Updates from 2nd Generation URBAN ARCH HIV/Alcohol P01s

It was a busy summer for the ARCHER team as we continued to recruit, screen, enroll, and collect data for the center’s Pain Trial and Physical Activity (PA) Trial. In collaboration with BuildClinical, a vendor specializing in targeted online campaigns to recruit participants for clinical research studies, we have received over 2,300 potentially eligible participants to screen for eligibility for the ARCHER trials. We have phone screened 526 potentially eligible participants for the Pain Trial, and 520 potentially eligible participants for the PA Trial. In total, we currently have 209 participants enrolled and randomized: 93 in the Pain Trial and 116 in the PA Trial. We have surpassed the halfway point to our randomization goal for the PA Trial and are quickly approaching the halfway point for 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 and 6-month follow-up data: 69 participants in the Pain Trial have completed their 3-month interview and 3-month EMA surveys, and 64 participants in the PA Trial have completed their 3-month interview and 3-month EMA surveys. Fifty-two participants in the Pain Trial have completed their 6-month interview, of which 47 also completed the at-home blood draw which is shipped to a lab and analyzed for Phosphatidylethanol (PEth), an alcohol biomarker. Forty-eight participants in the PA Trial have completed their 6-month interview, of which 45 completed the at-home blood draw which is shipped to a lab and analyzed for PEth.

We are pleased to welcome Sally Bendiks Young, who will be giving some of her time to the ARCHER study. Sally is a Senior Research Manager at Boston Medical Center and manages various research studies, including studies under the International URBAN ARCH Center.

The team is excited to announce the publication of the ARCHER Physical Activity Trial Protocol paper: Design and rationale for a randomized clinical trial testing the efficacy of a lifestyle physical activity intervention for people with HIV and engaged in unhealthy drinking which was accepted by Contemporary Clinical Trials in July 2024 and published online in September 2024.

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 welcomed new team members Tracy Goddard and Molly Divine. Along with the strong foundation built by our team at Vanderbilt University Medical Center’s Comprehensive Care Clinic (CCC), Tracy and Molly greatly expanded our recruitment and enrollment efforts. Over 20 patients are currently enrolled with double as many passing their screenings and scheduled to enroll in the near future. On the other end of the timeline, CCC staff successfully completed the first 12-month visit for a participant, demonstrating that a patient can complete all study visits. Study visits have been expanded to Vanderbilt’s Clinical Research Center to accommodate the growing number of participants.

The Integrated Metagenomic and Metabolomics Core Lab at the University of Louisville and Dr. Kaku So-Armah and his team continue to analyze data for the other aspects of the Program Project Grant.