Harlem

Harlem Prevention Center

ICAP’s two research centers in New York, the Bronx Prevention Center and the Harlem Prevention Center, are hubs of research in New York City that have been historically underserved and disproportionately impacted by the HIV epidemic and, more recently, the COVID-19 epidemic. ICAP works with local community-based organizations, religious leaders, and advocates to promote community awareness of, and engagement with the research studies.

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The Community Advisory Board (CAB) for the ICAP Clinical Trials Unit (CTU) provides guidance and feedback on proposed studies, outreach strategies, feedback on study materials, and information regarding community perceptions of the potential or current research studies.

Current studies include investigations of antibody-mediated prevention using broadly neutralizing antibodies (bnAbs) to prevent HIV or COVID-19, an injectable long-acting pre-exposure prophylaxis (PrEP) option, mobile technologies to improve PrEP adherence, integrated care for people who inject opiates, HIV vaccine studies, and studies of COVID-19 immunity, vaccine efficacy, and treatment among others.

Projects

ACTG 5418 STOMP Study

current

A randomized, placebo-controlled, double-blinded trial of the safety and efficacy of tecovirimat for the treatment of human monkeypox virus disease. https://actgnetwork.org/studies/a5418-study-of-tecovirimat-for-human-monkeypox-virus-stomp/; https://www.stomptpoxx.org/main ...

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DMID 19-0004 (The MAGI Study)

current

A Phase II randomized, observer-blind, placebo-controlled study to assess the efficacy of meningococcal Group B vaccine rMenB+OMV NZ (Bexsero) in preventing gonococcal infection Link(s): https://clinicaltrials.gov/ct2/show/NCT04350138 ...

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HPTN 091: I AM Study

current

HPTN 091 is a study assessing the feasibility, acceptability, preliminary impact of a multi-component strategy that provides HIV prevention services, gender-affirming hormone therapy, and Peer Health Navigation to improve pre-exposure prophylaxis (PrEP) uptake and adherence. Web Links: https://www.hptn.org/research/studies/hptn091 ...

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HTPN 083: Give PrEP a Shot

current

HPTN 083 recruited HIV-uninfected men who have sex with men and transgender women at risk for acquiring HIV infection to evaluate the efficacy of the long-acting injectable agent, cabotegravir (CAB LA), for PrEP and demonstrated the superiority of cabotegravir for HIV prevention in these populations.Closed to enrollment, in active study follow-up Web Links: https://clinicaltrials.gov/ct2/show/NCT02720094 https://www.hptn.org/research/studies/hptn083 ...

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SMARTest COVID-19 Study

current

A randomized control field trial of an app-based intervention to improve the perception of, and willingness to self-test with rapid COVID-19 antigen tests in an urban environment. ...

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ICAP in Harlem

Program Start

2004

Key Technical Areas

Clinical Research and Trials
COVID-19 Research
PreP Research
Surveys

Current Funders

National Institute of Health
National Institute of Allergy and Infectious Diseases (NIH/NIAID)
Department of Health and Human Services (DHHS)
Family Health International (FHI)
Fred Hutchinson Cancer Research Center
Janssen

Site Leader

Sharon Mannheimer, MD

Dr. Sharon Mannheimer has been the Site Leader of the Columbia University Mailman School of Public Health ICAP Harlem Prevention Center CRS since its inception over a decade ago. She is a practicing board certified Infectious Disease physician with over twenty years of experience and expertise in HIV/AIDS treatment and prevention. Most of her career has been in Harlem where she provides clinical care and conducts clinical research, including HIV prevention studies of oral pre-exposure prophylaxis (PrEP), long-acting injectable PrEP, broadly neutralizing monoclonal antibodies, and an HIV vaccine. In HPTN, in addition to Site Leader, she has served as a protocol team member and currently serves as protocol co-chair of HVTN 130/HPTN 089, a combination monoclonal antibody trial for HIV prevention. Recently her research has shifted to also include COVID, overseeing the implementation of vaccine and monoclonal antibody trials for COVID prevention at the CRS.