# Harvard/Boston/Providence Clinical Trials Unit (Harvard/B/P CTU)

> **NIH NIH UM1** · BETH ISRAEL DEACONESS MEDICAL CENTER · 2020 · $900,000

## Abstract

Harvard/Boston/Providence Clinical Trials Unit (H/B/P CTU)
Administrative Supplement (06/01/20-11/30/20)
PROJECT SUMMARY
The Harvard/Boston/Providence Clinical Trials Unit (CTU) conducts clinical trials to address research areas of
three NIAID HIV Clinical Research Networks: vaccines against HIV infection (HVTN); integrated HIV
prevention strategies (HPTN); and adult HIV therapeutic strategies including HIV cure, management of non-
infectious co-morbidities and infectious co-morbidities of viral hepatitis and tuberculosis (ACTG). The CTU is
comprised of five clinical research sites (CRSs) at institutions where the clinical trials are conducted. These
institutions are Beth Israel Deaconess Medical Center, Massachusetts General Hospital, Brigham and
Women’s Hospital, Fenway Health Center, and The Miriam Hospital. The CTU is led by three highly
experienced principal investigators, Drs. Raphael Dolin, Kenneth Mayer and Daniel Kuritzkes, and includes
highly accomplished CRS leaders and collaborating investigators. The CTU functions as an integrated, highly
collaborative entity, which has centralized planning, resource allocation, decision-making and financial
management through an efficient administration plan. Decisions are driven by a rigorous evaluation process
based on established metrics of performance and robust communication among leadership and staff of the
CTU and CRSs. Centralized resources of the CTU include a Clinical Research Laboratory (CRL), a Research
Pharmacy Coordinator (RPC), Data and Quality Management Plans, and a Community Engagement Core. The
CTU has diverse and accessible populations for study, representing communities most affected by HIV/AIDS,
hepatitis C virus infection, and tuberculosis, and have well-grounded connections with the communities in
which they are based. The CTU is well poised and experienced to carry out efficient, high quality clinical trials
to address major questions in HIV clinical research. Its leadership and administrative structure facilitates the
conduct of studies which cross traditional network boundaries and that enables rapid responses to new
scientific directions as they emerge.
Under this Administrative Supplement application, The HBP CTU is responding to NIAID’s Notice of Special
Interest (NOSI) (NOT-AI-20-031) to address the need for research on Severe Acute Respiratory Syndrome
Coronavirus 2 (SARS-CoV-2) and Coronavirus Disease 2019 (COVID-19). NIAID is particularly interested in
projects focusing on viral natural history, pathogenicity, transmission, as well as projects developing/expanding
medical countermeasures and suitable animal models for pre-clinical testing of vaccines and therapeutics
against SARS-CoV-2/COVID-19. In order to address this urgent public health need, the NIAID-supported
networks have been charged to serve as a focal point of sponsored trials in COVID-19 vaccines and
monoclonal antibodies (mAbs) for preventing the acquisition of SARS-CoV-2, as well as to increase
underst...

## Key facts

- **NIH application ID:** 10166336
- **Project number:** 3UM1AI069412-14S1
- **Recipient organization:** BETH ISRAEL DEACONESS MEDICAL CENTER
- **Principal Investigator:** Raphael Dolin
- **Activity code:** UM1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $900,000
- **Award type:** 3
- **Project period:** 2020-06-15 → 2020-11-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10166336

## Citation

> US National Institutes of Health, RePORTER application 10166336, Harvard/Boston/Providence Clinical Trials Unit (Harvard/B/P CTU) (3UM1AI069412-14S1). Retrieved via AI Analytics 2026-06-01 from https://api.ai-analytics.org/grant/nih/10166336. Licensed CC0.

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