SDMC: HIV Prevention Trials Network

PROJECT SUMMARY/ABSTRACT
This application to RFA-AI-19-002 is to continue as the statistical and data management center (SDMC) for the
HIV Prevention Trials Network (HPTN). The overarching goal of the HPTN is to identify acceptable, feasible,
safe, effective, and scalable interventions for HIV prevention that address the needs of populations at risk in the
US and around the world. The HPTN will address this goal through identifying: 1) new biomedical products and
tools for HIV prevention that have unique characteristics, such as longer duration of action, new targets of HIV
inhibition or as multi-purpose technologies; 2) integrated strategies that optimize use of proven efficacious
prevention interventions tailored to specific populations at risk to achieve maximal public health impact.
The HPTN SDMC is housed at the Fred Hutchinson Cancer Research Center in Seattle and takes advantage of
the particular strengths of the institution, which also includes the HVTN SDMC, and data and coordinating centers
for several other research networks. The HPTN SDMC has faculty biostatisticians experienced in the design,
conduct and analysis of global HIV prevention studies, who support the goals of HPTN research through
leadership in statistical design, trial conduct and analysis, and development and implementation of innovative
statistical methods as needed and motivated by HPTN scientific goals. The SDMC provides regulatory compliant
data management functions for all HPTN trials, including electronic data capture directly from research sites,
integration of laboratory specimens and assay results, and electronic participant reported outcomes.
During the grant period, the SDMC will design and analyze Phase 1-3 trials of both antiretroviral and broadly
neutralizing monoclonal antibody (bNAb) products, including completion of two Phase 3 active-controlled
randomized clinical trials (RCTs) of long-acting cabotegravir (CAB LA) and two Phase 3 placebo-controlled RCTs
of the bNAb VRC-01. The SDMC will fully support the development pathway for multi-purpose technologies,
encompassing both acceptability and user-based design. If CAB LA proves efficacious, it will be incorporated
into integrated strategy trials for populations at risk. Trial designs for integrated strategies will range from
individual-randomized, to cluster-randomized (either parallel or step-wedge), to non-randomized trials,
depending on the context and population. Mathematical modeling will estimate the population impact and cost-
effectiveness of successful HPTN interventions in specific populations at risk.
The SDMC will continue to deliver high-quality, timely, cost-efficient, and secure data management and safety
monitoring functions for HPTN trials. State-of-the-art systems for data acquisition, storage, quality control,
curation, and annotation, will be compliant with Clinical Data Interchange Standards Consortium (CDISC) and
maintained using a continuous quality improvement strategy. HPTN socio-behavioral research is supported
through flexible data interface processes with external data sources including mobile apps, SMS, tablets, and
electronic Patient Reported Outcomes.

Grant Number: 5UM1AI068617-21
NIH Institute/Center: NIH
Principal Investigator: Elizabeth Brown