Updates from 2nd Generation URBAN ARCH HIV/Alcohol P01s
On May 10, 2022, Dr. Michael Stein (PI of ARCHER) presented the ARCHER study during the 2022 URBAN ARCH Annual Meeting, which was held both in-person in Boston and virtually. He laid out the Aims of the center and described the two planned ARCHER clinical trials, which are related to physical activity and chronic pain and will be run entirely remotely. Dr. Stein also presented plans to conduct secondary analyses of existing Boston ARCH data, and he introduced the center investigators and staff.
As we move through spring and into summer, the ARCHER team has been hard at work with study start-up activities. The team has been preparing IRB applications for both center trials which will be submitted to the Boston University Medical Campus IRB this month. Recent progress has focused on finalizing study measures, including engaging Dr. Kristine Erlandson as an expert on our function measures, and completing pre-IRB review consultations with the Clinical Research Resources Office (CRRO) at Boston University. In addition, the team has started work with Michael Winter and Clara Chen from BU’s Biostatistics and Epidemiology Data Analytics Center (BEDAC) to create REDCap databases to track participants and store data from each trial.
In collaboration with the ARCHER team, a number of vendors have begun work on the trials in support of trial recruitment and data collection efforts. We are utilizing services from BuildClinical, whose expertise is in creating and targeting research advertisements to populations based on study-specific criteria. Their team is currently working to create an online recruitment campaign for both trials that will reach across many large metropolitan areas in the United States through various social media platforms and websites. Ecological momentary assessment (EMA) data will be collected through MetricWire, a specialized mobile application for research data collection and, specific to our physical activity trial, Fitabase’s services will be used to manage and track participants’ Fitbit data. Last, we will utilize Tasso, Inc.’s self-administered blood draw devices, which will be sent directly to trial participants to collect and return a blood sample for phosphatidylethanol (PEth) analysis. We are hopeful that our research will support the implementation of remotely-conducted interventions and follow-up to lower participant burden and increase engagement and retention.
Our newly constituted DSMB, consisting of Drs. Sarah Woolf-King, Jennifer Edelman and W. Evan Johnson, will be convened for the first time in the near future. We have also formed our five-member Program Advisory Committee (PAC), consisting of Drs. Gary Bennett, Jessica Merlin, Geetanjali Chander, Christopher Kahler, and NiCole Keith, which will also convene in the near future.
Finally, we would like to welcome Nicolle Rueras, who joined the team on April 18, 2022 as research project manager for ARCHER. Prior to joining the ARCHER team, Nicolle served as a research project manager at the Goldman School of Dental Medicine’s Department of Health Policy & Health Services Research at Boston University. Her prior research has focused on improving oral health outcomes among young children utilizing a text message program. Nicolle is managing study-start-up, and upon trial launch, Nicolle will be supporting both of the center’s trials with day-to-day administration and oversight. The center is also looking forward to the addition of new study personnel as a search for research assistants has commenced.
We invite any interested investigators who wish to use existing Boston ARCH data for secondary analysis to contact Dr. Stein, Kara Magane or Nicolle Rueras for additional information.
The META HIV CVD PPG administrative, education, and analytic support core hosted a symposium focusing on alcohol, gut dysbiosis, inflammation, and non-AIDS diseases among people with HIV at the Research Society of Alcoholism annual meeting. The symposium featured presentations by both PPG investigators and early career investigators. Data from the Alcohol Associated Comorbidities and Microbiome Evaluation in HIV (ACME HIV) study, which provided preliminary data for the overall aims of the PPG, was presented alongside data from other collaborating studies. Presenters of the symposium were Drs. Kendall Bryant, Matt Freiberg, Shirish Barve, Smita Ghare, Kaku So-Armah, Samuel Mensah, Natalie Chichetto, Vaughn Bryant, and Curtis Gabriel.
META HIV CVD RCT (project 1) continues protocol development with plans to begin enrollment in Fall 2022. META HIV CVD (project 2) has put into place material transfer agreements and shipments of specimens to the laboratory core are underway. The PPG plans to host an annual meeting for investigators and collaborators in Fall 2022 and will facilitate initial program advisory committee and DSMB meetings.
