Using Financial Incentives to Improve Rates of Viral Suppression and Engagement in Care of Patients Receiving HIV Care at 3 Health Clinics in Louisiana: The Health Models Program, 2013-2016.

OBJECTIVES: The Care and Prevention in the United States Demonstration Project aimed to reduce HIV/AIDS-related morbidity and mortality among racial/ethnic minority groups in 8 states. We evaluated Health Models, a pay-for-performance program piloted by the Louisiana Department of Health that used financial incentives to improve rates of engagement in HIV medical care and viral suppression among people with HIV. METHODS: We enrolled 2076 patients of 3 urban HIV specialty clinics in Louisiana in the Health Models pay-for-performance program on a rolling basis from September 2013 through September 2016 and gave patients cash incentives to attend HIV medical appointments, achieve or maintain viral suppression, and link to supportive services. We used laboratory data collected from Louisiana's HIV surveillance database to calculate rates of engagement in care and viral suppression during the first 24 months of enrollment. RESULTS: Of the 2076 patients who enrolled, 1400 (67.4%) were non-Hispanic black, 1480 (71.3%) were male, 1175 (56.6%) were men who have sex with men, and 1371 (66.0%) reported an annual income of <$15 000. At enrollment, 1456 (70.1%) patients were engaged in HIV care, and 1197 (57.7%) patients were virally suppressed. After 12 months of enrollment, 1474 of 1783 (82.7%) patients were virally suppressed. Of enrolled patients with at least 12 or 24 months of follow-up data, 1299 of 1317 (98.6%) patients were engaged in care during their first 12 months of enrollment, and 995 of 1033 (96.3%) patients were engaged in care between 12 and 24 months of enrollment. CONCLUSIONS: During the implementation of Health Models, enrolled patients had increases in rates of viral suppression and achieved rates of engagement in care and viral suppression that were higher than national levels; however, additional supportive services may be needed to further reduce socioeconomic disparities in the rates of viral suppression.

Implementing a Data to Care Strategy to Improve Health Outcomes for People With HIV: A Report From the Care and Prevention in the United States Demonstration Project.

OBJECTIVES: The Care and Prevention in the United States Demonstration Project included implementation of a Data to Care strategy using surveillance and other data to (1) identify people with HIV infection in need of HIV medical care or other services and (2) facilitate linkages to those services to improve health outcomes. We present the experiences of 4 state health departments: Illinois, Louisiana, Tennessee, and Virginia. METHODS: The 4 state health departments used multiple databases to generate listings of people with diagnosed HIV infection (PWH) who were presumed not to be in HIV medical care or who had difficulty maintaining viral suppression from October 1, 2013, through September 29, 2016. Each health department prioritized the listings (eg, by length of time not in care, by viral load), reviewed them for accuracy, and then disseminated the listings to staff members to link PWH to HIV care and services. RESULTS: Of 16 391 PWH presumed not to be in HIV medical care, 9852 (60.1%) were selected for follow-up; of those, 4164 (42.3%) were contacted, and of those, 1479 (35.5%) were confirmed to be not in care. Of 794 (53.7%) PWH who accepted services, 694 (87.4%) were linked to HIV medical care. The Louisiana Department of Health also identified 1559 PWH as not virally suppressed, 764 (49.0%) of whom were eligible for follow-up. Of the 764 PWH who were eligible for follow-up, 434 (56.8%) were contacted, of whom 269 (62.0%) had treatment adherence issues. Of 153 PWH who received treatment adherence services, 104 (68.0%) showed substantial improvement in viral suppression. CONCLUSIONS: The 4 health departments established procedures for using surveillance and other data to improve linkage to HIV medical care and health outcomes for PWH. To be effective, health departments had to enhance coordination among surveillance, care programs, and providers; develop mechanisms to share data; and address limitations in data systems and data quality.

Refining Liver Safety Risk Assessment: Application of Mechanistic Modeling and Serum Biomarkers to Cimaglermin Alfa (GGF2) Clinical Trials.

Cimaglermin alfa (GGF2) is a recombinant human protein growth factor in development for heart failure. Phase I trials were suspended when two cimaglermin alfa-treated subjects experienced concomitant elevations in serum aminotransferases and total bilirubin, meeting current US Food and Drug Administration criteria for a serious liver safety signal (i.e., "Hy's Law"). We assayed mechanistic biomarkers in archived clinical trial serum samples which confirmed the hepatic origin of the aminotransferase elevations in these two subjects and identified apoptosis as the major mode of hepatocyte death. Using a mathematical model of drug-induced liver injury (DILIsym) and a simulated population, we estimated that the maximum hepatocyte loss in these two subjects was <13%, which would not result in liver dysfunction sufficient to significantly increase serum bilirubin levels. We conclude that the two subjects should not be considered Hy's Law cases and that mechanistic biomarkers and modeling can aid in refining liver safety risk assessment in clinical trials.

Impact of the BCG vaccination policy on tuberculous meningitis in children under 6 years in metropolitan France between 2000 and 2011.

In France, Bacillus Calmette­Guérin (BCG) vaccination by multipuncture device was withdrawn in 2006. In 2007, universal mandatory BCG vaccination was replaced by vaccination of high-risk children. To evaluate the impact of these changes on tuberculous meningitis (TBM) epidemiology, data on culture-positive and culture-negative (or unknown microbiological result) TBM in ≤5 years olds were collected from 2000­2011. Ten culture-positive and 17 culture-negative TBM cases were identified, with an annual incidence rate ranging from 0.16 to 0.66 cases per 10 million inhabitants. The average annual numbers of TBM cases were 2.7 and 1.8 from 2000­2005 and 2006­2011, respectively. In Ile-de-France where all children are considered at risk, the overall incidence rates were 1.14 and 0.29 per million for the two periods. In other regions where only at-risk children are vaccinated since 2007, rates were 0.30 and 0.47, respectively. None of these differences were significant. Annual incidence rates for each one year age group cohort were comparable before and after changes. Childhood TBM remains rare in France. No increase in incidence was observed after changes in BCG vaccination strategy. Ongoing surveillance should be maintained, as a slight increase in TBM in the coming years remains possible, in the context of suboptimal vaccination coverage of high-risk children.

The Cognitive Assessment scale for Stroke Patients (CASP) vs. MMSE and MoCA in non-aphasic hemispheric stroke patients.

INTRODUCTION: CASP specifically assesses post-stroke cognitive impairments. Its items are visual and as such can be administered to patients with severe expressive aphasia. We have previously shown that the CASP was more suitable than the Mini Mental State Examination (MMSE) and Montreal Cognitive Assessment (MoCA) in aphasic patients. Our objective was to compare the above scales in non-aphasic stroke patients, and assess to what extent the solely visual items of the CASP were problematic in cases of neurovisual impairments. METHODS: Fifty non-aphasic patients admitted to Physical Medicine and Rehabilitation (PM&R) units after a recent left- or right-hemisphere stroke were evaluated with the CASP, MMSE and MoCA. We compared these three scales in terms of feasibility, concordance, and influence of neurovisual impairments on the total score. RESULTS: Twenty-nine men and 21 women were included (mean age 63 ± 14). For three patients, the MoCa was impossible to administer. It took significantly less time to administer the CASP (10 ± 5 min) than the MoCA (11 ± 5 min, P=0.02), yet it still took more time than MMSE administration (7 ± 3 min, P<10(-6)). Neurovisual impairments affected equally the total scores of the three tests. Concordance between these scores was poor and only the CASP could specifically assess unilateral spatial neglect. CONCLUSION: The sole visual format of the CASP scale seems suitable for administration in post-stroke patients.

Feasibility of the cognitive assessment scale for stroke patients (CASP) vs. MMSE and MoCA in aphasic left hemispheric stroke patients.

INTRODUCTION: Post-stroke aphasia makes it difficult to assess cognitive deficiencies. We thus developed the CASP, which can be administered without using language. Our objective was to compare the feasibility of the CASP, the Mini Mental State Examination (MMSE) and the Montreal Cognitive Assessment (MoCA) in aphasic stroke patients. MATERIAL AND METHODS: All aphasic patients consecutively admitted to seven French rehabilitation units during a 4-month period after a recent first left hemispheric stroke were assessed with CASP, MMSE and MoCA. We determined the proportion of patients in whom it was impossible to administer at least one item from these 3 scales, and compared their administration times. RESULTS: Forty-four patients were included (age 64±15, 26 males). The CASP was impossible to administer in eight of them (18%), compared with 16 for the MMSE (36%, P=0.05) and 13 for the MoCA (30%, P=0.21, NS). It was possible to administer the CASP in all of the patients with expressive aphasia, whereas the MMSE and the MoCA could not be administered. Administration times were longer for the CASP (13±4min) than for the MMSE (8±3min, P<10(-6)) and the MoCA (11±5min, P=0.23, NS). CONCLUSION: The CASP is more feasible than the MMSE and the MoCA in aphasic stroke patients.

Factors associated with patient and health care system delay in the diagnosis of tuberculosis in France.

OBJECTIVE: To analyse diagnostic delay in tuberculosis (TB) patients. DESIGN: Cross-sectional study: all patients with TB notified to the French national surveillance system from April to June 2010 were interviewed face-to-face using a standardised questionnaire to assess symptom history and health-seeking trajectories. RESULTS: Of 225 patients enrolled, 172 (76.4%) had pulmonary TB, including 88 who were smear-positive. Mean delay between first symptoms and diagnosis (total delay) was 97 days (median 68, IQR 33-111), with a mean of 47 days (median 14, IQR 0-53) between first symptoms and health care contact (patient delay), and 48 days (median 25, IQR 6-67) between health care contact and diagnosis (health system delay). Factors independently associated with shortened total delay were medical insurance (OR 0.24, P = 0.014) and previous TB (OR 0.28, P = 0.049). Those associated with reduced patient delay were initial fever (OR 0.42, P = 0.03) and being followed by a general practitioner (OR 0.22, P = 0.004), while those associated with reduced health system delay were first health care contact within a hospital (OR 0.15, P < 0.001). Empirical antibiotic treatment was associated with increased health system delay (OR 4.4, P = 0.001). CONCLUSION: TB diagnostic delay needs to be reduced in France. This may be achieved through improved access to care, earlier hospital referral, and less use of empirical antibiotic treatment.