International URBAN ARCH Center Core and Project Updates
Administrative Core
The Admin Core has had a busy few months. Our Visiting Scholar Research-in-Progress webinar with Dr. Patricia Molina in September was a success (you can watch it here), and we are now looking forward to our next webinar on December 12, where Drs. Michael Stein, Tibor Palfai, Ana Abrantes, and Lisa Quintiliani will discuss their NIAAA-funded HIV/alcohol center, ARCHER. An upcoming trainee workshop on December 8 will focus on abstract review, giving early stage investigators a chance to receive feedback on abstracts to be submitted to upcoming conferences. Register here for the webinar and here for the workshop.
The Admin Core has also begun to plan for the 2024 URBAN ARCH Annual Meeting, which will take place on May 3, 2024, in Boston, MA and virtually via Zoom. A preliminary agenda is available here and registration is now open! We are excited to bring together International URBAN ARCH Center investigators and affiliates to celebrate another year of progress on our studies, and we hope to see many familiar faces in Boston!
Biostatistics and Data Management Core
The BDM Core continues to support the TALC and TRAC project teams to advance both studies. For TALC, the core completed testing of the REDCap assessments in both English and in Runyankole; systems have been developed to share spirometry data with the Uganda team; qualitative tracking forms are being developed and participant tracking reports are being created to summarize information such as screening & enrollment, participant characteristics, upcoming and missed visits, participation summary, and adverse events. The core also continues to collaborate on a number of papers 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 December 2023, 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 388 6-month follow up visits (98% completion rate) all done via phone calls, and 225 12-month in-person visits (98% completion rate). At the 12-month visit, we placed PPDs on only those who were negative at baseline. Of the 198 PPDs placed, 19 were positive (10% positivity rate). We have completed 66 18-month visits over the phone.
Aim 2 procedures are in progress, with a goal of reviewing records from 18 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. Overall, 81 participants transferred out of their original clinics and we have gotten permission to review new clinic records of 25, while the rest are pending.
Tuberculosis, Alcohol, and Lung Comorbidities (TALC) Study
The TALC team is excited to report that we have started study recruitment and enrollment. 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 living with HIV (PWH). So far, the team has prescreened 32 charts for Aim 1, of which 18 moved onto screening. After screening, 4 participants were found to be ineligible for the study. The remaining 14 eligible participants have all been enrolled into the study and have completed the baseline study visit.
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 two key informant interviews.
As we noted in our last update, we received supplemental funding to launch the TB HIV Aging in Uganda 50-over-50 (THAU 50/50) study. In this study, we will utilize the existing infrastructure of the TALC study to determine the association between lifetime alcohol exposure and frailty, and explore whether this association differs by age or TB status. We are currently working on finalizing the protocol, instruments, and IRB application for this study. We look forward to beginning recruitment in the coming months.
The team also launched another study in Mbarara, Gabapentin to Reduce Alcohol and Improve Viral Load Suppression (GRAIL). The primary objective is to test the efficacy of gabapentin versus placebo to achieve undetectable HIV viral load and the secondary outcomes are to assess the impact of gabapentin compared to placebo on alcohol consumption, pain severity, ART adherence, and engagement in HIV care, via a randomized, double-blinded, placebo-controlled clinical trial. The GRAIL team began recruitment in November 2023.
