Updates from 2nd Generation URBAN ARCH HIV/Alcohol P01s

As the summer comes to an end, the ARCHER team has been busy recruiting, screening, enrolling, and collecting data for the center’s Physical Activity (PA) Trial and Pain Trial. By working in collaboration with BuildClinical, a vendor specializing in targeted online campaigns to recruit participants for clinical research studies, we have received over 568 potentially eligible participants to screen for eligibility for the ARCHER trials. We have screened 91 participants for the Pain Trial, and 97 participants for the Physical Activity Trial. In total, we currently have 36 participants enrolled and randomized: 17 in the Physical Activity Trial and 19 in the Pain Trial. These participants have consented, completed the baseline interview, and completed 15 days of ecological momentary assessment (EMA) data collection. In the PA Trial, participants have also completed 15 days of Fitbit wear. Additionally, we have begun to collect 3-month follow-up data: 2 participants in the PA Trial have completed their 3-month research interview and 3-month EMA surveys, and 4 participants in the Pain Trial have completed their 3-month research interview and 3-month EMA surveys.

The team has been working to advance and refine our study procedures, workflows, and operations. We continue to work closely with our collaborators at the Boston University Biostatistics and Epidemiology Data Analytics Center (BEDAC) to develop data-based reports that update in real-time and will be utilized by the study team to track trial participants throughout their duration in the trial in order to facilitate longitudinal follow-up and retention, as well as data quality and completeness.

The ARCHER team has finalized 6-month follow-up study measures for both trials and BEDAC is working to program these 6-month assessments into REDCap (our platform for electronic data collection).  Additionally, we executed a contract with the Biological and Psychological Analytics Laboratory (BPAL) at the University of Texas Health Science Center at San Antonio. This laboratory will receive and process ARCHER trial participants’ blood samples to test for phophatidylethanol (PEth) at the 6-month follow-up. The ARCHER team is working with the META HIV CVD P01 team to plan our second shared Data and Safety Monitoring Board (DSMB) meeting, scheduled for October 2023.

Over the summer, a few additional members joined the ARCHER team. In June of 2023, we welcomed Sarah Fielman as the new ARCHER Research Project Manager. Prior to joining the ARCHER team, Sarah was a research coordinator in the community health sciences department at the BU School of Public Health working across several studies focused on improving care for individuals with a substance use disorder. Sarah will support day-to-day administration and maintain oversight of both the Pain and PA trials.

Steven Miyawaki, who joined ARCHER in June and July as part of the Medical Student Summer Research Program, returned in August as a part-time graduate Research Assistant working on the ARCHER trials through the fall semester.

We invite any interested investigators who wish to use existing Boston ARCH data for secondary analysis to contact ARCHER PI, Dr. Stein, or Kara Magane, Senior Director of Research Operations, for additional information.

The META HIV CVD Program Project Grant team highlight for the past quarter was hosting our second annual Satellite Meeting to the Research Society on Alcoholism’s Annual Meeting. The Admin, Education, and Analytic Core, with support from members of the Integrated Metagenomic and Metabolomic Core Lab at the University of Louisville, organized this meeting titled “Alcohol Research Involving People with HIV.” It was held in Bellevue, Washington and featured presentations from Drs. Kendall Bryant, Matt Freiberg, Scott Edwards, Tibor Palfai, Theresa Kim, Judy Hahn, Lesley Park, Alex Yaw Werekuu, Aakarsha Rao, Natalie Chichetto, Robert Cook, and Shirish Barve. These presenters represented the following groups: The Southern HIV and Alcohol Research Consortium, NOAH’S ARC, ARCHER, the Veterans Aging Cohort Study, the TN and Providence/Boston Centers for AIDS Research, and, of course, International URBAN ARCH. We concluded the day with an invigorating one-on-one mentoring session for early-career investigators and senior investigators organized by Natalia Gnatienko at URBAN ARCH. We plan to continue and expand this satellite meeting in upcoming years.

Since the meeting, the META team has continued to work on launching the randomized controlled trial which will recruit at Vanderbilt University Medical Center’s Therapeutic Clinical Research Site. Project Manager Grace Wallace is leading these efforts by finalizing a critical IRB amendment, with assistance from the Boston University Biostatistics and Epidemiology Data Analytics Center (BEDAC). We aim to recruit our first patient by the time of the next newsletter update.