International URBAN ARCH Center Core and Project Updates

Administrative Core

Over the past few months, the Admin Core has facilitated a number of training and mentoring events. In February, Dr. Karen Jacobson hosted a workshop on an overview of tuberculosis disease. The March quarterly Visiting Scholar Research in Progress webinar featured Dr. Amy Justice, who presented her work with the HARP P01. Recordings of past webinars are now available to view here. The team has also been working on planning the upcoming URBAN ARCH Annual Meeting on May 23, 2023. This year’s meeting will be virtual and will feature presentations from early stage investigators who are using URBAN ARCH repository data for analyses.  Please keep an eye out for registration information.

Dr. Jeffrey Samet also represented the Admin Core in Uganda, traveling with members of the TALC, TRAC, and GRAIL studies for a site visit and study staff training in Mbarara.

The Admin Core team will also be organizing one-on-one mentoring meetings on June 24, 2023 for early stage investigators attending RSA. These meetings will be held during a satellite meeting titled, Alcohol Research Involving People with HIV. You can find out more and register to attend the meeting here.

Biostatistics and Data Management Core

The BDM Core has been actively working with the TALC and TRAC project teams to advance the progress of both studies. BDM members continue to support the TRAC study with study design issues and monitoring study conduct.  The core has been working with the TALC study team to plan their study launch. The core is also guiding and supporting trainees who are developing abstracts for the spring. Various papers are also in progress and the BDM is supporting the analyses and interpretation of results.

TB Risk by Alcohol Consumption (TRAC) Study

The aims of the TB Risk by Alcohol Consumption (TRAC) study are to estimate the incidence rate of new TB infection among people with HIV (PWH) with prior negative tuberculin skin test (TST) results by level of alcohol use (Aim 1) and to determine the incidence of active TB disease among PWH with prior latent TB infection (LTBI), who received TB preventative therapy (TPT), by level of alcohol use (Aim 2).

As of April, 2023, we have attempted phone contact of 489 prior study participants for Aim 1 screening. We reached 381 participants and invited all of them for screening. Of the 381 screened, we found 354 to be eligible and 11 people declined. Therefore, we have enrolled 343 participants into the study (96 in the no alcohol consumption group, 89 in the low/moderate alcohol use group, and 158 in the high-risk alcohol use group). All enrolled participants have completed baseline procedures including questionnaire, biological specimen collection for dried blood spot (DBS) preparation and storage for PEth testing, urine collection for real time cotinine testing, and PPD placement. Of the 343 (189 females and 154 males) enrolled, 298 have negative TST results following placement and reading of TST within 72 hours and 45 have received a positive TST result; a 13% positivity rate. We have successfully completed 162 6-month follow up visits all done via phone calls.

Aim 2 procedures are in progress, with a goal of reviewing records from 13 HIV clinics from which we have previously recruited study participants. To date we have reviewed 987 patient records from two clinics in Mbarara, and only 1 record has not been found in this process. These are records of prior study participants who were TST positive and received INH as TB preventive therapy. Of the records reviewed, 20 participants were diagnosed with active TB after receiving INH and 23 participants had died. We are investigating the cause of death in these participants.

The highlight of this quarter was a site visit by the PI, Judy Hahn and project director, Nneka Emenyonu, where we had a chance to see the wonderful progress first hand, and meet with the Uganda-based team and our collaborators at MUST. We had the pleasure of attending oral presentations given by TRAC Uganda PI, Dr. Winnie Muyindike, as well as TRAC research assistant, Caroline Asiimwe, at the 17th MUST Annual Research Dissemination Conference.

The TALC team has continued to make exciting progress with study startup. The project was approved by both the Mbarara University of Science and Technology (MUST) IRB and the Uganda National Council for Science and Technology (UNCST). Study staff in Mbarara have been hired, including Naomi Sanyu, the team’s new field coordinator, who has been working on the study since March. Members of the US-based team, including Dr. Kaku So-Armah (project lead), Dr. Karsten Lunze (co-investigator), Dr. Jeffrey Samet (co-investigator) and Sarah Rossi (project manager) traveled to Uganda in March for a study site visit. The visit consisted of conducting training with study staff, visiting recruitment sites, and finalizing study procedures and protocols, as well as a launch party for both the Gabapentin to Reduce Alcohol and Improve Viral Load Suppression (GRAIL) and TALC studies. The team is very excited to begin recruitment for the study once data collection systems are up and running!