Safety and Effectiveness of Intravenous Artesunate for Treatment of Severe Malaria in the United States-April 2019 Through December 2020.

BACKGROUND: Severe malaria can be deadly and requires treatment with intravenous artesunate (IVAS). The Centers for Disease Control and Prevention provided IVAS starting 1 April 2019 for all patients with severe malaria in the United States. This study describes the safety and effectiveness of IVAS in these patients. METHODS: Patients meeting criteria for severe malaria April 2019-December 2020 who received IVAS were included. Demographic, clinical, laboratory, adverse event, and outcome information were collected. Clinical presentation, time to reach 1% and 0% parasitemia, adverse events, and death were described using proportions, medians, interquartile range (IQR), and tests of significance for differences in proportions. RESULTS: Of 280 patients included, the majority were male (61.4%), Black (75.0%), with a median age of 35 years (IQR: 15.8-53.9). Most had Plasmodium falciparum (83.6%) with median parasitemia of 8.0% (IQR: 4.6-13.2). Of 170 patients with information, 159 (93.5%) reached ≤1% parasitemia by the third IVAS dose with a median time of 17.6 hours (IQR: 10.8-28.8), and 0% parasitemia in a median of 37.2 hours (IQR 27.2-55.2). Patients with parasite densities >10% and those requiring adjunct therapy had significantly higher parasite clearance times. Adverse events associated with IVAS were reported in 4.8% (n = 13 of 271). Eight patients had post-artesunate delayed hemolysis that resolved. There were 5 (1.8%) deaths, all attributable to severe malaria. CONCLUSIONS: IVAS is a safe and effective drug for the treatment of severe malaria in the United States; timely administration can be lifesaving.

Relationship between Highly Active Antiretroviral Therapy (HAART) and human papillomavirus type 16 (HPV 16) infection among women in Sub-Saharan Africa and public health implications: A systematic review.

Invasive cervical cancer is the most prevalent cancer among women in Sub-Saharan Africa. In 2013, the World Health Organization (WHO) emitted recommendations to start Highly Active Antiretroviral Therapy (HAART) regardless of CD4 count. Although HAART has been shown to reduce the prevalence of high-risk human papillomavirus (HR-HPV) genotypes, it is unclear whether it confers a protective effect specifically for HPV 16. This review summarizes the existing evidence regarding the effect of HAART on HPV 16 infection, as this genotype may not be influenced by immunity level and explores its implications for Sub Saharan Africa. A comprehensive literature review was undertaken and quality assessment was carried out on the selected papers. Four cohort studies and three cross-sectional studies were identified for which the overall quality score assessment ranged from weak/moderate (Score of 1.8) to strong (Score of 3). The evidence yielded by our review was conflicting. Thus, the high heterogeneity between study populations and results did not allow us to draw any firm conclusions as to whether HAART has an impact on HPV 16 acquisition/prevalence. As only three studies were conducted in Africa, there are insufficient grounds for solid comparison between geographic regions. In light of inadequate data, HPV unvaccinated women on HAART should still receive more frequent follow-up.

Associations between highly active antiretroviral therapy and the presence of HPV, premalignant and malignant cervical lesions in sub-Saharan Africa, a systematic review: current evidence and directions for future research.

OBJECTIVES: In sub-Saharan Africa, substantial international funding along with evidence-based clinical practice have resulted in an unparalleled scale-up of access to antiretroviral treatment at a higher CD4 count. The role and timing of highly active antiretroviral therapy (HAART) in mediating cervical disease remains unclear. The aim of this article is to systematically review all evidence pertaining to Africa and identify research gaps regarding the epidemiological association between HAART use and the presence of premalignant/malignant cervical lesions. METHOD: Five databases were searched until January 2017 to retrieve relevant literature from sub-Saharan Africa. Publications were included if they addressed prevalence, incidence or clearance of human papillomavirus (HPV) infection in women undergoing HAART as well as cytological or histological neoplastic abnormalities. RESULTS: 22 studies were included, of which seven were prospective studies. Women receiving HAART are less likely to develop squamous intraepithelial lesions (SILs). There is evidence that duration of HAART along with the CD4 count may reduce the prevalence of high-risk HPV (HR-HPV), suggesting that without HAART, severe immunosuppression increases the risk of becoming or remaining infected with HR-HPV. Furthermore, according to existent literature, the CD4 count, rather than HAART coverage or its duration, plays a central role in the prevalence of cervical intraepithelial neoplasia (CIN) 2 and CIN 3. CONCLUSION: Our findings suggest a positive impact of HAART duration, in conjunction and interaction with CD4 count, on reducing the prevalence of HR-HPV. The greatest treatment effect might be seen among women starting at the lowest CD4 count, which may have a more instrumental role in cervical oncogenesis than either HAART use or the treatment duration on the prevalence of CIN 2 and CIN 3. There is still insufficient evidence to show a clear association between HAART coverage and the incidence of invasive cervical cancer. Enhanced surveillance on the impact of HAART treatment is crucial.

Comparing 2 National Organization-Level Workplace Health Promotion and Improvement Tools, 2013-2015.

Creating healthy workplaces is becoming more common. Half of employers that have more than 50 employees offer some type of workplace health promotion program. Few employers implement comprehensive evidence-based interventions that reach all employees and achieve desired health and cost outcomes. A few organization-level assessment and benchmarking tools have emerged to help employers evaluate the comprehensiveness and rigor of their health promotion offerings. Even fewer tools exist that combine assessment with technical assistance and guidance to implement evidence-based practices. Our descriptive analysis compares 2 such tools, the Centers for Disease Control and Prevention's Worksite Health ScoreCard and Prevention Partners' WorkHealthy America, and presents data from both to describe workplace health promotion practices across the United States. These tools are reaching employers of all types (N = 1,797), and many employers are using a comprehensive approach (85% of those using WorkHealthy America and 45% of those using the ScoreCard), increasing program effectiveness and impact.

Socio-demographic, anthropometric, and psychosocial predictors of attrition across behavioral weight-loss trials.

Preventing attrition is a major concern in behavioral weight loss intervention studies. The purpose of this analysis was to identify baseline and six-month predictors associated with participant attrition across three independent clinical trials of behavioral weight loss interventions (PREFER, SELF, and SMART) that were conducted over 10 years. Baseline measures included body mass index, Barriers to Healthy Eating, Beck Depression Inventory-II (BDI), Hunger Satiety Scale (HSS), Binge Eating Scale (BES), Medical Outcome Study Short Form (MOS SF-36 v2) and Weight Efficacy Lifestyle Questionnaire (WEL). We also examined early weight loss and attendance at group sessions during the first 6 months. Attrition was recorded at the end of the trials. Participants included 504 overweight and obese adults seeking weight loss treatment. The sample was 84.92% female and 73.61% white, with a mean (± SD) age of 47.35 ± 9.75 years. After controlling for the specific trial, for every one unit increase in BMI, the odds of attrition increased by 11%. For every year increase in education, the odds of attrition decreased by 10%. Additional predictors of attrition included previous attempts to lose 50-79 lbs, age, not possessing health insurance, and BES, BDI, and HSS scores. At 6 months, the odds of attrition increased by 10% with reduced group session attendance. There was also an interaction between percent weight change and trial (p<.001). Multivariate analysis of the three trials showed education, age, BMI, and BES scores were independently associated with attrition (ps ≤ .01). These findings may inform the development of more robust strategies for reducing attrition.

Reducing Medication Costs to Prevent Cardiovascular Disease: A Community Guide Systematic Review.

INTRODUCTION: Hypertension and hyperlipidemia are major cardiovascular disease risk factors. To modify them, patients often need to adopt healthier lifestyles and adhere to prescribed medications. However, patients' adherence to recommended treatments has been suboptimal. Reducing out-of-pocket costs (ROPC) to patients may improve medication adherence and consequently improve health outcomes. This Community Guide systematic review examined the effectiveness of ROPC for medications prescribed for patients with hypertension and hyperlipidemia. METHODS: We assessed effectiveness and economics of ROPC for medications to treat hypertension, hyperlipidemia, or both. Per Community Guide review methods, reviewers identified, evaluated, and summarized available evidence published from January 1980 through July 2015. RESULTS: Eighteen studies were included in the analysis. ROPC interventions resulted in increased medication adherence for patients taking blood pressure and cholesterol medications by a median of 3.0 percentage points; proportion achieving 80% adherence to medication increased by 5.1 percentage points. Blood pressure and cholesterol outcomes also improved. Nine studies were included in the economic review, with a median intervention cost of $172 per person per year and a median change in health care cost of -$127 per person per year. CONCLUSION: ROPC for medications to treat hypertension and hyperlipidemia is effective in increasing medication adherence, and, thus, improving blood pressure and cholesterol outcomes. Most ROPC interventions are implemented in combination with evidence-based health care interventions such as team-based care with medication counseling. An overall conclusion about the economics of the intervention could not be reached with the small body of inconsistent cost-benefit evidence.

The use of mHealth to deliver tailored messages reduces reported energy and fat intake.

BACKGROUND: Evidence supports the role of feedback in reinforcing motivation for behavior change. Feedback that provides reinforcement has the potential to increase dietary self-monitoring and enhance attainment of recommended dietary intake. OBJECTIVE: The aim of this study was to examine the impact of daily feedback (DFB) messages, delivered remotely, on changes in dietary intake. METHODS: This was a secondary analysis of the Self- Monitoring And Recording using Technology (SMART) Trial, a single-center, 24-month randomized clinical trial of behavioral treatment for weight loss. Participants included 210 obese adults (mean body mass index, 34.0 kg/m²) who were randomized to either a paper diary (PD), personal digital assistant (PDA), or PDA plus daily tailored feedback messages (PDA + FB). To determine the role of daily tailored feedback in dietary intake, we compared the self-monitoring with DFB group (DFB group; n = 70) with the self-monitoring without DFB group (no-DFB group, n = 140). All participants received a standard behavioral intervention for weight loss. Self-reported changes in dietary intake were compared between the DFB and no-DFB groups and were measured at baseline and at 6, 12, 18, and 24 months. Linear mixed modeling was used to examine percentage changes in dietary intake from baseline. RESULTS: Compared with the no-DFB group, the DFB group achieved a larger reduction in energy (-22.8% vs -14.0%; P = .02) and saturated fat (-11.3% vs -0.5%; P = .03) intake and a trend toward a greater decrease in total fat intake (-10.4% vs -4.7%; P = .09). There were significant improvements over time in carbohydrate intake and total fat intake for both groups (P values < .05). CONCLUSION: Daily tailored feedback messages designed to target energy and fat intake and delivered remotely in real time using mobile devices may play an important role in the reduction of energy and fat intake.

Weight loss is more important than the diet type in improving adiponectin levels among overweight/obese adults.

OBJECTIVE: The study objective was to compare the effect of a standard calorie- and fat-restricted diet (STD-D) and a calorie- and fat-restricted lacto-ovo-vegetarian diet (LOV-D) on total and high-molecular-weight (HMW) adiponectin levels after 6 months of behavioral intervention. DESIGN: This study is an ancillary study to a randomized clinical trial. SUBJECTS: Subjects included 143 overweight/obese adults (STD-D = 79; LOV-D = 64). INTERVENTION: Both groups received the same standard behavioral intervention; the only difference was that LOV-D participants were instructed to eliminate meat, poultry, and fish from their diet. MEASURES: Weight, dietary intake with the 3-day food diary, and total and HMW adiponectin levels were measured. RESULTS: Both groups significantly increased total (STD-D +7.2 ± 17.8%; LOV-D +9.4 ± 21.8%) and HMW adiponectin levels (STD-D +18.5 ± 32.9%; LOV-D +15.8 ± 34.5%; ps < 0.05) with no significant differences between the groups. We found significant associations between weight loss and increases in total (ß (SE) = -.071(.27); p = 0.003) and HMW adiponectin (ß (SE) = -1.37(.47); p = 0.001) levels independent of the diet type. Weight loss at the higher quartile was associated with improvements of adiponectin levels (p < 0.05). CONCLUSION: Weight loss was associated with increased total and HMW adiponectin levels regardless of the diet type. Enhancing weight loss may be a means to improve adiponectin levels.

Total and high-molecular-weight adiponectin levels in relation to insulin resistance among overweight/obese adults.

OBJECTIVE: To determine whether baseline levels or intervention-associated changes in total and high molecular weight (HMW) adiponectin levels were associated with insulin resistance after six months of behavioral treatment for weight loss. DESIGN: An ancillary study to a behavioral weight loss trial; the intervention was delivered in group sessions. METHODS: Participants included 143 overweight/obese adults with a mean BMI of 33.7 kg/m2. The sample was 88% female, 67% white, and 44.2 ± 8.5 years old. Circulating adiponectin levels (total and HMW) and the homeostasis model assessment (HOMA) of insulin resistance were measured and evaluated. RESULTS: At baseline, there was significant inverse associations between total adiponectin and HOMA (p < 0.001) and between HMW adiponectin and HOMA (p < 0.001) independent of weight. At 6-mo, there was a 17% improvement in HOMA, 8% increase in total adiponectin, 17% increase in HMW adiponectin levels, and 8.72% weight loss (p's for all< 0.001). There was also a significant inverse association between changes in total adiponectin and HOMA (p = 0.04) that was independent of baseline weight and weight loss. In contrast, the association between changes in HMW adiponectin and HOMA was attenuated after adjustment for weight loss. CONCLUSIONS: An increased level of total adiponectin was associated with improved insulin sensitivity, regardless of baseline weight and weight loss. However, baseline total and HMW adiponectin levels were more strongly associated with HOMA than changes in these measures at six months. HMW adiponectin level was not related more closely to insulin resistance than total adiponectin level.

Self-monitoring as a mediator of weight loss in the SMART randomized clinical trial.

BACKGROUND: Integral components of behavioral weight-loss treatment include self-monitoring of diet and physical activity along with feedback to participants regarding their behaviors. While providing feedback has been associated with weight loss, no studies have examined the impact of feedback frequency on weight loss or the mediating role of self-monitoring adherence in this relationship. PURPOSE: This study examined the effect of participant feedback frequency on weight loss and determined if this effect was mediated by adherence to self-monitoring in a behavioral weight-loss trial conducted in the USA. METHOD: Participants (N = 210) were randomly assigned to one of three self-monitoring methods with either no-daily feedback messages or daily feedback messages: (1) paper diary (PD), no-daily feedback; (2) personal digital assistant (PDA), no-daily feedback; and (3) PDA, daily tailored feedback messages (PDA + FB). The Sobel test via bootstrapping examined the direct effect of feedback frequency on weight loss and the indirect effect through self-monitoring adherence. RESULTS: Receiving daily feedback messages significantly increased participants' self-monitoring adherence. A significant effect of feedback frequency on weight loss was noted; however, after adjusting for self-monitoring adherence, the effect of feedback frequency on weight loss was no longer significant. Feedback frequency had a significant indirect effect on weight loss through self-monitoring adherence. CONCLUSION: Self-monitoring adherence mediated the effect of feedback frequency on weight loss. Increasing the frequency with which participants receive feedback could enhance self-monitoring adherence, a critical component of behavioral weight-loss treatment.

Health-related quality of life among participants in the SMART weight loss trial.

Obesity has been associated with a decreased health-related quality of life (HRQoL); however, the association between weight change and HRQoL is unclear. This secondary analysis of the SMART (Self Monitoring And Recording using Technology) trial, a clinical trial of behavioral weight loss treatment, provides evidence that quality of life improves with weight loss.

Using a personal digital assistant for self-monitoring influences diet quality in comparison to a standard paper record among overweight/obese adults.

Self-monitoring has traditionally been done using a paper record, which can be tedious and burdensome. A personal digital assistant (PDA) with dietary software can provide an alternative to a paper record. The study aimed to describe the differences in dietary changes at 6 months between participants randomly assigned to use a paper record or PDA for self-monitoring in a clinical trial of weight-loss treatment. Self-monitoring adherence and changes in weight and diet were assessed between 2006 and 2009. The sample (n=192) was 84% female and 78% white, with a mean age of 49 years and body mass index (calculated as kg/m(2)) of 34.1. At baseline, the groups did not differ in energy intake, percent calories from fat, and number of servings of the examined food groups. At 6 months, both groups had significant reductions in weight, energy intake, and percent calories from total fat and saturated fatty acids (P<0.001); no between-group differences were found. Compared to the paper record group, the PDA group significantly increased consumption of fruit (P=0.02) and vegetables (P=0.04) and decreased consumption of refined grains (P=0.02). Interactions among self-monitoring and the two groups were found in relation to changes in percent calories from total fat (P=0.02), monounsaturated fatty acids (P=0.002), and trans-fatty acids (P=0.04). Frequent self-monitoring was significantly associated with total sugar (P=0.02) and added sugar (P=0.01) intake in both groups. Our findings suggest that use of a PDA for self-monitoring might improve self-awareness of behavior and dietary changes.

The effect of electronic self-monitoring on weight loss and dietary intake: a randomized behavioral weight loss trial.

Technology may improve self-monitoring adherence and dietary changes in weight loss treatment. Our study aimed to investigate whether using a personal digital assistant (PDA) with dietary and exercise software, with and without a feedback message, compared to using a paper diary/record (PR), results in greater weight loss and improved self-monitoring adherence. Healthy adults (N = 210) with a mean BMI of 34.01 kg/m(2) were randomized to one of three self-monitoring approaches: PR (n = 72), PDA with self-monitoring software (n = 68), or PDA with self-monitoring software and daily feedback messages (PDA+FB, n = 70). All participants received standard behavioral treatment. Self-monitoring adherence and change in body weight, waist circumference, and diet were assessed at 6 months; retention was 91%. All participants had a significant weight loss (P < 0.01) but weight loss did not differ among groups. A higher proportion of PDA+FB participants (63%) achieved ≥ 5% weight loss in comparison to the PR group (46%) (P < 0.05) and PDA group (49%) (P = 0.09). Median percent self-monitoring adherence over the 6 months was higher in the PDA groups (PDA 80%; PDA+FB 90%) than in the PR group (55%) (P < 0.01). Waist circumference decreased more in the PDA groups than the PR group (P = 0.02). Similarly, the PDA groups reduced energy and saturated fat intake more than the PR group (P < 0.05). Self-monitoring adherence was greater in the PDA groups with the greatest weight change observed in the PDA+FB group.

Adherence to a behavioral weight loss treatment program enhances weight loss and improvements in biomarkers.

OBJECTIVES: To describe participants' adherence to multiple components (attendance, energy intake, fat gram, exercise goals, and self-monitoring eating and exercise behaviors) of a standard behavioral treatment program (SBT) for weight loss and how adherence to these components may influence weight loss and biomarkers (triglycerides, low density lipoproteins [LDL], high density lipoprotein, and insulin) during the intensive and less-intensive intervention phases. METHODS: A secondary analysis of a randomized clinical trial consisting of a SBT with either fat-restricted standard or lacto-ovo vegetarian diet. The 12-month intervention was delivered in 33 group sessions. The first six months reflected the intensive phase; the second six months, the less-intensive intervention phase. We conducted the analysis without regard to treatment assignment. Eligible participants included overweight/obese adults (N = 176; mean body mass index = 34.0 kg/m(2)). The sample was 86.9% female, 70.5% White, and 44.4 +/- 8.6 years old. The outcome measures included weight and biomarkers. RESULTS: There was a significant decline in adherence to each treatment component over time (P < 0.0001). In the first six months, adherence to attendance, self-monitoring and the energy goal were significantly associated with greater weight loss (P < 0.05). Adherence to attendance and exercise remained significantly associated with weight loss in the second six months (P < 0.05). Adherence to attendance, self-monitoring and exercise had indirect effects through weight loss on LDL, triglycerides, and insulin (P < 0.05). CONCLUSIONS: We observed a decline in adherence to each treatment component as the intervention intensity was reduced. Adherence to multiple treatment components was associated with greater weight loss and improvements in biomarkers. Future research needs to focus on improving and maintaining adherence to all components of the treatment protocol to promote weight loss and maintenance.

SMART trial: A randomized clinical trial of self-monitoring in behavioral weight management-design and baseline findings.

BACKGROUND: The primary form of treatment for obesity today is behavioral therapy. Self-monitoring diet and physical activity plays an important role in interventions targeting behavior and weight change. The SMART weight loss trial examined the impact of replacing the standard paper record used for self-monitoring with a personal digital assistant (PDA). This paper describes the design, methods, intervention, and baseline sample characteristics of the SMART trial. METHODS: The SMART trial used a 3-group design to determine the effects of different modes of self-monitoring on short- and long-term weight loss and on adherence to self-monitoring in a 24-month intervention. Participants were randomized to one of three conditions (1) use of a standard paper record (PR); (2) use of a PDA with dietary and physical activity software (PDA); or (3), use of a PDA with the same software plus a customized feedback program (PDA + FB). RESULTS: We screened 704 individuals and randomized 210. There were statistically but not clinically significant differences among the three cohorts in age, education, HDL cholesterol, blood glucose and systolic blood pressure. At 24 months, retention rate for the first of three cohorts was 90%. CONCLUSIONS: To the best of our knowledge, the SMART trial is the first large study to compare different methods of self-monitoring in a behavioral weight loss intervention and to compare the use of PDAs to conventional paper records. This study has the potential to reveal significant details about self-monitoring patterns and whether technology can improve adherence to this vital intervention component.