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

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 ...

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 ...

INSIGHT Cohort

  • current
A prospective, observational, open-label cohort study to evaluate daily oral PrEP uptake, adherence, persistence and preferences for attributes of PrEP among young women (18-30 y) ...

Population-based HIV Impact Assessment (PHIA)

  • Multi-Country,
  • current
PHIA is a multi-country initiative led by ICAP, the U.S. Centers for Disease Control and Prevention (CDC), and ministries of health in PEPFAR-supported countries. Each survey offers household-based HIV counseling and testing conducted by trained survey staff, with return of results. The surveys also ask questions about access to preventive care and treatment services for adults and children. The results measure national and regional progress toward UNAIDS’ 90-90-90 goals and guide policy ...

Resolve to Save Lives

  • Multi-Country,
  • current
ICAP has launched a multi-country emergency response training initiative to prepare health care workers on the front lines of the COVID-19 response, The trainings will build the competence and confidence of frontline health care workers to safely identify, report and support people with COVID-19, implement effective infection prevention and control (IPC) activities, and serve as ...

The CQUIN Project for Differentiated Service Delivery

  • Multi-Country,
  • current
CQUIN is a multi-country learning network dedicated to improving differentiated service delivery (DSD) for people living with HIV. Launched in 2017 with support from the Bill & Melinda Gates Foundation, the network convenes health system leaders from countries in sub-Saharan Africa to participate in joint learning and information exchange, with the goal of fostering scale-up ...

The Fleming Fund (Improving laboratory capacity for diagnosis and surveillance of antimicrobial resistance – AMR – in low-income countries)

  • current
The Fleming Fund represents the UK Government’s investment into improving laboratory capacity for diagnosis and surveillance of antimicrobial resistance (AMR) in low-income countries where AMR has a disproportionate impact. The Fleming Fund will do this through support to implementation of AMR National Action Plans by making investments in: building laboratory capacity; collecting drug resistance data; ...

Tracking with Recency Assays to Control the Epidemic (TRACE)

  • Multi-Country,
  • current
Disease surveillance to stop HIV transmission in its tracks. Remarkable progress has been made toward HIV epidemic control in some high-burden countries, but many gaps remain. Identifying people with undiagnosed HIV infection, especially those who have been recently infected, is essential to realize the individual benefit of rapid treatment initiation and to prevent HIV transmission to others. ...

Columbia Univesity
Mailman School of Public Health

The LEXICON Study 2.0

  • current
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 2.0 will conduct a community-based online survey on the burden of COVID-19 disease, current use of COVID-19 preventative behaviors, COVID-19 vaccine willingness, access, and update among LGBTQ+ persons in ...

Harlem Prevention Center

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 ...

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 ...

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  ...

SMARTest COVID-19 Study

  • current
A randomized control field trial of an app-based intervention to improve the perception of, and willingness to self-test with rapid COVID-19 antigen tests in an urban environment. ...

Bronx Prevention Center

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 ...

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  ...

IMPOWER-022: The Merck Study

  • current
A randomized, active-controlled, double-blind clinical study to investigate the safety and efficacy of oral Islatravir, a once-monthly pill as pre-exposure prophylaxis (PrEP) in cisgender women at high risk for HIV-1 infection. Closed to enrollment. In active study follow-up. Web Links: https://clinicaltrials.gov/ct2/show/NCT04644029 ...

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 ...