International URBAN ARCH Center Core and Project Updates

Administrative Core

The Admin Core is looking forward to another year of training and mentoring events. Our first Visiting Scholar Research-in-Progress webinar of the academic year took place on September 10. Dr. Michael Vinikoor presented progress and emerging results from the Zambia Alabama HIV Alcohol Comorbidities Program (ZAMBAMA) P01. You can view a recording of this webinar here.

We are also preparing for the upcoming fall Program Advisory Committee (PAC) meeting to update our PAC on core/project activities and progress.

The Admin Core successfully organized one-on-one mentoring sessions during the RSA Satellite Meeting on HIV/Alcohol in June. You can read more about these and other URBAN ARCH activities at summer conferences in this issue’s main story!

Biostatistics and Data Management Core

The BDM Core continues to collaborate closely with project teams to advance the International URBAN ARCH studies. Data collection and data management activities, including derived variable creation and documentation, are ongoing for all studies. In addition, analytic plans and data analyses are in progress for TRAC and TALC conference abstract submissions. The Core is also helping to prepare for the fall PAC meeting. Finally, the core is collaborating on a number of manuscripts using data from the URBAN ARCH Consortium.

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 August 31, 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, 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.

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 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), 443 12-month in-person visits (97% completion rate), 316 18-month follow-up phone calls (98% completion rate), and 133 24-month in-person visits (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 384 PPDs placed at the 12-month visit, 40 were positive (10% positivity rate). Of the 111 PPDs placed at the 24-month visit, 10 were positive (9% positivity rate). Seven participants were disenrolled from the study and 7 died due to reasons unrelated to study participation.

Aim 2 procedures are in progress. We have completed two 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, 28 (2.8%) participants were diagnosed with active TB after receiving INH and 30 (3%) participants were dead. We are investigating the cause of death in these participants. We also found that 109 (11%) participants transferred out of their original clinics.

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). The team has screened 116 participants for Aim 1, of which 106 are currently enrolled and have completed the baseline visit. The team is actively completing follow-up visits at the 3-month, 6-month, and 9-month time points. The team will begin completing 12-month follow-up visits in October. In celebration of hitting 50% of our target enrollment, study staff at MUST had a team-building retreat.

In July, the team obtained a spirometer with DLCO measurement capabilities for Aim 1 of the study. Training with the new equipment occurred in August with Amtronix representative Jacques Ewald.

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. As of September 4, the team has completed 11 interviews with participants and 11 interviews with key informants.

The team would like to extend a special thanks to our qualitative RA, Catherine Kyampire, who will be leaving the study team at the end of the month. We are grateful to Catherine for her work on the TALC and THAU studies and she will be missed!

Eunice Kanini will step into the qualitative RA role at the end of the month, and we are excited to welcome her as a new addition to the team. Her qualitative experience on other studies at MUST will be an asset to the team!

All regulatory approvals have been received and all necessary supplies have been purchased for the TB HIV Aging in Uganda 50-over-50 (THAU 50/50) sub-study. The team hired an additional RA for this sub-study. Brian Kamugisha began working with the study team in July and we are excited to have him as part of the team. He has begun conducting sub-study procedures with TALC participants aged 50 or older.

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

GRAIL study enrollment began in November 2023, and as of September 4, 2024, the study has enrolled and randomized 87/300 participants. A total of 419 pre-screenings and 244 in-person screenings have been completed to date. The main reasons for ineligibility include an undetectable HIV viral load (62/79; 78.4%), a negative AUDIT-C score (34/242; 14.0%), and a negative EtG test (84/212; 39.6%). Women comprise 22.9% of the sample. The average age of enrolled participants is 40 years, and 33 participants 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, 6 (383 in-person and 272 phone visits completed to date) with follow-up rates above 80% for all visits.