ICAP CTU
ICAP at Columbia University Clinical Trials UnitICAP 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
Current Studies
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PHIA
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MTCT-Plus
MCAP
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TRACE
COVID
CTU
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Tajikistan
Brazil
Guatemala
Georgia
Haiti
China
Kazakhstan
Kyrgyzstan
Namibia
Nigeria
Rwanda
Central Asia
Burundi
Liberia
Philippines
Senegal
Panama
Honduras
El Salvador
Harlem
Bronx
Colombia & Peru
Tanzania
Angola
Cameroon
Côte d’Ivoire
Democratic Republic of the Congo
Lesotho
Kenya
Ethiopia
Malawi
Sierra Leone
Zimbabwe
Mozambique
Eswatini
South Sudan
Mali
South Africa
Uganda
Zambia
United States
Ukraine
Myanmar
february
Project Details
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
Project Details
Web link: https://www.coronaviruspreventionnetwork.org/ubuntu-vaccine-research-study
Soon to Launch
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Global TA
PHIA
QICIP
CQUIN
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OPTIMIZE
HPTN
MTCT-Plus
MCAP
UTAP
TRACE
COVID
CTU
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All
Tajikistan
Brazil
Guatemala
Georgia
Haiti
China
Kazakhstan
Kyrgyzstan
Namibia
Nigeria
Rwanda
Central Asia
Burundi
Liberia
Philippines
Senegal
Panama
Honduras
El Salvador
Harlem
Bronx
Colombia & Peru
Tanzania
Angola
Cameroon
Côte d’Ivoire
Democratic Republic of the Congo
Lesotho
Kenya
Ethiopia
Malawi
Sierra Leone
Zimbabwe
Mozambique
Eswatini
South Sudan
Mali
South Africa
Uganda
Zambia
United States
Ukraine
Myanmar
A Randomized Non-Inferiority Study
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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
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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. https://icap.columbia.edu/where-we-work/icap-ctu/
Project Details
https://icap.columbia.edu/where-we-work/icap-ctu/
Columbia Univesity
Mailman School of Public Health
Current Studies
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PHIA
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MTCT-Plus
MCAP
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TRACE
COVID
CTU
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Tajikistan
Brazil
Guatemala
Georgia
Haiti
China
Kazakhstan
Kyrgyzstan
Namibia
Nigeria
Rwanda
Central Asia
Burundi
Liberia
Philippines
Senegal
Panama
Honduras
El Salvador
Harlem
Bronx
Colombia & Peru
Tanzania
Angola
Cameroon
Côte d’Ivoire
Democratic Republic of the Congo
Lesotho
Kenya
Ethiopia
Malawi
Sierra Leone
Zimbabwe
Mozambique
Eswatini
South Sudan
Mali
South Africa
Uganda
Zambia
United States
Ukraine
Myanmar
No Projects
Completed Studies
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Global TA
PHIA
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OPTIMIZE
HPTN
MTCT-Plus
MCAP
UTAP
TRACE
COVID
CTU
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All
Tajikistan
Brazil
Guatemala
Georgia
Haiti
China
Kazakhstan
Kyrgyzstan
Namibia
Nigeria
Rwanda
Central Asia
Burundi
Liberia
Philippines
Senegal
Panama
Honduras
El Salvador
Harlem
Bronx
Colombia & Peru
Tanzania
Angola
Cameroon
Côte d’Ivoire
Democratic Republic of the Congo
Lesotho
Kenya
Ethiopia
Malawi
Sierra Leone
Zimbabwe
Mozambique
Eswatini
South Sudan
Mali
South Africa
Uganda
Zambia
United States
Ukraine
Myanmar
The LEXICON StudyDistricts (or national)New York City
Project Details
The LGBTQ+ Experience in COVID-19 NYC Study To assess the impact of COVID-19 on the lives and well-being of LGBTQ+ persons in NYC, the LEXICON study will conduct a community-based online
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The SILVER StudyDistricts (or national)New York City
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The SARS-CoV-2 Impact on Lives and Views of Elderly Residents Study To better understand the impact of COVID-19 on older adults living at home, the SILVER study conducted a phone survey
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Harlem Prevention Center
Current HPC Studies
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Global TA
PHIA
QICIP
CQUIN
GNCBP
OpCon
OPTIMIZE
HPTN
MTCT-Plus
MCAP
UTAP
TRACE
COVID
CTU
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All
Tajikistan
Brazil
Guatemala
Georgia
Haiti
China
Kazakhstan
Kyrgyzstan
Namibia
Nigeria
Rwanda
Central Asia
Burundi
Liberia
Philippines
Senegal
Panama
Honduras
El Salvador
Harlem
Bronx
Colombia & Peru
Tanzania
Angola
Cameroon
Côte d’Ivoire
Democratic Republic of the Congo
Lesotho
Kenya
Ethiopia
Malawi
Sierra Leone
Zimbabwe
Mozambique
Eswatini
South Sudan
Mali
South Africa
Uganda
Zambia
United States
Ukraine
Myanmar
CoVPN 3003 -The ENSEMBLE StudyDistricts (or national)Harlem
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Closed to enrollment and study follow-up Study to Assess the Efficacy and Safety of Ad26.COV2.S (the Johnson & Johnson COVID vaccine) for the Prevention of SARS-COV-2 mediated COVID-19 in Adults Aged
Project Details
Study to Assess the Efficacy and Safety of Ad26.COV2.S (the Johnson & Johnson COVID vaccine) for the Prevention of SARS-COV-2 mediated COVID-19 in Adults Aged 18 Years and Older
Web Links:
https://clinicaltrials.gov/ct2/show/NCT04505722
https://clinicalresearch.itmat.upenn.edu/clinicaltrial/6568/covid19-covid-vaccine-covpn-3003-janssen/
CoVPN 3006Districts (or national)Harlem
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A Study of SARS CoV-2 Infection and Potential Transmission in Individuals Immunized With Moderna COVID-19 Vaccine Study to assess SARS CoV-2 infection, viral shedding, and subsequent potential transmission in university students
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Study to assess SARS CoV-2 infection, viral shedding, and subsequent potential transmission in university students immunized with Moderna COVID-19 Vaccine
Web Links:
https://clinicaltrials.gov/ct2/show/NCT04811664
https://www.coronaviruspreventionnetwork.org/moderna-vaccine-university-study/
HPTN 091: I AM StudyDistricts (or national)Harlem
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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
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Web Links:
https://www.hptn.org/research/studies/hptn091
HTPN 083: Give PrEP a ShotDistricts (or national)Harlem
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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
Project Details
Closed to enrollment, in active study follow-up
Web Links:
https://clinicaltrials.gov/ct2/show/NCT02720094
https://www.hptn.org/research/studies/hptn083
https://giveprepashot.org/
HVTN 706 - The MOSAICO StudyDistricts (or national)Harlem
Project Details
HIV Vaccine Trials Network Open to enrollment Study of Heterologous Vaccine Regimen to prevent HIV-1 Infection among Cis-gender Men and Transgender Individuals who have Sex with Cis-gender Men and/or Transgender Individuals Web Links:
Project Details
Web Links:
https://clinicaltrials.gov/ct2/show/NCT03964415
https://www.hvtn.org/en/community/community-compass/vol19-issue2/mosaico.html
https://www.avac.org/trial/hpx-3002-hvtn-706-mosaico
Soon to Launch
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Global TA
PHIA
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OpCon
OPTIMIZE
HPTN
MTCT-Plus
MCAP
UTAP
TRACE
COVID
CTU
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All
Tajikistan
Brazil
Guatemala
Georgia
Haiti
China
Kazakhstan
Kyrgyzstan
Namibia
Nigeria
Rwanda
Central Asia
Burundi
Liberia
Philippines
Senegal
Panama
Honduras
El Salvador
Harlem
Bronx
Colombia & Peru
Tanzania
Angola
Cameroon
Côte d’Ivoire
Democratic Republic of the Congo
Lesotho
Kenya
Ethiopia
Malawi
Sierra Leone
Zimbabwe
Mozambique
Eswatini
South Sudan
Mali
South Africa
Uganda
Zambia
United States
Ukraine
Myanmar
Evergreen StudyDistricts (or national)Harlem
Project Details
A randomized, double-blind, placebo-controlled Phase 3 efficacy study of an Ad26.RSV.preF-based vaccine in the prevention of lower respiratory tract disease caused by RSV in adults aged 60 years and older.
Project Details
Completed HPC Studies
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Current
Soon to Launch
Program Affiliation
All
Global TA
PHIA
QICIP
CQUIN
GNCBP
OpCon
OPTIMIZE
HPTN
MTCT-Plus
MCAP
UTAP
TRACE
COVID
CTU
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All
Tajikistan
Brazil
Guatemala
Georgia
Haiti
China
Kazakhstan
Kyrgyzstan
Namibia
Nigeria
Rwanda
Central Asia
Burundi
Liberia
Philippines
Senegal
Panama
Honduras
El Salvador
Harlem
Bronx
Colombia & Peru
Tanzania
Angola
Cameroon
Côte d’Ivoire
Democratic Republic of the Congo
Lesotho
Kenya
Ethiopia
Malawi
Sierra Leone
Zimbabwe
Mozambique
Eswatini
South Sudan
Mali
South Africa
Uganda
Zambia
United States
Ukraine
Myanmar
CoVPN 3502 The HEROIC StudyDistricts (or national)Harlem
Project Details
Closed to enrollment and study follow-up 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 More information:
Project Details
CoVPN 5002: The COMPASS StudyDistricts (or national)Harlem
Project Details
SARS- COV-2 Prevalence Study – to assess the prevalence of active and recovered COVID infections in the Harlem community Open to enrollment Web Links: https://clinicaltrials.gov/ct2/show/NCT04658121 https://www.compassstudy.org/
Project Details
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The ADAPT Study recruited men who have sex with men (MSM) and transgender women and was designed to identify oral pre-exposure prophylaxis (PrEP) pill-taking schedules that participants are more likely
Project Details
HVTN 704/HPTN 085: Antibody Mediated Prevention (Amp Study)Districts (or national)Harlem
Project Details
HVTN 704/HPTN 085, or the AMP (Antibody Mediated Prevention) Study, is a five-year study that tested the safety, tolerability, and prevention benefit of an experimental manufactured antibody (VRC01) against HIV..
Project Details
HVTN130/HPTN089Districts (or national)Harlem
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Closed to enrollment and study follow-up A Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of combinations of monoclonal antibodies administered via intravenous infusion in healthy,
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HVTN405/HPTN1901: HIV Vaccine Trials NetworkDistricts (or national)Harlem
Project Details
Open to enrollment Characterizing SARS-CoV-2-specific immunity in convalescent individuals Report Links: https://clinicaltrials.gov/ct2/show/NCT04403880 https://www.hvtn.org/content/dam/hvtn/MEDIAROOM/study-fact-sheet_HVTN405-HPTN1901_v2.pdf
Project Details
PrEPared & Strong - Clinic-based PrEP for Black MSMDistricts (or national)Harlem
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This five-year, multi-method implementation study tested an enhanced PrEP adherence package against a standard package in a randomized clinical trial located in a community setting. The study compared the effectiveness
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The STAR Study is a five-year study that tested the effectiveness of respondent-driven sampling to seek and recruit substance-using Black men who have sex with men (MSM) at high risk
Project Details
Bronx Prevention Center
Current BPC Studies
Date
Title
Status
All
Completed
Current
Soon to Launch
Program Affiliation
All
Global TA
PHIA
QICIP
CQUIN
GNCBP
OpCon
OPTIMIZE
HPTN
MTCT-Plus
MCAP
UTAP
TRACE
COVID
CTU
Project Location
All
Tajikistan
Brazil
Guatemala
Georgia
Haiti
China
Kazakhstan
Kyrgyzstan
Namibia
Nigeria
Rwanda
Central Asia
Burundi
Liberia
Philippines
Senegal
Panama
Honduras
El Salvador
Harlem
Bronx
Colombia & Peru
Tanzania
Angola
Cameroon
Côte d’Ivoire
Democratic Republic of the Congo
Lesotho
Kenya
Ethiopia
Malawi
Sierra Leone
Zimbabwe
Mozambique
Eswatini
South Sudan
Mali
South Africa
Uganda
Zambia
United States
Ukraine
Myanmar
ACTIV-2/A5401: The ACTIV StudyDistricts (or national)Bronx
Project Details
Adaptive Platform Treatment Trial for Outpatients with COVID-19 (Adapt Out COVID). This multicenter study aims to rapidly identify safe and effective treatments for COVID-19. Ambulatory adults who have recently been
Project Details
Soon to begin enrollment
Web Links:
https://clinicaltrials.gov/ct2/show/NCT04885530
CoVPN 3002: The AstraZeneca StudyDistricts (or national)Bronx
Project Details
This randomized, double-blind, placebo-controlled multicenter s investigates the AstraZeneca (AZD1222) vaccine to prevent COVID-19 Closed to enrollment, follow up ongoing Web Links: https://clinicaltrials.gov/ct2/show/NCT04516746
Project Details
Closed to enrollment, follow up ongoing
Web Links:
https://clinicaltrials.gov/ct2/show/NCT04516746
HPTN 094: The INTEGRA StudyDistricts (or national)Bronx
Project Details
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
Project Details
Soon to begin enrollment
Web Links:
https://clinicaltrials.gov/ct2/show/NCT04804072 https://www.hptn.org/research/studies/190
HTPN 083: Give PrEP a ShotDistricts (or national)Bronx
Project Details
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
Project Details
Closed to enrollment, in active study follow-up
Web Links:
https://clinicaltrials.gov/ct2/show/NCT02720094 https://www.hptn.org/research/studies/hptn083 https://giveprepashot.org/
IMPOWER-022: The Merck Study (on hold)Districts (or national)Bronx
Project Details
A randomized, active-controlled, double-blind clinical study to investigate the safety and efficacy of oral Islatravir, a once-monthly pill as preexposure prophylaxis (PrEP) in cisgender women at high risk for HIV-1
Project Details
Making PrEP SmartDistricts (or national)Bronx
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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
Project Details
Soon to Launch
Date
Title
Status
All
Completed
Current
Soon to Launch
Program Affiliation
All
Global TA
PHIA
QICIP
CQUIN
GNCBP
OpCon
OPTIMIZE
HPTN
MTCT-Plus
MCAP
UTAP
TRACE
COVID
CTU
Project Location
All
Tajikistan
Brazil
Guatemala
Georgia
Haiti
China
Kazakhstan
Kyrgyzstan
Namibia
Nigeria
Rwanda
Central Asia
Burundi
Liberia
Philippines
Senegal
Panama
Honduras
El Salvador
Harlem
Bronx
Colombia & Peru
Tanzania
Angola
Cameroon
Côte d’Ivoire
Democratic Republic of the Congo
Lesotho
Kenya
Ethiopia
Malawi
Sierra Leone
Zimbabwe
Mozambique
Eswatini
South Sudan
Mali
South Africa
Uganda
Zambia
United States
Ukraine
Myanmar
No Projects
Completed BPC Studies
Date
Title
Status
All
Completed
Current
Soon to Launch
Program Affiliation
All
Global TA
PHIA
QICIP
CQUIN
GNCBP
OpCon
OPTIMIZE
HPTN
MTCT-Plus
MCAP
UTAP
TRACE
COVID
CTU
Project Location
All
Tajikistan
Brazil
Guatemala
Georgia
Haiti
China
Kazakhstan
Kyrgyzstan
Namibia
Nigeria
Rwanda
Central Asia
Burundi
Liberia
Philippines
Senegal
Panama
Honduras
El Salvador
Harlem
Bronx
Colombia & Peru
Tanzania
Angola
Cameroon
Côte d’Ivoire
Democratic Republic of the Congo
Lesotho
Kenya
Ethiopia
Malawi
Sierra Leone
Zimbabwe
Mozambique
Eswatini
South Sudan
Mali
South Africa
Uganda
Zambia
United States
Ukraine
Myanmar
CoVPN 5002: The COMPASS StudyDistricts (or national)Bronx
Project Details
The SARS-COV-2 prevalence study is to assess the prevalence of active and recovered COVID infections in the Bronx community Open to enrollment Web Links: https://clinicaltrials.gov/ct2/show/NCT04658121 https://www.compassstudy.org/
Project Details
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HPTN 076 was a two-year study that recruited sexually active women age 18 to 45 and evaluated the safety and acceptability of a new injectable HIV prevention medication, Rilpivirine, for
Project Details
HVTN 704/HPTN 085: Antibody Mediated Prevention (Amp Study)Districts (or national)Bronx
Project Details
HVTN 704/HPTN 085, or the AMP (Antibody Mediated Prevention) Study, is a five-year study testing the safety, tolerability, and prevention benefit of an experimental manufactured antibody (VRC01) against HIV. The
Project Details
Project Details
This study investigated the experimental microbicide gel tenofovir to protect women against HIV. The study provided information on how much vaginal tenofovir gel, when used in combination with common vaginal
Project Details
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This study examined the drug levels of the antiretroviral agent tenofovir in rectal tissue after it has been used as a gel in the vagina and vice versa. (funded by
Project Details