Core and Cohort Updates

Admin Core

Thank you all for a great URBAN ARCH Annual Meeting! The Annual Meeting took place from March 27-28 at Boston Medical Center/Boston University, and the Admin Core has spent the past few months working on evaluations and other wrap-up tasks. We look forward to seeing you all at next year’s annual meeting (April 8th, 2019)!

The Admin Core has also been busy working with the ARCH data and sample repository. Christine Capozzi (pictured right) and Natalia Gnatienko received and unpacked over 6,000 samples sent from the Russia ARCH team in St. Petersburg. Samples included plasma, serum, PBMCs, DBS cards, and fecal samples. Jules Canfield and Christine Capozzi also inventoried Russia and Uganda ARCH DBS cards and plan to ship some to USDTL for PEth testing. The Admin Core has also been assisting ARCH investigators with IRB protocols.

Lastly, the Admin Core is looking forward to seeing collaborators at the Research Society on Alcoholism meeting in San Diego next week!

BDM Core

The BDM Core remains active in both data management and biostatistics activities across URBAN ARCH. Over the past 3 months we worked closely with investigators in preparing for the spring DSMB meeting, the annual meeting, and for numerous conference presentations. In April, Debbie Cheng and Leah Forman traveled to Mbarara, Uganda along with Judy Hahn and Nneka Emenyonu to participate in the training and launch of the DIPT Study (pictured right).

Uganda Cohort

As of June 1, 2018, we have enrolled 107 participants into the ADEPTT study. We have screened 581 participants with 475 eligible for further screening for latent TB, and 111 positive and eligible for the study. We’ve completed baseline procedures for all 107 participants, 101 two-week follow up study visits, 97 month-one visits, 86 month-two visits, 76 month-three visits, 59 month-four visits, 53 month-five visits, 56 month-six visits, and 8 12-month visits. Eight participants have discontinued TB preventive therapy (INH) due to grade 3/4 level toxicities and one person has due to being pregnant. Based on recent data from CROI, 2018 showing increased risk of adverse pregnancy outcomes among HIV-positive women taking INH during pregnancy compared to HIV-positive women taking INH post-partum, we are adding pregnancy to our exclusion criteria for the study. (Source: http://www.croiconference.org/sessions/randomized-trial-safety-isoniazid-preventive-therapy-during-or-after-pregnancy). We are almost done with recruitment of participants from our previous ADEPT cohort and will continue with recruiting new participants from the ISS Clinic in the next quarter.

We had a very successful launch of the new DIPT Study, also in southwestern Uganda in April, 2018. Two weeks were spent training newly hired staff and the launch activities culminated in a scientific meeting where investigators of the DIPT study and collaborators presented their research work as it relates to the DIPT study. The DIPT Study will examine whether economic incentives contingent on reduced alcohol use, assessed by point-of-care urine tests, reduces heavy alcohol use over six months of INH compared to a control group, and whether economic incentives contingent on INH positive point-of-care urine tests increases INH adherence over six months compared to a control group.

Russia Cohort and ZINC RCT

As of June 1^st, St PETER has enrolled 154 participants and an additional 18 participants have continued on in the Russia ARCH cohort without enrolling into St PETER. Three-month completion rate for St PETER is 96%.

In March, members of the Russian study team traveled to Boston to attend the URBAN ARCH Annual Meeting. During this time, study team meetings were held to discuss study start-up for the PETER PAIN trial, which will begin recruitment in this month.

Study team in St. Petersburg, Russia in March 2018

The team is gearing up for summer conferences, The College on Problems of Drug Dependence Annual Scientific Meeting, the Research Society on Alcoholism Annual Scientific Meeting, and the International AIDS Conference, where team members will meet to discuss study progress and present findings.

The team is actively pursuing data analyses, abstract submissions and manuscript preparation.

Pavlov Study Team — Members of the Pavlov study team during an all-team meeting held in St. Petersburg in March 2018

Published Manuscripts:

Gnatienko N, Freiberg MS, Blokhina E, Yaroslavtseva T, Bridden C, Cheng DM, Chaisson CE, Lioznov D, Bendiks S, Koerbel G, Coleman SM, Krupitsky E, Samet JH. Design of a randomized controlled trial of zinc supplementation to improve markers of mortality and HIV disease progression in HIV-positive drinkers in St. Petersburg, Russia. HIV Clin Trials. 2018;19(3):101-11. PMCID: PMC5957784
Wagman JA, Samet JH, Cheng DM, Gnatienko N, Raj A, Blokhina E, Toussova O, Forman LS, Lioznov D, Tsui JI . Female gender and HIV transmission risk behaviors among people living with HIV who have used injection drugs in St. Petersburg, Russia. AIDS Behav. 2018 May 24. [Epub ahead of print] NIHMSID: NIHMS970493

Boston Cohort

Rich Saitz and Aldina Mesic at the 2018 Boston University School of Public Health Graduation Ceremony

Boston ARCH has continued to progress in its recruitment and enrollment efforts over the past few months. Research assistants have been screening and enrolling “legacy” participants from the original Boston ARCH cohort, who were initially recruited from Boston Medical Center’s Center for Infectious Disease and Boston Healthcare for the Homeless. As of May 25, RAs have administered 34 baseline assessments that include breath alcohol tests, interviews, physical assessment batteries, saliva sample collection, and clinical blood draws.

To assist with participant recruitment, enrollment, tracking, and data collection, Boston ARCH has hired two new research assistants – Alexandra Chretien and Allie Ferreira. DJ Smithers, a medical student at BU, will also be joining the team for the summer to contribute to these efforts. Aldina Mesic (pictured graduating with Richard Saitz), a research assistant, will be leaving the team, as will the Project Manager, Mariana Krueger. Susie Kim will be assuming the role of Project Manager moving forward.

During early implementation of the baseline assessment, the RAs noticed some changes that needed to be made to enhance their delivery of the interview and augment patient understanding. Analysts at Boston University’s Biostatistics and Epidemiology Data Analytics Center (BEDAC) assist us in developing and making changes to our electronic data collection tools.