Mobile-Enhanced Prevention Support Study for Men Who Have Sex With Men and Transgender Women Leaving Jail: Protocol for a Randomized Controlled Trial.

BACKGROUND: Men who have sex with men (MSM) and transgender women, particularly those who have experienced criminal justice involvement, have particularly high HIV burdens, and a majority of those in jail have substance use disorders (SUDs). MSM and transgender women also experience elevated rates of incarceration. Once community re-entry occurs, individuals are in a critical period for addressing potential risks of HIV and sexually transmitted infection (STI) acquisition and negative sequelae of substance use. Further, the impact experienced by one's social and sexual networks experienced at the time of detention and release have important health implications for MSM and transgender women. OBJECTIVE: The purpose of this study is to test a new intervention-Mobile-Enhanced Prevention Support (MEPS)-that involves a GPS-based mobile app called GeoPassport (referred to as GeoPass in practice), incentives, and peer support for promoting HIV prevention, substance use treatment, and use of related services. METHODS: A two-arm, unblinded, randomized controlled trial will seek to enroll 300 HIV-negative MSM and transgender women, aged 18-49 years, with SUDs, who are either in jail or have recently left jail. Participants will be enrolled by study staff and randomized to the MEPS intervention group or usual care group. The intervention group will receive customized wellness goals in addition to GeoPass, cash incentives, and the support of a trained peer mentor for 6 months. Data collection will consist of a baseline survey and three follow-up surveys at 3, 6, and 9 months postenrollment, either in person or by phone or videoconference when necessary. The primary outcomes include establishing a primary care provider; being prescribed and adhering to pre-exposure prophylaxis (PrEP) for HIV; screening for HIV, STIs, and hepatitis C virus; and engagement in recommended treatment for SUDs. Secondary outcomes include obtaining treatment for any identified infections and avoiding recidivism. RESULTS: Enrollment began in November 2019 and study completion is expected in 2023. CONCLUSIONS: This study will advance our knowledge base on patient navigation and peer mentor interventions. Peer navigation services have been studied for the treatment of HIV, but less often in the context of HIV and STI prevention among sexual and gender minority populations at the time of re-entry into the community from jail. The MEPS study will examine the acceptability and feasibility of combining peer mentor services with a mobile app to facilitate service utilization and participant-peer mentor communication. MEPS will assess patterns of PrEP uptake and utilization in MSM and transgender women leaving jail. The study will provide heretofore unavailable data from persons leaving jail regarding HIV PrEP, STI screening, substance abuse treatment, and service utilization patterns and experiences, including geocoded data for those in the intervention arm. TRIAL REGISTRATION: ClinicalTrials.gov (NCT04036396); https://www.clinicaltrials.gov/ct2/show/NCT04036396. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/18106.

Association of a Care Bundle for Early Sepsis Management With Mortality Among Patients With Hospital-Onset or Community-Onset Sepsis.

Importance: The Early Management Bundle for Severe Sepsis/Septic Shock (SEP-1) is a quality metric based on a care bundle for early sepsis management. Published evidence on the association of SEP-1 with mortality is mixed and largely excludes cases of hospital-onset sepsis. Objective: To assess the association of the SEP-1 bundle with mortality and organ dysfunction in cohorts with hospital-onset or community-onset sepsis. Design, Setting, and Participants: This retrospective cohort study used data from 4 University of California hospitals from October 1, 2014, to October 1, 2017. Adult inpatients with a diagnosis consistent with sepsis or disseminated infection and laboratory or vital signs meeting the Sepsis-3 (Third International Consensus Definitions for Sepsis and Septic Shock) criteria were divided into community-onset sepsis and hospital-onset sepsis cohorts based on whether time 0 of sepsis occurred after arrival in the emergency department or an inpatient area. Data were analyzed from April to October 2019. Additional analyses were performed from December 2019 to January 2020. Exposures: Administration of SEP-1 and 4 individual bundle components (serum lactate level testing, blood culture, broad-spectrum intravenous antibiotic treatment, and intravenous fluid treatment). Main Outcomes and Measures: The primary outcome was in-hospital mortality. The secondary outcome was days requiring vasopressor support, measured as vasopressor days. Results: Among the 6404 patient encounters identified (3535 men [55.2%]; mean [SD] age, 64.0 [18.2] years), 2296 patients (35.9%) had hospital-onset sepsis. Among 4108 patients (64.1%) with community-onset sepsis, serum lactate level testing within 3 hours of time 0 was associated with reduced mortality (absolute difference, -7.61%; 95% CI, -14.70% to -0.54%). Blood culture (absolute difference, -1.10 days; 95% CI, -1.85 to -0.34 days) and broad-spectrum intravenous antibiotic treatment (absolute difference, -0.62 days; 95% CI, -1.02 to -0.22 days) were associated with fewer vasopressor days. Among patients with hospital-onset sepsis, broad-spectrum intravenous antibiotic treatment was the only bundle component significantly associated with any improved outcome (mortality difference, -5.20%; 95% CI, -9.84% to -0.56%). Care that was adherent to the complete SEP-1 bundle was associated with increased vasopressor days in patients with community-onset sepsis (absolute difference, 0.31 days; 95% CI, 0.11-0.51 days) but was not significantly associated with reduced mortality in either cohort (absolute difference, -0.07%; 95% CI, -3.02% to 2.88% in community-onset; absolute difference, -0.42%; 95% CI, -6.77% to 5.93% in hospital-onset). Conclusions and Relevance: SEP-1-adherent care was not associated with improved outcomes of sepsis. Although multiple components of SEP-1 were associated with reduced mortality or decreased days of vasopressor therapy for patients who presented with sepsis in the emergency department, only broad-spectrum intravenous antibiotic treatment was associated with reduced mortality when time 0 occurred in an inpatient unit. Current sepsis quality metrics may need refinement.

ImPlementation REsearCh to DEvelop Interventions for People Living with HIV (the PRECluDE consortium): Combatting chronic disease comorbidities in HIV populations through implementation research.

Antiretroviral therapy (ART) prevented premature mortality and improved the quality of life among people living with the human immunodeficiency virus (PLWH), such that now more than half of PLWH in the United States are 50 years of age and older. Increased longevity among PLWH has resulted in a significant rise in chronic, comorbid diseases. However, the implementation of guideline-based interventions for preventing, treating, and managing such age-related, chronic conditions among the HIV population is lacking. The PRECluDE consortium supported by the Center for Translation Research and Implementation Science at the National Heart, Lung, and Blood Institute catalyzes implementation research on proven-effective interventions for co-occurring heart, lung, blood, and sleep diseases and conditions among PLWH. These collaborative research studies use novel implementation frameworks with HIV, mental health, cardiovascular, and pulmonary care to advance comprehensive HIV and chronic disease healthcare in a variety of settings and among diverse populations.

Adherence to the SEP-1 Sepsis Bundle in Hospital-Onset v. Community-Onset Sepsis: a Multicenter Retrospective Cohort Study.

BACKGROUND: Sepsis is the leading cause of in-hospital death. The SEP-1 sepsis bundle is a protocol for early sepsis care that requires providers to diagnose and treat sepsis quickly. Limited evidence suggests that adherence to the sepsis bundle is lower in cases of hospital-onset sepsis. OBJECTIVE: To compare sepsis bundle adherence in hospital-onset vs. community-onset sepsis. DESIGN: Retrospective cohort study using multivariable analysis of clinical data. PARTICIPANTS: A total of 4658 inpatients age 18 or older were identified by diagnosis codes consistent with sepsis or disseminated infection. SETTING: Four university hospitals in California between 2014 and 2016. MAIN OUTCOMES AND MEASURES: The primary outcome was adherence to key components of the sepsis bundle defined by the Centers for Medicare and Medicaid Services in their core measure, SEP-1. Covariates included clinical characteristics related to the patient, infection, and pathogen. KEY RESULTS: Compared with community-onset, cases of hospital-onset sepsis were less likely to receive SEP-1 adherent care (relative risk 0.33, 95% confidence interval 0.29-0.38, p < 0.001). With the exception of vasopressors (RR 1.11, p = 0.002), each component of SEP-1 evaluated-blood cultures (RR 0.76, p < 0.001), serum lactate (RR 0.51, p < 0001), broad-spectrum antibiotics (RR 0.62, p < 0.001), intravenous fluids (0.47, p < 0.001), and follow-up lactate (RR 0.71, p < 0.001)-was less likely to be performed within the recommended time frame in hospital-onset sepsis. Within the hospital, cases of hospital-onset sepsis arising on the ward were less likely to receive SEP-1-adherent care than were cases arising in the intensive care unit (RR 0.68, p = 0.004). CONCLUSIONS: Inpatients with hospital-onset sepsis receive different management than individuals with community-onset sepsis. It remains to be determined whether system-level factors, provider-level factors, or factors related to measurement explain the observed variation in care or whether variation in care affects outcomes.

Reducing cardiovascular risk among people living with HIV: Rationale and design of the INcreasing Statin Prescribing in HIV Behavioral Economics REsearch (INSPIRE) randomized controlled trial.

Cardiovascular disease (CVD) is a major cause of morbidity among people living with HIV (PLWH). Statins can safely and effectively reduce CVD risk in PLWH, but evidence-based statin therapy is under-prescribed in PLWH. Developed using an implementation science framework, INcreasing Statin Prescribing in HIV Behavioral Economics REsearch (INSPIRE) is a stepped-wedge cluster randomized trial that addresses organization-, clinician- and patient-level barriers to statin uptake in Los Angeles community health clinics serving racially and ethnically diverse PLWH. After assessing knowledge about statins and barriers to clinician prescribing and patient uptake, we will design, implement and measure the effectiveness of (1) educational interventions targeting leadership, clinicians, and patients, followed by (2) behavioral economics-informed clinician feedback on statin uptake. In addition, we will assess implementation outcomes, including changes in clinician acceptability of statin prescribing for PLWH, clinician acceptability of the education and feedback interventions, and cost of implementation.

Impact of Abstinence and of Reducing Illicit Drug Use Without Abstinence on Human Immunodeficiency Virus Viral Load.

BACKGROUND: Substance use is common among people living with human immunodeficiency virus (PLWH) and a barrier to achieving viral suppression. Among PLWH who report illicit drug use, we evaluated associations between HIV viral load (VL) and reduced use of illicit opioids, methamphetamine/crystal, cocaine/crack, and marijuana, regardless of whether or not abstinence was achieved. METHODS: This was a longitudinal cohort study of PLWH from 7 HIV clinics or 4 clinical studies. We used joint longitudinal and survival models to examine the impact of decreasing drug use and of abstinence for each drug on viral suppression. We repeated analyses using linear mixed models to examine associations between change in frequency of drug use and VL. RESULTS: The number of PLWH who were using each drug at baseline ranged from n = 568 (illicit opioids) to n = 4272 (marijuana). Abstinence was associated with higher odds of viral suppression (odds ratio [OR], 1.4-2.2) and lower relative VL (ranging from 21% to 42% by drug) for all 4 drug categories. Reducing frequency of illicit opioid or methamphetamine/crystal use without abstinence was associated with VL suppression (OR, 2.2, 1.6, respectively). Reducing frequency of illicit opioid or methamphetamine/crystal use without abstinence was associated with lower relative VL (47%, 38%, respectively). CONCLUSIONS: Abstinence was associated with viral suppression. In addition, reducing use of illicit opioids or methamphetamine/crystal, even without abstinence, was also associated with viral suppression. Our findings highlight the impact of reducing substance use, even when abstinence is not achieved, and the potential benefits of medications, behavioral interventions, and harm-reduction interventions.

Life Chaos is Associated with Reduced HIV Testing, Engagement in Care, and ART Adherence Among Cisgender Men and Transgender Women upon Entry into Jail.

Life chaos, the perceived inability to plan for and anticipate the future, may be a barrier to the HIV care continuum for people living with HIV who experience incarceration. Between December 2012 and June 2015, we interviewed 356 adult cisgender men and transgender women living with HIV in Los Angeles County Jail. We assessed life chaos using the Confusion, Hubbub, and Order Scale (CHAOS) and conducted regression analyses to estimate the association between life chaos and care continuum. Forty-eight percent were diagnosed with HIV while incarcerated, 14% were engaged in care 12 months prior to incarceration, mean antiretroviral adherence was 65%, and 68% were virologically suppressed. Adjusting for sociodemographics, HIV-related stigma, and social support, higher life chaos was associated with greater likelihood of diagnosis while incarcerated, lower likelihood of engagement in care, and lower adherence. There was no statistically significant association between life chaos and virologic suppression. Identifying life chaos in criminal-justice involved populations and intervening on it may improve continuum outcomes.

Self-reported antiretroviral therapy adherence and viral load in criminal justice-involved populations.

BACKGROUND: Self-reported antiretroviral therapy (ART) adherence measures that are associated with plasma viral load (VL) are valuable to clinicians and researchers, but are rarely examined among groups vulnerable to dropping out of care. One-seventh of all those living with HIV pass through incarceration annually and criminal-justice (CJ) involved people living with HIV (PLH) are vulnerable to falling out of care. We examined the association of self-reported ART adherence with VL in a criminal-justice sample compared to a routine-care sample. METHODS: Samples: We examined data from a multisite collaboration of studies addressing the continuum of HIV care among CjJ involved persons in the Seek, Test, Treat, and Retain cohort. Data pooled from seven CJ- studies (n = 414) were examined and compared with the routine-care sample from the Centers for AIDS Research Network of Integrated Clinical Systems' seven sites (n = 11,698). MEASURES: In both samples, data on self-reported percent ART doses taken were collected via the visual analogue scale adherence measure. Viral load data were obtained by blood-draw. ANALYSIS: We examined the associations of adherence with VL in both cohorts using mixed effects linear regression of log-VL, and mixed effects logistic regression of binary VL (≥ 200 copies/mL) outcomes. Interactions by CD4 count and self-reported health status were also tested. RESULTS: Among the CJ sample, the coefficient for log-VL was - 0.31 (95% CI = - 0.43, - 0.18; P < 0.01) and that in the routine-care sample was - 0.42 (95% CI = - 0.45, - 0.38; P < 0.01). For the logistic regression of binary detectable VL on 10% increments of adherence we found the coefficient was - 0.26 (95% CI = - 0.37, - 0.14; P < 0.01) and in the routine-care sample it was - 0.38 (95% CI = - 0.41, - 0.35; P < 0.01). There was no significant interaction by CD4 count level in the CJ sample, but there was in the routine-care sample. Conversely, there was a significant interaction by self-reported health status level in the criminal-justice sample, but not in the routine-care sample. CONCLUSIONS: The visual analogue scale is valid and useful to measure ART adherence, supporting treatment for CJ- involved PLH vulnerable to falling out of care. Research should examine adherence and VL in additional populations.

Methamphetamine use drives decreases in viral suppression for people living with HIV released from a large municipal jail: Results of the LINK LA clinical trial.

BACKGROUND: People living with HIV (PLWH) often experience decreases in HIV viral suppression (VS) after release from jail. The Linking Inmates to Care in LA (LINK LA) peer navigation intervention helped maintain VS 12 months after release from jail compared to standard of care. In this study, we analyzed correlates of substance use and tested whether substance use was an independent correlate of decreased VS in LINK LA participants. METHODS: We analyzed LINK LA data collected at baseline, 3, and 12 months. We defined high-risk drug use as any reported methamphetamine, cocaine, or opioid use in the 30 days prior to a study visit (or jail entry at baseline). We used generalized linear mixed models to test associations of sociodemographic variables with type of substance used, and we tested correlates of VS while controlling for time, the intervention, and their interaction. RESULTS: At baseline (n = 356), 71% of participants reported high-risk drug use: 58%, methamphetamine; 17%, cocaine; 7%, heroin; and 4%, prescription opioids. Non-Hispanic Whites and those younger than 35 were most likely to use methamphetamine; Blacks were most likely to use cocaine; people who inject drugs were most likely to use opioids. Participants who used high-risk drugs had 53% lower adjusted odds than non-users of maintaining VS (AOR 0.47, 95% CI 0.31-0.70, p < 0.001). CONCLUSION: High-risk drug use, dominated by methamphetamine use, independently correlated with decreased VS among recently incarcerated PLWH. Improving HIV care continuum outcomes among populations leaving jail requires attention to efforts to address high-risk drug use.

Preferences of adults with spinal cord injury for widely used health-related quality of life and subjective well-being measures.

OBJECTIVE: To describe preferences for survey instruments on health-related quality of life (HRQOL) and subjective well-being (SWB) among adults with spinal cord injury (SCI), and compare perspectives on the instruments between the United States and the United Kingdom. DESIGN: We conducted 20 in-depth interviews. SETTING: Participants were interviewed in their homes, some in person and some via Skype. PARTICIPANTS: A convenience sample of 20 adults with SCI (10 in the US and 10 in the UK) were recruited via print and on-line advertisements. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Interviewees reviewed six instruments and rated how important it was for their medical providers to know answers to each survey. Two coders analyzed verbatim transcriptions independently using an inductive approach. Keyword-in-context (KWIC) analysis identified the most frequently used words by interviewees to discuss the merits of each instrument. RESULTS: Participants in both samples identified the Fatigue Severity Scale (FSS) as "vital" that their medical providers know about it. This was followed by the Spinal Cord Injury Independence Measure III, and a stand-alone Eudaimonic Well-Being question. The KWIC analysis showed that the most distinctive words used to discuss FSS were "fatigue" and "pain." CONCLUSIONS: Understanding what HRQOL and SWB measures are valued by adults living with SCI can lead to selection of informative instruments, which could help clinicians to complement and tailor established care and rehabilitation protocols for individual needs. Participants identified fatigue as a significant issue, and the FSS as a vitally important instrument to share with medical providers.

Competing subsistence needs are associated with retention in care and detectable viral load among people living with HIV.

Competing priorities between subsistence needs and health care may interfere with HIV health. Longitudinal data from the Los Angeles-based HIV Outreach Initiative were analyzed to examine the association between competing subsistence needs and indicators of poor retention-in-care among hard-to-reach people with HIV. Sacrificing basic needs for health care in the previous six months was associated with a 1.55 times greater incidence of missed appointments (95% CI 1.17, 2.05), 2.32 times greater incidence of emergency department visits (95% CI 1.39, 3.87), 3.66 times greater incidence of not receiving ART if CD4 < 350 (95% CI 1.60, 8.37), and 1.35 times greater incidence of detectable viral load (95% CI 1.07, 1.70) (all p < 0.01). Among hard-to-reach PLHIV, sacrificing basic needs for health care delineates a population with exceptional vulnerability to poor outcomes along the HIV treatment cascade. Efforts to identify and reduce competing needs for this population are crucial to HIV health outcomes.

Criminal justice measures for economic data harmonization in substance use disorder research.

BACKGROUND: The consequences of substance use disorders (SUDs) are varied and broad, affecting many sectors of society and the economy. Economic evaluation translates these consequences into dollars to examine the net economic impact of interventions for SUD, and associated conditions such as HCV and HIV. The nexus between substance use and crime makes criminal justice outcomes particularly significant for estimating the economic impact of SUD interventions, and important for data harmonization. METHODS: We compared baseline data collected in six NIDA-funded Seek, Test, Treat and Retain (STTR) intervention studies that enrolled HIV-infected/at-risk individuals with SUDs (total n = 3415). Criminal justice measures included contacts with the criminal justice system (e.g., arrests) and criminal offenses. The objective was to develop a list of recommended measures and methods supporting economic data harmonization opportunities in HIV and SUD research, with an initial focus on crime-related outcomes. RESULTS: Criminal justice contacts and criminal offenses were highly variable across studies. When measures grouped by offense classifications were compared, consistencies across studies emerged. Most individuals report being arrested for property or public order crimes (> 50%); the most commonly reported offenses were prostitution/pimping, larceny/shoplifting, robbery, and household burglary. CONCLUSIONS: We identified four measures that are feasible and appropriate for estimating the economic consequences of SUDs/HIV/HCV: number of arrests, number of convictions, days of incarceration, and times committing criminal offenses, by type of offense. To account for extreme variation, grouping crimes by offense classification or calculating monthly averages per event allows for more meaningful comparisons across studies.

Anti-Racism Methods for Big Data Research: Lessons Learned from the HIV Testing, Linkage, & Retention in Care (HIV TLR) Study.

Public Health Critical Race Praxis (PHCRP) contributes three functional elements to health equity studies: a race conscious orientation; an antiracism lexicon based on Critical Race Theory (CRT); and an integrated, reflexive approach. Few big data studies employ all three functional elements. Therefore, this article describes the application of PHCRP to the Human Immunodeficiency Virus Testing, Linkage and Retention in care (HIV TLR) study (N=3,476,741), which connects multiple large datasets to electronic medical records to examine contextual determinants of racial/ethnic disparities in HIV care continuum outcomes in southern California. As HIV TLR demonstrates, PHCRP's innovative tools and strategies help big data research maintain fidelity to CRT.

Risk behaviors and HIV care continuum outcomes among criminal justice-involved HIV-infected transgender women and cisgender men: Data from the Seek, Test, Treat, and Retain Harmonization Initiative.

BACKGROUND: Transgender persons are highly victimized, marginalized, disproportionately experience incarceration, and have alarmingly increased rates of HIV infection compared to cis-gender persons. Few studies have examined the HIV care continuum outcomes among transgender women (TW), particularly TW who are involved with the criminal justice (CJ) system. METHODS: To improve our understanding of HIV care continuum outcomes and risk behaviors among HIV-infected TW who are involved with the CJ system, we analyzed data from the National Institute on Drug Abuse-supported Seek, Test, Treat, Retain (STTR) Data Harmonization Initiative. Baseline data were pooled and analyzed from three U.S. STTR studies to examine HIV risk and care continuum indicators among CJ-involved HIV-infected TW compared to cisgender men (CM), matched on age (within 5 years) and study at a ratio of 1:5. RESULTS: Eighty-eight TW and 440 CM were included in the study. Among matched participants, TW were more likely to report crack and cocaine use compared to CM (40%,16% respectively, p<0.001); both TW and CM reported high rates of condomless sex (58%, 64%, respectively); TW were more likely than CM to have more than one sexual partner (OR = 2.9, 95% CI: 1.6, 5.2; p<0.001) and have engaged in exchange sex (OR = 3.9, 95% CI: 2.3, 6.6; p<0.001). There were no significant differences between TW and CM in the percentage currently taking ART (52%, 49%, respectively), the mean percent adherence to ART (77% for both groups), and the proportion who achieved viral suppression (61%, 58%, respectively). CONCLUSIONS: HIV-infected CJ-involved TW and CM had similar use of ART and viral suppression but TW were more likely than matched CM to engage in exchange sex, have multiple sexual partners, and use crack/cocaine. TW and CM had similarly high rates of condomless sex and use of other drugs. TW require tailored risk reduction interventions, however both CJ-involved TW and CM require focused attention to reduce HIV risk and improve HIV continuum of care outcomes.

Development and Psychometric Evaluation of a Fatigability Index for Full-Time Wheelchair Users With Spinal Cord Injury.

OBJECTIVE: To develop and evaluate psychometrically a self-reported instrument assessing physical fatigability (PF) and mental fatigability (MF) in adults with spinal cord injury (SCI). DESIGN: Cross-sectional. SETTING: Peer-support groups at rehabilitation centers, online support groups. PARTICIPANTS: Adults with SCI (N=464) in the United States. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: The dimensional structure was assessed by confirmatory factor analysis. The relationship between item responses and fatigability was measured with item response theory (graded response model). Reliability was measured with test information functions. Differential item functioning was evaluated with Wald chi-square tests and the weighted area between the curves. Construct validity was assessed using the known groups method. RESULTS: An 82-item pool was developed from prior qualitative research and consultations with rehabilitation experts. A non-probability sample (N=464) was used to evaluate the psychometric properties of the PF and MF scales. The item pool was reduced to 75 based on factor loadings and R2. Both scales are primarily unidimensional, despite moderate multidimensionality. There is good discrimination overall: 18 PF items and 26 MF items have high or very high discrimination power (slopes > 1.35). The measurement precision in the theta range -2.0 to 2.5 is the equivalent of 0.94 reliability for PF and 0.91 for MF. For both measures, F statistics P values were significant at P<.01, and means were higher for those with paraplegia vs quadriplegia, and for those with incomplete paraplegia. CONCLUSIONS: The Fatigability Index is the first instrument designed to assess physical and mental fatigability in adults with SCI. The index highlights causes of fatigue and areas requiring immediate intervention. Development of short-forms and further research on representative samples are necessary.

Effectiveness of a Peer Navigation Intervention to Sustain Viral Suppression Among HIV-Positive Men and Transgender Women Released From Jail: The LINK LA Randomized Clinical Trial.

Importance: Diagnosis of human immunodeficiency virus (HIV) infection, linkage and retention in care, and adherence to antiretroviral therapy are steps in the care continuum enabling consistent viral suppression for people living with HIV, extending longevity and preventing further transmission. While incarcerated, people living with HIV receive antiretroviral therapy and achieve viral suppression more consistently than after they are released. No interventions have shown sustained viral suppression after jail release. Objective: To test the effect on viral suppression in released inmates of the manualized LINK LA (Linking Inmates to Care in Los Angeles) peer navigation intervention compared with standard transitional case management controls. Design, Setting, and Participants: Randomized clinical trial conducted from December 2012 through October 2016 with people living with HIV being released from Los Angeles (LA) County Jail. All participants were (1) 18 years or older; (2) either men or transgender women diagnosed with HIV; (3) English speaking; (4) selected for the transitional case management program prior to enrollment; (5) residing in LA County; and (6) eligible for antiretroviral therapy. Main Outcomes and Measures: Change in HIV viral suppression (<75 copies/mL) over a 12-month period. Interventions: During the 12-session, 24-week LINK LA Peer Navigation intervention, trained peer navigators counseled participants on goal setting and problem solving around barriers to HIV care and adherence, starting while the participants were still in jail. After their release, they continued counseling while they accompanied participants to 2 HIV care visits, then facilitated communication with clinicians during visits. Results: Of 356 participants randomized, 151 (42%) were black; 110 (31%) were Latino; 303 (85%) were men; 53 (15%) were transgender women; and the mean (SD) age was 39.5 (10.4) years. At 12 months, viral suppression was achieved by 62 (49.6%) of 125 participants in the peer navigation (intervention) arm compared with 45 (36.0%) of 125 in the transitional case management (control) arm, for an unadjusted treatment difference of 13.6% (95% CI, 1.34%-25.9%; P = .03). In the repeated measures, random effects, logistic model the adjusted probability of viral suppression declined from 52% at baseline to 30% among controls, while those in the peer navigation arm maintained viral suppression at 49% from baseline to 12 months, for a difference-in-difference of 22% (95% CI, 0.03-0.41; P = .02). Conclusions and Relevance: The LINK LA peer navigation intervention was successful at preventing declines in viral suppression, typically seen after release from incarceration, compared with standard transitional case management. Future research should examine ways to strengthen the intervention to increase viral suppression above baseline levels. Trial Registration: clinicaltrials.gov Identifier: NCT01406626.

Perceived access and barriers to care among illicit drug users and hazardous drinkers: findings from the Seek, Test, Treat, and Retain data harmonization initiative (STTR).

BACKGROUND: Illicit drug use (DU) and hazardous drinking (HD) among marginalized populations may be associated with greater barriers to care. METHODS: We used baseline data on the participants of the Seek, Test, Treat, and Retain data harmonization initiative. DU includes use of any illicit drugs within the past 6 months. HD was defined as scores ≥8 for men and ≥ 7 for women on Alcohol Use Disorders Identification Test within the past 12 months. Social support scores were assigned by summing scores from individual questions related to social support. Two outcomes for multivariable regression models and mediation analysis were perceived access to care and perceived barriers to care scores, calculated from summated points from individual questions within each domain. All models were adjusted for age, gender, race/ethnicity, and social support and stratified by HIV status. RESULTS: Among 1403 illicit drug users and 4984 non-drug users, the mean age was 39.6 ± 12.2 years old, 71% were male, 57% African Americans, and 39% Hispanic/Latinos. Over 25% reported difficulties in covering medical costs and finding transportation to health care facilities and greater proportions of drug users and hazardous drinkers reported these issues than non-DU/non-HD. In multivariable models, DU and HD were both independently associated with having greater barriers to care (ß: 0.49 (95% confidence interval: 0.19 to 0.79) p < 0.01; 0.31 (0.18 to 0.45) < 0.01) in HIV-negative participants. Neither DU nor HD was strongly associated with barriers to care for HIV-positive participants. Social support was associated with better perceived access to care and fewer barriers to care in the HIV-negative participants. CONCLUSION: The current study found that financial burdens of care, logistical difficulties in accessing care, and low social support were common challenges among individuals using illicit drugs and/or drinking hazardously. Addressing structural barriers and strengthening social support may be important strategies to improve health care among marginalized populations, regardless of HIV status.

Efficacy of a Chronic Care-Based Intervention on Secondary Stroke Prevention Among Vulnerable Stroke Survivors: A Randomized Controlled Trial.

BACKGROUND: Disparities of care among stroke survivors are well documented. Effective interventions to improve recurrent stroke preventative care in vulnerable populations are lacking. METHODS AND RESULTS: In a randomized controlled trial, we tested the efficacy of components of a chronic care model-based intervention versus usual care among 404 subjects having an ischemic stroke or transient ischemic attack within 90 days of enrollment and receiving care within the Los Angeles public healthcare system. Subjects had baseline systolic blood pressure (SBP) ≥120 mm Hg. The intervention included a nurse practitioner/physician assistant care manager, group clinics, self-management support, report cards, decision support, and ongoing care coordination. Outcomes were collected at 3, 8, and 12 months, analyzed as intention-to-treat, and used repeated-measures mixed-effects models. Change in SBP was the primary outcome. Low-density lipoprotein reduction, antithrombotic medication use, smoking cessation, and physical activity were secondary outcomes. Average age was 57 years; 18% were of black race; 69% were of Hispanic ethnicity. Mean baseline SBP was 150 mm Hg in both arms. SBP decreased to 17 mm Hg in the intervention arm and 14 mm Hg in the usual care arm; the between-arm difference was not significant (-3.6 mm Hg; 95% confidence interval, -9.2 to 2.2). Among secondary outcomes, the only significant difference was that persons in the intervention arm were more likely to lower their low-density lipoprotein <100 md/dL (2.0 odds ratio; 95% confidence interval, 1.1-3.5). CONCLUSIONS: This intervention did not improve SBP control beyond that attained in usual care among vulnerable stroke survivors. A community-centered component could strengthen the intervention impact. CLINICAL TRIAL REGISTRATION: URL: https://clinicaltrials.gov. Unique identifier: NCT00861081.

Disparities in the Quality of Cardiovascular Care Between HIV-Infected Versus HIV-Uninfected Adults in the United States: A Cross-Sectional Study.

BACKGROUND: Cardiovascular disease is emerging as a major cause of morbidity and mortality among patients with HIV. We compared use of national guideline-recommended cardiovascular care during office visits among HIV-infected versus HIV-uninfected adults. METHODS AND RESULTS: We analyzed data from a nationally representative sample of HIV-infected and HIV-uninfected patients aged 40 to 79 years in the National Ambulatory Medical Care Survey/National Hospital Ambulatory Medical Care Survey, 2006 to 2013. The outcome was provision of guideline-recommended cardiovascular care. Logistic regressions with propensity score weighting adjusted for clinical and demographic factors. We identified 1631 visits by HIV-infected patients and 226 862 visits by HIV-uninfected patients with cardiovascular risk factors, representing ≈2.2 million and 602 million visits per year in the United States, respectively. The proportion of visits by HIV-infected versus HIV-uninfected adults with aspirin/antiplatelet therapy when patients met guideline-recommended criteria for primary prevention or had cardiovascular disease was 5.1% versus 13.8% (P=0.03); the proportion of visits with statin therapy when patients had diabetes mellitus, cardiovascular disease, or dyslipidemia was 23.6% versus 35.8% (P<0.01). There were no differences in antihypertensive medication therapy (53.4% versus 58.6%), diet/exercise counseling (14.9% versus 16.9%), or smoking cessation advice/pharmacotherapy (18.8% versus 22.4%) between HIV-infected versus HIV-uninfected patients, respectively. CONCLUSIONS: Physicians generally underused guideline-recommended cardiovascular care and were less likely to prescribe aspirin and statins to HIV-infected patients at increased risk-findings that may partially explain higher rates of adverse cardiovascular events among patients with HIV. US policymakers and professional societies should focus on improving the quality of cardiovascular care that HIV-infected patients receive.

A comparison of perceptions of quality of life among adults with spinal cord injury in the United States versus the United Kingdom.

PURPOSE: To identify which aspects of life are most important to adults with spinal cord injury (SCI) and compare perspectives in the United States and the United Kingdom. METHODS: We conducted 20 in-depth interviews with adults with SCI (ten in the US and ten in the UK). Verbatim transcriptions were independently analyzed line-by-line by two coders using an inductive approach. Codes were grouped into themes about factors that constitute and affect quality of life (QOL). RESULTS: Five overarching themes emerged: describing QOL in the context of SCI; functional adjustment; medical care; financial resources; and socio-political issues. Twenty subthemes emerged on factors that affect QOL. Participants in both samples identified medical care as a key influence on QOL. The US group talked about a predominantly negative influence (e.g., fragmented primary and specialist care, insurance constraints, bureaucracy), whereas UK interviewees mentioned a predominantly positive influence (e.g., universal provision, including free and continuous care, free wheelchairs and home care, and length of rehabilitation commensurate with level of injury). Functional adjustment, such as physical and mental adjustment post-discharge and aging with SCI, was another important contributor to QOL, and varied by country. Most US interviewees reported poor knowledge about self-care post-discharge and poor quality of home adaptations compared to the UK group. CONCLUSIONS: For adults living with SCI, good QOL is essential for successful rehabilitation. Differences between interviewees from the two countries in perceived medical care and functional adjustment suggest that factors affecting QOL may relate to broader health system characteristics.