Social Vulnerability and Mental Health Among People with HIV and Substance Use: The Role of Race.

Poor mental health significantly impacts people with HIV (PWH) and those who drink alcohol. Limited data exist on the combined effects of social determinants of health (social vulnerability) on mental health in PWH with unhealthy substance use. We investigated the relationship between social vulnerability and poor mental health in PWH and whether this relationship differed by race/ethnicity. We conducted a cross-sectional analysis using data from the Boston ARCH Cohort among PWH with current or past unhealthy substance use. We created a 23-item social vulnerability index (SVI) using a deficit accumulation approach comprised of social determinants of health indicators. We estimated whether higher SVI score is associated with anxiety and depressive symptoms using logistic regression analysis. Among 251 participants with a mean age of 52 (SD = 10) years, 67.3% were male, 52% Black, 21% Hispanic, 19% White, and 73% unemployed. The SVI had a mean of 9.30 (SD = 3.4) with a 1.5-18 range. Nearly two in five persons reported past month heavy alcohol use and 35% illicit drug use. The prevalence of anxiety and depressive symptoms was 34.4% and 54.2% respectively. Higher SVI score was associated with anxiety symptoms (adjusted odds ratio [aOR] = 2.01, 95% confidence interval [CI] 1.46, 2.76, p ≤ 0.001), and depressive symptoms (aOR = 2.42, 95% CI 1.74, 3.36, p ≤ 0.001). Race/ethnicity did not moderate the relationship between SVI and each mental health outcome. SVI was significantly associated with poor mental health across racial/ethnicity groups in this cohort. Interventions that address social vulnerability may improve well-being and quality of life for PWH.

Limited Risk Compensation Among Women Who Inject Drugs: Results From the Project Sexual Health Equity Preexposure Prophylaxis Demonstration Study in Philadelphia.

ABSTRACT: The impact of preexposure prophylaxis uptake on sexual and injection-related behaviors among women who inject drugs is poorly understood. Over 24 weeks, preexposure prophylaxis uptake among women who inject drugs was associated with increased sharing of injection equipment but not syringes and no changes in condomless sex, providing limited evidence of risk compensation in this vulnerable population.

Predictors of Willingness to Diffuse PrEP Information within Ego-Centric Networks of Women Who Inject Drugs.

Little is known about how social networks among women who inject drugs (WWID) can be leveraged to increase awareness about pre-exposure prophylaxis (PrEP). We tested the hypothesis that interpersonal characteristics influence willingness of WWID to communicate PrEP information with peers. Forty WWID ≥ 18 years completed social network surveys. Participants named on average 9.3 (SD = 3.3) network members, resulting in 375 unique relationships. WWID were willing to share PrEP information with 83% of network members. Participants had higher odds of willingness to share information within relationships when the network member was female, homeless and perceived to be at risk for HIV. Among relationships with family members and transactional sex clients, stronger emotional closeness was associated with higher odds of willingness to share information. Peer interventions where WWID share PrEP information with peers may be an efficient approach to increase PrEP awareness among this vulnerable population.

Intention to initiate and uptake of PrEP among women who injects drugs in a demonstration project: an application of the theory of planned behavior.

Some women who inject drugs (WWID) would benefit from pre-exposure prophylaxis (PrEP), yet there are few studies of issues related to uptake in real-world settings. In this study, participants (n = 95) were offered PrEP and responded to items measuring PrEP-related attitudes, norms, and perceived behavioral control based on the Theory of Planned Behavior. We tested associations with intention to initiate PrEP and uptake. Most WWID (88%) intended to initiate PrEP and 78% accepted a prescription. Compared to WWID who did not express PrEP intentions, those who did were less concerned about attitudinal and perceived behavioral control constructs such as temporary (75% vs. 36%, p = 0.01) and long-term (63% vs. 27%, p = 0.05) side effects, negative interactions with their birth control (93% vs. 38%, p < 0.01), their ability to take a daily pill (80% vs. 36%, p < 0.01), and the cost of PrEP (87% vs. 36%, p < 0.01). WWID who went on to take PrEP had fewer concerns with subjective norms constructs such as talking to health care providers about sex (91% vs. 65%, p < 0.01) and drug use (88% vs. 55%, p < 0.01) compared to those who did not. Attitudes and perceived behavioral control influenced intention while subjective norms had a greater impact on actual uptake.

Respiratory Medications in Infants <29 Weeks during the First Year Postdischarge: The Prematurity and Respiratory Outcomes Program (PROP) Consortium.

OBJECTIVE: To determine patterns of respiratory medications used in neonatal intensive care unit graduates. STUDY DESIGN: The Prematurity Respiratory Outcomes Program enrolled 835 babies <29 weeks of gestation in the first week. Of 751 survivors, 738 (98%) completed at least 1, and 85% completed all 4, postdischarge medication usage in-person/telephone parental questionnaires requested at 3, 6, 9, and 12 months of corrected age. Respiratory drug usage over the first year of life after in neonatal intensive care unit discharge was analyzed. RESULTS: During any given quarter, 66%-75% of the babies received no respiratory medication and 45% of the infants received no respiratory drug over the first year. The most common postdischarge medication was the inhaled bronchodilator albuterol; its use increased significantly from 13% to 31%. Diuretic usage decreased significantly from 11% to 2% over the first year. Systemic steroids (prednisone, most commonly) were used in approximately 5% of subjects in any one quarter. Inhaled steroids significantly increased over the first year from 9% to 14% at 12 months. Drug exposure changed significantly based on gestational age with 72% of babies born at 23-24 weeks receiving at least 1 respiratory medication but only 40% of babies born at 28 weeks. Overall, at some time in the first year, 55% of infants received at least 1 drug including an inhaled bronchodilator (45%), an inhaled steroid (22%), a systemic steroid (15%), or diuretic (12%). CONCLUSION: Many babies born at <29 weeks have no respiratory medication exposure postdischarge during the first year of life. Inhaled medications, including bronchodilators and steroids, increase over the first year.

Quantitative Evidence for Revising the Definition of Primary Graft Dysfunction after Lung Transplant.

RATIONALE: Primary graft dysfunction (PGD) is a form of acute lung injury that occurs after lung transplantation. The definition of PGD was standardized in 2005. Since that time, clinical practice has evolved, and this definition is increasingly used as a primary endpoint for clinical trials; therefore, validation is warranted. OBJECTIVES: We sought to determine whether refinements to the 2005 consensus definition could further improve construct validity. METHODS: Data from the Lung Transplant Outcomes Group multicenter cohort were used to compare variations on the PGD definition, including alternate oxygenation thresholds, inclusion of additional severity groups, and effects of procedure type and mechanical ventilation. Convergent and divergent validity were compared for mortality prediction and concurrent lung injury biomarker discrimination. MEASUREMENTS AND MAIN RESULTS: A total of 1,179 subjects from 10 centers were enrolled from 2007 to 2012. Median length of follow-up was 4 years (interquartile range = 2.4-5.9). No mortality differences were noted between no PGD (grade 0) and mild PGD (grade 1). Significantly better mortality discrimination was evident for all definitions using later time points (48, 72, or 48-72 hours; P < 0.001). Biomarker divergent discrimination was superior when collapsing grades 0 and 1. Additional severity grades, use of mechanical ventilation, and transplant procedure type had minimal or no effect on mortality or biomarker discrimination. CONCLUSIONS: The PGD consensus definition can be simplified by combining lower PGD grades. Construct validity of grading was present regardless of transplant procedure type or use of mechanical ventilation. Additional severity categories had minimal impact on mortality or biomarker discrimination.

Polymorphisms in cytochrome P450 are associated with extensive efavirenz pharmacokinetics and CNS toxicities in an HIV cohort in Botswana.

Inter-individual variability in efavirenz (EFV) pharmacokinetics and dynamics is dominantly driven by the polymorphism in cytochrome P450 (CYP) isoenzyme 2B6 516G>T. We hypothesized that additional CYP polymorphisms mediate the relationship between CYP2B6 516G>T, EFV metabolism, and clinical events. We investigated 21 SNPs in 814 HIV-infected adults initiating EFV-based therapy in Botswana for population pharmacokinetics, CNS toxicities, and treatment outcomes. Two SNPs (rs28399499 and rs28399433) showed reduced apparent oral EFV clearance. Four SNPs (rs2279345, rs4803417, rs4802101, and rs61663607) showed extensive clearance. Composite CYP2B-mediated EFV metabolism was significantly associated with CNS toxicity (p = 0.04), with extensive metabolizers reporting more and slow and very slow metabolizers reporting less toxicity after 1 month compared to intermediate metabolizers. Composite CYP2B6 metabolism was not associated with composite early treatment failure. In conclusion, our data suggest that CNS-related toxicities might not be solely the result of super-therapeutic parent EFV concentrations in HIV-infected individuals in patients of African ancestry.

Women's Healthcare Utilization Following Routine Screening for Past-Year Intimate Partner Violence in the Veterans Health Administration.

BACKGROUND: Experience of intimate partner violence (IPV) can have adverse health impacts and has been associated with elevated rates of healthcare service utilization. Healthcare encounters present opportunities to identify IPV-related concerns and connect patients with services. The Veterans Health Administration (VHA) conducts IPV screening within an integrated healthcare system. OBJECTIVE: The objectives of this study were to compare service utilization in the 6 months following IPV screening between those screening positive and negative for past-year IPV (IPV+, IPV-) and to examine the timing and types of healthcare services accessed among women screening IPV+. DESIGN: A retrospective chart review was conducted for 8888 female VHA patients across 13 VHA facilities who were screened for past-year IPV between April 2014 and April 2016. MAIN MEASURES: Demographic characteristics (age, race, ethnicity, marital status, veteran status), IPV screening response, and healthcare encounters (based on visit identification codes). KEY RESULTS: In the 6 months following routine screening for past-year IPV, patients screening IPV+ were more likely to utilize outpatient care (aOR = 1.85 [CI 1.26, 2.70]), including primary care or psychosocial care, and to have an inpatient stay (aOR = 2.09 [CI 1.23, 3.57]), compared with patients screening IPV-. Among those with any utilization, frequency of outpatient encounters within the 6-month period following screening was higher among those screening IPV+ compared with those screening IPV-. The majority of patients screening positive for past-year IPV returned for an outpatient visit within a brief time frame following the screening visit (> 70% within 14 days, >95% within 6 months). More than one in four patients screening IPV+ had an emergency department visit within the 6 months following screening. CONCLUSIONS: Women who screen positive for past-year IPV have high rates of return to outpatient visits following screening, presenting opportunities for follow-up support. Higher rates of emergency department utilization and inpatient stays among women screening IPV+ may indicate adverse health outcomes related to IPV experience.

Bronchopulmonary Dysplasia and Perinatal Characteristics Predict 1-Year Respiratory Outcomes in Newborns Born at Extremely Low Gestational Age: A Prospective Cohort Study.

OBJECTIVE: To assess the utility of clinical predictors of persistent respiratory morbidity in extremely low gestational age newborns (ELGANs). STUDY DESIGN: We enrolled ELGANs (<29 weeks' gestation) at ≤7 postnatal days and collected antenatal and neonatal clinical data through 36 weeks' postmenstrual age. We surveyed caregivers at 3, 6, 9, and 12 months' corrected age to identify postdischarge respiratory morbidity, defined as hospitalization, home support (oxygen, tracheostomy, ventilation), medications, or symptoms (cough/wheeze). Infants were classified as having postprematurity respiratory disease (PRD, the primary study outcome) if respiratory morbidity persisted over ≥2 questionnaires. Infants were classified with severe respiratory morbidity if there were multiple hospitalizations, exposure to systemic steroids or pulmonary vasodilators, home oxygen after 3 months or mechanical ventilation, or symptoms despite inhaled corticosteroids. Mixed-effects models generated with data available at 1 day (perinatal) and 36 weeks' postmenstrual age were assessed for predictive accuracy. RESULTS: Of 724 infants (918 ± 234 g, 26.7 ± 1.4 weeks' gestational age) classified for the primary outcome, 68.6% had PRD; 245 of 704 (34.8%) were classified as severe. Male sex, intrauterine growth restriction, maternal smoking, race/ethnicity, intubation at birth, and public insurance were retained in perinatal and 36-week models for both PRD and respiratory morbidity severity. The perinatal model accurately predicted PRD (c-statistic 0.858). Neither the 36-week model nor the addition of bronchopulmonary dysplasia to the perinatal model improved accuracy (0.856, 0.860); c-statistic for BPD alone was 0.907. CONCLUSION: Both bronchopulmonary dysplasia and perinatal clinical data accurately identify ELGANs at risk for persistent and severe respiratory morbidity at 1 year. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01435187.

Childhood Sexual Abuse and Sociodemographic Factors Prospectively Associated with Intimate Partner Violence Perpetration Among South African Heterosexual Men.

BACKGROUND: Intimate partner violence directed at women by men continues to be a global concern. However, little is known about the factors associated with perpetrating intimate partner violence among heterosexual men. PURPOSE: History of childhood sexual abuse and other sociodemographic variables were examined as potential factors associated with severe intimate partner violence perpetration toward women in a sample of heterosexual men in South Africa. METHODS: Longitudinal logistic generalized estimating equations examined associations of childhood sexual abuse and sociodemographic variables at baseline with intimate partner violence perpetration at subsequent time points. RESULTS: Among participants with a steady female partner, 21.81 % (190/ 871) reported perpetrating intimate partner violence in the past year at baseline. Having a history of childhood sexual abuse (p < .001), binge drinking (p = .002), being employed (p = .050), and more difficulty controlling sexual impulses in order to use a condom (p = .006) at baseline were associated with self-reported intimate partner violence perpetration in the past year at subsequent time points. CONCLUSIONS: With high levels of recent severe physical and/or sexual intimate partner violence perpetration in South Africa, comprehensive interventions are urgently needed. To more fully address gender-based violence, it is important to address associated factors, including exposure to childhood sexual abuse that could impact behavior later in life and that have long-lasting and deleterious effects on men and their female partners.

Framing Financial Incentives to Increase Physical Activity Among Overweight and Obese Adults: A Randomized, Controlled Trial.

BACKGROUND: Financial incentive designs to increase physical activity have not been well-examined. OBJECTIVE: To test the effectiveness of 3 methods to frame financial incentives to increase physical activity among overweight and obese adults. DESIGN: Randomized, controlled trial. (ClinicalTrials.gov: NCT 02030119). SETTING: University of Pennsylvania. PARTICIPANTS: 281 adult employees (body mass index ≥27 kg/m2). INTERVENTION: 13-week intervention. Participants had a goal of 7000 steps per day and were randomly assigned to a control group with daily feedback or 1 of 3 financial incentive programs with daily feedback: a gain incentive ($1.40 given each day the goal was achieved), lottery incentive (daily eligibility [expected value approximately $1.40] if goal was achieved), or loss incentive ($42 allocated monthly upfront and $1.40 removed each day the goal was not achieved). Participants were followed for another 13 weeks with daily performance feedback but no incentives. MEASUREMENTS: Primary outcome was the mean proportion of participant-days that the 7000-step goal was achieved during the intervention. Secondary outcomes included the mean proportion of participant-days achieving the goal during follow-up and the mean daily steps during intervention and follow-up. RESULTS: The mean proportion of participant-days achieving the goal was 0.30 (95% CI, 0.22 to 0.37) in the control group, 0.35 (CI, 0.28 to 0.42) in the gain-incentive group, 0.36 (CI, 0.29 to 0.43) in the lottery-incentive group, and 0.45 (CI, 0.38 to 0.52) in the loss-incentive group. In adjusted analyses, only the loss-incentive group had a significantly greater mean proportion of participant-days achieving the goal than control (adjusted difference, 0.16 [CI, 0.06 to 0.26]; P = 0.001), but the adjusted difference in mean daily steps was not significant (861 [CI, 24 to 1746]; P = 0.056). During follow-up, daily steps decreased for all incentive groups and were not different from control. LIMITATION: Single employer. CONCLUSION: Financial incentives framed as a loss were most effective for achieving physical activity goals. PRIMARY FUNDING SOURCE: National Institute on Aging.

Individual Versus Team-Based Financial Incentives to Increase Physical Activity: A Randomized, Controlled Trial.

BACKGROUND: More than half of adults in the United States do not attain the minimum recommended level of physical activity to achieve health benefits. The optimal design of financial incentives to promote physical activity is unknown. OBJECTIVE: To compare the effectiveness of individual versus team-based financial incentives to increase physical activity. DESIGN: Randomized, controlled trial comparing three interventions to control. PARTICIPANTS: Three hundred and four adult employees from an organization in Philadelphia formed 76 four-member teams. INTERVENTIONS: All participants received daily feedback on performance towards achieving a daily 7000 step goal during the intervention (weeks 1- 13) and follow-up (weeks 14- 26) periods. The control arm received no other intervention. In the three financial incentive arms, drawings were held in which one team was selected as the winner every other day during the 13-week intervention. A participant on a winning team was eligible as follows: $50 if he or she met the goal (individual incentive), $50 only if all four team members met the goal (team incentive), or $20 if he or she met the goal individually and $10 more for each of three teammates that also met the goal (combined incentive). MAIN MEASURES: Mean proportion of participant-days achieving the 7000 step goal during the intervention. KEY RESULTS: Compared to the control group during the intervention period, the mean proportion achieving the 7000 step goal was significantly greater for the combined incentive (0.35 vs. 0.18, difference: 0.17, 95 % confidence interval [CI]: 0.07-0.28, p <0.001) but not for the individual incentive (0.25 vs 0.18, difference: 0.08, 95 % CI: -0.02-0.18, p = 0.13) or the team incentive (0.17 vs 0.18, difference: -0.003, 95 % CI: -0.11-0.10, p = 0.96). The combined incentive arm participants also achieved the goal at significantly greater rates than the team incentive (0.35 vs. 0.17, difference: 0.18, 95 % CI: 0.08-0.28, p < 0.001), but not the individual incentive (0.35 vs. 0.25, difference: 0.10, 95 % CI: -0.001-0.19, p = 0.05). Only the combined incentive had greater mean daily steps than control (difference: 1446, 95 % CI: 448-2444, p ≤ 0.005). There were no significant differences between arms during the follow-up period (weeks 14- 26). CONCLUSIONS: Financial incentives rewarded for a combination of individual and team performance were most effective for increasing physical activity. TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT02001194.

Mediation Analysis of the Efficacy of the Eban HIV/STD Risk-Reduction Intervention for African American HIV Serodiscordant Couples.

Targeting couples is a promising behavioral HIV risk-reduction strategy, but the mechanisms underlying the effects of such interventions are unknown. We report secondary analyses testing whether Social-Cognitive-Theory variables mediated the Eban HIV-risk-reduction intervention's effects on condom-use outcomes. In a multisite randomized controlled trial conducted in four US cities, 535 African American HIV-serodiscordant couples were randomized to the Eban HIV risk-reduction intervention or attention-matched control intervention. Outcomes were proportion condom-protected sex, consistent condom use, and frequency of unprotected sex measured pre-, immediately post-, and 6 and 12 months post-intervention. Potential mediators included Social-Cognitive-Theory variables: outcome expectancies and self-efficacy. Mediation analyses using the product-of-coefficients approach in a generalized-estimating-equations framework revealed that condom-use outcome expectancy, partner-reaction outcome expectancy, intention, self-efficacy, and safer-sex communication improved post-intervention and mediated intervention-induced improvements in condom-use outcomes. These findings underscore the importance of targeting outcome expectancies, self-efficacy, and safer-sex communication in couples-level HIV risk-reduction interventions.

Evaluation of a Mobile Health Approach to Tuberculosis Contact Tracing in Botswana.

Tuberculosis (TB) contact tracing is typically conducted in resource-limited settings with paper forms, but this approach may be limited by inefficiencies in data collection, storage, and retrieval and poor data quality. In Botswana, we developed, piloted, and evaluated a mobile health (mHealth) approach to TB contact tracing that replaced the paper form-based approach for a period of six months. For both approaches, we compared the time required to complete TB contact tracing and the quality of data collected. For the mHealth approach, we also administered the Computer System Usability Questionnaire to 2 health care workers who used the new approach, and we identified and addressed operational considerations for implementation. Compared to the paper form-based approach, the mHealth approach reduced the median time required to complete TB contact tracing and improved data quality. The mHealth approach also had favorable overall rating, system usefulness, information quality, and interface quality scores on the Computer System Usability Questionnaire. Overall, the mHealth approach to TB contact tracing improved on the paper form-based approach used in Botswana. This new approach may similarly benefit TB contact tracing efforts in other resource-limited settings.

Increased mucosal CD4+ T cell activation in rhesus macaques following vaccination with an adenoviral vector.

UNLABELLED: The possibility that vaccination with adenovirus (AdV) vectors increased mucosal T cell activation remains a central hypothesis to explain the potential enhancement of HIV acquisition within the Step trial. Modeling this within rhesus macaques is complicated because human adenoviruses, including human adenovirus type 5 (HAdV-5), are not endogenous to macaques. Here, we tested whether vaccination with a rhesus macaque-derived adenoviral vector (simian adenovirus 7 [SAdV-7]) enhances mucosal T cell activation within rhesus macaques. Following intramuscular SAdV-7 vaccination, we observed a pronounced increase in SAdV-7-specific CD4(+) T cell responses in peripheral blood and, more dramatically, in rectal mucosa tissue. Vaccination also induced a significant increase in the frequency of activated memory CD4(+) T cells in SAdV-7- and HAdV-5-vaccinated animals in the rectal mucosa but not in peripheral blood. These fluctuations within the rectal mucosa were also associated with a pronounced decrease in the relative frequency of naive resting CD4(+) T cells. Together, these results indicate that peripheral vaccination with an AdV vector can increase the activation of mucosal CD4(+) T cells, potentially providing an experimental model to further evaluate the role of host-vector interactions in increased HIV acquisition after AdV vector vaccination. IMPORTANCE: The possibility that vaccination with a human adenovirus 5 vector increased mucosal T cell activation remains a central hypothesis to explain the potential enhancement of human immunodeficiency virus (HIV) acquisition within the Step trial. In this study, we tested whether vaccination with a rhesus macaque-derived adenoviral vector in rhesus macaques enhances mucosal CD4(+) T cell activation, the main cell target of simian immunodeficiency virus (SIV)/HIV. The results showed that vaccination with an adenoviral vector indeed increases activation of mucosal CD4(+) T cells and potentially increases susceptibility to SIV infection.

Computed tomography-defined abdominal adiposity is associated with acute kidney injury in critically ill trauma patients*.

OBJECTIVES: Higher body mass index is associated with increased risk of acute kidney injury after major trauma. Since body mass index is nonspecific, reflecting lean, fluid, and adipose mass, we evaluated the use of CT to determine if abdominal adiposity underlies the body mass index-acute kidney injury association. DESIGN: Prospective cohort study. SETTING: Level I Trauma Center of a university hospital. PATIENTS: Patients older than 13 years with an Injury Severity Score greater than or equal to 16 admitted to the trauma ICU were followed for development of acute kidney injury over 5 days. Those with isolated severe head injury or on chronic dialysis were excluded. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Clinical, anthropometric, and demographic variables were collected prospectively. CT images at the level of the L4-5 intervertebral disc space were extracted from the medical record and used by two operators to quantitate visceral adipose tissue and subcutaneous adipose tissue areas. Acute kidney injury was defined by Acute Kidney Injury Network creatinine and dialysis criteria. Of 400 subjects, 327 (81.8%) had CT scans suitable for analysis: 264 of 285 (92.6%) blunt trauma subjects and 63 of 115 (54.8%) penetrating trauma subjects. Visceral adipose tissue and subcutaneous adipose tissue areas were highly correlated between operators (intraclass correlation > 0.99, p < 0.001 for each) and within operator (intraclass correlation > 0.99, p < 0.001 for each). In multivariable analysis, the standardized risk of acute kidney injury was 15.1% (95% CI, 10.6-19.6%), 18.1% (14-22.2%), and 23.1% (18.3-27.9%) at the 25th, 50th, and 75th percentiles of visceral adipose tissue area, respectively (p = 0.001), with similar findings when using subcutaneous adipose tissue area as the adiposity measure. CONCLUSIONS: Quantitation of abdominal adiposity using CT scans obtained for clinical reasons is feasible and highly reliable in critically ill trauma patients. Abdominal adiposity is independently associated with acute kidney injury in this population, confirming that excess adipose tissue contributes to the body mass index-acute kidney injury association. Further studies of the potential mechanisms linking adiposity with acute kidney injury are warranted.

Financial incentives for home-based health monitoring: a randomized controlled trial.

BACKGROUND: Home wireless device monitoring could play an important role in improving the health of patients with poorly controlled chronic diseases, but daily engagement rates among these patients may be low. OBJECTIVE: To test the effectiveness of two different magnitudes of financial incentives for improving adherence to remote-monitoring regimens among patients with poorly controlled diabetes. DESIGN: Randomized, controlled trial. (Clinicaltrials.gov Identifier: NCT01282957). PARTICIPANTS: Seventy-five patients with a hemoglobin A1c greater than or equal to 7.5% recruited from a Primary Care Medical Home practice at the University of Pennsylvania Health System. INTERVENTIONS: Twelve weeks of daily home-monitoring of blood glucose, blood pressure, and weight (control group; n = 28); a lottery incentive with expected daily value of $2.80 (n = 26) for daily monitoring; and a lottery incentive with expected daily value of $1.40 (n = 21) for daily monitoring. MAIN MEASURES: Daily use of three home-monitoring devices during the three-month intervention (primary outcome) and during the three-month follow-up period and change in A1c over the intervention period (secondary outcomes). KEY RESULTS: Incentive arm participants used devices on a higher proportion of days relative to control (81% low incentive vs. 58%, P = 0.007; 77% high incentive vs. 58%, P = 0.02) during the three-month intervention period. There was no difference in adherence between the two incentive arms (P = 0.58). When incentives were removed, adherence in the high incentive arm declined while remaining relatively high in the low incentive arm. In month 6, the low incentive arm had an adherence rate of 62% compared to 35% in the high incentive arm (P = 0.015) and 27% in the control group (P = 0.002). CONCLUSIONS: A daily lottery incentive worth $1.40 per day improved monitoring rates relative to control and had significantly better efficacy once incentives were removed than a higher incentive.

Clinical risk factors for primary graft dysfunction after lung transplantation.

RATIONALE: Primary graft dysfunction (PGD) is the main cause of early morbidity and mortality after lung transplantation. Previous studies have yielded conflicting results for PGD risk factors. OBJECTIVES: We sought to identify donor, recipient, and perioperative risk factors for PGD. METHODS: We performed a 10-center prospective cohort study enrolled between March 2002 and December 2010 (the Lung Transplant Outcomes Group). The primary outcome was International Society for Heart and Lung Transplantation grade 3 PGD at 48 or 72 hours post-transplant. The association of potential risk factors with PGD was analyzed using multivariable conditional logistic regression. MEASUREMENTS AND MAIN RESULTS: A total of 1,255 patients from 10 centers were enrolled; 211 subjects (16.8%) developed grade 3 PGD. In multivariable models, independent risk factors for PGD were any history of donor smoking (odds ratio [OR], 1.8; 95% confidence interval [CI], 1.2-2.6; P = 0.002); FiO2 during allograft reperfusion (OR, 1.1 per 10% increase in FiO2; 95% CI, 1.0-1.2; P = 0.01); single lung transplant (OR, 2; 95% CI, 1.2-3.3; P = 0.008); use of cardiopulmonary bypass (OR, 3.4; 95% CI, 2.2-5.3; P < 0.001); overweight (OR, 1.8; 95% CI, 1.2-2.7; P = 0.01) and obese (OR, 2.3; 95% CI, 1.3-3.9; P = 0.004) recipient body mass index; preoperative sarcoidosis (OR, 2.5; 95% CI, 1.1-5.6; P = 0.03) or pulmonary arterial hypertension (OR, 3.5; 95% CI, 1.6-7.7; P = 0.002); and mean pulmonary artery pressure (OR, 1.3 per 10 mm Hg increase; 95% CI, 1.1-1.5; P < 0.001). PGD was significantly associated with 90-day (relative risk, 4.8; absolute risk increase, 18%; P < 0.001) and 1-year (relative risk, 3; absolute risk increase, 23%; P < 0.001) mortality. CONCLUSIONS: We identified grade 3 PGD risk factors, several of which are potentially modifiable and should be prioritized for future research aimed at preventative strategies. Clinical trial registered with www.clinicaltrials.gov (NCT 00552357).

Early immunologic failure is associated with early mortality among advanced HIV-infected adults initiating antiretroviral therapy with active tuberculosis.

BACKGROUND: The relationship between antiretroviral therapy (ART) response and early mortality after ART initiation is unknown. We hypothesized that early mortality is associated with decreased early immunologic response to ART. METHODS: We prospectively determined the association between changes in plasma human immunodeficiency virus type 1 (HIV-1) RNA and CD4(+) T-cell counts (CD4 count) after 4 weeks of ART and early mortality in adults with pulmonary tuberculosis and pre-ART CD4 counts ≤ 125 cells/µL. Purified protein derivative (PPD)-specific immune recovery was determined by interferon-γ enzyme-linked immunosorbent spot assays. Levels of interleukin 6, C-reactive protein, and soluble CD14 were assessed. Patients with CD4 count and viral load values at baseline and week 4 were analyzed using multiple logistic regression. RESULTS: Early immunologic response, but not pre-ART CD4 counts or virologic response, was related to early mortality (8 [interquartile range {IQR}, -18 to 43] vs 68 [IQR, 24-131] cells/µL, P = .002). In a logistic regression model, every 20 cells/µL increase in the CD4 count from baseline to week 4 was independently associated with a 40% reduction in the odds of death (odds ratio, 0.59 [95% confidence interval, .41-.87]). PPD-specific immune recovery was lower, whereas levels of immune activation were higher, among deaths. CONCLUSIONS: Early immunologic failure despite virologic suppression is associated with early mortality after ART initiation in advanced HIV/tuberculosis.

The adult respiratory distress syndrome cognitive outcomes study: long-term neuropsychological function in survivors of acute lung injury.

RATIONALE: Cognitive and psychiatric morbidity is common and potentially modifiable after acute lung injury (ALI). However, practical measures of neuropsychological function for use in multicenter trials are lacking. OBJECTIVES: To determine whether a validated telephone-based neuropsychological test battery is feasible in a multicenter trial. To determine the frequency and risk factors for long-term neuropsychological impairment. METHODS: As an adjunct study to the Acute Respiratory Distress Syndrome Clinical Trials Network Fluid and Catheter Treatment Trial, we assessed neuropsychological function at 2 and 12 months post-hospital discharge. MEASUREMENTS AND MAIN RESULTS: Of 406 eligible survivors, we approached 261 to participate and 213 consented. We tested 122 subjects at least once, including 102 subjects at 12 months. Memory, verbal fluency, and executive function were impaired in 13% (12 of 92), 16% (15 of 96), and 49% (37 of 76) of long-term survivors. Long-term cognitive impairment was present in 41 of the 75 (55%) survivors who completed cognitive testing. Depression, post-traumatic stress disorder, or anxiety was present in 36% (37 of 102), 39% (40 of 102), and 62% (63 of 102) of long-term survivors. Enrollment in a conservative fluid-management strategy (P = 0.005) was associated with cognitive impairment and lower partial pressure of arterial oxygen during the trial was associated with cognitive (P = 0.02) and psychiatric impairment (P = 0.02). CONCLUSIONS: Neuropsychological function can be assessed by telephone in a multicenter trial. Long-term neuropsychological impairment is common in survivors of ALI. Hypoxemia is a risk factor for long-term neuropsychological impairment. Fluid management strategy is a potential risk factor for long-term cognitive impairment; however, given the select population studied and an unclear mechanism, this finding requires confirmation.