluated the association of IPV and police-perpetrated violence experiences with HIV risk behaviors and substance use in a cohort of HIV-positive people who inject drugs in Ukraine. We also evaluated possible moderation effects of gender and socioeconomic status in the links between violence exposure and HIV risk and polysubstance use behaviors. Data came from the Providence/Boston-CFAR-Ukraine Study involving 191 HIV-positive people who inject drugs conducted at seven addiction treatment facilities in Ukraine. Results from logistic regressions suggest that people who inject drugs and experienced IPV had higher odds of polysubstance use than those who did not experience IPV. Verbal violence and sexual violence perpetrated by police were associated with increased odds of inconsistent condom use. The odds of engaging in polysubstance use were lower for women in relation to police physical abuse. We found no evidence supporting socioeconomic status moderations. Violence experiences were associated with substance use and sexual HIV risk behaviors in this cohort of HIV-positive people who inject drugs in Ukraine. Trauma-informed prevention approaches that consider both individual and structural violence could improve this population's HIV risks.

RESUMEN: La experiencia de violencia se ha asociado sistemáticamente con las conductas de riesgo para la adquisición o transmisión del VIH y con el uso de sustancias. Aunque muchos estudios se han centrado en la violencia infligida por la pareja íntima (VPI), el papel de la violencia estructural (es decir, el abuso policial) sigue siendo relevante para las personas que se inyectan drogas. Este estudio evaluó la asociación entre las experiencias de violencia perpetrada por la policía y la pareja íntima con los conductas de riesgo para la adquisición o transmisión del VIH y el uso de sustancias en una cohorte de personas VIH positivas que se inyectan drogas en Ucrania. También evaluamos los posibles efectos de moderación del género y el estatus socioeconómico entre la exposición a la violencia y los comportamientos de riesgo para la transmisión del VIH y uso de múltiples sustancias. Los datos provienen del estudio Providence / Boston-CFAR-Ucrania en el que participaron 191 personas infectadas por el VIH que se inyectan drogas, realizado en siete centros de tratamiento de adicciones en Ucrania. Los resultados de las regresiones logísticas sugieren que, en comparación con las personas que se inyectan drogas que no experimentaron IPV, las que experimentaron IPV tenían mayor probabilidad de uso de múltiples sustancias. La violencia sexual perpetrada por la policía se asoció con mayores probabilidades de un uso inconsistente del condón. No encontramos evidencia que apoye las moderaciones de género o estatus socioeconómico. Las experiencias de violencia se asociaron con el uso de sustancias y las conductas sexuales de riesgo para la transmisión del VIH en esta cohorte de personas VIH positivas que se inyectan drogas en Ucrania. Los enfoques de prevención basados en las experiencias traumáticas que tienen en cuenta tanto la violencia individual como la estructural podrían mejorar las conductas de riesgo para la transmission del VIH de esta población.

Healthcare Providers' Views on Hepatitis C Testing and Counseling Among Sexual Partners of Hepatitis-C-Infected Persons: An Online Survey.

BACKGROUND: Current hepatitis C virus (HCV) counseling guidelines do not recommend that HCV-infected patients notify their partners or encourage them to get tested. We aimed to assess healthcare professionals' knowledge of and attitudes toward counseling and testing recommendations for HCV-infected patients. METHODS: A 15-question, anonymous survey was designed and distributed via email to a convenience sample of healthcare professionals who work with Brown University or Boston University affiliated hospitals to assess their knowledge of and attitudes toward counseling recommendations for HCV-infected patients. The data was collected electronically and analyzed using descriptive statistical methods. RESULTS: Of the 55 respondents (a 20% response rate), 73% incorrectly believed that, at the time the survey was completed, CDC HCV testing guidelines already recommended partners of HCV-infected patients be tested for HCV infection. Furthermore, 80% of respondents believed recommendations should be revisited to explicitly include that HCV-infected patients encourage their partners to get tested. When counseling patients with HCV, 44% of respondents reported they always ask whether the patient's partners have been tested for HCV and 42% reported they sometimes do. Similarly, 42% reported they always suggest that the HCV-infected patient's partners be tested for HCV. CONCLUSIONS: Our survey shows that healthcare providers believe that HCV-counseling and testing recommendations could be revisited, with specific attention given to the promotion of HCV testing for partners of HCV-infected patients.

Modified Antiretroviral Treatment Access Study (MARTAS): A Randomized Controlled Trial of the Efficacy of a Linkage-to-Care Intervention Among HIV-Positive Patients in Ukraine.

Between October 2015 and March 2018, we conducted the Modified Antiretroviral Treatment Access Study (MARTAS), a nurse-delivered case management intervention to improve linkage-to-care for persons recently tested HIV positive. Adult participants from nine urban clinics in three regions of Ukraine were randomized to either MARTAS or standard of care (SOC) using individual, parallel, two-arm design. The main study outcome was linkage-to-care (defined as registration at an HIV clinic) within a 3-month period from enrollment in the study. Intention-to-treat analysis of MARTAS (n = 135) versus SOC (n = 139) showed intervention efficacy in linkage to HIV care (84.4% vs. 33.8%; adjusted RR 2.45; 95% CI 1.72, 3.47; p < 0.001). MARTAS is recommended for implementation in Ukraine and may be helpful in other countries with similar gaps in linkage-to-care. Clinicaltrials.gov registration number: NCT02338024.

Falling Through the Cracks: Risk Factors for Becoming Lost to HIV Care After Incarceration in a Southern Jail.

Using a retrospective cohort analysis of inmates released from Dallas County Jail between January 2011 and November 2013, this study characterizes people living with HIV/AIDS (PLWHA) who are lost to care after release from jail. We used Kaplan-Meier analysis to estimate the risk of becoming lost to post-release HIV care and a Cox proportional hazards regression model to identify associated factors. The majority of individuals (78.2%) were men and 65.5% were black. Of the incarcerations that ended with release to the community, approximately 43% failed to link to community HIV care. Non-Hispanic Whites were more likely than Hispanics or Blacks to drop out of care after release. Individuals with histories of substance use or severe mental illness were more likely to become lost, while those under HIV care prior to incarceration and/or who had adhered to antiretroviral therapy (ART) were more likely to resume care upon release. Targeted efforts such as rapid linkage to care and re-entry residence programs could encourage formerly incarcerated individuals to re-engage in care.

A qualitative analysis of interprofessional students' perceptions toward patients with opioid use disorder after a patient panel experience.

Background: Students from health professional schools participated in a half-day interprofessional education workshop centered on substance use disorder training. One component was a patient panel featuring individuals with a history of opioid use disorder who described the impact of addiction on their lives and their road to recovery using varied treatment options. We hypothesized that interacting with individuals with opioid use disorder early in training would elicit more humanistic perspectives and decrease bias and stigma in future health care professionals. Methods: After participating in the panel experience, health professional students (N = 580) from medicine, nursing, pharmacy, physical therapy, and social work were asked to complete short, 5-minute, rapid reflections. Prompts asked students whether the panel changed their perception of individuals with substance use disorder, to reflect on their attitudinal changes or lack thereof, and how working in interprofessional teams could impact the management and treatment of these patients. Conventional content analysis was performed. Results: Eighty-nine percent of students who attended the session completed the rapid reflections (n = 514). Overall, approximately 70% (n = 369) of students indicated that their perceptions of individuals with substance use disorder had changed as a result of the patient panel, with students from pharmacy more likely to indicate a change in attitudes. Themes across all professions included a change toward a more humanistic perspective, value of hearing real patient stories, and learning about treatment and recovery options. Student responses described how interprofessional health care teams can provide more holistic care with a broader range of therapeutic options that may improve long-term outcomes. Conclusions: A patient panel experience is influential on interprofessional students' attitudes toward patients who suffer from opioid use disorder. Students identified an interprofessional approach as being a valuable component of management and treatment of these patients.

Patient and provider perspectives inform an intervention to improve linkage to care for HIV patients in Ukraine.

BACKGROUND: Engagement with HIV medical care is critical to successful HIV treatment and prevention efforts. However, in Ukraine, delays in the timely initiation of HIV treatment hamper viral suppression. By January 01, 2016, only 126,604 (57.5%) of the estimated 220,000 people living with HIV (PLWH) had registered for HIV care, and most (55.1%) of those who registered for HIV care in 2015 did that at a late stage of infection. In the US, Anti-Retroviral Treatment and Access to Services (ARTAS) intervention successfully linked newly diagnosed PLWH to HIV services using strengths-based case management with a linkage coordinator. To tailor the ARTAS intervention for Ukraine, we conducted a qualitative study with patients and providers to understand barriers and facilitators that influence linkage to HIV care. METHODS: During September-October 2014, we conducted 20 in-depth interviews with HIV-positive patients and two focus groups with physicians in infectious disease, sexually transmitted infection (STI), and addiction clinics in Dnipropetrovsk Region of Ukraine. Interviews and focus groups were audio-recorded and transcribed verbatim. We translated illustrative quotes into English. We used thematic analysis for the data analysis. RESULTS: Participants (20 patients and 14 physicians) identified multiple, mostly individual-level factors influencing HIV care initiation. Key barriers included lack of HIV knowledge, non-acceptance of HIV diagnosis, fear of HIV disclosure, lack of psychological support from health providers, and HIV stigma in community. Responsibility for one's health, health deterioration, and supportive provider communication were reported as facilitators to linkage to care. Expected benefits from the case management intervention included psychological support, HIV education, and help with navigating the segmented health system. CONCLUSIONS: The findings from the study will be used to optimize the ARTAS for the Ukrainian context. Our findings can also support future linkage-to-care strategies in other countries of Eastern Europe and Central Asia.

Risk factors for poor multidrug-resistant tuberculosis treatment outcomes in Kyiv Oblast, Ukraine.

BACKGROUND: Ukraine is among ten countries with the highest burden of multidrug- resistant TB (MDR-TB) worldwide. Treatment success rates for MDR-TB in Ukraine remain below global success rates as reported by the World Health Organization. Few studies have evaluated predictors of poor MDR-TB outcomes in Ukraine. METHODS: We conducted a retrospective analysis of patients initiated on MDR-TB treatment in the Kyiv Oblast of Ukraine between January 01, 2012 and March 31st, 2015. We defined good treatment outcomes as cure or completion and categorized poor outcomes among those who died, failed treatment or defaulted. We used logistic regression analyses to identify baseline patient characteristics associated with poor MDR-TB treatment outcomes. RESULTS: Among 360 patients, 65 (18.1%) achieved treatment cure or completion while 131 (36.4%) died, 115 (31.9%) defaulted, and 37 (10.3%) failed treatment. In the multivariate analysis, the strongest baseline predictors of poor outcomes were HIV infection without anti-retroviral therapy (ART) initiation (aOR 10.07; 95% CI 1.20-84.45; p 0.03) and presence of extensively-drug resistant TB (aOR 9.19; 95% CI 1.17-72.06; p 0.03). HIV-positive patients initiated on ART were not at increased risk of poor outcomes (aOR 1.43; 95% CI 0.58-3.54; p 0.44). There was no statistically significant difference in risk of poor outcomes among patients who received baseline molecular testing with Gene Xpert compared to those who were not tested (aOR 1.31; 95% CI 0.63-2.73). CONCLUSIONS: Rigorous compliance with national guidelines recommending prompt initiation of ART among HIV/TB co-infected patients and use of drug susceptibility testing results to construct treatment regimens can have a major impact on improving MDR-TB treatment outcomes in Ukraine.

Attitudes Toward HIV Pre-Exposure Prophylaxis in a United States Urban Clinic Population.

A majority of US studies on attitudes toward PrEP focus on men who have sex with men with little representation of African Americans. This cross-sectional study seeks to determine openness to PrEP, and examine motivations for openness among Philadelphia residents. Patients undergoing HIV rapid testing between May 2012 and December 2014 in a public setting were administered a survey. Questions included openness to PrEP and reasons for openness to PrEP. Multivariate logistic regression models were used to investigate associations between openness and potential predictors. Analyses were conducted using R version 3.2.4 and the epitools and car packages. Of 5606 respondents, over 90 % were African American. Men were more likely to express openness (61.4 % of men, 54.8 % of women, p < 0.0001). Predictors of openness were younger age, black race, higher perceived risk for HIV by patient or as assessed by Tester, intermittent /no condom use, greater number of partners in 12 months and previous HIV testing. The main reason for openness was fear of HIV, and for disinterest was lack of recognition of risk. Understanding openness to PrEP, and reasons for openness to or disinterest in PrEP are critical to determining the best approaches to facilitate engagement in PrEP care by communities and persons at elevated risk for HIV acquisition. Further study is needed on how best to manage disinterest in PrEP by those at high risk for HIV, and how openness to PrEP translates into concrete steps to take PrEP.

Proportion and factors associated with Hepatitis B viremia in antiretroviral treatment naïve and experienced HIV co-infected Ghanaian patients.

BACKGROUND: The global burden of Hepatitis B virus (HBV) and HIV co-infection is enormous. The risk of developing cirrhosis and hepatocellular cancer is associated with HBV DNA levels. The main objective of the study was to determine proportion of Hepatitis B viremia in ART-naïve and ART-experienced co-infected Ghanaian patients and factors associated with HBV viremia after at least 36 weeks of lamivudine with or without tenofovir containing ART. METHODS: Hepatitis B and HIV co-infected patients who were ART-naïve or had received at least 9 months of lamivudine-containing ART were enrolled in a cross-sectional study at Korle-Bu Teaching Hospital. Demographic and clinical data were collected and samples obtained for Hepatitis B serology, liver function tests and HBV DNA. Factors associated with viremia were determined using univariate and multivariate logistic regression analysis. RESULTS: Of 3108 HIV-infected patients screened, 257 (8.3%) were HBsAg-positive, of which 235 enrolled. Overall, 152 (64.7%) were ART-experienced and 83 (35.3%) were ART-naïve. Eighty-nine-percent of ART-naïve and 42.1% of ART-experienced patients had HBV DNA > 20 IU/mL. In multivariate analysis of all patients, being ART-naïve (OR 10.1, 95% CI 4.6-21.9) and elevated ALT (OR 3.7, 95% CI 1.8-7.9) were associated with Hepatitis B viremia. In treatment experienced patients, elevated ALT (OR 4.8 CI 2.0-12.1) and male sex (OR 2.1, 95% CI 1.0-4.2) were associated with Hepatitis B viremia. CONCLUSIONS: Majority of ART-naïve (89%) and 42% of ART-experienced patients had detectable hepatitis B viremia > 20 IU/mL. An abnormal serum ALT was significantly associated with hepatitis B viremia in HBV and HIV co-infected patients irrespective of treatment status. Baseline and on-treatment ALT may be a useful non-invasive predictor of Hepatitis B viremia in resource-constrained countries in sub-Saharan Africa where infection is endemic and viral load tests are not widely available.

Evaluation of a Nurse-Initiated Routine HIV Testing Pilot on a Medical-Surgical Unit.

National guidelines recommending a shift from risk-based to routine HIV testing for persons ages 13-64 are described. The role of nurses, particularly medical-surgical nurses, in increasing the number of people screened is discussed.

Pretreatment HIV Drug Resistance and HIV-1 Subtype C Are Independently Associated With Virologic Failure: Results From the Multinational PEARLS (ACTG A5175) Clinical Trial.

BACKGROUND: Evaluation of pretreatment HIV genotyping is needed globally to guide treatment programs. We examined the association of pretreatment (baseline) drug resistance and subtype with virologic failure in a multinational, randomized clinical trial that evaluated 3 antiretroviral treatment (ART) regimens and included resource-limited setting sites. METHODS: Pol genotyping was performed in a nested case-cohort study including 270 randomly sampled participants (subcohort), and 218 additional participants failing ART (case group). Failure was defined as confirmed viral load (VL) >1000 copies/mL. Cox proportional hazards models estimated resistance-failure association. RESULTS: In the representative subcohort (261/270 participants with genotypes; 44% women; median age, 35 years; median CD4 cell count, 151 cells/µL; median VL, 5.0 log10 copies/mL; 58% non-B subtypes), baseline resistance occurred in 4.2%, evenly distributed among treatment arms and subtypes. In the subcohort and case groups combined (466/488 participants with genotypes), used to examine the association between resistance and treatment failure, baseline resistance occurred in 7.1% (9.4% with failure, 4.3% without). Baseline resistance was significantly associated with shorter time to virologic failure (hazard ratio [HR], 2.03; P = .035), and after adjusting for sex, treatment arm, sex-treatment arm interaction, pretreatment CD4 cell count, baseline VL, and subtype, was still independently associated (HR, 2.1; P = .05). Compared with subtype B, subtype C infection was associated with higher failure risk (HR, 1.57; 95% confidence interval [CI], 1.04-2.35), whereas non-B/C subtype infection was associated with longer time to failure (HR, 0.47; 95% CI, .22-.98). CONCLUSIONS: In this global clinical trial, pretreatment resistance and HIV-1 subtype were independently associated with virologic failure. Pretreatment genotyping should be considered whenever feasible. CLINICAL TRIALS REGISTRATION: NCT00084136.

Preventing HIV Transmission Among Partners of HIV-Positive Male Sex Workers in Mexico City: A Modeling Study.

Mexico has a concentrated HIV epidemic, with male sex workers constituting a key affected population. We estimated annual HIV cumulative incidence among male sex workers' partners, and then compared incidence under three hypothetical intervention scenarios: improving condom use; and scaling up HIV treatment as prevention, considering current viral suppression rates (CVS, 60.7 %) or full viral suppression among those treated (FVS, 100 %). Clinical and behavioral data to inform model parameterization were derived from a sample (n = 79) of male sex workers recruited from street locations and Clínica Condesa, an HIV clinic in Mexico City. We estimated annual HIV incidence among male sex workers' partners to be 8.0 % (95 % CI: 7.3-8.7). Simulation models demonstrated that increasing condom use by 10 %, and scaling up HIV treatment initiation by 50 % (from baseline values) would decrease the male sex workers-attributable annual incidence to 5.2, 4.4 % (CVS) and 3.2 % (FVS), respectively. Scaling up the number of male sex workers on ART and implementing interventions to ensure adherence is urgently required to decrease HIV incidence among male sex workers' partners in Mexico City.

Epidemiology of hepatitis C virus in Pennsylvania state prisons, 2004-2012: limitations of 1945-1965 birth cohort screening in correctional settings.

OBJECTIVES: We described hepatitis C virus antibody (anti-HCV) prevalence in a state prison system and retrospectively evaluated the case-finding performance of targeted testing of the 1945 to 1965 birth cohort in this population. METHODS: We used observational data from universal testing of Pennsylvania state prison entrants (June 2004-December 2012) to determine anti-HCV prevalence by birth cohort. We compared anti-HCV prevalence and the burden of anti-HCV in the 1945 to 1965 birth cohort with that in all other birth years. RESULTS: Anti-HCV prevalence among 101,727 adults entering prison was 18.1%. Prevalence was highest among those born from 1945 to 1965, but most anti-HCV cases were in people born after 1965. Targeted testing of the 1945 to 1965 birth cohort would have identified a decreasing proportion of cases with time. CONCLUSIONS: HCV is endemic in correctional populations. Targeted testing of the 1945 to 1965 birth cohort would produce a high yield of positive test results but would identify only a minority of cases. We recommend universal anti-HCV screening in correctional settings to allow for maximum case identification, secondary prevention, and treatment of affected prisoners.

Sex differences in perceived risk and testing experience of HIV in an urban fishing setting in Ghana.

INTRODUCTION: Understanding sex differences in willingness to test and testing experience could aid the design of focus interventions to enhance uptake and engagement with care, treatment and support services. This study determined differences in perceived risk of acquiring HIV, willingness to test and HIV testing experience in an urban fishing community. METHODS: A cross-sectional community survey was conducted in 2013 among men and women in two fishing communities (Chorkor and James Town) in Accra. In all, 554 subjects (≥ 18 years) were involved, 264 in Chorkor and 290 in James Town. Data on demographic characteristics, perceived risk for HIV and willingness to test for HIV and testing experience were collected with a structured questionnaire. Descriptive statistics and Chi square test were used for the analysis at 95% significant level, using SPSS version 21. RESULTS: Of 554 subjects, 329 (59.4%) were females, and median age was 32 years. Overall, only 91(40.4%) men and 118(35.9%) women perceived themselves to be at risk of acquiring HIV. A significant proportion of women were willing to test for HIV compared to men (86.3% vs. 80.0%, P = 0.048). Women were more likely to have ever tested for HIV compared to men (42.2% vs. 28.6%, P = 0.001) and more women had tested within 12 months prior to survey than men (49.6% vs. 40.6%, P = 0.230). Of the number who had tested for HIV infection, a higher proportion of men tested voluntarily 42(65.6%), while a higher proportion of women tested as part of healthcare service received 96(69.1%); (P = 0.001; indicating women vs. men). CONCLUSION: Sex differences in risk perception and willingness to test need more focused public education and behaviour change communication strategies to achieve high coverage. Community-based strategies could improve HIV testing among men whilst more access to testing in health settings should be available to women in these communities.

Love, lust and the emotional context of multiple and concurrent sexual partnerships among young Swazi adults.

Men and women in Swaziland who are engaged in multiple or concurrent sexual partnerships, or who have sexual partners with concurrent partners, face a very high risk of HIV infection. Ninety-four in-depth interviews were conducted with 28 Swazi men and women (14 of each sex) between the ages of 20 and 39 to explore participants' sexual partnership histories, including motivations for sexual relationships which carried high HIV risk. Concurrency was normative, with most men and women having had at least one concurrent sexual partnership, and all women reporting having had at least one partner who had a concurrent partner. Men distinguished sexual partnerships that were just for sex from those that were considered to be 'real relationships', while women represented most of their relationships, even those which included significant financial support, as being based on love. Besides being motivated by love, concurrent sexual partnerships were described as motivated by a lack of sexual satisfaction, a desire for emotional support and/or as a means to exact revenge against a cheating partner. Social and structural factors were also found to play a role in creating an enabling environment for high-risk sexual partnerships. These factors included social pressure and norms; a lack of social trust; poverty and a desire for material goods; and geographical separation of partners.

Changes in HIV-1 subtypes B and C genital tract RNA in women and men after initiation of antiretroviral therapy.

BACKGROUND: Combination antiretroviral therapy (cART) reduces genital tract human immunodeficiency virus type 1 (HIV-1) load and reduces the risk of sexual transmission, but little is known about the efficacy of cART for decreasing genital tract viral load (GTVL) and differences in sex or HIV-1 subtype. METHODS: HIV-1 RNA from blood plasma, seminal plasma, or cervical wicks was quantified at baseline and at weeks 48 and 96 after entry in a randomized clinical trial of 3 cART regimens. RESULTS: One hundred fifty-eight men and 170 women from 7 countries were studied (men: 55% subtype B and 45% subtype C; women: 24% subtype B and 76% subtype C). Despite similar baseline CD4(+) cell counts and blood plasma viral loads, women with subtype C had the highest GTVL (median, 5.1 log10 copies/mL) compared to women with subtype B and men with subtype C or B (4.0, 4.0, and 3.8 log10 copies/mL, respectively; P < .001). The proportion of participants with a GTVL below the lower limit of quantification (LLQ) at week 48 (90%) and week 96 (90%) was increased compared to baseline (16%; P < .001 at both times). Women were significantly less likely to have GTVL below the LLQ compared to men (84% vs 94% at week 48, P = .006; 84% vs 97% at week 96, P = .002), despite a more sensitive assay for seminal plasma than for cervical wicks. No difference in GTVL response across the 3 cART regimens was detected. CONCLUSIONS: The female genital tract may serve as a reservoir of persistent HIV-1 replication during cART and affect the use of cART to prevent sexual and perinatal transmission of HIV-1.

HIV among persons incarcerated in the USA: a review of evolving concepts in testing, treatment, and linkage to community care.

PURPOSE OF REVIEW: People who are incarcerated have a disproportionately high risk of HIV infection. They also tend to have risk factors associated with underutilization of antiretroviral therapy (ART) such as substance abuse, mental illness, and poor access to care. In this review, we describe how incarceration is a marker of vulnerability for suboptimal HIV care, and also how criminal justice settings may be leveraged as a platform for promoting testing, linkage, and retention in HIV care for a high-risk, marginalized population. RECENT FINDINGS: In both prisons and jails, routine, opt-out HIV testing strategies are more appropriate for screening correctional populations than traditional, risk-based strategies. Rapid HIV testing is feasible and acceptable in busy, urban jail settings. Although ART is successfully administered in many prison settings, release to the community is strongly associated with inconsistent access to medications and other structural factors leading to loss of viral suppression. SUMMARY: Collaborations among HIV clinicians, criminal justice personnel, and public health practitioners represent an important strategy for turning the tide on the HIV epidemic. Success will depend upon scaled-up efforts to seek individuals with undiagnosed infection and bring those who are out-of-care into long-term treatment.

Contribution of substance use disorders on HIV treatment outcomes and antiretroviral medication adherence among HIV-infected persons entering jail.

HIV and substance use are inextricably intertwined. One-sixth of people living with HIV/AIDS (PLWHA) transition through the correctional system annually. There is paucity of evidence on the impact of substance use disorders on HIV treatment engagement among jail detainees. We examined correlates of HIV treatment in the largest sample of PLWHA transitioning through jail in 10 US sites from 2007 to 2011. Cocaine, alcohol, cannabis, and heroin were the most commonly used substances. Drug use severity was negatively and independently correlated with three outcomes just before incarceration: (1) having an HIV care provider (AOR = 0.28; 95 % CI 0.09-0.89); (2) being prescribed antiretroviral therapy (AOR = 0.12; 95 % CI 0.04-0.35) and (3) high levels (>95 %) of antiretroviral medication adherence (AOR = 0.18; 95 % CI 0.05-0.62). Demographic, medical and psychiatric comorbidity, and social factors also contributed to poor outcomes. Evidence-based drug treatments that include multi-faceted interventions, including medication-assisted therapies, are urgently needed to effectively engage this vulnerable population.