STAR 2.0: Miller School to Host Continuation of Multi-center Study of HIV and Young Women in American South
Summary
- The University of Miami Miller School of Medicine is hosting a kickoff of the second five-year phase of STAR (Study of Treatment and Reproductive Outcomes), a multi-center, longitudinal investigation of HIV and women of reproductive age in the southern region of the United States.
- The first phase of STAR launched in 2019 and investigated lifestyles and HIV exposure, pregnancy and reproductive health, oral health, novel antiretrovirals, HPV, sexually transmitted infections and mental health.
- STAR 2.0 is intentionally longitudinal, which will allow researchers to see how events like pregnancy and perimenopause impact study participants.
February 6 will mark the kickoff of the second five-year phase of STAR (Study of Treatment and Reproductive Outcomes), a multi-center, longitudinal investigation of HIV and women of reproductive age in the southern region of the United States. The meeting, to be hosted by the University of Miami Miller School of Medicine, will gather researchers and medical leaders from the University of Miami, as well as representatives from 10 other universities, five of whom are co-investigators and five of whom are on an expert advisory panel.
Joining virtually will be representatives of the National Institutes of Health, which has provided $38 million in funding support through the Eunice Kennedy Shriver National Institute of Child Health and Human Development, with supplemental funding from the National Institute of Dental and Craniofacial Research, the National Institute of Allergy and Infectious Diseases, and the National Heart, Lung, and Blood Institute.
“There is a common belief that HIV is a virus affecting mostly men, but the majority of people living with HIV worldwide are women. Just within the U.S., women comprise about 20% of the 1.1 million people living with HIV,” said Maria Alcaide, M.D., professor of infectious diseases in the Miller School’s Department of Medicine, with appointments in the Department of Obstetrics, Gynecology and Reproductive Sciences and the Department of Public Health Sciences. Dr. Alcaide is one of the founders of STAR and the lead principal investigator in the ongoing research at the University of Miami. “Other studies in the U.S. began as long ago as 1993, and the majority of studies of HIV and women focused on women in sub-Saharan Africa. Women in the U.S. experience very different social and cultural circumstances, and those in the southern region of the U.S. — especially racial and ethnic minorities — are disproportionately impacted by HIV. In addition, the women in those earlier studies in the U.S. are getting older, and STAR provides an opportunity to study younger women throughout their reproductive life.”
Building on Previous HIV Research
The first phase of STAR was launched in 2019 with a $14.6 million NIH grant. The Miller School collaborated with investigators at Emory University, the University of Mississippi Medical Center, the University of Alabama at Birmingham, the University of North Carolina at Chapel Hill and Georgetown University Medical Center. STAR’s Data Analysis and Coordination Center is located at Johns Hopkins University in Baltimore.
“We did very well,” Dr. Alcaide said. “We recruited a cohort of more than 1,000 women up to age 45, with and without HIV — the largest such cohort in existence in the U.S. — for the study and began seeking answers to some basic questions about their lifestyles and how they got exposed to HIV, along with information about pregnancy and reproductive health, oral health, novel antiretrovirals, HPV, sexually transmitted infections and mental health.”
The morning portion of the program on February 6 will be devoted to presenting the researchers’ findings during that first phase of the study, as well as feedback and suggestions from research and funding partners.
“Through STAR 1.0, we learned that additional longitudinal data, cohort retention, engagement, data analysis support and expanded collaborations are needed to maximize STAR’s potential,” Dr. Alcaide said.
Moving the Research Forward
Dr. Alcaide believes the new, $38 million grant will enable STAR 2.0, which will be the focus during the afternoon portion of the meeting, to achieve those goals and more. The Miller School and Emory University have become the lead research sites; the other four original partners are now collaborating sites. Data analysis remains at Johns Hopkins.
Structurally, the study will be comprised of a Scientific Administrative Core, a Data Management and Analysis Core and a Community Engagement Core, which will be led by Deborah Jones, Ph.D., professor of psychiatry and behavioral sciences at the Miller School. There will also be an increased focus on comorbidities and HPV and two specific studies.
Dr. Jones will lead the GLOW study, which will evaluate the impact of health behaviors on reproductive health and HPV infection using novel statistical analysis. Miller School cardiologist Claudia Martinez, M.D., professor in the Division of Cardiovascular Medicine, will co-lead a project studying how hormones affect cardiovascular health in women with HIV, including development of a cardiovascular risk predictor, which has not been done before. Dr. Martinez will also co-lead a program to facilitate the development of junior investigators in the field of women’s health by providing mentorship and pilot awards.
“On February 6, we will be planning the launch of the second phase, timelines, benchmarks, how to engage the community at each of the sites and the science that we will be developing,” Dr. Alcaide said. “Afterward, we will get additional feedback from our advisory board and funding partners.”
The Importance of Longitudinal Research
The longitudinal component is key to the research, Dr. Alcaide added.
“We will be studying how different events in a woman’s life affect their overall health and HIV,” she explained. “For example, we know that, as women get pregnant, they are more vulnerable to acquiring sexually transmitted infections and HIV which, if untreated, can be transmitted to their babies. We are currently seeing a resurgence in cases of congenital syphilis, which we hadn’t seen in a long time. So it is important to keep following these women throughout their reproductive lives.”
Additional women will be recruited as women in the study age.
“At about 45 years, women enter perimenopause, and that period is key for developing markers for certain aging conditions, such as cardiovascular disease and dementia,” Dr. Alcaide said. “Following women longitudinally will allow us to examine those transitions. We will also continue to recruit younger participants, which will allow us to compare the effects of evolving HIV medications across different age groups. For example, one of the big advances is a long-term injectable medication that can be given every two months. There’s also a new injectable that has just been approved that’s given only every six months to prevent HIV. We are also aiming to use the study as a platform to investigate how new medications or models of care can be implemented in the health care or community settings.”
The researchers will use questionnaires to collect information from the women in the study about their social demographics, education, mental health, reproductive health and other health conditions. They will also collect a variety of physical samples and swabs to generate data that may also be useful to researchers conducting other studies.
Making a Difference in Women’s Health
“I have big expectations for the outcomes of this study,” Dr. Alcaide said. “It has the potential to stimulate the development of interventions that will improve women’s health. I am also very optimistic that it will help to stimulate younger investigators to go into science, not just to learn, but to make a difference in the lives of those living with certain conditions — in this case, HIV. I’m very happy and excited to continue this work.”
The researchers plan to hold a large community event at a later date.
“This is not a treatment study, but we always try to give back to the community and share what we have learned,” Dr. Alcaide said. “More than ever, it’s important for people to have trust in science.”
Tags: Department of Medicine, Division of Infectious Diseases, Dr. Maria Alcaide, HIV, HIV research, Infectious diseases, women's health, young women with HIV