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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.

Harlem Prevention Center

Active studies:

  • HPTN 091: Integrating HIV Prevention, Gender-Affirmative Medical Care, and Peer Health Navigation for Transgender Women in the Americas: A Vanguard Study
  • HVTN 706/ HPX3002 MOSAICO: A Phase 3 Study of Heterologous Vaccine Regimen to Prevent HIV-1 Infection Among Cisgender Men and Transgender Individuals Who Have Sex with Cisgender Men and/or Transgender Individuals.
  • CoVPN 5002 COMPASS: Community Prevalence of SARS-COV-2 Study
  • HPTN 083: A Phase 2b/3 Study of Injectable Cabotegravir Compared to Daily Oral Tenofovir Disoproxil Fumarate/Emtricitabine (Truvada) for Pre-Exposure Prophylaxis in HIV-Uninfected Cisgender Men and Transgender Women Who Have Sex with Men
  • HVTN 405/HPTN 1901: Characterizing SARS-CoV-2-Specific Immunity in Convalescent Individuals
  • CoVPN 3502/REGN 2069: Study Assessing the Efficacy and Safety of Anti-Spike SARS-CoV-2 Monoclonal Antibodies in Preventing SARS-CoV-2 Infection in Household Contacts of Individuals Infected with SARS-CoV-2
  • CoVPN 3003 Janssen ENSEMBLE: Study to Assess the Efficacy and Safety of Ad26.COV2.S for the Prevention of SARS-COV-2 Mediated COVID-19 in Adults Aged 18 Years and Older

Studies soon-to-launch:

  • CoVPN 3006: A Randomized Controlled Study to Assess SARS CoV-2 Infection, Viral Shedding, and Subsequent Potential Transmission in University Students Immunized with Moderna COVID-19 Vaccine

Studies that have completed follow up:

  • HVTN 704/HPTN 085: A Phase 2b Study to Evaluate the Safety and Efficacy of VRC01 Broadly Neutralizing Monoclonal Antibody in Reducing Acquisition of HIV-1 Infection Among Men and Transgender Persons Who Have Sex with Men
  • HVTN 130/HPTN 089: A Phase 1 Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of Combinations of Monoclonal Antibodies Administered Via Intravenous Infusion in Healthy, HIV-Uninfected Adults
  • PrEPared & Strong: PrEP for Black MSM: Community-Based Ethnography and Clinic-Based Treatment
  • Seek, Test, and Retain (STAR Study): Seek, Test, and Retain. Linkages for Black HIV+, Substance-Using Men Who Have Sex with Men
  • HPTN 067 ADAPT: A Phase 2 Randomized, Open-Label, Pharmacokinetic, and Behavioral Study of the Use of Intermittent Oral Emtricitabine/Tenofovir Disoproxil Fumarate Pre-Exposure Prophylaxis (PrEP) for Men Who Have Sex with Men (MSM) and Transgender Women
  • HPTN 061 BROTHERS: Feasibility Study of a Community-Level, Multi-Component Intervention for Black Men Who Have Sex with Men
  • HPTN 064: The Women’s HIV Seroincidence Study

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

Bronx Prevention Center

Active studies:

  • CoVPN 5002 COMPASS: Community Prevalence of SARS-COV-2 Study
  • HPTN 083: A Phase 2b/3 Study of Injectable Cabotegravir Compared to Daily Oral Tenofovir Disoproxil Fumarate/Emtricitabine (Truvada), for Pre-Exposure Prophylaxis in HIV- Uninfected Cisgender Men and Transgender Women Who Have Sex with Men
  • HVTN 405/HPTN 1901: Characterizing SARS-CoV-2-Specific Immunity in Convalescent Individuals
  • CoVPN 3002: A Randomized, Double-Blind, Placebo-Controlled Multicenter Study in Adults to Determine the Safety, Efficacy, and Immunogenicity of AZD1222, a Non-Replicating ChAdOx1 Vector Vaccine, for the Prevention of COVID-19

Studies soon-to-launch:

  • HPTN 094: A Vanguard Study of Health Service Delivery in the Mobile Health Delivery Unit to Link Persons Who Inject Drugs to Integrated Care and Prevention for Addiction, HIV, HCV, and Primary Care
  • 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 3006: A Randomized Controlled Study to Assess SARS CoV-2 Infection, Viral Shedding, and Subsequent Potential Transmission in University Students Immunized with Moderna COVID-19 Vaccine
  • Making PrEP Smart: An HIV Testing and PrEP Electronic Support tool (“SmartPrEP” app) for Women on PrEP
  • ACTIV-2/A5401: Adaptive Platform Treatment Trial for Outpatients with COVID-19 (Adapt Out COVID)

Studies that have completed follow up:

  • HVTN 704/HPTN 085: A Phase 2b Study to Evaluate the Safety and Efficacy of VRC01 Broadly Neutralizing Monoclonal Antibody in Reducing Acquisition of HIV-1 Infection Among Men and Transgender Persons Who Have Sex with Men
  • CONRAD A11-118: In Vivo Drug Interaction Pharmacokinetic Study of Tenofovir 1% Gel and Three Commonly Used Vaginal Products
  • MTN-014: A Phase 1 Crossover Trial Evaluating the Pharmacokinetics of Tenofovir Reduced-Glycerin 1% Gel in the Rectal and Vaginal Compartments in Women
  • HPTN 076: Phase II Safety and Acceptability of an Investigational Injectable Product, TMC278 LA, for Pre-Exposure Prophylaxis (PrEP)
  • HPTN 064: The Women’s HIV Seroincidence Study