International URBAN ARCH Center Core and Project Updates

Administrative Core

The Admin Core has had an engaging and productive fall season. In October, we hosted our latest quarterly International URBAN ARCH Visiting Scholar Research-in-Progress webinar featuring Dr. Bob Cook, who presented progress and emerging findings from the Southern HIV and Alcohol Research Consortium (SHARC) P01 program. The webinar recording can be viewed here.

We are also continuing to plan the 2026 URBAN ARCH Annual Meeting, which will take place from March 30 in Boston and virtually. View the meeting agenda here and register to attend here.

As always, we look forward to sharing more updates and connecting with the URBAN ARCH community in the months ahead!

Biostatistics and Data Management Core

General Updates
Data management and analyses are moving forward across GRAIL, TALC, and TRAC, including derived variable creation and documentation.

TALC Reaches Enrollment Target
Great news—TALC has enrolled all 200 target participants! Follow-up is continuing, and the BDM Core has supported development of four analytic plans:
• Social Vulnerability Index and CD4 Cell Count (Sylvia Shangani)
• Hazardous Alcohol Use and Lung Damage in People with HIV and TB (Anacret Byamukama, Kaku So-Armah)
• LAM, GeneXpert, and Chest CT Findings (Julian Adong)
• Intersectional Stigma Analysis (Karsten Lunze, Fatema Shafie Khorassani)

TRAC Analysis Support
The BDM Core continues supporting TRAC with multiple analytic plans, analyses, and manuscripts covering new TB infection/disease, smoking, depression and under-reported alcohol use, PEth sampling mechanisms, bar attendance, and alcohol expenditures.

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 December 1, 2025, 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, while 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. 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.

Of the 500 (217 (43%) females and 283 (57%) males) enrolled with a median age of 42 years, 75 had positive TST results following placement and reading of TST within 72 hours. After excluding 4 participants (2 with prior active TB on chart review, and 2 with no TST result), and including 8 with active TB on chart review but with TST negative results, we found 83 out of 496 (16.7%) had new TB infection/disease. We found no associations with active TB/positive TST at baseline by smoking status, household TB diagnosis, or number of rooms in the household.

We successfully completed 474 6-month follow up phone calls (95% completion rate), 478 12-month in-person visits (96% completion rate), 480 18-month follow-up phone calls (97% completion rate), 480 24-month in-person visits (98% completion rate), 301 30-month follow-up phone calls (80% completion rate), and 189 36-month in-person visits (83% completion rate). At the 12-, 24-, and 36-month visits, we placed PPDs on only those who had negative results at baseline, 12, and 24 months. Of the 407 PPDs placed at the 12-month visit, 42 were positive (10% positivity rate). Of the 358 PPDs placed at the 24-month visit, 33 were positive (9% positivity rate). Of the 95 PPDs placed at the 36-month visit, 7 were positive (7% positivity rate). Ten participants were disenrolled from the study and ten died due to reasons unrelated to study participation.

Aim 2 procedures are in progress. We have completed three rounds of review from TB registries, clinical registries, and medical records in 18 clinics from which participants were recruited in previous studies. We found all records (988 total) included in Aim 2. Of the 988 records reviewed, 30 (3%) participants were diagnosed with active TB after receiving INH and 39 (4%) participants were dead. We are investigating the cause of death in these participants. We also found that 139 (14%) participants transferred out of their original clinics.

Judy Hahn (PI) and Nneka Emenyonu (Project Director) completed a successful site visit in Mbarara, Uganda and attended the Global Health Collaborative Symposium and the MUST Annual Research Dissemination Conference on November 19, 2025.

TRAC (left) and PERC (right) study teams outside of the study offices in Mbarara.

Study team members at the MUST Conference (left) and the GHC Symposium (right).

Tuberculosis, Alcohol, and Lung Comorbidities (TALC) Study

In Aim 1 of the TALC study, we enrolled 200 participants to investigate the relationship between alcohol use and post-TB lung disease in people with HIV (PWH). Follow-up continues at the 3-, 6-, 9-, 12-, 15-, and 18-month timepoints. The team expects to complete 3-month follow-up for the entire cohort by the end of the year.

In Aim 2, we are qualitatively evaluating factors for tailoring alcohol and smoking interventions in PWH being treated for TB. We interviewed 24 TALC study participants and 12 key stakeholders, including TB providers and other health workers. All interviews have now been fully transcribed and coded, and the team is actively developing manuscripts using the data.

The past few months also brought exciting dissemination milestones. Three members of the TALC team presented their work at the Mbarara University of Science and Technology (MUST) Research Dissemination Conference in November. TALC radiologist Dr. Anacret Byamukama presented an abstract entitled, “Hazardous alcohol use among people with HIV and Mycobacterium tuberculosis: physiologic, anatomical, and functional indices of TB-related lung damage,” and TALC site coordinator Naomi Sanyu presented an abstract entitled “Unhealthy alcohol use and readiness to quit among people with HIV & TB in Uganda.”

TALC qualitative research assessor Eunice Kanini presented an abstract entitled, “Client and provider perspectives on interventions for unhealthy alcohol use among people with HIV and TB in Southwestern Uganda,” which was recognized as one of the top six abstracts of the conference and received an award. The TALC study team was also honored with a conference plaque acknowledging their contributions.

Another exciting recent update is that TALC site coordinator Naomi Sanyu completed all requirements and officially graduated with her MPH from MUST in October. Congratulations, Naomi!

Looking ahead, the team is excited for the upcoming CROI Conference in Denver, Colorado this February, where Dr. Anacret will present his work examining alcohol use and anatomical and functional indices of TB-related lung damage among people with HIV. He was also selected for a prestigious New Investigator Award, which includes dedicated support to attend the conference.

Thanks to all for the continued commitment and exceptional work!

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

GRAIL study enrollment began in November 2023 and recruitment was temporarily paused from June 9, 2025 through September 15, 2025 due to funding constraints. Given this pause and its impact on our recruitment period, we re-examined the study power. The revised sample size is 220 participants instead of 300. The projected recruitment end date is end of April 2025.

As of December 3, 2025 the study has enrolled and randomized 183/220 participants. A total of 466 in-person screenings have been completed to date. The main reasons for ineligibility include an undetectable HIV viral load (114/157; 72.6%), a negative AUDIT-C score (40/463; 8.6%), and a negative EtG test (162/422; 38.4%). Women comprise 24% of the sample. The study team has continued to actively complete follow-up visits, with 944 in-person and 665 phone visits completed to date with follow-up rates above 80% for all visits.

The GRAIL study team are preparing for the next DSMB meeting in January 2026.

Olivia Allison (project coordinator) recently presented a poster at Boston University’s Annual Department of Medicine Evans Day. This poster explored GRAIL study screening data and found that self-reported unhealthy alcohol use was highly prevalent (90% by AUDIT-C) and recent use was common (EtG biomarker-confirmed in 75%) among people who drink any alcohol and have non-suppressed HIV in the GRAIL study in Mbarara, Uganda.

The team recently submitted the GRAIL protocol paper “Gabapentin to achieve HIV viral load suppression in people with risky drinking in Mbarara, Uganda: study protocol for a randomized, double-blinded, placebo-controlled trial (GRAIL).”