The Safety and Comparative Effectiveness of Non-Psychoactive Cannabinoid Formulations for the Improvement of Sleep: A Double-Blinded, Randomized Controlled Trial.

BACKGROUND: Clinical evidence on the use of cannabidiol (CBD) for sleep remains limited. Even fewer studies have tested the comparative effectiveness of cannabinoid formulations found within CBD products used for sleep or how they compare to other complementary therapies such as melatonin. METHODS: Participants (N = 1,793 adults experiencing symptoms of sleep disturbance) were randomly assigned to receive a 4-week supply of 1 of 6 products (all capsules) containing either 15 mg CBD or 5 mg melatonin, alone or in combination with minor cannabinoids. Sleep disturbance was assessed over a period of 5 weeks (baseline week and 4 weeks of product use) using Patient-Reported Outcomes Measurement Information System (PROMIS™) Sleep Disturbance SF 8A, administered via weekly online surveys. A linear mixed-effects regression model was used to assess the differences in the change in sleep disturbance through time between each active product arm and CBD isolate. RESULTS: All formulations exhibited a favorable safety profile (12% of participants reported a side effect and none were severe) and led to significant improvements in sleep disturbance (p < 0.001 in within-group comparisons). Most participants (56% to 75%) across all formulations experienced a clinically important improvement in their sleep quality. There were no significant differences in effect, however, between 15 mg CBD isolate and formulations containing 15 mg CBD and 15 mg cannabinol (CBN), alone or in combination with 5 mg cannabichromene (CBC). There were also no significant differences in effect between 15 mg CBD isolate and formulations containing 5 mg melatonin, alone or in combination with 15 mg CBD and 15 mg CBN. CONCLUSIONS: Our findings suggest that chronic use of a low dose of CBD is safe and could improve sleep quality, though these effects do not exceed that of 5 mg melatonin. Moreover, the addition of low doses of CBN and CBC may not improve the effect of formulations containing CBD or melatonin isolate.

A behavioral economics perspective on the COVID-19 vaccine amid public mistrust.

The COVID-19 vaccine development, testing, and approval processes have moved forward with unprecedented speed in 2020. Although several vaccine candidates have shown promising results in clinical trials, resulting in expedited approval for public use from the U.S. Food and Drug Administration, recent polls suggest that Americans strongly distrust the vaccine and its approval process. This mistrust stems from both the unusual speed of vaccine development and reports about side effects. This article applies insights from behavioral economics to consider how the general public may make decisions around whether or not to receive a future COVID-19 vaccine in a context of frequent side effects and preexisting mistrust. Three common cognitive biases shown to influence human decision-making under a behavioral economics framework are considered: confirmation bias, negativity bias, and optimism bias. Applying a behavioral economics framework to COVID-19 vaccine decision-making can elucidate potential barriers to vaccine uptake and points of intervention for clinicians and public health professionals.

Role of temporal discounting in a conditional cash transfer (CCT) intervention to improve engagement in the prevention of mother-to-child transmission (PMTCT) cascade.

BACKGROUND: Temporal discounting, the tendency of individuals to discount future costs and benefits relative to the present, is often associated with greater engagement in risky behaviors. Incentives such as conditional cash transfers (CCTs) have the potential to counter the effects of high discount rates on health behaviors. METHODS: With data from a randomized trial of a CCT intervention among 434 HIV-positive pregnant women in the Democratic Republic of Congo, we used binomial models to assess interactions between discount rates (measured using a delay-discounting task) and the intervention. The analysis focused on two outcomes: 1) retention in HIV care, and 2) uptake of prevention of mother-to-child transmission (PMTCT) services. RESULTS: The effect of high discount rates on retention was small, and we did not observe evidence of interaction between high discount rates and CCT on retention. However, our findings suggest that CCT may mitigate the negative effect of high discount rates on uptake of PMTCT services (interaction contrast (IC): 0.18, 95% CI: - 0.09, 0.44). CONCLUSIONS: Our findings provide evidence to support the continued use of small, frequent incentives, to motivate improved uptake of PMTCT services, especially among women exhibiting high rates of temporal discounting. TRIAL REGISTRATION: Clinicaltrials.gov number NCT01838005 , April 23, 2013.

A Tale of Two Cities: Exploring the Role of Race/Ethnicity and Geographic Setting on PrEP Use Among Adolescent Cisgender MSM.

Although pre-exposure prophylaxis (PrEP) could substantially reduce the risk of HIV acquisition among adolescent cisgender men who have sex with men (cisMSM), various barriers faced by people of color, particularly within the southern region of the U.S., may lead to racial disparities in the utilization of PrEP. Few studies, however, have explored racial/ethnic differences in PrEP use by geographic setting among adolescent cisMSM. We conducted a cross-sectional analysis examining racial disparities in PrEP use among cisMSM ages 15-24 years in New Orleans, Louisiana, and Los Angeles, California recruited between May, 2017 and September, 2019. The odds of PrEP use among AA adolescents were considerably lower than White adolescents in New Orleans (OR (95% CI): 0.24 (0.10, 0.53)), although we did not find evidence of differences in Los Angeles. Our findings underscore the need for targeted interventions to promote PrEP use among adolescent MSM, particularly among AA adolescent cisMSM living in the southern region of U.S.

Parental Perceptions and Behaviors Regarding Child Weight Status among Toddlers Born Preterm.

OBJECTIVE: Childhood obesity is a significant determinant of adult obesity. Among children born preterm, rapid "catch-up growth" in infancy increases the risk of later obesity. Parental perceptions of their child's weight status may compound the child's biologically heightened risk of obesity. STUDY DESIGN: We performed a secondary analysis of data on parental perceptions of child weight status from a randomized controlled trial (2012-2017, n = 331 toddlers born preterm). We used the Child Feeding Questionnaire (CFQ) to measure parental child feeding behaviors and beliefs. We calculated the prevalence of incorrect weight estimation, and used t-tests and chi-square tests to compare sample characteristics by correct versus incorrect weight estimation. We calculated odds ratios (ORs) for factors associated with parental underestimation of child weight status. RESULTS: Most (90%) children were of normal weight, whereas 3% were underweight and 7% were overweight. A majority (75%) of parents correctly estimated their child's weight status. Incorrect weight estimation was only associated with child's actual weight. Parents of overweight children were more likely to underestimate their child's weight status than parents of normal weight children (OR: 2.23, 95% confidence interval: 2.00-2.49). Mean CFQ scores differed by the child's actual weight status but not by the child's estimated weight status. CONCLUSION: Among these toddlers born preterm, significantly higher proportions of parents with underweight and overweight children incorrectly estimated their child's weight status relative to parents of normal weight children. Our findings suggest that weight underestimation could be a problem in this population, although it was not associated with changes in feeding practices.

Who owns guns and how do they keep them? The influence of household characteristics on firearms ownership and storage practices in the United States.

Our paper aims to describe firearm-related behavior among American households and to quantify the influence of household characteristics on the probability of firearms possession and storage practices. Applying logistic regression techniques to data from the 2004 Behavioral Risk Factor Surveillance Survey (BRFSS), we use separate models to estimate the effect of an array of respondent demographic characteristics factors on the likelihood that households will have a gun at home and, if so, whether they will keep it at either of two levels of risk. We find that rates of firearm ownership vary widely by household characteristics, including the state in which they reside. Simultaneously controlling for all of these factors scarcely diminishes variation in odds for ownership. Differences in the likelihood that owners will store guns unsafely are narrower and significant for fewer factors. Having children in the home scarcely affects the propensity to possess firearms but greatly reduces the chances a domestic firearm will be stored loaded and unsecured. Our findings support a consensus on the demographics of ownership but show more and stronger predictors of storage behavior than previous work. Differing dynamics of ownership and storage reveal the existence of two regional gun cultures. From these findings, we conclude that to mitigate mortality risks associated with guns in the home, encouraging safer storage by owners may be as effective as controlling sales. States and localities should test a range of promising but largely unproven interventions.

Correlates of Rectal Douching Practices Among Men Who Have Sex With Men in Kenya.

BACKGROUND: Among men who have sex with men (MSM), rectal douching (RD) has been associated with increased prevalence of human immunodeficiency virus and other sexually transmitted infections. Substances commonly used for RD, especially water-based solutions, could disrupt the rectal epithelium and increase susceptibility to infection. The few existing reports on RD among MSM are primarily in middle- and high-income settings, and to date, no study has focused on RD among MSM in Africa. METHODS: We conducted a secondary data analysis of programmatic data from key population service centers in western Kenya. Data were extracted from records of clients who identified as MSM and accessed services between January 1, 2014, and September 1, 2016. We compared demographic and behavioral characteristics of men who did and did not practice RD. Logistic regression assessed associations with RD. RESULTS: Of the 202 MSM in this analysis, 63% engaged in RD. All who engaged in RD used water-based substances. Those who engaged in receptive anal intercourse in the last 3 months were more likely to report RD (odds ratio, 3.19; 95% confidence interval, 1.67-6.07). Among MSM who engaged in sex work, those who practiced RD reported more regular clients per week (2.8 clients vs. 1.3 clients, P = 0.01). Rectal douching practices did not vary by other sexual risk practices. CONCLUSIONS: Rectal douching is common in this population of Kenyan MSM, especially among those who have recently engaged in receptive anal intercourse, suggesting that a rectal douche that delivers microbicides could be a potential intervention to reduce human immunodeficiency virus/sexually transmitted infection within this population.

Use of Antiretroviral Therapy During Pregnancy and Adverse Birth Outcomes Among Women Living With HIV-1 in Low- and Middle-Income Countries: A Systematic Review.

BACKGROUND: Worldwide, nearly 18 million women of reproductive age are living with HIV-1. Although increased access to antiretroviral therapy (ART) during pregnancy has significantly reduced HIV-1 mother-to-child transmission (MTCT), a similarly robust reduction in preterm birth (PTB) and low birthweight (LBW) among infants born to women living with HIV has not been observed. This study was designed to identify associations between classes of ART regimens and risk of PTB or LBW. SETTING: Low- and middle-income countries. METHODS: We conducted a systematic review of randomized and observational studies that assessed the effect of ART regimen on the risk of PTB (≤37 completed weeks of gestation) or LBW (<2500 g at birth) among pregnant women in low- and middle-income countries living with HIV-1. We searched Medline, COCHRANE, Web of Science, SCOPUS, and CPCI-S for included studies. RESULTS: When compared to monotherapy, both nonnucleoside reverse transcriptase inhibitor- and protease inhibitor-based regimens had a consistent, harmful association with LBW. There is mixed evidence suggesting both potential harm and potential benefit for most other regimens on risk of LBW and PTB, and the harmful or protective effects of certain regimens varies depending on the drug backbone. CONCLUSIONS: Although the benefits of ART during pregnancy for prevention of MTCT are undisputed, this systematic review indicates that ART regimens vary substantially in their association with LBW and PTB. Although challenging, optimization of ART regimens could simultaneously promote maternal health, prevent MTCT, and also minimize risks of PTB and LBW.