International URBAN ARCH Center Core and Project Updates

Administrative Core

The Admin Core continues to organize training and mentoring events and coordinate activities of the International URBAN ARCH Center. We recently hosted Dr. Matthew Freiberg, who presented at our Visiting Scholar Research-in-Progress webinar on March 12. The recording from this event is available to watch here. Dr. Natalie Chichetto and Dr. Mollie Monnig also presented on the effects of alcohol on the gut-brain axis among people with HIV at our recent trainee workshop on March 26.

The 2024 URBAN ARCH Annual Meeting will take place May 3 in Boston, MA with the option to attend in-person or virtually. You can view the agenda and register for the meeting here. We look forward to connecting with you at the meeting! We are also excited to highlight four early career investigator abstracts at this year’s meeting (see agenda for more details). Thank you to all who submitted an abstract for consideration!

In conjunction with this year’s RSA Satellite Meeting on HIV and Alcohol on June 22 in Minneapolis, MN, the Admin Core will also coordinate one-on-one mentoring sessions for early career investigators. Please read more about the meeting and register by May 1 here.

Biostatistics and Data Management Core

The BDM Core has been working closely with the TALC and TRAC study teams on multiple facets including harmonization of data elements, management of biospecimen samples, and building REDCap participant qualitative tracking forms and forms for chart review.  For TALC, spirometry files are being shared via OneDrive with BEDAC and Uganda team and multiple study reports have been created and maintained including: screening & enrollment, participant characteristics report, participation summary, adverse events, upcoming  visits, and visit completions. The core also continues collaborating on several manuscripts in progress.

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 March, 2024, we have successfully concluded TRAC study enrollment with 500 participants! To achieve this goal, we made phone call attempts to 694 prior study participants for Aim 1 screening. We reached 558 participants and invited all of them for screening. Of the 558 screened, we found 522 to be eligible but 20 people declined consent to participate in the study. Therefore, we enrolled a total of 502 participants into the study, however 2 participants were enrolled in error and were subsequently excluded, leaving the total number enrolled as 500. Based on alcohol use data at screening, 103 are in the no alcohol consumption group, 103 are in the low/moderate alcohol use group, and 294 are in the high-risk alcohol use as assessed from prior drinking status. Self-reported AUDIT-C scores from TRAC baselines visits show 138 (28%) in the no alcohol group, 203 (41%) in the low/moderate alcohol use group, and 158 (32%) in the high-risk alcohol use group. Baseline PEth results of 451 participants show 155 (34%) in the no alcohol use group with PEth levels of <20 ng/ml, 155 (34%) in the no alcohol use group with PEth levels of 20-<200 ng/ml, 155 (34%) in the no alcohol use group with PEth levels of >200 ng/ml.

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 500 (217 (43%) females and 283 (57%) males) enrolled, 75 have positive TST results following placement and reading of TST within 72 hours; a 15% positivity rate. We have successfully completed 440 6-month follow up phone calls (95% completion rate), 312 12-month in-person visits (98% completion rate), and 134 18-month follow-up phone calls (99% completion rate). At the 12-month visit, we placed PPDs on only those who were negative at baseline. Of the 275 PPDs placed, 27 were positive (10% positivity rate). Seven participants have been disenrolled from the study and five have died due to reasons unrelated to study participation.

Aim 2 procedures are in progress, with a goal of reviewing records from 18 HIV clinics from which we have previously recruited study participants. We are currently in the second round of records review since the start of the study and in this second round, we have reviewed 911 out of 988 patient records from four clinics in Mbarara. These are records of prior study participants who were TST positive and received INH as TB preventive therapy. Of the records reviewed to date, 26 participants were diagnosed with active TB after receiving INH and 28 participants had died. We are investigating the cause of death in these participants. Overall, 96 participants transferred out of their original clinics and we have gotten permission to review new clinic records.

Tuberculosis, Alcohol, and Lung Comorbidities (TALC) Study

The TALC team is making great progress in recruiting and enrolling participants into our study. In Aim 1 of the study, we will enroll 200 participants in order to investigate the relationship between alcohol use and post-TB lung disease in people with HIV (PWH). So far, the team has completed 52 baseline assessments and 20 3-month follow up visits.

In Aim 2, we will qualitatively evaluate factors for tailoring alcohol and smoking interventions in PWH being treated for TB. To this end, we will interview 24 TALC study participants and 12 key informants, including TB providers and other health workers. So far, the team has completed 4 interviews with study participants and 5 interviews with key informants.

We are also in the process of obtaining IRB approval to conduct additional study activities as a part of the TB HIV Aging in Uganda 50-over-50 (THAU 50/50) sub-study. Read more about the THAU 50/50 study in this issue’s main story!

Gabapentin to Reduce Alcohol and Improve Viral Load Suppression (GRAIL) Study

GRAIL study enrollment began in November 2023, and as of March 21, 2024, and the study has enrolled and randomized 32/300 participants. A total of 115 pre-screenings and 111 in-person screenings have been completed to date. The main reasons for ineligibility include a detectable HIV viral load (30/111; 27%), a negative AUDIT-C score (21/111; 19%), and a negative EtG test (15/111; 14%). Women comprise 19%% of the sample. The average age of enrolled participants is 39 years and 11 had an AUDIT score >=20. The study team is actively completing follow-up visits at weeks 1, 2, 3, 6, and 10, and months 1, 2, 3 (68 in-person and 75 phone visits completed to date) with follow-up rates above 80% for all visits. Recognizing the need to enhance recruitment, the team has recently extended recruitment efforts to an additional site and is actively preparing to expand to further sites.