Core and Cohort Updates
This has been a productive winter for the Admin Core! In the sample repository, we received a large shipment from St. Petersburg, Russia, which included whole blood samples, plasma samples, serum samples, PBMCs, DBS cards, and fecal samples from the St PETER, TMAO, ACME, and HIV Latency studies. In addition, multiple shipments from the repository were sent out to collaborators at various labs across the country for biomarker testing, including the Cleveland Heart Lab, Vanderbilt University, and the University of Louisville.
The sample repository has not been the only focus of the Admin Core these past few months. The team was extremely busy preparing for the 2020 Annual Meeting, which took place on March 12th at Boston Medical Center/Boston University. The Admin Core also coordinated additional activities surrounding the Annual Meeting, including the Annual URBAN ARCH/Providence/Boston CFAR Trainee Networking Breakfast, and the Specific Aims Critique Session with Judy Hahn which occurred on March 11th. The Data Safety Monitoring Board meeting was also held the day before the Annual Meeting, on March 11th. Due to the COVID-19 pandemic, annual meeting activities took place mostly virtually. The Admin Core team was able to accommodate those who were unable to attend in-person due to travel bans and health concerns. As always, it was wonderful to reconnect with collaborators from around the world.
Thank you to all who were able to attend the URBAN ARCH Annual Meeting, both in-person and virtually! We greatly enjoyed hosting those who travelled to Boston and hope to see everyone again next year.
The BDM Core worked hard to prepare analyses and reports for the 2020 URBAN ARCH Annual Meeting as well as the spring Data Safety Monitoring Board meeting. Core members continue to work closely with investigators from each cohort and the Admin Core on numerous manuscripts and projects across the consortium.
The big news in the ADEPTT study is that we are done with enrollment! As of March 1, 2020, we have enrolled all 302 of our target participants, including 147 males and 155 females. Of these, 200 are current alcohol drinkers and 102 are alcohol abstainers. To achieve our enrollment, we screened 1,434 patients from the Mbarara ISS Clinic, of whom 1,312 were consented for further screening for latent TB. Out of 1,192 purified protein derivative (PPD) placements completed, 308 (26%) participants had positive results for latent TB and were eligible for the study. We’ve completed baseline visits for all 302 participants enrolled, 297 two-week follow up study visits, 294 month-1 visits, 283 month-2 visits, 289 month-3 visits, 261 month-4 visits, 253 month-5 visits, 271 month-6 visits, 214 month-7 visits, 163 month-12 visits, 121 month-18 visits, 70 month-24 visits, and 35 month-30 visits. Twenty-four participants have discontinued TB preventive therapy (INH) due to grade 3/4 liver toxicities and three women have discontinued INH due to being pregnant. One participant is deceased, and the cause of death was unrelated to the study. Five participants have been disenrolled from the study.
We continue to provide training and mentorship in abstract and manuscript preparation and results dissemination to the junior investigator on the team (Adong), project coordinators (Ngabirano, Kekibiina, Sanyu) and senior data manager (Tumwegamire), thereby building research capacity at our collaborating institution, Mbarara University of Science and Technology (MUST). These mentees presented abstracts in the past year at local and international conferences and are currently working on manuscripts for publication with mentorship from the PI (Hahn) and Co-investigators.
The main aims of the DIPT randomized controlled trial are to examine whether economic incentives provided to HIV/TB co-infected heavy drinkers can reduce alcohol use and increase adherence to isoniazid preventive therapy (IPT). As of February 1, 2020, we have screened 3,002 participants, of whom 2,386 were further screened to determine heavy drinking status using point-of-care urine ethyl glucuronide (EtG) tests, which detect recent heavy drinking. Out of the 2,386 screened for heavy drinking, 1,166 (49%) participants were positive for heavy drinking using the EtG test. Following the above screening steps, we completed 1,029 PPD skin tests to confirm latent TB status. Of the 1,027 PPD tests completed, 409 (40%) participants had positive results for latent TB and 403 participants were enrolled, including 278 (69%) males and 125 (31%) females.
The main aims of the EXTEND RCT are to estimate the uptake and acceptability, preliminary efficacy, and cost of methods of delivery of an intervention to reduce unhealthy drinking and HIV viral failure among persons in HIV care in rural Uganda (n=270). To date, we have screened a total of 404 patients at the Mbarara ISS Clinic and enrolled 92 participants including 62 males and 30 females. Of the 92 participants enrolled in the RCT, 25 were randomized to arm 1 (in-persons counseling plus live call boosters); 32 were randomized to arm 2 (in-person counseling plus automated boosters); and 35 were randomized to arm 3 (standard of care, wait-list control). Participants in arm 2 (automated boosters) are given a choice between Interactive Voice Response (IVR) or Short Message service (SMS) messages for their booster sessions and so far, two thirds (21) of them have chosen IVR while one third (11) of them have chosen SMS as their preferred automated booster message delivery option.
St PETER, our clinical trial to examine whether smoking cessation medications cytisine and varenicline reduce alcohol use, smoking, and improve health outcomes among HIV-positive smokers and drinkers in Russia, completed enrollment (n=400) on December 25th, 2019. Three-month follow-up visit completion rate for St PETER as of March 2nd is 81.5%. We expect to complete follow-up for St PETER by the end of 2020. In February, the team received the fourth batch of St PETER, TMAO, ACME, and HIV Latency study samples (whole blood, PBMC, plasma, serum, stool, nasal samples, DBS cards) from Russia.
In a previous issue, it was mentioned that Jeffrey Samet was interviewed while in St. Petersburg for a film celebrating the 25th anniversary of the Valdman Institute of Pharmacology, which is headed by collaborator Edwin Zvartau. This film was presented and released to the public in January 2020 at the Annual Valdman Conference. The film interviews many Russia ARCH team members, including Jeffrey Samet (24:29), Edwin Zvartau, Evgeny Krupitsky, Elena Blokhina, and Tatiana Yaroslavtseva. For those interested, the film can be found here. The majority of the film is in Russian, however you can select the closed captions (CC) icon, and then the auto-translate option in the settings icon to your preferred language subtitles.
In January 2020, Karsten Lunze presented “Understanding and Intervening on Stigma Affecting HIV Key Populations” at the Seminar Series of the Southern HIV & Alcohol Research Consortium (SHARC), located at the University of Florida. SHARC is a fellow CHAART (Consortia for HIV & Alcohol Research Translation) site and is led by Bob Cook. SHARC and URBAN ARCH are collaborators on the ACME 1/2 and 2/2 studies.
The team is actively pursuing data analyses, abstract submissions, and manuscript preparation.
- Mensah SO, et al. The association between heavy alcohol consumption and trimethylamine N-oxide (TMAO) levels: a cross sectional study. Accepted as a poster presentation to RSA/ISBRA-2020 Scientific Meeting in New Orleans, LA.
- Vetrova M, et al. A Longitudinal Analysis of HIV stigma and ART initiation among HIV-positive people who inject drugs in Saint Petersburg, Russia. Accepted to 2020 NIDA International Forum’s Poster Session in Hollywood, FL.
- Yaroslavtseva T, et al. Electronic cigarette use among HIV-positive heavy drinking smokers in Russia. Accepted to College on Problems of Drug Dependence (CPDD) 2020 in Hollywood, FL.
- So-Armah KA, et al. HIV, alcohol and dysbiosis – Exploring the association between alcohol and dysbiosis among HIV-positive heavy drinkers. Accepted as a poster presentation to RSA/ISBRA-2020 Scientific Meeting in New Orleans, LA.
- Fuster D, et al. Tobacco use and liver fibrosis in HIV-infected Russians. Accepted to College on Problems of Drug Dependence (CPDD) 2020 in Hollywood, FL.
- So-Armah KA, Freiberg MS, Cheng DM, Lim JK, Gnatienko N, Patts G, Doyle M, Fuster D, Lioznov D, Krupitsky EM, Samet JH. Liver fibrosis and accelerated immune dysfunction (immunosenescence) among HIV-infected Russians with heavy alcohol consumption – an observational cross-sectional study. BMC Gastroenterol. 2019;20(1):1. PMCID:PMC6938606
- Ragan EJ, Klienman MB, Sweigart B, Gnatienko N, Parry CD, Horsburgh CR, LaValley MP, Myers B, Jacobson KR. The impact of alcohol use on tuberculosis treatment outcomes: A systematic review and meta-analysis. Int J Tuberc Lung Dis. 2020;24(1):73-82(10).
- White LF, Jiang W, Ma Y, So-Armah K, Samet JH, Cheng DM. Tutorial in Biostatistics: The use of generalized additive models to evaluate alcohol consumption as an exposure variable. Drug Alcohol Depend. 2020;209:107944.
The Boston ARCH Cohort, a study that aims to assess the association between alcohol consumption and bone density among people living with HIV and substance dependence, began recruitment in December 2012.
As of March 1, 2020 the team has completed 250 baseline visits (176 with participants from the original Boston ARCH Bone Cohort and 74 with participants new to the cohort). Follow-up assessment began in June 2013 and is ongoing. As of March 1, 2020, 199 6-month follow-up phone interviews, 155 12-month follow-up in-person visits, 96 18-month follow-up phone interviews, and 11 24-month follow-up in-person visits have been completed. Two subjects have been lost to follow-up and 8 deaths have been reported.
Additionally, we have completed 5 individual qualitative interviews and are scheduling qualitative focus groups to take place in the next few months. Qualitative data will inform the development of a falls prevention intervention.
Leading this qualitative work is Dr. Christine Helfrich, an Associate Professor of Occupational Therapy at the American International College and an experienced qualitative researcher. She has worked in community-based research, working with vulnerable populations including individuals who are/have been homeless, survivors of domestic violence and their children, and individuals with mental illness. She has worked on needs assessments, intervention development, and outcome evaluation.