Faculty Bibliography

BACKGROUND:The American Heart Association funded a Health Equity Research Network on the prevention of hypertension, the RESTORE Network, as part of its commitment to achieving health equity in all communities. This article provides an overview of the RESTORE Network. METHODS:The RESTORE Network includes five independent, randomized trials testing approaches to implement non-pharmacological interventions that have been proven to lower blood pressure (BP). The trials are community-based, taking place in churches in rural Alabama, mobile health units in Michigan, barbershops in New York, community health centers in Maryland, and food deserts in Massachusetts. Each trial employs a hybrid effectiveness-implementation research design to test scalable and sustainable strategies that mitigate social determinants of health (SDOH) that contribute to hypertension in Black communities. The primary outcome in each trial is change in systolic BP. The RESTORE Network Coordinating Center has five cores: BP measurement, statistics, intervention, community engagement, and training that support the trials. Standardized protocols, data elements and analysis plans were adopted in each trial to facilitate cross-trial comparisons of the implementation strategies, and application of a standard costing instrument for health economic evaluations, scale up, and policy analysis. Herein, we discuss future RESTORE Network research plans and policy outreach activities designed to advance health equity by preventing hypertension. CONCLUSIONS:The RESTORE Network was designed to promote health equity in the US by testing effective and sustainable implementation strategies focused on addressing SDOH to prevent hypertension among Black adults.

BACKGROUND:Although many behavioral interventions are adapted, little is known about the reasons for adaptations and the process and outcomes influencing adaptations. To address this gap, we explored the adaptations made to promote HIV prevention services, including HIV self-testing (HIVST), among Nigerian youth. METHODS:The main objective of this qualitative case study design was to document the adaptations made over time using the Framework for Reporting Adaptations and Modifications - Expanded (FRAME). Between 2018 and 2020, we organized four participatory activities as part of the 4 Youth by Youth project to increase the uptake of HIVST services in Nigeria-an open call, a designathon, a capacity-building bootcamp and a pilot feasibility trial. We also began the process of implementing a final intervention using a pragmatic randomized control trial (RCT). The open call solicited creative strategies to promote HIVST among Nigerian youth and then had experts evaluate them. The designathon brought together youth teams to further develop their HIVST service strategies into implementation protocols. Teams determined to be exceptional were invited to a four-week capacity-building bootcamp. The five teams that emerged from the bootcamp were supported to pilot their HIVST service strategies over a 6-month period. The adapted intervention is currently being evaluated in a pragmatic RCT. We transcribed meeting reports and conducted document reviews of study protocols and training manuals. RESULTS:Sixteen adaptations were identified and categorized into three domains: (1) modifications to the content of the intervention (i.e. photo verification system and/or Unstructured Supplementary Service Data (USSD) system to verify HIVST); (2) modifications to the delivery the intervention (i.e. implement participatory learning community sessions to provide supportive supervision and technical support); (3) modifications to the evaluation processes (i.e. economic evaluation to estimate the cost of implementing intervention on a larger scale). Frequent reasons for adaptation included increasing intervention reach, modifying interventions to enhance their appropriateness and fit with the recipient, and increasing the intervention's feasibility and acceptability. Most adaptations were planned and reactive, and the need for modifications was determined by the youths, 4YBY program staff, and advisory group. CONCLUSIONS:Findings suggest that the nature of adaptations made throughout the implementation process reflects the necessity of evaluating services in context while adjusting to specific challenges as they are identified. Further research is needed to understand the effect of these adaptations on the overall intervention effect as well as the quality of youth engagement.

BACKGROUND:Black men in the United States have higher hypertension (HTN) prevalence than other groups, largely due to adverse social determinants of health, including poor healthcare access. The Community-to-Clinic Linkage Implementation Program (CLIP) is effective for HTN screening in Black-owned barbershops. However, its effect on HTN prevention among Black men is untested. Here, we describe the rationale and study protocol for the development and testing of a barbershop facilitation (BF) strategy, with trained Community Health Workers, to implement and scale CLIP for HTN prevention in Black men. METHODS:The study is part of the American Heart Association (AHA)-funded RESTORE (Addressing Social Determinants to Prevent Hypertension) Health Equity Research Network. The study is tri-phasic: (i) pre-implementation-qualitative examination of factors affecting adoption of CLIP and development of BF strategy, (ii) implementation-cluster randomized control trial to test the effectiveness of CLIP with and without BF. We will partner with 20 barbershops and enroll 420 Black men with elevated blood pressure (BP)/Stage 1 HTN (2017 ACC/AHA HTN guidelines). Outcomes include reduction in BP, rate of CLIP adoption and linkage to care, and incidence of Stage 2 HTN. The study time frame is 12 months, (iii) post-implementation-we will evaluate program sustainability (6 months post-trial conclusion) and cost-effectiveness (up to 10 years). CONCLUSIONS:This study harnesses community-based resources to address HTN prevention in Black men, who are more adversely impacted by HTN than other groups. It has major policy relevance for health departments and other stakeholders to address HTN prevention in Black communities. CLINICALTRIALS.GOV IDENTIFIER/BACKGROUND:NCT05447962.

OBJECTIVES:We used the National Health Interview Survey (NHIS) data set to examine the prevalence of comorbid medical conditions; explore barriers to accessing healthcare and special educational services; and assess the associations between sickle cell disease (SCD) status and demographics/socioeconomic status (SES), and social determinants of health (SDoH) on comorbidities among children in the USA. DESIGN:Cross-sectional. SETTING:NHIS Sample Child Core questionnaire 2007-2018 data set. PARTICIPANTS:133 481 children; presence of SCD was determined by an affirmative response from the adult or guardian of the child. MAIN OUTCOME MEASURES:Multivariate logistic regression was used to compare the associations between SCD status, SES and SDoH for various medical conditions for all races and separately for black children at p<0.05. RESULTS:133 481 children (mean age 8.5 years, SD: 0.02), 215 had SCD and ~82% (weighted) of the children with SCD are black. Children with SCD were more likely to suffer from comorbid conditions, that is, anaemia (adjusted OR: 27.1, p<0.001). Furthermore, children with SCD had at least two or more emergency room (ER) visits (p<0.001) and were more likely to have seen a doctor 1-15 times per year (p<0.05) compared with children without SCD. Household income (p<0.001) and maternal education were lower for children with SCD compared with children without SCD (52.4% vs 63.5% (p<0.05)). SCD children with a maternal parent who has < / > High School degree were less likely to have no ER visits or 4-5 ER visits, and more likely to have 2-3 ER visits within 12 months. CONCLUSION:Children with SCD experienced significant comorbid conditions and have high healthcare usage, with black children being disproportionately affected. Moreover, maternal education status and poverty level illustrates how impactful SES can be on healthcare seeking behaviour for the SCD population. SDoH have significant implications for managing paediatric patients with SCD in clinical settings.

Objectives: This study sought to assess the current impact of health insurance coverage on medication adherence and blood pressure control of patients being managed for hypertension in Ghana and Nigeria. Methods: The study was a prospective study among 109 patients with hypertension in two health facilities with similar population dynamics in Ghana and Nigeria. Patients were systematically selected, categorized as having health insurance coverage or not, and followed up monthly for 6 months. The outcome variables (medication adherence and blood pressure control) were then measured and compared at 6 months. Analysis was done using Stata with level of significance set at p ⩽ 0.05. Results: There was a 90% insurance coverage among participants from Ghana compared to 15% from Nigeria. National Health Insurance Authority enrolees in both countries had better blood pressure control and medication adherence compared to non-enrolees (adjusted odds ratio = 2.6 and 4.5, respectively). Conclusion: National Health Insurance Authority enrolment was found to be poor among respondents in Nigeria compared to Ghana. Enrolment into the National health financing schemes in both countries led to better blood pressure control and medication adherence among patients with hypertension at primary health facilities. There is therefore the need for system strengthening to improve their sustainability.

IMPORTANCE:Although peer review is an important component of publication for new research, the viability of this process has been questioned, particularly with the added stressors of the COVID-19 pandemic. OBJECTIVE:To characterize rates of peer reviewer acceptance of invitations to review manuscripts, reviewer turnaround times, and editor-assessed quality of reviews before and after the start of the COVID-19 pandemic at a large, open-access general medical journal. DESIGN, SETTING, AND PARTICIPANTS:This retrospective, pre-post cohort study examined all research manuscripts submitted to JAMA Network Open between January 1, 2019, and June 29, 2021, either directly or via transfer from other JAMA Network journals, for which at least 1 peer review of manuscript content was solicited. Measures were compared between the period before the World Health Organization declaration of a COVID-19 pandemic on March 11, 2020 (14.3 months), and the period during the pandemic (15.6 months) among all reviewed manuscripts and between pandemic-period manuscripts that did or did not address COVID-19. MAIN OUTCOMES AND MEASURES:For each reviewed manuscript, the number of invitations sent to reviewers, proportions of reviewers accepting invitations, time in days to return reviews, and editor-assessed quality ratings of reviews were determined. RESULTS:In total, the journal sought review for 5013 manuscripts, including 4295 Original Investigations (85.7%) and 718 Research Letters (14.3%); 1860 manuscripts were submitted during the prepandemic period and 3153 during the pandemic period. Comparing the prepandemic with the pandemic period, the mean (SD) number of reviews rated as high quality (very good or excellent) per manuscript increased slightly from 1.3 (0.7) to 1.5 (0.7) (P < .001), and the mean (SD) time for reviewers to return reviews was modestly shorter (from 15.8 [7.6] days to 14.4 [7.0] days; P < .001), a difference that persisted in linear regression models accounting for manuscript type, study design, and whether the manuscript addressed COVID-19. CONCLUSIONS AND RELEVANCE:In this cohort study, the speed and editor-reported quality of peer reviews in an open-access general medical journal improved modestly during the initial year of the pandemic. Additional study will be necessary to understand how the pandemic has affected reviewer burden and fatigue.

OBJECTIVES/OBJECTIVE:Although technology-supported interventions are effective for reducing chronic disease risk, little is known about the relative and combined efficacy of mobile health strategies aimed at multiple lifestyle factors. The purpose of this clinical trial is to evaluate the efficacy of technology-supported behavioral intervention strategies for managing multiple lifestyle-related health outcomes in overweight adults with type 2 diabetes (T2D) and chronic kidney disease (CKD). DESIGN AND METHODS/METHODS:, age ≥40 years), T2D, and CKD stages 2-4 were randomized to an advice control group, or remotely delivered programs consisting of synchronous group-based education (all groups), plus (1) Social Cognitive Theory-based behavioral counseling and/or (2) mobile self-monitoring of diet and physical activity. All programs targeted weight loss, greater physical activity, and lower intakes of sodium and phosphorus-containing food additives. RESULTS:Of 256 randomized participants, 186 (73%) completed 6-month assessments. Compared to the ADVICE group, mHealth interventions did not result in significant changes in weight loss, or urinary sodium and phosphorus excretion. In aggregate analyses, groups receiving mobile self-monitoring had greater weight loss at 3 months (P = .02), but between 3 and 6 months, weight losses plateaued, and by 6 months, the differences were no longer statistically significant. CONCLUSIONS:When engaging patients with T2D and CKD in multiple behavior changes, self-monitoring diet and physical activity demonstrated significantly larger short-term weight losses. Theory-based behavioral counseling alone was no better than baseline advice and demonstrated no interaction effect with self-monitoring.

PURPOSE OF REVIEW/OBJECTIVE:To identify intervention strategies that were effective in promoting medication adherence and HTN control among racial/ethnic minority groups in the US. RECENT FINDINGS/RESULTS:Twelve articles were included in this review and 4 categories of intervention strategies were identified as counseling by trained personnel, mHealth tools, mHealth tools in combination with counseling by trained personnel, and quality improvement. The findings show that interventions delivered by trained personnel are effective in lowering BP and improving medication adherence, particularly for those delivered by health educators, CHWs, medical assistants, and pharmacists. Additionally, the combination of mHealth tools with counseling by trained personnel has the potential to be more effective than either mHealth or counseling alone and report beneficial effects on medication adherence and BP control. This review provides potential next steps for future research to examine the effectiveness of mHealth interventions in combination with support from trained health personnel and its effects on racial disparities in HTN outcomes.

BACKGROUND:Hypertension (HTN) control among Blacks in the USA has become a major public health challenge. Barriers to HTN control exist at multiple levels including patient, physician, and the health system. Patients also encounter significant community-level barriers, such as poor linkage to social services that impact health (unstable housing, food access, transportation). We describe a multi-component needs assessment to inform the development, implementation, and evaluation of a program to improve HTN management within a large healthcare system in New York City (NYC). METHODS:Guided by the Community-Based Participatory Research (CBPR) and Consolidated Framework for Implementation Research (CFIR) frameworks, data will be collected from four main sources: (1) quantitative surveys with health systems leadership, providers, and staff and with community-based organizations (CBOs) and faith-based organizations (FBOs); (2) qualitative interviews and focus groups with health systems leadership, providers, and staff and with CBOs and FBOs; (3) NYC Community Health Survey (CHS); and (4) New York University (NYU) Health system Epic Electronic Health Record (EHR) system. The data sources will allow for triangulation and synthesis of findings. DISCUSSION/CONCLUSIONS:Findings from this comprehensive needs assessment will inform the development of a clinic-community-based practice facilitation program utilizing three multi-level evidence-based interventions (nurse case management, remote blood pressure (BP) monitoring, and social determinants of health (SDoH) support) integrated as a community-clinic linkage model for improved HTN control in Black patients. Integration of stakeholders' priorities, perspectives, and practices into the development of the program will improve adoption, sustainability, and the potential for scale-up. TRIAL REGISTRATION/BACKGROUND:NCT05208450; registered on January 26, 2022.