Updates from 2nd Generation URBAN ARCH HIV/Alcohol P01s
This fall, 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 1000 potentially eligible participants to screen for eligibility for the ARCHER trials. We have phone screened 194 potentially eligible participants for the Pain Trial, and 206 potentially eligible participants for the Physical Activity Trial. In total, we currently have 84 participants enrolled and randomized: 44 in the Physical Activity Trial and 40 in the Pain Trial. Randomized 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. In addition to collecting baseline data, we have been actively collecting 3-month follow-up data: 16 participants in the PA Trial have completed their 3-month research interview and 3-month EMA surveys, and 21 participants in the Pain Trial have completed their 3-month research interview and 3-month EMA surveys.
Most recently, we have begun collecting 6-month follow-up data: 3 participants in the PA Trial have completed their 6-month research interview, and 10 participants in the Pain Trial have completed their 6-month research interview. In addition to the interview at the 6-month time point, participants complete a self-administrated blood draw using the Tasso M-20 device.
We convened our second Data and Safety Monitoring Board (DSMB) meeting in October. We received positive feedback from the DSMB, with no recommended modifications to the protocol or informed consent.
In October of 2023, we welcomed a new research assistant, Robert Siebers, to the ARCHER project. Rob recently graduated from the University of Virginia with a Master of Public Health with a concentration in Research in Practice. While at UVA, Rob worked in a Mental Health Law lab where he collected and analyzed data to investigate fatal interactions between individuals with mental illness and police officers. He also collaborated with community partners at an employee wellness research group at UVA to evaluate the relationship between physical activity, work engagement, and anxiety levels. Rob will provide administrative support on ARCHER, and assist with recruiting, enrolling, and data collection for both the Pain and PA Trials. Additionally, we have onboarded 2 new interventionists to the PA Trial, Donnell Van Noppen and Jennie Min, and 1 new interventionist to the Pain Trial, Majo Bustamante Wiess. They will meet with randomized participants to deliver the intervention of each trial.
The team is excited to announce a new publication of a secondary analysis of the Boston ARCH data supported by ARHCER. Self-medication of pain and discomfort with alcohol and other substances by people with HIV infection and substance use disorder: preliminary findings from a secondary analysis was accepted by AIDS Care in October 2023, and published online ahead of print in November 2023. 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 has focused their efforts this quarter on recruiting and enrolling patients for the Randomized Control Trial. Seven participants have been successfully enrolled and randomized. Study visits have been conducted by the wonderful group at Vanderbilt University Medical Center’s Comprehensive Care Clinic, our clinical research site. Project Manager Grace Wallace has skillfully and rapidly led the effort to make adjustments as we enrolled our first participants. These adjustments include IRB amendments, REDCap edits, and team meetings.
The Integrated Metagenomic and Metabolomic Core Lab at the University of Louisville continues to work with Dr. Kaku So-Armah and his team on the Cohort project. Mentees Sonam Tandon and Dr. Samuel Mensah have submitted an abstract for the upcoming Conference on Retroviruses and Opportunistic Infections (CROI) titled “The Association between HIV status and Trimethylamine N-Oxide (TMAO) Levels.”
The Admin, Education, and Analytic Core applied for the third iteration of our annual meeting titled “Alcohol Research Involving People with HIV” as a satellite meeting to the Research Society on Alcoholism’s annual meeting.
