2M Clinical discussed the impact of #COVID19 on the largest ever single-site study of cardiovascular disease and its causes in African Americans: The Jackson Heart Study

Regina James, MD, Senior Vice President and Chief Medical Officer of 2M Clinical interviewed Mario Sims, PhD, Chief Science Officer of the Jackson Heart Study

Today we have the pleasure of speaking with Dr. Mario Sims, from the Jackson Heart Study. Dr. Sims, what is your role in the study?

I am Chief Science Officer of the Jackson Heart Study (JHS). In this role, I’m responsible for prioritizing of the scientific direction of the study, research management and oversight of JHS activities, and participation on subcommittees such as the Scientific Council and Steering Committee. I also facilitate JHS collaborations with local and national investigators.

From what I understand, the Jackson Heart Study is an integral part of the Jackson community – grandparents, parents, and children are participants. The research team has been quite successful in the recruitment and retention of African Americans for the study. Knowing that engaging populations typically underrepresented in clinical research can be a challenge, what do you attribute to the success of JHS recruitment and retention efforts?

This is a good question. I can answer it in two ways: First, we have been successful with cohort engagement by creating and forging a relationship of trust over the last 20 years with the Jackson, Mississippi, community. This trust has enabled us to successfully recruit more than 5,300 African American participants to provide their clinical, survey, and genetic data in a study to understand the causes of heart disease in African Americans. This trust has also enabled us to successfully retain a substantial portion of the original cohort at each exam visit.

We have also made our participants active partners with the study, meaning they participate in community health networks that educate and disseminate information about cardiovascular health to the community. They also sit on select committees and task forces in the Field and Coordinating Centers, such as the Steering Committee, Ethics Advisory board, and cohort engagement task force.

Secondly, JHS has been successful due to the unique collaborations that comprise the study. The study involves a collaboration between a major medical research center (UMMC), two historically black colleges and universities (Tougaloo College and Jackson State University), and a state health department (Mississippi State Department of Health), and it uses a multilevel approach to address cardiovascular disparities in a state with a high burden of heart disease among African Americans.

Participants get to see people who look like them, so they are more likely to be engaged in their health, their futures, their children’s health, and their own cardiovascular disease. That result has been one of the best parts of engaging the community for this period of well over 20 years.

Dr. Sims, as you know, we are now in a time of crisis, with the COVID-19 global pandemic: Healthcare workers in hospitals and clinics are working overtime trying to meet the health needs of their patients, and the clinical research arena is racing to develop safe and effective treatments and vaccines for coronavirus. Understanding that it is a challenge dealing with quarantines and risk of infections of site personnel, how has JHS dealt with follow-up with study participants?

JHS has continued to perform the telephone annual follow-up interviews. Participants are not showing up for physical in-person appointments at this point because we have postponed the start of Exam IV until we have weathered this pandemic or, as we say, “flatten the curve.” At that point, we will start bringing in most of our participants. At present, follow-up is by phone appointment only, and we have since canceled the in-person appointments that we had on the books, which would have started last week.

Are you still recruiting for JHS? If so, have you seen any immediate impacts of the pandemic on recruitment efforts?

We are continuing some of our recruitment efforts, such as quarterly newsletters, planning for television PSAs, and radio announcements, but we have placed a hold on community events. Understanding that we are working with a vulnerable population, more than 70 percent of whom have hypertension and comorbid health conditions, we have informed the community that many of our efforts are now postponed.

You noted that JHS has placed a hold on community events. I understand that community engagement is a major component of the study. Can you share more detail about the community engagement efforts and how they have been revised during the pandemic?

The Community Engagement Center, which we call the “CEC,” directly involves participants, and it serves as a resource to the scientific community to promote cardiovascular health and encourage underrepresented minority students to pursue biomedical careers. The Community Health Action Networks, or “CHANS,” works in partnership with CEC and typically hosts meetings within the community, health fairs, or seminars on topics such as how to become more participatory in your healthcare and about how to get involved in the JHS. In response to the pandemic, all these gatherings and meetings have been placed on hold until further notice.

It seems that updated information about COVID-19 is being conveyed to the public every day; how do you keep your cohort informed?

The telephone is our primary mode of communication, but we also send out mail notices and post information on our website. For those who are active on social media, we also have a Facebook page where we are preparing to update information.

A significant portion of the cohort is older, so some may wonder if they are actively engaged in social media such as Facebook and Twitter. It is interesting—we conducted a pilot study to see what percentages of our participants were using mobile technology; and we found that 87 percent use cell phones, and 73 percent use cell phones that are smartphones. We plan to publish some of the work and try to leverage more mobile technology with our next exam to see how many people would be willing to receive text messages regarding appointments, alerts, and health information from JHS. We are also considering creating an App for the JHS. More to come on the health information technology front.

Once the social distancing requirement is lifted, what is the plan to “jump start” scheduling follow-up exams?

We plan to start calling participants to schedule them for their in-person exams, but we will do so by inviting a small number of people per day, per week, per month so that we can ramp up and become more efficient over time.

So, in closing, are there any lessons learned that you would like to share about how JHS team is handling the impact of COVID-19?

Since the spread of the COVID-19, we are learning that several adjustments are necessary in our scientific, community, administrative and training operations. This pandemic has adversely impacted several areas of the JHS, such as teleworking by staff, hiring and training new staff for exam 4, postponing exam 4, scientific meetings and training activities. We have also learned that our participants understand the gravity of this pandemic and are willing to comply with state, local and university-related guidelines and recommendations. Communication is key. We have maintained contact with our cohort to answer questions and to keep them informed on any changes with the study.

About 2M Clinical
2M Clinical is a division of 2M Research, a minority-owned clinical research organization (CRO) and professional services firm that is Small Business Administration 8A- and HUBZone-certified business. It provides quality, cost-effective, and timeline-driven clinical trial services for pharmaceutical and medical device companies around the world. Its team has the knowledge, expertise, and hands-on experience to manage Phase II-IV domestic and international clinical trials, health services research, epidemiologic studies, and bespoke consulting services surrounding clinical trial diversity and reimbursement and market access. www.2mclinical.com

About Jackson Heart Study
JHS is the largest ever single-site study of cardiovascular disease and its causes in African Americans. This research is a collaboration between the National Institutes of Health, the Metro Jackson community, and four institutional partners: UMMC, Jackson State University, Tougaloo College, and the Mississippi State Department of Health. In addition, JHS conducts community education and outreach activities to promote healthy lifestyles and reduce disease risk burden, undergraduate- and graduate-level research training programs, and high school science and math enrichment programs to prepare and encourage underrepresented minority students to pursue biomedical careers. www.jacksonheartstudy.org

About the author: Joshua Townley