Association of a Count of Inpatient Morbidities with Two-Year Outcomes among Infants Born Extremely Preterm.

Objective: To determine if number of neonatal morbidities is associated with death or severe neurodevelopmental impairment (sNDI) among infants born extremely preterm who survived to 36 weeks' postmenstrual age (PMA).

Study Design: This is a retrospective cohort analysis of prospectively collected data from 15 NICHD Neonatal Research Network (NRN) centers. Neonatal morbidities and 2-year outcomes were examined for 3794 infants born at 22 to 26 weeks' gestation from 2014 through 2019 who survived to 36 weeks' PMA.

Estimating the Effect of PrEP in Black Men Who Have Sex with Men: A Framework to Utilize Data from Multiple Non-Randomized Studies to Estimate Causal Effects.

Black men who have sex with men (MSM) are disproportionately burdened by the HIV epidemic in the US. The effectiveness of pre-exposure prophylaxis (PrEP) in preventing HIV infection has been demonstrated through randomized placebo-controlled clinical trials in several populations. Importantly, no such trial has been conducted exclusively among Black MSM in the US, and it would be unethical and infeasible to do so now.

Adaptive Time-Location Sampling for COMPASS: A SARS-CoV-2 Prevalence Study in Fifteen Diverse Communities in the United States.

Background: COVID-19 has placed a disproportionate burden on underserved racial and ethnic groups, community members working in essential industries, those living in areas of high population density, and those reliant on in-person services such as transportation. The goal of this study was to estimate the cross-sectional prevalence of SARS-CoV-2 (active SARS-CoV-2 or prior SARS-CoV-2 infection) in children and adults attending public venues in 15 sociodemographically diverse communities in the United States and to develop a statistical design that could be rigorously implemented amidst unpredictable stay-at-home COVID-19 guidelines.

Methods: We used time-location sampling with complex sampling involving stratification, clustering of units, and unequal probabilities of selection to recruit individuals from selected communities.

Composite Indices of Social Determinants of Health: Overview, Measurement Gaps, and Research Priorities for Health Equity.

The goal of health equity is for all people to have opportunities and resources for optimal health outcomes regardless of their social identities, residence in marginalized communities, and/or experience with oppressive systems. Social determinants of health (SDOH)-the conditions in which we are born, grow, live, work, and age-are inextricably tied to health equity. Advancing health equity thus requires reliable measures of SDOH.

ADAPTIVE TIME LOCATION SAMPLING FOR COMPASS, A SARS-COV-2 PREVALENCE STUDY IN FIFTEEN DIVERSE COMMUNITIES IN THE UNITED STATES.

The COVPN 5002 (COMPASS) study aimed to estimate the prevalence of SARS-CoV-2 (active SARS-CoV-2 or prior SARS-CoV-2 infection) in children and adults attending public venues in 15 socio-demographically diverse communities in the United States. To protect against potential challenges in implementing traditional sampling strategies, time-location sampling (TLS) using complex sampling involving stratification, clustering of units, and unequal probabilities of selection was used to recruit individuals from neighborhoods in selected communities. The innovative design adapted to constraints such as closure of venues; changing infection hotspots; and uncertain policies.

Pregnancy rates and clinical outcomes among women living with HIV enrolled in HPTN 052.

HPTN 052 was a multi-country clinical trial of cART for preventing heterosexual HIV-1 transmission. The study allowed participation of pregnant women and provided access to cART and contraceptives. We explored associations between pregnancy and clinical measures of HIV disease stage and progression.

Islet Autoimmunity is Highly Prevalent and Associated With Diminished β-Cell Function in Patients With Type 2 Diabetes in the Grade Study.

Islet autoimmunity may contribute to β-cell dysfunction in type 2 diabetes (T2D). Its prevalence and clinical significance have not been rigorously determined. In this ancillary study to the Glycemia Reduction Approaches in Diabetes-A Comparative Effectiveness (GRADE) Study, we investigated the prevalence of cellular and humoral islet autoimmunity in patients with T2D duration 4·0±3·0 y, HbA1c 7·5±0·5% on metformin alone.

Geographic Variation in HIV Testing Among Transgender and Nonbinary Adults in the United States.

Background: Transgender and nonbinary (TNB) populations are disproportionately affected by HIV and few local health departments or HIV surveillance systems collect/report data on TNB identities. Our objective was to estimate the prevalence of HIV testing among TNB adults by US county and state, with a focus on the Ending the HIV Epidemic (EHE) geographies.

Methods: We applied a Bayesian hierarchical spatial small area estimation model to data from the 2015 US Transgender Survey, a large national cross-sectional Internet-based survey.

Association between live childhood vaccines and COVID-19 outcomes: a national-level analysis.

We investigated whether countries with higher coverage of childhood live vaccines [BCG or measles-containing-vaccine (MCV)] have reduced risk of coronavirus disease 2019 (COVID-19)-related mortality, while accounting for known systems differences between countries. In this ecological study of 140 countries using publicly available national-level data, higher vaccine coverage, representing estimated proportion of people vaccinated during the last 14 years, was associated with lower COVID-19 deaths. The associations attenuated for both vaccine variables, and MCV coverage became no longer significant once adjusted for published estimates of the Healthcare access and quality index (HAQI), a validated summary score of healthcare quality indicators.

Association between live childhood vaccines and COVID-19 outcomes: a national-level analysis.

We investigated whether countries with higher coverage of childhood live vaccines [BCG or measles-containing-vaccine (MCV)] have reduced risk of COVID-19 related mortality, accounting for known systems differences between countries. In this ecological study of 140 countries using publicly available national-level data, higher vaccine coverage, representing estimated proportion of people vaccinated during the last 15 years, was associated with lower COVID-19 deaths. The associations attenuated for both vaccine variables, and MCV coverage became no longer significant once adjusted for a validated summary score accounting for life expectancy and healthcare quality indicators, the Healthcare access and quality index (HAQI).

Persistence of oral pre-exposure prophylaxis (PrEP) among adolescent girls and young women initiating PrEP for HIV prevention in Kenya.

The Determined, Resilient, Empowered, AIDS-free, Mentored, and Safe (DREAMS) Initiative aims to reduce HIV infections among adolescent girls and young women (AGYW) in Africa. Oral pre-exposure prophylaxis (PrEP) is offered through DREAMS in Kenya to eligible AGYW in high burden counties including Kisumu and Homa Bay. This study examines PrEP persistence among AGYW in high burden community-based PrEP delivery settings.

Acceptability of Long-Acting Injectable Cabotegravir (CAB LA) in HIV-Uninfected Individuals: HPTN 077.

Long-acting injectable PrEP could offer an alternative to daily oral PrEP, improve adherence and protection, if found acceptable, safe and effective. HPTN 077 evaluated injectable cabotegravir safety, tolerability and pharmacokinetics among HIV-uninfected males and females in sequentially-enrolled cohorts of two dosing strategies. We compared acceptability of product attributes, prevention preferences and future interest in injectable PrEP (FIIP) by region, sex-at-birth, arm and cohort and used multivariable analysis to identify FIIP determinants.

Methods for generalized change-point models: with applications to human immunodeficiency virus surveillance and diabetes data.

In many epidemiological and biomedical studies, the association between a response variable and some covariates of interest may change at one or several thresholds of the covariates. Change-point models are suitable for investigating the relationship between the response and covariates in such situations. We present change-point models, with at least one unknown change-point occurring with respect to some covariates of a generalized linear model for independent or correlated data.

Acceptability of a long-acting injectable HIV prevention product among US and African women: findings from a phase 2 clinical Trial (HPTN 076).

Introduction: High HIV incidence and low adherence to daily oral PrEP among women underscore the need for more acceptable and easier to use HIV prevention products. Global demand for injectable contraception suggests that new, long-acting, injectable formulations could meet this need. We examine acceptability of a long-acting injectable PrEP among HIV-uninfected women in Zimbabwe, South Africa and two United States phase 2 trial sites.

Cabotegravir Is Not Associated With Weight Gain in Human Immunodeficiency Virus-uninfected Individuals in HPTN 077.

Studies in human immunodeficiency virus (HIV)-infected individuals suggest excess weight gain with integrase inhibitor-based antiretroviral therapy. The HIV Prevention Trials Network Study 077 evaluated changes in weight and fasting metabolic parameters in HIV-uninfected individuals randomized to cabotegravir or a placebo. No differences between arms were found for change in weight or fasting metabolic parameters overall or for subgroups.

Effectiveness of Seasonal Influenza Vaccination in Children in Senegal During a Year of Vaccine Mismatch: A Cluster-randomized Trial.

Background: The population effects of influenza vaccination in children have not been extensively studied, especially in tropical, developing countries. In rural Senegal, we assessed the total (primary objective) and indirect effectiveness of a trivalent inactivated influenza vaccine (IIV3).

Methods: In this double-blind, cluster-randomized trial, villages were randomly allocated (1:1) for the high-coverage vaccination of children aged 6 months through 10 years with either the 2008-09 northern hemisphere IIV3 or an inactivated polio vaccine (IPV).

Design Issues in Transgender Studies.

Transgender individuals constitute an important focus for HIV prevention, but studies in this population present some unique methodologic and operational challenges. We consider issues related to sampling, sample size, number of sites, and trial cost. We discuss relevant design issues for evaluating interventions in both HIV-negative and HIV-infected transgender populations, as well as a method for assessing the impact of an intervention on population HIV incidence.

Serial plasma metabolites following hypoxic-ischemic encephalopathy in a nonhuman primate model.

Biomarkers that indicate the severity of hypoxic-ischemic brain injury and response to treatment and that predict neurodevelopmental outcomes are urgently needed to improve the care of affected neonates. We hypothesize that sequentially obtained plasma metabolomes will provide indicators of brain injury and repair, allowing for the prediction of neurodevelopmental outcomes. A total of 33 Macaca nemestrina underwent 0, 15 or 18 min of in utero umbilical cord occlusion (UCO) to induce hypoxic-ischemic encephalopathy and were then delivered by hysterotomy, resuscitated and stabilized.