Randomized Trial to Prevent Vascular Events in HIV
The Randomized Trial to Prevent Vascular Events in HIV (REPRIEVE) study was launched in 2015 and completed enrollment in 2018. The study enrolled 7770 participants between the ages of 40 and 75 to determine if a daily dose of a cholesterol-lowering statin can reduce the risk of major cardiovascular disease in people living with HIV. Study volunteers were enrolled at 145 sites in 11 countries. Volunteers are 31% female, 65% non-white and 43% black.
Investigators analyzed baseline data from the REPRIEVE study and published an issue supplement with 7 research articles. In one report, researchers examined data from a global cohort of midlife women with HIV (WWH) enrolled in the REPRIEVE trial. Among the full cohort of WWH, cardiometabolic risk factors, such as increased waist circumference and hemoglobin levels, were associated with more advanced reproductive age, controlling for chronologic age (PMID 32645159). Another study analyzed the characteristics of REPRIEVE trial participants identifying across the transgender spectrum, a key population that is overrepresented among persons with HIV yet underrepresented in HIV and cardiovascular research. The findings provide support for the practice of reporting HIV trial participation and outcomes by gender in addition to sex assigned at birth, to optimize medical care for PATS (PMID: 32645160).
Inner-City Asthma Consortium
The Inner-City Asthma Consortium (ICAC) conducts studies to better understand asthma and allergies among children and adolescents residing in US urban communities with a high prevalence of poverty. The vast majority of participants in ICAC studies are African American and Hispanic children and adolescents.
During FY2019 and FY2020 investigators using data generated in ICAC studies published several reports in high-impact peer-reviewed journals, which data on a wide range of topics. Highlights of ICAC publications include:
- A prospective study of more than 200 children described patterns of gene activity associated with asthma exacerbations of viral vs non-viral origin. These patterns have identified biologic pathways that can now be investigated in depth to understand how asthma exacerbation occurs and how they can be prevented (PMID: 30962590).
- Data collected between birth and 7 years in the Urban Environment and Childhood Asthma (URECA) cohort identified five phenotypes, or composites of characteristics, mainly differentiated by patterns of wheezing and allergic sensitization. These data have provided potential new intervention targets for the prevention of asthma in this population (PMID: 30079758).
- In a study nasal secretion samples from more than 400 children, the nasal microbiome was found to be related to asthma exacerbations. These findings can lead to future studies examining whether altering the nasal microbiome may reduce asthma exacerbations in children (PMID: 31201890).
APOL1 Long-term Kidney Transplantation Outcomes Network
African Americans develop kidney failure at more than four times the rate of White Americans. In part, this increased risk can be attributed to two genetic APOL1 coding variants commonly found in African Americans. The NIH-supported APOLLO study will explore how APOL1 gene variants affect kidney transplantation outcomes, with the goal of improving the outcomes of both kidney donors and recipients.
The study enlisted a community advisory committee of African Americans with kidney disease to ensure that the people most affected by the findings have a key role in the research process, and this group has met in-person or by teleconference multiple times in FY19 and FY20. The APOLLO group published a detailed description of the design of their research activities, study design and goals in FY20 (PMID: 32154449). Despite the COVID-19 pandemic in the latter part of FY2019 and FY2020, the APOLLO consortium has so far banked DNA samples from 1114 deceased African American kidney donors across the nation who are paired with 2151 kidney transplant recipients followed in the United Network for Organ Sharing (UNOS). The study is still enrolling and the next phase, APOL1 genotyping in the deceased donor DNA samples, has just begun. More information can be found at www.theapollonetwork.org.
SARS-CoV-2 Pandemic Serosurvey and Blood Sampling
The NIH “SARS-CoV-2 Pandemic Serosurvey and Blood Sampling” (NIAID Protocol #20-I-0083) is one of the largest clinical studies of SARS-CoV-2 infection in the United States. The study recruited more than 11,000 participants to help assess how many adults in the U.S. without a known history of exposure to or infection with SARS-CoV-2, have antibodies to the virus. Importantly, the study leveraged highly novel data tracking tools and systems for proactive, real-time data analysis. These approaches exploit evolving recruitment data to identify trends and recognize potential needs for increased participation while the study is still enrolling. By tracking diversity and inclusiveness in the trial in real time, investigators were able to generate data identifying where and with whom to focus efforts such as increasing awareness of the trial and/or reducing burdens or hurdles that impair enrollment. Results of the study demonstrated that the highest seropositivity estimates were in African American participants; younger, female, and Hispanic participants; and residents of urban centers. (PMID: 34158410). More information on the study can be found at clinicaltrials.gov.