COVID-19-Related Outcomes Among Group Home Residents with Serious Mental Illness in Massachusetts in the First Year of the Pandemic.

This study examined COVID-19 infection and hospitalizations among people with serious mental illness who resided in residential care group homes in Massachusetts during the first year of the COVID-19 pandemic. The authors analyzed data on 2261 group home residents and COVID-19 data from the Massachusetts Department of Public Health. Outcomes included positive COVID-19 tests and COVID-19 hospitalizations March 1, 2020-June 30, 2020 (wave 1) and July 1, 2020-March 31, 2021 (wave 2). Associations between hazard of outcomes and resident and group home characteristics were estimated using multi-level Cox frailty models including home- and city-level frailties. Between March 2020 and March 2021, 182 (8%) residents tested positive for COVID-19, and 51 (2%) had a COVID-19 hospitalization. Compared with the Massachusetts population, group home residents had age-adjusted rate ratios of 3.0 (4.86 vs. 1.60 per 100) for COVID infection and 13.5 (1.99 vs. 0.15 per 100) for COVID hospitalizations during wave 1; during wave 2, the rate ratios were 0.5 (4.55 vs. 8.48 per 100) and 1.7 (0.69 vs. 0.40 per 100). In Cox models, residents in homes with more beds, higher staff-to-resident ratios, recent infections among staff and other residents, and in cities with high community transmission risk had greater hazard of COVID-19 infection. Policies and interventions that target group home-specific risks are needed to mitigate adverse communicable disease outcomes in this population.Clinical Trial Registration Number This study provides baseline (i.e., pre-randomization) data from a clinical trial study NCT04726371.

Systematic Review and Meta-analysis of Linkage to HIV Care Interventions in the United States, Canada, and Ukraine (2010-2021).

We conducted a systematic review and meta-analysis of interventions targeting linkage to HIV care in the US, Canada, and Europe. We searched six databases (PubMed, Embase, Cochrane Library, Web of Science and CINAHL). Inclusion criteria were English language studies in adults in the US, Canada, or Europe, published January 1, 2010 to January 1, 2021. We synthesized interventions by type and linkage to care outcome. The outcome was cumulative incidence of 3-month linkage. We estimated cumulative incidence ratios of linkage with 95% confidence intervals (CIs). We screened 945 studies; 13 met selection criteria (n = 1 from Canada, n = 1 from Ukraine, n = 11 from the US) and were included after full text review (total 37,549 individuals). The cumulative incidence of 3-month linkage in the intervention group was 0.82 (95% CI 0.68-0.94) and control group 0.71 (95% CI 0.50-0.90); cIR of linkage for intervention versus control was 1.30 (95% CI 1.13, 1.49). Interventions to improve linkage to care after HIV diagnosis warrant further attention.

Group Home Staff Experiences With Work and Health in the COVID-19 Pandemic in Massachusetts.

Importance: Direct reports of the experiences of staff working in group homes for people with serious mental illness (SMI) and/or intellectual or developmental disabilities (ID/DD) are rarely reported. Hearing from workers about their experiences in the COVID-19 pandemic may inform future workforce and public policy. Objective: To gather baseline data on worker experience with the perceived effects of COVID-19 on health and work in the pandemic prior to initiating an intervention to mitigate the spread of COVID-19 and to measure differences in worker experience by gender, race, ethnicity, education, and resident population served (persons with SMI and/or IDD/DD). Design, Setting, and Participants: This mixed-mode, cross-sectional survey study was conducted using online then paper-based self-administration from May to September 2021 at the end of the first year of the pandemic. Staff working in 415 group homes that provided care within 6 Massachusetts organizations serving adults aged 18 years or older with SMI and/or ID/DD were surveyed. The eligible survey population included a census of staff who were currently employed in participating group homes during the study period. A total of 1468 staff completed or partially completed surveys. The overall survey response rate was 44% (range by organization, 20% to 52%). Main Outcomes and Measures: Self-reported experiential outcomes were measured in work, health, and vaccine completion. Bivariate and multivariate analyses explore experiences by gender, race, ethnicity, education, trust in experts and employers, and population served. Results: The study population included 1468 group home staff (864 [58.9%] women; 818 [55.7%] non-Hispanic Black; 98 [6.7%] Hispanic or Latino). A total of 331 (22.5%) group home staff members reported very serious perceived effects on health; 438 (29.8%) reported very serious perceived effects on mental health; 471 (32.1%) reported very serious perceived effects on health of family and friends; and 414 reported very serious perceived effects (28.2%) on access to health services, with statistically significant differences observed by race and ethnicity. Vaccine acceptance was higher among persons with higher educational attainment and trust in scientific expertise and lower among persons who self-reported as Black or Hispanic/Latino. A total of 392 (26.7%) respondents reported needing support for health needs, and 290 (19.8%) respondents reported needing support for loneliness or isolation. Conclusions and Relevance: In this survey study, approximately one-third of group home workers reported serious personal health and access to health care barriers during the first year of the COVID-19 pandemic in Massachusetts. Addressing unmet health needs and access to health and mental health services, including inequities and disparities by race, ethnicity, and education, should benefit staff health and safety, as well as that of the individuals with disabilities who rely on them for support and care.

Best practices to reduce COVID-19 in group homes for individuals with serious mental illness and intellectual and developmental disabilities: Protocol for a hybrid type 1 effectiveness-implementation cluster randomized trial.

BACKGROUND: People with serious mental illness (SMI) and intellectual disabilities and/or developmental disabilities (ID/DD) living in group homes (GHs) and residential staff are at higher risk for COVID-19 infection, hospitalization, and death compared with the general population. METHODS: We describe a hybrid type 1 effectiveness-implementation cluster randomized trial to assess evidence-based infection prevention practices to prevent COVID-19 for residents with SMI or ID/DD and the staff in GHs. The trial will use a cluster randomized design in 400 state-funded GHs in Massachusetts for adults with SMI or ID/DD to compare effectiveness and implementation of "Tailored Best Practices" (TBP) consisting of evidence-based COVID-19 infection prevention practices adapted for residents with SMI and ID/DD and GH staff; to "General Best Practices" (GBP), consisting of required standard of care reflecting state and federal standard general guidelines for COVID-19 prevention in GHs. External (i.e., community-based research staff) and internal (i.e., GH staff leadership) personnel will facilitate implementation of TBP. The primary effectiveness outcome is incident SARS-CoV-2 infection and secondary effectiveness outcomes include COVID-19-related hospitalizations and mortality in GHs. The primary implementation outcomes are fidelity to TBP and rates of COVID-19 vaccination. Secondary implementation outcomes are adoption, adaptation, reach, and maintenance. Outcomes will be assessed at baseline, 3-, 6-, 9-, 12-, and 15-months post-randomization. CONCLUSIONS: This study will advance knowledge on comparative effectiveness and implementation of two different strategies to prevent COVID-19-related infection, morbidity, and mortality and promote fidelity and adoption of these interventions in high-risk GHs for residents with SMI or ID/DD and staff. CLINICAL TRIAL REGISTRATION NUMBER: NCT04726371.

HIV testing in a large community health center serving a multi-cultural patient population: A qualitative study of providers.

In the United States, 15% of HIV-positive individuals do not know their HIV serostatus. While CDC guidelines recommend HIV testing for individuals age 13-64 years, racial and ethnic minorities continue to experience delays in HIV diagnosis. We assessed providers' perspectives on HIV testing at an urban community health center serving racial/ethnic minority populations of low socioeconomic status. We conducted five focus groups from January 2017 to November 2017 with 74 health center staff: 20 adult medicine/primary care providers, 34 community health workers (CHWs) and community health administrators, six urgent care physicians, and fourteen behavioral health providers. Study staff analyzed transcripts using a grounded theory approach and used open coding to develop themes. We identified five themes affecting HIV testing: 1) provider perception of patients' preferences for HIV testing; 2) competing medical and social issues; 3) inter-professional communication; 4) knowledge of clinical indicators for HIV testing; and 5) knowledge of frequency of HIV testing. Primary care physicians desired mechanisms to easily identify patients for HIV testing and assistance with testing for non-English speakers. Training to improve comfort with HIV testing, integrating CHWs into routine practice, and focusing on patients' cultural beliefs may increase HIV testing in diverse community health centers..

High HIV/STI Test Acceptance Through a Behavioral Health Encounter in Latino Immigrants with Substance Use and Mental Health Problems.

Latino immigrants with substance use and mental health problems are at risk for undiagnosed HIV and sexually transmitted infections (STIs). Participants in a randomized control trial were recruited in Boston, USA and Madrid and Barcelona, Spain. Eligibility criteria were Latino self-identification, age 18-70, elevated substance use and mental health symptoms, and not currently in substance or mental health care. A multinomial logistic regression examined predictors of HIV/STI testing decline and lost to follow-up (LTFU) prior to testing compared with acceptance. Of 341 participants, 74% accepted testing, 4% declined, and 22% were LTFU. The odds of LTFU were higher in those with high concern for HIV and those whose main partner had done HIV testing. Age ≥ 35 years, females, higher education, and higher report of discrimination lowered the odds of LTFU. Delivery of HIV/STI testing through community agencies and outreach could overcome barriers to HIV/STI diagnosis in this population of Latinos.Clinical Trial Number: NCT02038855.

Cognitive-affective depressive symptoms and substance use among Latino and non-Latino White patients in HIV care: an analysis of the CFAR network of integrated clinical systems cohort.

The disparity in viral suppression rates between Latino and non-Latino White patients in HIV care appears to be narrowing, but it is unclear if depression and substance use perpetuate this disparity. We analyzed electronic medical records from the CFAR network of integrated clinical systems cohort. First observations/enrollment data collected between 2007 and 2013 were analyzed, which included survey (race/ethnicity, depression, substance use, adherence) and clinical data (viral suppression). We estimated indirect effects with a regression-based bootstrapping method. In 3129 observations, Latinos and non-Latino Whites did not differ in depression or alcohol use (ORs 1.11, 0.99, ns), but did in drug use (OR 1.13, p < .001). For all patients, depression and substance use were indirectly associated with small increases (ORs 1.02-1.66) in the odds for a detectable viral load, via worse adherence. We conclude that variables not captured in EMR systems (e.g., health literacy, structural factors) may better explain viral suppression disparities that persist.

A Critical Review and Commentary on the Challenges in Engaging HIV-Infected Latinos in the Continuum of HIV Care.

Antiretroviral therapy for treatment of HIV infection has become increasingly effective. Persistent poor HIV outcomes in racial and ethnic minority populations in the US call for a closer examination into why Latinos are at significant risk for acquiring and dying from HIV. To improve clinical outcomes and achieve an AIDS-free generation, HIV research must address disparities in HIV outcomes in Latinos, the largest ethnic/racial minority population in the US. Immigrant status as well as cultural factors influence HIV care utilization and are essential to highlight for effective intervention development in Latinos. A better understanding of these individual and contextual factors is critical to developing tailored approaches to engaging Latinos in HIV care. Based on a comprehensive literature review, we offer a framework for understanding what is needed from clinical practice and research to improve engagement in HIV care for US-based Latinos. These findings may have implications for other minority populations.

Role of Country of Birth, Testing Site, and Neighborhood Characteristics on Nonlinkage to HIV Care Among Latinos.

The objective of this study was to estimate disparities in linkage to human immunodeficiency virus (HIV) care among Latinos by country/region of birth, HIV testing site, and neighborhood characteristics. A retrospective study was conducted using Florida HIV surveillance records of Latinos/Hispanics aged ≥13 diagnosed during 2014-2015. Linkage to HIV care was defined as a laboratory test (HIV viral load or CD4) within 3 months of HIV diagnosis. Multi-level Poisson regression models were used to estimate adjusted prevalence ratios (aPR) for nonlinkage to care. Of 2659 Latinos, 18.8% were not linked to care within 3 months. Compared with Latinos born in mainland United States, those born in Cuba [aPR 0.60, 95% confidence interval (CI) 0.47-0.76] and Puerto Rico (aPR 0.61, 95% CI 0.41-0.90) had a decreased prevalence of nonlinkage. Latinos diagnosed at blood banks (aPR 2.34, 95% CI 1.75-3.12), HIV case management and screening facilities (aPR 1.76, 95% CI 1.46-2.14), and hospitals (aPR 1.42, 95% CI 1.03-1.96) had an increased prevalence of nonlinkage compared with outpatient general, infectious disease, and tuberculosis/sexually transmitted diseases/family planning clinics. Latinos who resided in the lowest (aPR 1.57, 95% CI 1.19-2.07) and third lowest (aPR 1.33, 95% CI 1.01-1.76) quartiles of neighborhood socioeconomic status compared with the highest quartile were at increased prevalence. Latinos who resided in neighborhoods with <25% Latinos also had increased prevalence of nonlinkage (aPR 1.23, 95% CI 1.01-1.51). Testing site at diagnosis may be an important determinant of HIV care linkage among Latinos due to neighborhood or individual-level resources that determine location of HIV testing.

"Where It Falls Apart": Barriers to Retention in HIV Care in Latino Immigrants and Migrants.

Latino immigrants in the United States are disproportionately affected by HIV. Barriers to consistent attendance (retention) in HIV primary care constrain opportunities for HIV treatment success, but have not been specifically assessed in this population. We conducted semistructured interviews with 37 HIV-infected Latinos (aged ≥18 years and born in Puerto Rico or a Latin American Spanish-speaking country) and 14 HIV providers in metropolitan Boston (total n = 51). The Andersen Model of Healthcare Utilization informed a semistructured interview guide, which bilingual research staff used to explore barriers to HIV care. We used thematic analysis to explore the processes of retention in care. Six ubiquitous themes were perceived to influence HIV clinic attendance: (1) stigma as a barrier to HIV serostatus disclosure; (2) social support as a safety net during negative life circumstances; (3) unaddressed trauma and substance use leading to interruption in care; (4) a trusting relationship between patient and provider motivating HIV clinic attendance; (5) basic unmet needs competing with the perceived value of HIV care; and (6) religion providing a source of hope and optimism. Cultural subthemes were the centrality of family (familismo), masculinity (machismo), and trusting relationships (confianza). The timing of barriers was acute (e.g., eviction) and chronic (e.g., family conflict). These co-occurring and dynamic constellation of factors affected HIV primary care attendance over time. HIV-infected Latino immigrants and migrants experienced significant challenges that led to interruptions in HIV care. Anticipatory guidance to prepare for these setbacks may improve retention in HIV care in this population.

Foreign-born status as a predictor of engagement in HIV care in a large US metropolitan health system.

We sought to determine the linkage to and retention in HIV care after HIV diagnosis in foreign-born compared with US-born individuals. From a clinical data registry, we identified 619 patients aged ≥18 years with a new HIV diagnosis between 2000 and 2012. Timely linkage to care was the proportion of patients with an ICD-9 code for HIV infection (V08 or 042) associated with a primary care or infectious disease physician within 90 days of the index positive HIV test. Retention in HIV care was the presence of an HIV primary care visit in each 6-month period of the 24-month measurement period from the index HIV test. We used Cox regression analysis with adjustment for hypothesized confounders (age, gender, race/ethnicity, substance abuse, year, and location of HIV diagnosis). Foreign-born individuals comprised 36% (225/619) of the cohort. Index CD4 count was 225/µl (IQR 67-439/µl) in foreign-born compared with 328/µl (IQR 121-527/µl) in US-born individuals (p < .001). The proportion linked to care was 87% (196/225) in foreign-born compared with 77% (302/394) in US-born individuals (p = .002). The adjusted hazard ratio of linkage to HIV care in foreign-born compared with US-born individuals was 1.28 (95% confidence interval [CI], 1.05-1.56). Once linked, there was no difference in retention in care or virologic suppression at 24 months. These results show that despite late presentation to HIV care, foreign-born persons can subsequently engage in HIV care as well as US-born persons. Interventions that promote HIV screening in foreign-born persons are a promising way to improve outcomes in these populations.

Shifting the HIV Training and Research Paradigm to Address Disparities in HIV Outcomes.

Tailored programs to diversify the pool of HIV/AIDS investigators and provide sufficient training and support for minority investigators to compete successfully are uncommon in the US and abroad. This paper encourages a shift in the HIV/AIDS training and research paradigm to effectively train and mentor Latino researchers in the US, Latin America and the Caribbean. We suggest three strategies to accomplish this: (1) coaching senior administrative and academic staff of HIV/AIDS training programs on the needs, values, and experiences unique to Latino investigators; (2) encouraging mentors to be receptive to a different set of research questions and approaches that Latino researchers offer due to their life experiences and perspectives; and (3) creating a virtual infrastructure to share resources and tackle challenges faced by minority researchers. Shifts in the research paradigm to include, retain, and promote Latino HIV/AIDS researchers will benefit the scientific process and the patients and communities who await the promise of HIV/AIDS research.

The clinical and economic impact of genotype testing at first-line antiretroviral therapy failure for HIV-infected patients in South Africa.

BACKGROUND: In resource-limited settings, genotype testing at virologic failure on first-line antiretroviral therapy (ART) may identify patients with wild-type (WT) virus. After adherence counseling, these patients may safely and effectively continue first-line ART, thereby delaying more expensive second-line ART. METHODS: We used the Cost-Effectiveness of Preventing AIDS Complications International model of human immunodeficiency virus (HIV) disease to simulate a South African cohort of HIV-infected adults at first-line ART failure. Two strategies were examined: no genotype vs genotype, assuming availability of protease inhibitor-based second-line ART. Model inputs at first-line ART failure were mean age 38 years, mean CD4 173/µL, and WT virus prevalence 20%; genotype cost was $300 per test and delay to results, 3 months. Outcomes included life expectancy, per-person costs (2010 US dollars), and incremental cost-effectiveness ratios (dollars per years of life saved [YLS]). RESULTS: No genotype had a projected life expectancy of 106.1 months, which with genotype increased to 108.3 months. Per-person discounted lifetime costs were $16 360 and $16 540, respectively. Compared to no genotype, genotype was very cost-effective, by international guidance, at $900/YLS. The cost-effectiveness of genotype was sensitive to prevalence of WT virus (very cost-effective when prevalence ≥ 12%), CD4 at first-line ART failure, and ART efficacy. Genotype-associated delays in care ≥ 5 months decreased survival and made no genotype the preferred strategy. When the test cost was <$100, genotype became cost-saving. CONCLUSIONS: Genotype resistance testing at first-line ART failure is very cost-effective in South Africa. The cost-effectiveness of this strategy will depend on prevalence of WT virus and timely response to genotype results.

Virologic failure of protease inhibitor-based second-line antiretroviral therapy without resistance in a large HIV treatment program in South Africa.

BACKGROUND: We investigated the prevalence of wild-type virus (no major drug resistance) and drug resistance mutations at second-line antiretroviral treatment (ART) failure in a large HIV treatment program in South Africa. METHODOLOGY/ PRINCIPAL FINDINGS: HIV-infected patients ≥ 15 years of age who had failed protease inhibitor (PI)-based second-line ART (2 consecutive HIV RNA tests >1000 copies/ml on lopinavir/ritonavir, didanosine, and zidovudine) were identified retrospectively. Patients with virologic failure were continued on second-line ART. Genotypic testing for drug resistance was performed on frozen plasma samples obtained closest to and after the date of laboratory confirmed second-line ART failure. Of 322 HIV-infected patients on second-line ART, 43 were adults with confirmed virologic failure, and 33 had available plasma for viral sequencing. HIV-1 RNA subtype C predominated (n = 32, 97%). Mean duration on ART (SD) prior to initiation of second-line ART was 23 (17) months, and time from second-line ART initiation to failure was 10 (9) months. Plasma samples were obtained 7(9) months from confirmed failure. At second-line failure, 22 patients (67%) had wild-type virus. There was no major resistance to PIs found. Eleven of 33 patients had a second plasma sample taken 8 (5.5) months after the first. Median HIV-1 RNA and the genotypic resistance profile were unchanged. CONCLUSIONS/ SIGNIFICANCE: Most patients who failed second-line ART had wild-type virus. We did not observe evolution of resistance despite continuation of PI-based ART after failure. Interventions that successfully improve adherence could allow patients to continue to benefit from second-line ART therapy even after initial failure.

Genotype assays and third-line ART in resource-limited settings: a simulation and cost-effectiveness analysis of a planned clinical trial.

OBJECTIVES: To project the clinical and economic outcomes of a genotype assay for selection of third-line antiretroviral therapy (ART) in resource-limited settings, as per the planned international A5288 trial (MULTI-OCTAVE). METHODS: We used the Cost-effectiveness of Preventing AIDS Complications (CEPAC)-International Model to compare three strategies for patients who have failed second-line ART in South Africa: sustained second-line: no genotype assay, all patients remain on second-line ART; A5288: genotype to determine the resistance profile and assign an appropriate regimen; or population-based third-line: no genotype, all patients switch to a potent third-line regimen. Model inputs are from published data in South Africa. Resistance profiles, ART regimens, and efficacy data were those used for trial planning. RESULTS: Projected life expectancy for sustained second-line, A5288, and population-based third-line are 61.1, 103.8, and 104.2 months. Compared to sustained second-line ($12 ,460), per person lifetime costs increase for the A5288 ($39, 250) and population-based ($44, 120) strategies. The incremental cost-effectiveness ratio of A5288, compared to sustained second-line, is $7500/year of life saved (YLS), and for population-based third-line, compared to A5288, is $154 ,500/YLS. In the A5288 strategy, very late presentation to care, coupled with lengthy delays to obtain the genotype, dramatically reduces 5-year survival, making the population-based third-line strategy more attractive. CONCLUSIONS: We project that, whereas the public health approach to third-line therapy is unaffordable, genotype assays and third-line ART in resource-limited settings will increase survival and be cost-effective compared to the population-based approach, supporting the value of an efficacy study.

Early outcomes and the virological effect of delayed treatment switching to second-line therapy in an antiretroviral roll-out programme in South Africa.

BACKGROUND: More patients in resource-limited settings are starting second-line antiretroviral treatment (ART) following first-line ART failure. We aimed to describe predictors of lack of virological suppression in HIV-infected patients on second-line ART in a roll-out programme in South Africa. METHODS: A retrospective analysis was performed on an adult HIV treatment cohort who started second-line ART (lopinavir/ritonavir, didanosine and zidovudine) after virological failure of first-line ART (two consecutive HIV RNA>1,000 copies/ml). Predictors of week 24 lack of suppression (HIV RNA>400 copies/ml) on second-line ART were determined by bivariate analysis where missing equals failure. A multivariable model that adjusted for gender, age and time to ART switch was used. We tested these findings in sensitivity analyses defining lack of suppression at week 24 as HIV RNA>1,000 and >5,000 copies/ml. RESULTS: Of 6,339 patients on ART, 202 started second-line ART. At week 24, an estimated 41% (95% CI 34-47) did not achieve virological suppression. Female sex (adjusted OR 2.25, 95% CI 1.03-4.88) and time to ART switch (adjusted OR 1.07, 95% CI 1.01-1.14 for each additional month) increased the risk of lack of virological suppression. Age, CD4(+) T-cell count and HIV RNA at second-line ART initiation did not predict this outcome. In multivariate models, these findings were insensitive to the definition of lack of virological suppression. CONCLUSIONS: A substantial number of HIV-infected patients do not achieve virological suppression by week 24 of second-line ART. Women and patients with delayed start of second-line ART after first-line ART failure were at an increased risk of lack of virological suppression.

Pharmacokinetics and pharmacodynamics of antibacterial agents.

This article reviews pharmacodynamics of antibacterial drugs, which can be used to optimize treatment strategies, prevent emergence of resistance and rationalize the determination of antimicrobial susceptibility. Important pharmacodynamic concepts include the requirements for bactericidal therapy for endocarditis and meningitis, for synergistic combinations to treat enterococcal endocarditis or to shorten the course of antimicrobial therapy, for obtaining maximal plasma concentration/minimal inhibitory concentration (MIC) ratios that are greater than 10 or 24 hour-area under the plasma concentration curve (AUC)/MIC ratios that are greater than 100-125 for concentration-dependent agents against gram-negative bacilli and 25-35 against Streptococcus pneumoniae, and for obtaining percent of time that drug levels are greater than the MIC that is at least 40% to 50% of the dosing interval for time-dependent agents.

Recovery of Herbaspirillum species from persons with cystic fibrosis.

Herbaspirillum species are not known to be human pathogens. We report on the identification of Herbaspirillum from cultures from 28 persons with cystic fibrosis (CF). Most isolates were initially identified as members of the Burkholderia cepacia complex. Although the role that these species play in lung disease in persons with CF is not known, their differentiation from other species is important and has serious implications for clinical care and patient well-being.