Situated in the Center for Infectious Diseases (CID), the Infectious Disease Clinical Research Unit (ID-CRU) is a centralized unit for the conduct of all studies involving active recruitment of people living with HIV within the CID clinic at Boston Medical Center.
Our study portfolio includes clinical translational studies sponsored by the National Institutes of Health as well as industry-sponsored, investigator-initiated studies and clinical trials. Our directors and clinicians are also investigators within these NIH-funded research groups. Additionally, the team is available to assist Principal Investigators in developing research ideas and study start-up.
The ID-CRU provides a wide range of services necessary for the conduct of clinical research, including:
- IRB applications and regulatory compliance
- Study design and protocol consultation
- Study initiation
- Study activities including, but not limited to, the following:
- Administration of investigational medication
- Body composition measurements
- Electrocardiograms (ECGs)
- Expertise in collection of bronchoalveolar and colonic specimens
- Interviews
- Phlebotomy
- Questionnaires
- Source Documentation creation and implementation
- REDCap (Research Electronic Data Capture) development and data entry
- Specimen processing, storage, and shipping in conjunction with our lab at the Evans Biomedical Research Building (650 Albany St.)
We offer a broad range of ongoing trials that members of the community may be eligible to join. During their clinic visits in CID, our team, with the assistance of their healthcare provider, approaches eligible individuals to see if they are interested in learning more about our clinical research programs.
The ID-CRU has a particular interest in strategizing inclusive research recruitment and improving representation of underserved populations in research. This aligns with BMC’s overall mission to promote health equity. We welcome collaboration from other investigators to achieve this goal.
If you are interested in finding out more about the CRU, please contact us or our director, Archana Asundi.
Featured Publications
Papers
- Efficacy of Tocilizumab in Patients Hospitalized with Covid-19
- Immunological and Neurometabolite Changes Associated With Switch From Efavirenz to an Integrase Inhibitor
- Integrase Inhibitor Use Associated with Weight Gain in Women and Incident Diabetes Mellitus
- HIV-1 latency reversal agent boosting is not limited by opioid use
- Prevalence of strongyloidiasis and schistosomiasis among migrants: a systematic review and meta-analysis
- Vδ1 Effector and Vδ2 γδ T-Cell Subsets Shift in Frequency and Are Linked to Plasma Inflammatory Markers During Antiretroviral Therapy-Suppressed HIV Infection
- Additional publications: Archana Asundi Bibliography
Posters
- Implementation of Text-Messaging Based Medication Reminders to Improve Adherence to Antiretrovirals in People Living with HIV
- 153. pilot Study of a Novel Whole-genome Sequencing Based Rapid Bacterial Identification Assay in Patients with Bacteremia
HIV-Endurance (HIVE) Clinic (Funded by HRSA)
The purpose of the HRSA HIVE Clinic is to provide geriatrics-centered care to persons living with HIV aged 50 and older within the Center for Infectious Disease through a new integrated care model. The HIVE Clinic is a referral-based, integrated infectious disease–geriatric clinic for patients living with HIV. The clinic’s model seeks to identify, demonstrate, refine, and assess emerging strategies to comprehensively screen and manage comorbidities, geriatric conditions, behavioral health, and psychosocial needs of people living with HIV aged 50 years and older at Boston Medical Center (BMC). The core component of this intervention will be an integrated geriatric–HIV consultation clinic within the Center for Infectious Disease.
Industry Studies
EYEWITNESS
PI: Archana Asundi
Sponsor: GSK/ViiV
The purpose of this study is to determine the effectiveness and safety of switching from Biktarvy to Dovato. Dovato is also a single tablet of study drug that contains a combination of two study drugs, dolutegravir (DTG) and lamivudine (3TC). Dovato is a complete ViiV regimen given to treat people living with HIV. This drug has been approved for use in the United States and forms part of HIV treatment guidelines for both treatment-naïve and treatment-experienced individuals.
In addition, this study will provide three optional implementation strategies for participants and/or clinical staff to support conversations and understanding regarding Dovato and healthy aging in general. Acceptability, use, adherence, persistence, and usefulness of the implementation strategies are evaluated as well as providers’ experience of switching participants’ regimens to Dovato.
GILEAD 5925
PI: Archana Asundi
Sponsor: Gilead
The purpose of this research study is to see if switching to a single tablet of islatravir (ISL) combined with lenacapavir (LEN) once a week is safe, tolerable, and effective to use for the treatment of HIV infection compared to taking B/F/TAF every day. Additionally, the study aims to determine how ISL/LEN and B/F/TAF affect the HIV infection in your body. Other study endpoints include safety, drug tolerance, and quantity of investigative drugs in your body, which will be determined while enrolled in the study.
GILEAD 5926
PI: Archana Asundi
Sponsor: Gilead
The purpose of this research study is to see if switching to a single tablet of islatravir (ISL) combined with lenacapavir (LEN) once a week is safe, tolerable, and effective to use for the treatment of HIV infection compared to taking a standard-of-care ART regimen every day. Additionally, the study aims to determine how ISL/LEN and B/F/TAF affect the HIV infection in your body. Other study endpoints include safety, drug tolerance, and quantity of investigative drugs in your body, which will be determined while enrolled in the study.
GILEAD 6041
PI: Archana Asundi
Sponsor: Gilead
The purpose of this study is to see if taking ISL combined with LEN (ISL+LEN) once a week is safe, tolerable, and effective to use for the treatment of HIV infection. Another HIV medication administered in this study is B/F/TAF (Biktarvy®). B/F/TAF (Biktarvy®) is currently approved by the United States Food and Drug Administration (FDA) as a once-daily pill for the treatment of HIV infection. This study will compare ISL+LEN with B/F/TAF. The other purpose of this study is to determine how long ISL+LEN stays in your body.
GILEAD 6372 (TriNetX Weight Gain)
PI: Archana Asundi
Sponsor: Gilead
The purpose of this study is to define the association of INSTI (integrase strand transfer inhibitor antiretroviral agent) more comprehensively with weight gain, the risk factors associated with those who exhibit INSTI-associated weight gain, and cardiometabolic consequences, using a real-world HIV-positive cohort. This will be a large retrospective cohort study of real-world clinical data from the TriNetX network. The TriNetX database aggregates electronic medical record data from more than 50 healthcare organizations globally. Such data will be necessary to inform HIV treatment guidelines on how to use INSTI-based regimens on specific populations and guide future research directions into mechanisms and possible interventions to minimize or prevent these observed side effects of INSTIs.
PROMISE-US
PI: Archana Asundi
Sponsor: Theratechnologies Inc.
The purpose of the study is to look at routine healthcare data to see how effective and long-lasting Trogarzo is when used in combination with other drugs used to treat adults living with human immunodeficiency virus (HIV) who have tried multiple HIV medications and whose HIV infection cannot be successfully treated with other therapies because of resistance, intolerance, or safety considerations. This study will clarify the long-term efficacy, safety, and tolerability of antiretroviral (ARV) treatment regimens with or without Trogarzo.
Investigator Lead Studies
Dental and Mental Care among People with HIV
Collaboration between Larry Brown (Brown University/Miriam Hospital) and Michelle Henshaw (Boston Medical Center)
Sponsor: NIH
This study aims to gauge the satisfaction of dental health care, mental health care, and overall satisfaction with the care people receive for HIV. The study includes a digital survey conducted in the clinic, data extraction of laboratory results and HIV regimens from participants’ electronic health records, and an additional interview featuring more in-depth questions.
Social and Medical Determinants of Health and HIV
PI: Archana Asundi
The objective of this study is to identify the association between social and medical determinants of health and comorbid conditions for both people living with HIV (PLWH) and non-PLWH who receive care at Boston Medical Center (BMC). Case managers at BMC utilize the Massachusetts Department of Public Health (DPH) developed Acuity Scale as a screening tool to identify disparities in Social Determinants of Health (SDOH) and potential areas for intervention. The score on this screening tool is used to determine the level of case management assistance and ongoing needs to ensure patients have access to not only healthcare, but other SDOH needs such as access to nutritious food, housing, and medication. To date, there are no studies using such screening tools to demonstrate the correlation of SDOH and its impacts on other health outcomes such as hypertension, hyperlipidemia, diabetes mellitus, and obesity in PLWH. The aim of this project is to identify the impact of SDOH needs identified in such screening tools, including the MA DPH Acuity Scale and the THRIVE tool, and their correlations to comorbid health outcomes in PLWH and non-PLWH, respectively.
As a sub-analysis to the main analysis detailed above, we will also analyze how comorbid health outcomes are associated with patient medication regimen size and complexity in PLWH and non-PLWH for a portion of the patients in the main analysis. Polypharmacy, the number of medications a patient takes, has traditionally been used to determine a patient’s regimen complexity. A newer scoring index, Medication Regimen Complexity Index (MRCI), has been developed to account for additional complexities beyond number of medications, including dosing route and frequency. The sub-analysis will utilize both indices.
CFAR PROJECT
PI: Dr. Kaku So-Armah
Sponsor: IDEAAA
The purpose of this study is to identify the barriers, hypothesized to be rooted in Social Determinants of Health (SDOH), that are preventing linkage to HIV care following diagnosis in the following demographic groups identified to be vulnerable due to low linkage-to-care rates: 1) transgender women, 2) ages 13–24, 3) Black/African American individuals, and/or 4) men who use illicit substances via injection. Twenty participants in total will be recruited from Boston Medical Center and Miriam Hospital (Providence, RI). Participants will be asked to take part in a 45 to 60-minute semi-structured qualitative interview to assess a variety of barriers relating to their SDOH and how these barriers impacted their ability to link to care following diagnosis.
The Effects of Opioid Use on HIV-1 Reservoir Dynamics: Opioids, HIV, and Translation Study (OPHION)
PI: Athe Tsibris (Brigham and Women’s Hospital) and Nina Lin
Sponsor: NIDA (R61DA047038)
The objective of this study is to understand the effects of opioid use on HIV-1 latency. HIV latency is the residual virus remaining in people living with HIV despite achieving HIV suppression via antiretroviral therapy. Although opioids have been shown to interact with HIV in laboratory experiments, we want to understand how opioids react with HIV in humans and what health effects this may have.
In order to achieve these objectives we are collecting blood samples from approximately 120 patients from the Boston Medical Center community, including those actively injecting opioid drugs, those on methadone or suboxone for the treatment of OUD, and patients prescribed opioid drugs by their doctors, as well as people living with HIV who use no opioids.
Past Research Studies
Gamma delta T-cells and Inflammation in HIV Infection and Normal Aging
PI: Jennifer Cappione
Sponsor: NIA (R01AG065050)
In persons living with HIV, chronic inflammation is present even with undetectable viral loads, and such persons often present with co-morbidities associated with older age, including bone loss, cancers, stroke, cardiovascular disease, and dementia. In this application, we propose to test the hypothesis that gamma delta (γδ) T cells, a unique ‘innate-like’ T cell subset, exhibit hyperinflammatory activity in the gastrointestinal tract of aviremic older persons living with and without HIV, and this aberrant activation directly causes increased permeability of intestinal epithelium, leading to movement of GI microbial products and inflammatory γδ T cells into the circulation, which spurs and propagates systemic inflammation. Identification of the mechanisms driving increased intestinal permeability with aviremic HIV infection and normal aging is critical to develop novel therapeutic strategies to abrogate and/or prevent age-associated co-morbidities.
GILEAD 6738
PI: Archana Asundi
Sponsor: Gilead
The purpose of this study is to see if B/F/TAF FDC is safe in virologically suppressed participants who are unable or unwilling to continue on cabotegravir and rilpivirine (CAB+RPV) injections or wishing to switch to oral therapy. In addition, the study will see how much of the medicines are in your body and if B/F/TAF FDC is beneficial. The safety, how well these drugs are tolerated, and how much of these drugs are in your body will be determined by using physical exams, laboratory tests, any symptoms or problems you might experience during the study, and blood analysis.
HIV Aging of Immune Function
PI: Archana Asundi, Suryaram Gummuluru, Jennifer Cappione, Manish Sagar
Sponsor: NIA (R01AG060890)
The purpose of this study is to compare the aging of the immune system in people living with HIV to the general population. Among persons living with HIV, a persistent state of immune activation and inflammation accelerates the process of aging. This causes people living with HIV to have immune system defects common in older populations. These effects persist despite suppression of HIV with antiretroviral medications.
We believe that advancing age and HIV synergistically promote residual HIV gene expression that acts as a persistent and potential stimulus of immune activation. In order to investigate this relationship, we are collecting blood samples from young (under 35) and older (over 50) cohorts in people living both with and without HIV.
RABIT: Rapid Bacterial Identification Study
PI: Nina Lin
Sponsor: Day Zero Diagnostics
Bloodstream infections are one of the leading causes of morbidity and mortality in the United States. Rapid diagnosis is critical for improving survival, with an 8 percent rise in mortality for every hour that appropriate antibiotic treatment is delayed. However, the newest assays still either depend on a positive blood culture to initially isolate pathogenic bacteria, which takes at least 12–36 hours and fails in as many as 50% of cases of severe sepsis or assess a very limited panel of pathogens. This study will evaluate the efficacy of a novel microbial whole genome sequencing (WGS) technique relative to traditional culture for pathogen identification and antimicrobial resistance (AMR) determination.
Real-World Clinical Insights and Inflammatory Mechanisms of Integrase Inhibitor Associated Excess Weight Gain
PI: Archana Asundi
Sponsor: Boston-Providence Center for AIDS Research Developmental Grant (P30-AI042853)
The purpose of this study is to investigate and characterize weight changes associated with integrase strand transfer inhibitor (InSTI) antiretroviral agents by following anthropomorphic, metabolic, and inflammatory changes in persons with HIV who have gained weight on integrase inhibitors and are switching off these agents due to this effect. This is an observational study in which participants are monitored for a year after their switch with the option to undergo vibration-controlled transient elastography (Fibroscan) in addition to traditional body composition measurements.
Spatially multiplexed biogel nanosensors with boron-doped diamond microelectrode arrays for HIV self-testing
PI: Manish Sagar
Sponsors: Fraunhofer USA Center for Manufacturing Innovation (CMI), NIH NIAID
The purpose of this study is to explore the advanced integration of locked HIV nucleic acid amplification tests (NAAT) stored in hydrogels, which will be detected electrochemically using boron-doped diamond sensor microelectrode arrays. Each spot will separately read out amplification, effectively creating a novel digital electrochemical lateral flow assay. Completing this project will result in a demonstrator platform for semi-quantitative home-based monitoring of HIV viral loads.
Impact of Smoking and Its Cessation on Systemic and Airway Immune Activation
PI: Nina Lin
Sponsor: NIDA (R01DA042685)
Smoking is a major and urgent public health issue, especially for those living with HIV. Understanding the pathways by which smoking interacts with HIV-induced immune dysfunction in the lungs is critical to address this urgent public health concern. This project studies the immunological effects of smoking and quitting on lung health and the ensuing change in HIV disease progression.
The purpose of this study is to learn how smoking affects the immune systems in people with HIV infection. We would like to know if HIV-infected smokers who quit smoking have different responses in the lung and immune system from people who keep smoking.
Characterization of Systemic and Local Immune Responses to Chlamydia Antigens in Women to Support Vaccine Antigen Selection (The Chlamydia Study)
PI: Nina Lin
Sponsor: Merck
The purpose of this study is to characterize the cellular and humoral immune responses to Chlamydia candidate antigens among women with protective immunity to Chlamydia versus women susceptible for Chlamydia infection in order to support Chlamydia vaccine development.
SOLAR (Switch Onto Long-Acting Regimen)
PI: Archana Asundi
Sponsor: ViiV
People living with HIV undergo lifelong treatment with antiretroviral therapy (ART) in the form of fixed-dose combination pills taken orally. Taking ART daily is essential to achieve viral suppression and prevent the emergence of resistance mutations. Patients living with HIV and their physicians have observed that total pill burden, dosing frequency, and safety concerns are significant barriers to consistently adhering to their dosing schedules. Drug-resistant HIV eventually emerges in most patients who struggle with medication adherence. Our goal is to test whether a long-acting injectable combination of cabotegravir-rilpivirine is as effective as taking the same medication orally.
Patients participating in SOLAR will receive an injection of study medication every two months (60 days) or they will remain on oral ART (Biktarvy®) for the 12-month duration of the study. Patients chosen to receive the study medication will be offered a choice to begin with an oral study medication before proceeding to the injectable (oral lead-in) or receive the injectable right away (direct to inject).
During the study we will monitor participants to see if they maintain viral suppression, compare the efficacy and side effects of oral Biktarvy® compared to the long-acting injectable, and assess participant satisfaction across both arms of the study.
Other Studies
- Human Mosquito Immune Crosstalk
- Strategic Timing of Antiretroviral Treatment (START)
- Effects of Bictegravir-Emtricitabine-Tenofovir Alafenamide on Coronary Flow Reserve in Stable HIV Patients (B/F/TAF-CFR) — Pilot Study (PET)
- Randomized Trial to Prevent Vascular Events in HIV — REPRIEVE
- Cardiovascular Disease Risk In HIV-infected Women: Sex-Specific Mechanisms of Risk and Risk Reduction among REPRIEVE Trial Participants
Our Team
Archana Asundi, MD
Nina H. Lin, MD
Archana Asundi, MD
Director, Infectious Disease Clinical Research Unit (ID-CRU)
Medical Director, Boston Medical Center Clinical Research Unit (BMC-CRU)
Assistant Professor of Medicine, Boston University Chobanian & Avedisian School of Medicine
Dr. Archana Asundi is a physician-scientist and infectious disease clinician at Boston Medical Center. She specializes in care of people living with HIV through her clinical practice at BMC, with a specific focus on HIV and aging. Her individual research program focuses on topics around HIV, aging, and age-related comorbidities. In her role as Director of the Infectious Disease Clinical Research Unit (ID-CRU) at BMC, she also supports and oversees the conduction of a large portfolio of clinical trials and clinical-translational research studies in the Center for Infectious Disease (CID). She is the director of the HIV-Endurance (HIVE) Clinic, funded by a Health Resources and Services Administration (HRSA) Special Projects of National Significance grant on which she is the principal investigator.
Nina H. Lin, MD
Founding Director, Infectious Disease Clinical Research Unit (ID-CRU)
Assistant Professor of Infectious Disease, Boston University Chobanian & Avedisian School of Medicine
Dr. Nina Lin is a physician-scientist engaged in HIV translational research. During her time at BMC, her research has focused on the interplay of aging, non-communicable comorbidities such as smoking and opioid use, and chronic inflammation on the immune system of people with HIV. She was the principal investigator on several HIV therapeutic clinic trials as well as serving as co-chair of AIDS Clinical Trials Group A5325 and A5220, which evaluated interventions to improve or alter the clinical course of chronic HIV infection.
Dena Kivett, RN
Clinical Research Nurse
Dena is the Clinical Research Nurse of the ID-CRU. Her nursing career began in East Texas. She has over 30 years’ experience in Emergency and Trauma units. She has worked in various hospitals throughout the country from California to Massachusetts. She is a Registered Nurse and is certified in advanced cardiac life support and pediatric advanced life support.
In 2019 she joined the Infectious Disease Clinical Research Unit at Boston Medical Center working closely with Dr. Nina Lin and Dr. Archana Asundi on a number of clinical research studies relating to comorbidities of HIV/AIDS infection.
Dena is particularly passionate about the recruitment of underserved populations into clinical trials for the prevention and treatment of infectious diseases.
Samantha Roche, MPH
Senior Research Project Manager
Samantha joined the ID-CRU team in November 2018 as a Junior RA. Since then she has worked on multiple Investigator-Initiated and Sponsored Clinical Trials as part of the CRU leading to her current role. She has a passion for making sure all research conducted in the CRU is done ethically and with equal respect shown to all participants.Originally from Ireland, she obtained her MPH from University College Dublin.
Yunhan Chen, MPH
Research Project Manager
Yunhan is a Research Project Manager in the ID-CRU. He is responsible for maintaining regulatory compliance and approval for studies in the CRU and for conducting the Aging study as well as several industry-sponsored studies. He recently completed his MPH at the BU School of Public Health with certificates in epidemiology/biostatistics and pharmaceuticals development. He is currently interested in medication prescribing patterns in people with HIV (PWH) and the role polypharmacy and medication regimen complexity plays in this population.
Athina Schmidt
Research Project Manager
Athina is the clinic coordinator for the HIV-Endurance (HIVE) Clinic at Boston Medical Center and has been a dedicated member of the ID-CRU since 2020. With expertise in implementing research protocols, patient recruitment, and regulatory compliance, she contributes significantly to advancing clinical research in HIV and aging. Her work includes spearheading innovative interventions, such as text-message-based medication reminders, to enhance antiretroviral adherence. A Dartmouth College graduate with a BA in psychology, Athina combines her background in behavioral science with her commitment to improving care for people living with HIV.
Laura Mitten
Research Assistant
Laura graduated from Clemson University with a BS in Biological Sciences in May 2021. Since starting with the ID-CRU in September 2021, she has worked on several studies and currently leads recruitment for Dr. Asundi’s Real World InSTI Weight Gain study.
Sergio Romero, MHS
Research Assistant
Sergio graduated from Johns Hopkins University with a Master of Health Science (MHS) in Infectious Disease Epidemiology in May 2023. Since joining the ID-CRU in December 2023, he has been working on multiple studies related to HIV and aging, as well as industry-sponsored clinical trials. Additionally, he is involved in coordination efforts for the HIVE Clinic. Research areas of interest include health and equity among HIV populations and social determinants of health within the realm of infectious disease.