ICAP

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 

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 ...

PURPOSE 3/HPTN 102

  • current
A Phase 2, open-label, multicenter, randomized study to evaluate the pharmacokinetics, safety, and acceptability of twice-yearly long-acting subcutaneous lenacapavir for pre-exposure prophylaxis in cisgender women in the United States. ...

PURPOSE 4/HPTN 103

  • current
A Phase 2, Open-Label, Multicenter, Randomized Study to Evaluate the Pharmacokinetics and Safety of Twice Yearly Long-Acting Subcutaneous lenacapavir for Pre-Exposure Prophylaxis in People Who Inject Drugs. ...

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 ...

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 ...

PURPOSE 3/HPTN 102

  • current
A Phase 2, open-label, multicenter, randomized study to evaluate the pharmacokinetics, safety, and acceptability of twice-yearly long-acting subcutaneous lenacapavir for pre-exposure prophylaxis in cisgender women in the United States ...

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 ...

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 ...

HPTN 084 Open Access

  • current
The purpose of this study is to evaluate eligible participants who have completed DAIDS-sponsored pre-exposure prophylaxis (PrEP) studies HPTN 083 and HPTN 084 and associated sub-studies. Participants will continue receiving CAB LA and be followed for new HIV diagnoses, SAEs, Grade 3 and Grade 4 ISRs, and AEs leading to withdrawal. ...

HPTN 104

  • current
A multisite, open-label, randomized crossover study comparing adherence to a single daily dual prevention pill (DPP) versus FTC/TDF and Combined Oral Contraception separate pill dosing (2PR), given for pre-exposure prophylaxis and pregnancy prevention in people of childbearing potential. The purpose of the study is to evaluate adherence to a single, dual prevention pill (DPP; co-formulated ...

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 ...