International URBAN ARCH Center Core and Project Updates
Administrative Core
In June, the Admin Core successfully facilitated 18 one-on-one mentoring sessions during the Research Society on Alcohol (RSA) satellite meeting on HIV and alcohol use hosted by the META HIV CVD team. The Admin Core also planned two trainee events for September. This past Tuesday, September 12 from 12-1pm ET, Dr. Judy Hahn hosted a workshop titled, “Opportunities for HIV and Alcohol Secondary Data Analyses Using Data from Uganda and Beyond.” We are now looking forward to the next Visiting Scholar Research-in-Progress webinar on Wednesday, September 20 from 11am-12pm ET, when Dr. Patricia Molina will discuss her team’s NIAAA-funded HIV/Alcohol Center, LSUHSC-NO CARC. Interested in attending? Please register here.
The team is also happy to announce that the TALC study has received supplemental funding ($377,296) to launch the TB HIV Aging in Uganda 50-over-50 (THAU 50/50) study. The Admin Core is excited to be able to work with the TALC team to make this proposed research a reality!The THAU study will build on the infrastructure of the TALC study to accomplish the following specific aims:
- Aim 1: Determine the association between lifetime alcohol exposure and frailty and explore whether a) aging; b) history of TB disease moderates this association among PWH.
- Aim 2: Determine the association between social vulnerability and a) aging; b) history of TB disease in PWH.
- Aim 3: Qualitatively elicit health priorities and opportunities for differentiated healthcare delivery among older PWH with prior TB or unhealthy alcohol use.
The Admin Core team is also excited to start planning for our next URBAN ARCH Annual Meeting that will be held on Friday, May 3, 2024. The meeting’s agenda and registration information will be announced soon!
Biostatistics and Data Management Core
The BDM Core has been working with the TALC and TRAC project teams to advance the progress of both studies. For TRAC, the core has collaborated with the study team to complete testing of the REDCap assessments in both English and in Runyankole. We continue to collaborate on multiple statistical analyses and manuscripts in progress. These analyses cover a range of papers, including ones on food insecurity, mental health, and changes in alcohol use and inflammatory biomarkers over time.
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 September 2023, the TRAC team has attempted phone contact of 668 prior study participants for Aim 1 screening. We reached 516 participants and invited all of them for screening. Of the 516 screened, we found 465 to be eligible and 15 people declined. Therefore, we have enrolled 465 participants into the study and based on alcohol use data at screening, 103 are in the no alcohol consumption group, 100 are in the low/moderate alcohol use group, and 262 are in the high-risk alcohol use as assessed from prior drinking status. 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 465 (210 females and 255 males) enrolled, 397 have negative tuberculin skin test (TST) results following placement and reading of TST within 72 hours and 66 have received a positive TST result; a 14% positivity rate. We have successfully completed 318 6-month follow up visits (98% completion rate) all done via phone calls, and 136 12-month in-person visits (100% completion rate). At the 12-month visit, we placed PPDs on only those who were negative at baseline. Of the 116 PPDs placed, 10 were positive (9% positivity rate).
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 eagerly anticipating the beginning of study recruitment and enrollment. To that end, we have continued to finalize all items needed to launch the study, including obtaining regulatory approvals, testing data collection and management systems, purchasing supplies, and updating study standard operating procedures. We hope to begin recruitment very soon.
The team is also excited to announce that our application for supplemental funding to launch the THAU study was approved, as noted in the Admin Core update. In this study, we will determine the association between lifetime alcohol exposure and frailty, and explore whether this association differs by age or TB status. We look forward to utilizing the existing framework of the TALC study to recruit 100 participants for this new study. Thank you to everyone who provided valuable input on the application components!