International URBAN ARCH Center Core and Project Updates
Administrative Core
The Admin Core hosted Dr. Sylvie Naar for our quarterly Visiting Scholar Research-in-Progress webinar on Wednesday, February 26 as part of the International URBAN ARCH Training & Mentoring Program. This latest webinar highlighted some updates and exciting preliminary results from the Self-Management of HIV and Alcohol Reaching Emerging Adults (SHARE) P01 program. View a recording of this webinar (and all other past webinars) here.
We are looking forward to two upcoming training & mentoring events. On Tuesday, April 8 at 11am ET / 8am PT, Dr. Sarah Gutin and Dr. Alain Favina will present results from manuscripts they have developed using URBAN ARCH data. Register here to attend. We will also welcome Dr. Geetanjali Chander on Wednesday, May 28 at 1pm ET / 10am PT to present progress and emerging results from the University of Washington Alcohol Research Consortium in HIV (ARCH) P01 program. Register here to join us for this webinar.
International URBAN ARCH Center PI and Admin Core project lead Dr. Jeffrey Samet, TRAC project lead Dr. Judy Hahn, TRAC site PI Dr. Winnie Muyindike, and TRAC project director Dr. Nneka Emenyonu attended the CROI conference from March 9-12 in San Francisco. Dr. Judy Hahn presented a poster abstract from the TRAC project entitled “Effect of alcohol use on active TB incidence among PWH with prior receipt of TB preventive therapy.”
Biostatistics and Data Management Core
The BDM Core is thrilled to welcome Sara Lodi as co-Director of the ARCH BDM Core. Sara Lodi joined the ARCH BDM Core in 2017 and has worked extensively on the Uganda ARCH and Russia ARCH studies. Read more about Dr. Lodi in this issue’s featured story. Data management activities, including derived variable creation and documentation, are ongoing for TRAC, GRAIL, and TALC. The BDM Core supported the development of analytic plans for the TALC and TRAC studies and collaborated on analyses for four abstracts submitted to the International AIDS Society (IAS) conference.
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 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), 44718-month follow-up phone calls (98% completion rate), 307 24-month in-person visits (98% completion rate), and 136 30-month follow-up phone calls (99% completion rate). At the 12- and 24-month visits, we placed PPDs on only those who had negative results at baseline or 12 months. Of the 407 PPDs placed at the 12-month visit, 42 were positive (10% positivity rate). Of the 246 PPDs placed at the 24-month visit, 21 were positive (9% positivity rate). Eight participants were disenrolled from the study and 8 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.
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Tuberculosis, Alcohol, and Lung Comorbidities (TALC) Study
In Aim 1 of the TALC 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). As of March 6, the team has screened 146 participants for Aim 1, of which 133 are currently enrolled and have completed the baseline visit. The team is actively completing follow-up visits at the 3-month, 6-month, 9-month, and 15-month time points. The team will begin completing the final 18-month follow-up visits at the end of this month.
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 stakeholders, including TB providers and other health workers. As of March 6, the team has completed all 12 interviews with key stakeholders and 16 interviews with participants.
The TB HIV Aging in Uganda 50-over-50 (THAU 50/50) sub-study aims to investigate relationships between alcohol use, TB, and aging in PWH. Fifty TALC participants over the age of 50, and 50 new participants (without TB) over the age of 50 will be enrolled. The team has screened 32 new participants, of which 21 are currently enrolled and have completed study procedures. 8 TALC participants over the age of 50 have also completed procedures for the sub-study. Additionally, 4 interviews have been completed for the qualitative aim of the sub-study.
Lydia Carlson, TALC Research Project Manager, recently presented an abstract entitled “Physiologic, Anatomical, and Functional Indices of TB-Related Lung Damage by Hazardous Alcohol Use Among PWH” at the 29th Annual Conference of the Tuberculosis Union-North America Region in Vancouver, Canada. Naomi Sanyu, TALC Field Coordinator, will present this work next month at the 3rd International Post-TB Symposium in Stellenbosch, South Africa. In addition, two abstracts using TALC data were accepted to the Research Society on Alcohol conference. The abstracts are entitled “Drivers of unhealthy alcohol use among people with HIV and TB in Mbarara, Uganda: patient and provider perspectives” led by Dr. Sylvia Shangani, and “Is alcohol pharmacotherapy an acceptable treatment option among persons with HIV and Tuberculosis in Uganda?” led by Dr. Rebecca Fisk-Hoffman.
Gabapentin to Reduce Alcohol and Improve Viral Load Suppression (GRAIL) Study
GRAIL study enrollment began in November 2023, and as of February 12, 2025 the study has enrolled and randomized 120/300 participants. A total of 327 in-person screenings of individuals with detectable HIV viral load have been completed to date. The main reasons for ineligibility include a more recent (within past 2 months) undetectable HIV viral load (86/109; 78.9%), a negative AUDIT-C score (38/324; 11.7%), and a negative EtG test (115/292; 39.4%). Women comprise 24.2% of the sample. The study team is actively completing follow-up visits, with 529 in-person and 428 phone visits completed to date with follow-up rates above 80% for all visits.
The GRAIL study team recently met with the DSMB in January 2025 and are preparing for the next DSMB meeting in July 2025.
Dr. Nneka Emenyonu and GRAIL Study Coordinator, Allen Kekibiina, recently submitted abstracts to the Research Society on Alcohol (RSA) and International AIDS Society (IAS). These abstracts explored GRAIL study screening data and found that self-reported unhealthy alcohol use was highly prevalent (88% by AUDIT-C) and recent use was common (EtG biomarker-confirmed in 73%) among people with HIV with detectable HIV viral loads in the GRAIL study in Mbarara, Uganda. The RSA abstract was accepted for a poster presentation.