ICAP

Clinical Trials

Our Expertise Clinical Trials

ICAP at Columbia University Clinical Trials Unit (ICAP CTU)

An innovative and comprehensive approach to HIV prevention and therapeutic research.

Led by Wafaa El-Sadr, MD, MPH, MPA and Jessica Justman, MD, ICAP CTU aims to support the design and implementation of research to address gaps in the global HIV response, including through clinical research sites in the Harlem, Bronx, and Eswatini.

The Bronx and Harlem Prevention Centers

ICAP’s two research centers in New York City, the Bronx Prevention Center, and the Harlem Prevention Center, are hubs of research 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 research studies.

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

Eswatini

In Eswatini, ICAP, in collaboration with the Eswatini Ministry of Health and Family Life Association of Eswatini, established the Eswatini Prevention Center Clinical Research Site (Eswatini CRS). This pioneer CRS has the capacity to conduct clinical trials with investigational drugs and registered products. The clinical research is implemented in close collaboration with local stakeholders to strengthen clinical research systems and conduct studies that impact local and global public health programs. Over 2,400 participants from diverse populations have been enrolled in CRS studies and participated in studies relating to HIV prevention with oral and injectable pre-exposure prophylaxis (PrEP), COVID-19 vaccination, and HPV vaccination.

Bronx
Harlem
Eswatini

Bronx 

HPTN 094: The INTEGRA Study

  • current
A vanguard study of health service delivery in a mobile health delivery unit to link persons who inject opiates to integrated care and prevention for addiction, HIV, hepatitis, STIs and primary care Web Links: https://clinicaltrials.gov/ct2/show/NCT04804072 https://www.hptn.org/research/studies/190 ...
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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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Making PrEP Smart

  • current
The purpose of this study is to understand if a smartphone app, SmartPrEP, will help promote HIV self testing and PrEP adherence among cisgender and transgender women over a twelve-month period. We will help you to download the app on your phone and provide you with HIV self-test kits and PrEP (if not already taking ...
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Harlem 

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

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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Eswatini

CoVPN 3008: UBUNTU Study

  • current
The UBUNTU study is a research study evaluating the Moderna COVID-19 mRNA vaccine. We already know that this vaccine prevents COVID-19 disease, including severe COVID-19. The United States and many other countries use the Moderna vaccine. We want to know how many doses of vaccine are needed for protection against COVID-19 for adults living with ...
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HPTN 084 OLE Study

  • current
A Phase 3 Double-Blind Safety and Efficacy Study of Long-Acting Injectable Cabotegravir Compared to Daily Oral TDF/FTC for Pre-Exposure Prophylaxis in HIV-Uninfected Women Link: https://www.hptn.org/research/studies/hptn084 ...
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HPV Vaccine Study

  • current
A Randomized Non-Inferiority Study to Assess Immunogenicity, Safety, and Acceptability of Two vs. Three Doses of the Nonavalent Human Papillomavirus (HPV) Vaccine Among Children, Adolescents and Young Adults Living with HIV in Eswatini ...
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