Community Participation (CAB)

Initially, INSIGHT (International Network for Strategic Initiatives in Global HIV Trials) was funded to complete two large multisite clinical trials already in process: IL-2 and SMART; these studies have been completed. Since 2006, INSIGHT's scope has continued to broaden. INSIGHT'S mission is to define optimal strategies for the management of HIV and other infectious diseases through its global clinical research network. Structurally, INSIGHT runs four International Coordinating Centers (ICCs) that are responsible for the coordination of research in over 200 sites at over 35 countries across the globe. The ICCs are located in London, Copenhagen, Sydney and Washington, D.C.

INSIGHT is currently conducting the START (Strategic Timing of AntiRetroviral Treatment) trial. With 4600 participants, START is an international trial with the goal of definitively answering "when is the optimal time for HIV-positive individuals to begin antiretroviral treatment?" START is currently collecting follow-up data on study participants and is expected to be unblinded in 2022.

Initially responding to the H1N1 influenza outbreak, INSIGHT now conducts four international influenza trials. Each of these trials helps to track and type influenza, in real time, around the world. All influenza studies collect swabbed samples that are analyzed in real time, which helps track influenza strains. Two of these trials are observational and two are treatment trials for hospitalized participants.

In response to the COVID-19 pandemic, INSIGHT has been asked to design and run several clinical trials, one observational and two with interventions.

International Observational Study of Outpatients with COVID-19. This is an international, observational cohort study of adults with SARS-CoV-2 infection/COVID-19 who have been assessed as not requiring hospitalization. Adults who seek testing for SARS-CoV-2 will be screened following consent. Those with confirmed SARS-CoV-2 infection will form an observational cohort study and be followed for 28 days. Procedures and data collection have been streamlined to facilitate the enrollment of a large number of adults at INSIGHT sites around the world. The general aim of this study is to estimate the rate of disease progression for adults who seek testing and test positive for SARS-CoV-2. Enrollment opened August, 2020. Sample size = 10,000.

Inpatient Treatment with Anti-Coronavirus Immunoglobulin (ITAC). This protocol serves as a platform for assessing treatment for adult patients hospitalized for medical management of COVID-19 without related serious end-organ failure. ITAC compares hyperimmune intravenous immunoglobulin (hIVIG) with matched placebo, when added to standard of care (SOC), for preventing further disease progression and mortality related to COVID-19. SOC includes remdesivir unless it is contraindicated for an individual participant. Enrollment opened in October 2020. Sample size = 500. (An additional trial assessing treatment with hIVIG in outpatients is planned.)

Therapeutics for Inpatients with COVID-19 also known as TICO and ACTIV-3 (part of the Warp Speed program at NIH). This master protocol evaluates the safety and efficacy of multiple investigational agents aimed at modifying the host immune response to SARS-CoV-2 infection or directly enhancing viral control in order to limit disease progression. This protocol is adaptive, randomized, and placebo controlled. New investigational agents will be added as they become available. All participants receive standard of care (SOC) treatment, including remdesivir. If an investigational agent shows superiority over placebo + SOC as initially defined, SOC for future investigational treatment evaluations will be modified accordingly. 2020 Enrollment opened in August. Sample size = 300 in Stage 1 and 1,000 in Stage 2 (includes Stage 1).

The vast majority of INSIGHT research is funded by the U.S. government through grants from various institutes of the National Institutes of Health (NIH). The ICCs are funded through separate NIH grants as well as support from their host country federal research programs.

The four main ICCs, located in Copenhagen, London, Sydney, and Washington DC, provide essential regional coordination for the network, the national Site Coordinating Centers (SCCs), and the clinical sites. Three of the four (Copenhagen, London, and Sydney) also provide statistical support for the network.

INSIGHT has a network-level Community Advisory Board (CAB) made up of three community members from each of the four ICCs who represent the diverse sites and communities participating in HIV/AIDS clinical trials within the ICC. Additionally, each ICC maintains its own regional CAB from which the three representatives are drawn. The network-level CAB currently meets in person at least once a year, when possible, conducts quarterly conference calls, and has active email communication. This communication provides information flow and discussion and allows for and encourages community participation throughout the INSIGHT network. As the Community Liaison, I provide administrative support and coordination for the network-level CAB.

I am happy to discuss any concerns or questions you may have. Please feel free to contact me (insightclairer@gmail.com).

Thank you for your interest in the INSIGHT research network.

Sincerely,
Claire Rappoport
INSIGHT Community Liaison