The HIV Forum works in close collaboration with stakeholders, led by a Steering Committee and managed by Forum staff. In-person meetings are convened as-needed, with topic-specific working group conference calls and email/web-based communication in the intervening time. Agendas are determined by the Steering Committee and designed to focus on accelerating drug development by identifying gaps in research and synergizing ongoing work in HIV across various groups of experts. The HIV Forum brings together experts in virology and immunology from academia, regulatory agencies, industry, patient community, and professional societies.
HIV prevention is advancing, building on treatment success as prevention and once-daily oral pre-exposure prophylaxis (PrEP). However, additional prevention interventions are needed to meet the needs of individuals from diverse populations. Currently, the HIV Forum convenes a Pre-Exposure Prophylaxis Project, the PrEPProject, designed to review, discuss, and recommend strategies that would allow for less resource-intensive (cost and time) clinical trial options to approve new PrEP interventions while maintaining regulatory and scientific rigor.
Read more about The Forum for Collaborative Research's history, achievements, operating procedures and working process.
Current Projects
Pre-Exposure Prophylaxis Project, (PrEP Project)
The Forum’s contributions to the regulatory aspects of PrEP research began in 2008 through collaboration with the clinical trialists studying tenofovir and emtricitabine for HIV prevention. The traditional regulatory path of two large randomized controlled trials demonstrating efficacy and safety is not feasible in many circumstances, given the already available interventions' success. Specific challenges in design and analysis include the difficulty of demonstrating statistical superiority or non-inferiority due to the low number of events and identifying appropriate control populations against which to measure efficacy.The PrEP Project has established several working groups, each tasked to address specific issues related to HIV prevention and advancing PrEP development. These working groups are:
HIV Treatment Project
There is a gap in knowledge about the real-world feasibility and success of long-acting injectables (or other drug delivery modalities) in populations with adherence challenges, generally excluded from clinical research evaluating new treatments. The Forum for Collaborative Research aims to host a one-day roundtable-style workshop focused on how to study and evaluate long-acting ART to overcome adherence barriers among these communities in the United States. We will discuss key questions such as how to broaden inclusion criteria to make space for underrepresented populations in treatment trials or what regimens work best paired with adherence strategies. As we make strides in ending the HIV epidemic in the United States, the Forum emphasizes that this is only possible if we develop strategies to successfully achieve viral suppression among those who are unable to adhere to daily pill taking. The workshop will include representatives from all stakeholder groups, including the patient community, the ACTG, the NIH (OAR, NIAID/DAIDS, NIMH, NIDA), HRSA, VA, FDA, clinical researchers, and industry sponsors. Read more here.
External Events
The Global HIV Vaccine Enterprise, in partnership with the HIV Vaccine Trials Network, the HIV Prevention Trials Network, and the Forum for Collaborative Research, is hosting a series of online panel discussions on Design Approaches for Current and Future HIV Prevention Efficacy Trials. The Executive Director of the Forum for Collaborative Research, Dr. Veronica Miller, moderated session 2-panel discussion. This session can be viewed here.
