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.

The epidemiology of rotavirus diarrhea in countries in the Eastern Mediterranean Region.

OBJECTIVE: Rotavirus is the leading cause of severe diarrhea among children worldwide, killing approximately 600,000 children annually, including 64,800 in the Eastern Mediterranean Region. Safe, effective rotavirus vaccines will be available soon, and accurate disease burden data will be needed to assess the burden of rotavirus and the value of new vaccines and monitor vaccine program impact. METHODS: To identify epidemiologic studies in which rotavirus diagnostics were applied to children with acute gastroenteritis, we performed a systematic literature review. We selected studies that met 4 criteria and extracted rotavirus data on prevalence estimates, strain identification, age distribution of patients, and seasonal trends. RESULTS: Of the 63 published studies with some rotavirus detection data, 29 met inclusion criteria. Among patients with diarrhea, rotavirus was detected in 40% of inpatients and 23% of outpatients. By 3 years of age, 75% of children experienced a documented rotavirus infection. Circulation of rotavirus occurred year-round, and no clear relationship between the timing of the rotavirus peak with either season or latitude was observed. Comparison of country-specific rotavirus detection rates indicated that the proportion of hospitalizations for rotavirus infection increased with income. CONCLUSION: This systematic review of studies of rotavirus diarrhea among children in the countries of the Eastern Mediterranean Region documents that rotavirus is one of the most significant causes of childhood diarrhea in the region. The findings of this review will be used to establish sentinel hospital surveillance in these countries, estimate disease burden, and characterize its epidemiology using common protocols and diagnostics.

Diarrhea- and rotavirus-associated hospitalizations among children less than 5 years of age: United States, 1997 and 2000.

OBJECTIVE: A new rotavirus vaccine may be licensed in the United States in early 2006. Estimates of the burden of severe rotavirus disease, particularly hospitalizations, will help evaluate the potential benefits of a national rotavirus immunization program. DESIGN: The Kids' Inpatient Database, a robust sample of 10% of the uncomplicated births and 80% of other pediatric discharges was used to estimate the number and rate of diarrhea- and rotavirus-associated hospitalizations among US children <5 years of age in 1997 and 2000. RESULTS: In 1997 and 2000, diarrhea was coded in 13% of all childhood hospitalizations, for an estimated cumulative incidence of 1 diarrhea hospitalization per 23 to 27 children by age 5. Most diarrhea-associated hospitalizations (62%) were coded as unspecified etiology, and 35% as viral. Rotavirus was the most common pathogen recorded for 18% and 19% of diarrhea-associated hospitalizations in 1997 and 2000, respectively. Diarrhea-associated hospitalizations coded as unspecified or viral exhibited a marked winter peak similar to that of hospitalizations coded as rotavirus, suggesting that the rotavirus-specific code captures a fraction of all rotavirus hospitalizations. Using indirect methods, we estimated that rotavirus was associated with 51142-60155 and 46839-56820 hospitalizations in 1997 and 2000, respectively. By these estimates, rotavirus is associated with 4% to 5% of all childhood hospitalizations, and 1 in 67 to 1 in 85 children will be hospitalized with rotavirus by 5 years of age. CONCLUSIONS: Diarrhea is an important cause of hospitalization in US children, and rotavirus is the most important etiology. Disease burden estimates have remained stable during the past decade. An effective rotavirus vaccine will likely reduce substantially the burden of severe rotavirus disease, estimated to account for 4% to 5% of all hospitalizations and approximately 30% of hospitalizations for watery diarrhea among children <5 years of age.

Autologous cultured chondrocytes: adverse events reported to the United States Food and Drug Administration.

BACKGROUND: Carticel is an autologous cultured chondrocyte product that has been approved by the United States Food and Drug Administration for the repair of symptomatic cartilaginous defects of the femoral condyle that are caused by acute or repetitive trauma in patients who have been previously managed with arthroscopy or other surgical procedures. The present report describes the adverse events following Carticel implantation as reported to the Food and Drug Administration from 1996 to 2003. METHODS: We reviewed adverse event reports that had been submitted to the Food and Drug Administration's MedWatch system for information on demographic characteristics, adverse events, and surgical revisions. Adverse events were categorized into sixteen non-mutually exclusive groups. Five categories were used to classify reoperations. Food and Drug Administration regulations require manufacturers to report adverse events; however, reporting by clinicians and others is voluntary. Therefore, adverse event reporting is likely to underestimate the number of event occurrences. Adverse events may be either causally or coincidentally related to the product. RESULTS: A total of 497 adverse events among 294 patients receiving Carticel were reported. The median interval from Carticel implantation to the diagnosis of an adverse event was 240 days (range, one to 2105 days). The median age of the patients was thirty-eight years, and 63% of the patients were male. Of the 270 events for which the anatomic site was noted, 258 (96%) involved the femoral condyles. More than one adverse event was reported for 135 patients (46%). The most commonly reported events were graft failure (seventy-three patients; 25%), delamination (sixty-five patients; 22%), and tissue hypertrophy (fifty-two patients; 18%). In addition, eighteen surgical site infections were reported, including eleven joint and seven soft-tissue infections. Surgical revision subsequent to Carticel implantation was mentioned in the records for 273 patients (93%). The reasons for the 389 revision procedures included graft-related problems (187 procedures; 48.1%), periarticular soft-tissue problems (ninety-seven procedures; 24.9%), and intra-articular problems (sixty-three procedures; 16.2%). Eight patients had a total knee replacement. Based on the manufacturer's reported distribution of 7500 Carticel lots between 1995 and 2002, 285 patients (3.8%) had an adverse event that was reported to the Food and Drug Administration. CONCLUSIONS: The most common adverse events reported in association with the Carticel technique involved graft failure, delamination, and tissue hypertrophy.