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ICAP

ICAP CTU

ICAP at Columbia University Clinical Trials Unit

ICAP at Columbia University Clinical Trials Unit (ICAP CTU)

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

While much has been achieved in the global response to the HIV epidemic, enormous challenges remain. Only 60% of people living with HIV have access to treatment, and 1.7 million new HIV infections were reported in 2019. In sub-Saharan Africa, elimination of mother-to-child transmission has stalled, men and youth lag in knowledge of HIV status, and four of five new infections among adolescents occur among girls and young women. In addition, Black and Latino men who have sex with men (MSM) and women of color are disproportionately at risk for HIV infection.

Led by Wafaa El-Sadr, MD, MPH, MPA and Jessica Justman, MD, the ICAP at Columbia University Clinical Trials Unit (ICAP CTU) aims to support the design and implementation of research to address these gaps in the global HIV response. The ICAP CTU is one of the clinical trial units funded by the US National Institutes of Health, and it includes three clinical research sites (CRS): two in New York City, situated in Harlem and Bronx, and one in Eswatini. The Harlem and Bronx Prevention Centers serve priority populations of great relevance to the current HIV epidemic in the US, including Black and Latino MSM, women of color, young people, and people who inject drugs. The Eswatini Prevention Center, situated in the country with the highest HIV prevalence in the world, engages adolescents, women, men, and key populations in clinical trials.

 

With its highly experienced and skilled staff, the ICAP CTU pursues an innovative and comprehensive approach to HIV prevention and therapeutic research that tailors tools and strategies to the demographic characteristics, behavioral risks, co-morbidities, and life circumstances of persons living with or at risk of acquiring HIV. Research at the ICAP CTU-supported CRS focuses on interventions that will reduce HIV infections across populations and improve the quality of life for people living with HIV. Central to the ICAP CTU’s mission is full engagement of the communities where the research sites are situated to ensure full input from community organizations and members.

Most recently, in the context of the COVID-19 pandemic, the ICAP CTU has pivoted to add research for prevention and treatment of COVID-19 at all three research sites.
 

Eswatini Prevention Center

Active studies:

  • HPTN 084: 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

Studies soon-to-launch:

  • 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
  • IMPOWER 22: A Randomized, Active-Controlled, Double-Blind Clinical Study to Evaluate the Efficacy and Safety of Oral Islatravir Once-Monthly as Pre-Exposure Prophylaxis in Cisgender Women at High Risk for HIV-1 Infection
  • CoVPN 3008: Multi-Center, Randomized, Efficacy Study of COVID-19 mRNA Vaccine in Regions with SARS-CoV-2 Variants of Concern

Columbia Univesity
Mailman School of Public Health

Current Studies

The LEXICON StudyDistricts (or national):New York City

Completed Studies

The SILVER StudyDistricts (or national):New York City

Harlem Prevention Center

Current HPC Studies

CoVPN 3003 -The ENSEMBLE StudyDistricts (or national):Harlem

CoVPN 3006Districts (or national):Harlem

CoVPN 3502 The HEROIC StudyDistricts (or national):Harlem

CoVPN 5002: The COMPASS StudyDistricts (or national):Harlem

HPTN 091: I AM StudyDistricts (or national):Harlem

HTPN 083: Give PrEP a ShotDistricts (or national):Harlem

HVTN 704/HPTN 085: Antibody Mediated Prevention (Amp Study)Districts (or national):Harlem

HVTN 706 - The MOSAICO StudyDistricts (or national):Harlem

HVTN130/HPTN089Districts (or national):Harlem

HVTN405/HPTN1901: HIV Vaccine Trials NetworkDistricts (or national):Harlem

Completed HPC Studies

HPTN 067: Alternative Dosing to Augment Pre-Exposure Prophylaxis Pill Taking (The ADAPT Study)Districts (or national):Harlem

PrEPared & Strong - Clinic-based PrEP for Black MSMDistricts (or national):Harlem

The STAR Study-Seek, Test, and Retain: Linkages for Black HIV+, Substance-Using MSMDistricts (or national):Harlem

Bronx Prevention Center

Current BPC Studies

ACTIV-2/A5401: The ACTIV StudyDistricts (or national):Bronx

CoVPN 3002: The AstraZeneca StudyDistricts (or national):Bronx

CoVPN 5002: The COMPASS StudyDistricts (or national):Bronx

EVOGUARD/EVO100-311: The ICON StudyDistricts (or national):Bronx

HPTN 094: The INTEGRA StudyDistricts (or national):Bronx

HTPN 083: Give PrEP a ShotDistricts (or national):Bronx

HVTN 704/HPTN 085: Antibody Mediated Prevention (Amp Study)Districts (or national):Bronx

IMPOWER-022: The Merck StudyDistricts (or national):Bronx

Completed BPC Studies

HPTN 076: Phase II Safety and Acceptability of Injectible Rilpivirine for PrEPDistricts (or national):Bronx

In Vivo Drug Interaction Pharmacokinetic Study of Tenofovir 1% Gel and Three Commonly Used Vaginal ProductsDistricts (or national):Bronx

MTN-014: Tenofovir Levels Following Local Application of Tenofovir Reduced-Glycerin 1% GelDistricts (or national):Bronx